title: A Multicentre, Randomized, Double-blind, Placebo-controlled, Parallel-group Study Of Oral Cp-690,550 As An Induction Therapy In Subjects With Moderate To Severe Ulcerative Colitis.

acronym: OCTAVE

summary: This study is designed to evaluate the efficacy and safety of tofacitinib (CP-690,550) in patients with moderate to severe ulcerative colitis who have failed or be intolerant to one of following treatments for ulcerative colitis: oral steroids, azathiopurine/6-mercaptopurine, or anti-TNF-alpha therapy.

ReferenceCitation: Lichtenstein GR, Bressler B, Francisconi C, Vermeire S, Lawendy N, Salese L, Sawyerr G, Shi H, Su C, Judd DT, Jones T, Loftus EV. Assessment of Safety and Efficacy of Tofacitinib, Stratified by Age, in Patients from the Ulcerative Colitis Clinical Program. Inflamm Bowel Dis. 2023 Jan 5;29(1):27-41. doi: 10.1093/ibd/izac084.

repositories:
LIRIAS (KU Leuven)
PubMed Central

repositories_concat: LIRIAS (KU Leuven);PubMed Central

ReferenceCitation: Hudesman DP, Torres J, Salese L, Woolcott JC, Mundayat R, Su C, Mosli MH, Allegretti JR. Long-Term Improvement in the Patient-Reported Outcomes of Rectal Bleeding, Stool Frequency, and Health-Related Quality of Life with Tofacitinib in the Ulcerative Colitis OCTAVE Clinical Program. Patient. 2023 Mar;16(2):95-103. doi: 10.1007/s40271-022-00603-w. Epub 2022 Nov 7.

ReferenceCitation: Winthrop KL, Vermeire S, Long MD, Panes J, Ng SC, Kulisek N, Mundayat R, Lawendy N, Vranic I, Modesto I, Su C, Melmed GY. Long-term Risk of Herpes Zoster Infection in Patients With Ulcerative Colitis Receiving Tofacitinib. Inflamm Bowel Dis. 2023 Jan 5;29(1):85-96. doi: 10.1093/ibd/izac063.

ReferenceCitation: Mukherjee A, Tsuchiwata S, Nicholas T, Cook JA, Modesto I, Su C, D'Haens GR, Sandborn WJ. Exposure-Response Characterization of Tofacitinib Efficacy in Moderate to Severe Ulcerative Colitis: Results From Phase II and Phase III Induction and Maintenance Studies. Clin Pharmacol Ther. 2022 Jul;112(1):90-100. doi: 10.1002/cpt.2601. Epub 2022 Apr 27.

ReferenceCitation: Dubinsky MC, Magro F, Steinwurz F, Hudesman DP, Kinnucan JA, Ungaro RC, Neurath MF, Kulisek N, Paulissen J, Su C, Ponce de Leon D, Regueiro M. Association of C-reactive Protein and Partial Mayo Score With Response to Tofacitinib Induction Therapy: Results From the Ulcerative Colitis Clinical Program. Inflamm Bowel Dis. 2023 Jan 5;29(1):51-61. doi: 10.1093/ibd/izac061.

ReferenceCitation: Feagan BG, Khanna R, Sandborn WJ, Vermeire S, Reinisch W, Su C, Salese L, Fan H, Paulissen J, Woodworth DA, Niezychowski W, Sands BE. Agreement between local and central reading of endoscopic disease activity in ulcerative colitis: results from the tofacitinib OCTAVE trials. Aliment Pharmacol Ther. 2021 Dec;54(11-12):1442-1453. doi: 10.1111/apt.16626. Epub 2021 Oct 6.

ReferenceCitation: Farraye FA, Qazi T, Kotze PG, Moore GT, Mundayat R, Lawendy N, Sharma PP, Judd DT. The impact of body mass index on efficacy and safety in the tofacitinib OCTAVE ulcerative colitis clinical programme. Aliment Pharmacol Ther. 2021 Aug;54(4):429-440. doi: 10.1111/apt.16439. Epub 2021 Jun 24.

ReferenceCitation: Rubin DT, Reinisch W, Greuter T, Kotze PG, Pinheiro M, Mundayat R, Maller E, Fellmann M, Lawendy N, Modesto I, Vavricka SR, Lichtenstein GR. Extraintestinal manifestations at baseline, and the effect of tofacitinib, in patients with moderate to severe ulcerative colitis. Therap Adv Gastroenterol. 2021 May 16;14:17562848211005708. doi: 10.1177/17562848211005708. eCollection 2021.

ReferenceCitation: Sandborn WJ, Peyrin-Biroulet L, Sharara AI, Su C, Modesto I, Mundayat R, Gunay LM, Salese L, Sands BE. Efficacy and Safety of Tofacitinib in Ulcerative Colitis Based on Prior Tumor Necrosis Factor Inhibitor Failure Status. Clin Gastroenterol Hepatol. 2022 Mar;20(3):591-601.e8. doi: 10.1016/j.cgh.2021.02.043. Epub 2021 Mar 6.

ReferenceCitation: Vong C, Martin SW, Deng C, Xie R, Ito K, Su C, Sandborn WJ, Mukherjee A. Population Pharmacokinetics of Tofacitinib in Patients With Moderate to Severe Ulcerative Colitis. Clin Pharmacol Drug Dev. 2021 Mar;10(3):229-240. doi: 10.1002/cpdd.899. Epub 2021 Jan 29.

ReferenceCitation: Curtis JR, Regueiro M, Yun H, Su C, DiBonaventura M, Lawendy N, Nduaka CI, Koram N, Cappelleri JC, Chan G, Modesto I, Lichtenstein GR. Tofacitinib Treatment Safety in Moderate to Severe Ulcerative Colitis: Comparison of Observational Population Cohort Data From the IBM MarketScan(R) Administrative Claims Database With Tofacitinib Trial Data. Inflamm Bowel Dis. 2021 Aug 19;27(9):1394-1408. doi: 10.1093/ibd/izaa289.

ReferenceCitation: Sandborn WJ, Peyrin-Biroulet L, Quirk D, Wang W, Nduaka CI, Mukherjee A, Su C, Sands BE. Efficacy and Safety of Extended Induction With Tofacitinib for the Treatment of Ulcerative Colitis. Clin Gastroenterol Hepatol. 2022 Aug;20(8):1821-1830.e3. doi: 10.1016/j.cgh.2020.10.038. Epub 2020 Oct 27.

ReferenceCitation: Sands BE, Colombel JF, Ha C, Farnier M, Armuzzi A, Quirk D, Friedman GS, Kwok K, Salese L, Su C, Taub PR. Lipid Profiles in Patients With Ulcerative Colitis Receiving Tofacitinib-Implications for Cardiovascular Risk and Patient Management. Inflamm Bowel Dis. 2021 May 17;27(6):797-808. doi: 10.1093/ibd/izaa227.

repositories_institution: California Digital Library - eScholarship

ReferenceCitation: Panaccione R, Isaacs JD, Chen LA, Wang W, Marren A, Kwok K, Wang L, Chan G, Su C. Characterization of Creatine Kinase Levels in Tofacitinib-Treated Patients with Ulcerative Colitis: Results from Clinical Trials. Dig Dis Sci. 2021 Aug;66(8):2732-2743. doi: 10.1007/s10620-020-06560-4. Epub 2020 Aug 20. Erratum In: Dig Dis Sci. 2020 Oct 10;:

repository_institution: Newcastle Univesity - Newcastle University ePrints

repositories_institution: Newcastle Univesity - Newcastle University ePrints

ReferenceCitation: Dubinsky MC, DiBonaventura M, Fan H, Bushmakin AG, Cappelleri JC, Maller E, Thorpe AJ, Salese L, Panes J. Tofacitinib in Patients with Ulcerative Colitis: Inflammatory Bowel Disease Questionnaire Items in Phase 3 Randomized Controlled Induction Studies. Inflamm Bowel Dis. 2021 Jun 15;27(7):983-993. doi: 10.1093/ibd/izaa193.

ReferenceCitation: Lichtenstein GR, Rogler G, Ciorba MA, Su C, Chan G, Pedersen RD, Lawendy N, Quirk D, Nduaka CI, Thorpe AJ, Panes J. Tofacitinib, an Oral Janus Kinase Inhibitor: Analysis of Malignancy (Excluding Nonmelanoma Skin Cancer) Events Across the Ulcerative Colitis Clinical Program. Inflamm Bowel Dis. 2021 May 17;27(6):816-825. doi: 10.1093/ibd/izaa199.

repository_institution: Washington University School of Medicine - Digital Commons@Becker

ReferenceCitation: Sandborn WJ, Panes J, Sands BE, Reinisch W, Su C, Lawendy N, Koram N, Fan H, Jones TV, Modesto I, Quirk D, Danese S. Venous thromboembolic events in the tofacitinib ulcerative colitis clinical development programme. Aliment Pharmacol Ther. 2019 Nov;50(10):1068-1076. doi: 10.1111/apt.15514. Epub 2019 Oct 9.

ReferenceCitation: Sands BE, Taub PR, Armuzzi A, Friedman GS, Moscariello M, Lawendy N, Pedersen RD, Chan G, Nduaka CI, Quirk D, Salese L, Su C, Feagan BG. Tofacitinib Treatment Is Associated With Modest and Reversible Increases in Serum Lipids in Patients With Ulcerative Colitis. Clin Gastroenterol Hepatol. 2020 Jan;18(1):123-132.e3. doi: 10.1016/j.cgh.2019.04.059. Epub 2019 May 8.

ReferenceCitation: Sandborn WJ, Panes J, D'Haens GR, Sands BE, Su C, Moscariello M, Jones T, Pedersen R, Friedman GS, Lawendy N, Chan G. Safety of Tofacitinib for Treatment of Ulcerative Colitis, Based on 4.4 Years of Data From Global Clinical Trials. Clin Gastroenterol Hepatol. 2019 Jul;17(8):1541-1550. doi: 10.1016/j.cgh.2018.11.035. Epub 2018 Nov 23.

ReferenceCitation: Hanauer S, Panaccione R, Danese S, Cheifetz A, Reinisch W, Higgins PDR, Woodworth DA, Zhang H, Friedman GS, Lawendy N, Quirk D, Nduaka CI, Su C. Tofacitinib Induction Therapy Reduces Symptoms Within 3 Days for Patients With Ulcerative Colitis. Clin Gastroenterol Hepatol. 2019 Jan;17(1):139-147. doi: 10.1016/j.cgh.2018.07.009. Epub 2018 Sep 10.

ReferenceCitation: Winthrop KL, Melmed GY, Vermeire S, Long MD, Chan G, Pedersen RD, Lawendy N, Thorpe AJ, Nduaka CI, Su C. Herpes Zoster Infection in Patients With Ulcerative Colitis Receiving Tofacitinib. Inflamm Bowel Dis. 2018 Sep 15;24(10):2258-2265. doi: 10.1093/ibd/izy131.

repositories:
LIRIAS (KU Leuven)
PubMed Central
pdfs.semanticscholar.org

repositories_concat: LIRIAS (KU Leuven);PubMed Central;pdfs.semanticscholar.org

repositories_institution:
KU Leuven - Lirias
PubMed Central - Europe PMC

ReferenceCitation: Motoya S, Watanabe M, Kim HJ, Kim YH, Han DS, Yuasa H, Tabira J, Isogawa N, Arai S, Kawaguchi I, Hibi T. Tofacitinib induction and maintenance therapy in East Asian patients with active ulcerative colitis: subgroup analyses from three phase 3 multinational studies. Intest Res. 2018 Apr;16(2):233-245. doi: 10.5217/ir.2018.16.2.233. Epub 2018 Apr 30. Erratum In: Intest Res. 2018 Jul;16(3):499-501.

publisher_dissemination: Korean Association for the Study of Intestinal Diseases

ReferenceCitation: Panes J, Vermeire S, Lindsay JO, Sands BE, Su C, Friedman G, Zhang H, Yarlas A, Bayliss M, Maher S, Cappelleri JC, Bushmakin AG, Rubin DT. Tofacitinib in Patients with Ulcerative Colitis: Health-Related Quality of Life in Phase 3 Randomised Controlled Induction and Maintenance Studies. J Crohns Colitis. 2018 Jan 24;12(2):145-156. doi: 10.1093/ecco-jcc/jjx133. Erratum In: J Crohns Colitis. 2019 Jan 1;13(1):139-140.

ReferenceCitation: Sandborn WJ, Su C, Sands BE, D'Haens GR, Vermeire S, Schreiber S, Danese S, Feagan BG, Reinisch W, Niezychowski W, Friedman G, Lawendy N, Yu D, Woodworth D, Mukherjee A, Zhang H, Healey P, Panes J; OCTAVE Induction 1, OCTAVE Induction 2, and OCTAVE Sustain Investigators. Tofacitinib as Induction and Maintenance Therapy for Ulcerative Colitis. N Engl J Med. 2017 May 4;376(18):1723-1736. doi: 10.1056/NEJMoa1606910.

repository_institution: Universitat de Barcelona - Dipòsit Digital de la Universitat de Barcelona

location_country:
Germany
Poland
New Zealand
Australia
Brazil
Croatia
Canada
Serbia
France
Czech Republic
Colombia
Slovakia
Hungary
Denmark
United States
Latvia
Ukraine
Romania
Belgium
Estonia
United Kingdom
Netherlands
Austria
Korea, Republic of
Spain
South Africa
Taiwan
Russian Federation
Israel

location_facility: Severance Hospital, Yonsei University Health System

location_facility: State budget institution of healthcare "City Clinical Hospital # 51 healthcare department of Moscow"

location_facility: Lama Medical Care s.r.o., Gastroenterologicko-Hepatologicke centrum Thalion

location_facility: Municipal Healthcare Institution Kharkiv City Clinical Hospital #2, Proctology Department

location_facility: The Gastroenterology Group of South Jersey

location_facility: University Hospital Center Zagreb,Department of Gastroenterology

location_facility: University of Alberta - Zeidler Ledcor Centre

location_facility: Regional Gastroenterology Associates of Lancaster, Ltd.

location_facility: Regional Municipal Institution Chernivtsi Regional Clinical Hospital

location_facility: Borsod-Abauj-Zemplen Megyei Korhaz es Egyetemi Oktato Korhaz

location_facility: Vanderbilt University Medical Center - GI Research Office

location_facility: Medical Clinical Research Center "Health Clinic" on the base of

location_facility: Szent Janos Korhaz és Eszak-budai Egyesített Korhazak I Belgyogyaszat-Gasztroenterologiai Osztaly

location_facility: Clinical Centre of Serbia, Clinic for Gastroenterology and Hepatology

location_facility: Minicipal Institution "City Hospital #7" Therapeutic Department,

location_facility: H-T Centrum Medyczne sp. z o.o. sp. komandytowa

location_facility: Clinical Research Institute of Michigan, LLC

location_facility: Krankenhaus Barmherzige Brueder St. Veit/Glan

location_facility: Universitäetsklinik Schleswig-Holstein, Campus Kiel

location_facility: Vanderbilt University Medical Center - GCRC

location_facility: Clinical Centre of Vojvodina, Clinic for Gastroenterology and Hepatology

location_facility: East Tallinn Central Hospital Internal Medicine Clinic

location_facility: The Edith Wolfson Medical Center/Gastroenterology Institute

location_facility: Krajska Zdravotni a.s., Masarykova nemocnice Usti nad Labem, o.z.

location_facility: X-Ray Unit, East Tallinn Central Hospital

location_facility: OOO Medical Center of Diagnostics and Prophylaxis "Sodruzhestvo"

location_facility: Carolina Research - Carolina Digestive Diseases

location_facility: Center for Digestive & Liver Disease, Inc.

location_facility: ECG Unit, Innomedica OU and Qualitas AS (ECG Only)

location_facility: Hospital de Clinicas de Porto Alegre - HCPA

location_facility: VCU Health System Digestive Health Center

location_facility: Regional Municipal Institution "Chernivtsi Regional Clinical Hospital"

location_facility: Connecticut Clinical Research Foundation

location_facility: Vanderbilt University Medical Center - Drug Shipment

location_facility: Virginia Commonwealth University, Clinical Research Services (CRSU)

location_facility: Atlanta Center for Gastroenterology, P.C.

location_facility: The University of Texas Health Science Center at Houston

location_facility: University of Alberta Hospital - Walter C. Mackenzie Health Sciences Centre

location_facility: Nemocnice Strakonice, a.s., Interni oddeleni

location_facility: MGG Group Co., Inc., Chevy Chase Clinical Research

location_facility: University Hospital Center Osijek, Clinic of Internal Medicine,

location_facility: Centrum Medyczne Szpital Sw. Rodziny Sp. z o. o.

location_facility: Chevy Chase Endoscopy Center (Endoscopies Only)

location_facility: Peterfy Sandor utcai Korhaz- Rendelointezet es Baleseti Kozpontl. Belgyogyaszat

location_facility: Debreceni Egyetem Klinikai Központ Belgyógyászati Intézet, Gasztroenterológiai Tanszék

location_facility: Vanderbilt University Medical Center - IBD Clinic

location_facility: Federal state budget institution "State scientific centre of coloproctology"

location_facility: Citrus Surgery & Endoscopy Center (Colonoscopy)

location_facility: Montreal General Hospital - McGill University Health Centre

location_facility: Dr. Rethy Pal Korhaz-Rendelointezet- III. Belgyogyaszat

location_facility: Municipal Institution "Odesa Regional Clinical Hospital"

location_facility: Municipal institution of healthcare "Clinical Hospital # 2"

location_facility: Austin Gastroenterology PA/Professional Quality Research, Inc.

location_facility: Department of Gastroenterology, Old Building

location_facility: Municipal institution of healthcare "City clinical hospital 12"

location_facility: State budget Healthcare Institution Moscow regional scientific research clinical institute

location_facility: Hanyang University Guri Hospital, Clinical Laboratory

location_facility: Federal State Budgetary Institution "Scientific Research Institute of Physiology and

location_facility: Concord Hospital -Concord Repatriation Hospital

location_facility: VCU Medical Center Investigational Drug Service (IDS)

location_facility: Klinikum der Johann Wolfgang Goethe-Universitaet

location_facility: Spitalul Universitar de Urgenta Bucuresti, Sectia de Medicina Interna 2 si Gastroenterologie

location_facility: University Medical Center Groningen (UMCG)

location_facility: Centrum Endoskopii Zabiegowej, Poradnia Chorob Jelitowych,

location_facility: Vanderbilt University Medical Center - Radiology

location_facility: Spitalul Clinic Judetean Mures, Sectia Clinica de Gastroenterologie

location_facility: Vanderbilt University Medical Center - Heart Station

location_facility: Clinical Centre of Vojvodina, Emergency Internal Medicine Division

location_facility: CHA Bundang Medical Center, CHA University

location_facility: State Institution Institute of Gastroenterology of the National Academy of Medical Sciences

location_facility: Los Angeles Biomedical Research Institute at Harbor-UCLA Medical Center

location_facility: Cotton-O'Neil Clinical Research Center, Digestive Health

location_facility: Oddzial Chorob Wewnetrznych i Gastroenterologii,

location_facility: State budget institution of healthcare of Yaroslavl region Regional clinical hospital


type: EudraCT Number

type: Registry Identifier

title: A Phase-3 Randomized, Double-Blind, Efficacy and Safety Study Evaluating the Fixed Dose Combinations of TAK-491 Plus Chlorthalidone (40/12.5 mg and 40/25 mg) in Subjects With Grades 2 or 3 Essential Hypertension, Who Do Not Achieve Target Blood Pressure Following Treatment With TAK-491 40 mg Monotherapy

summary: The purpose of this study is to evaluate the efficacy and safety of the fixed dose combinations of azilsartan medoxomil plus chlorthalidone (40/12.5 and 40/25 mg), once daily, in participants with grades 2 or 3 essential hypertension who do not reach target blood pressure following treatment with 40 mg azilsartan medoxomil monotherapy after 4 weeks.

status: Completed

study_completion_date_type: Actual

study_type: Interventional

design_allocation: Randomized

primary_purpose: Treatment

enrollment_type: Actual

lead_sponsor: Takeda

location_country:
Germany
Italy
Lithuania
Poland
Slovakia
Hungary
United Kingdom
Sweden
Netherlands
Spain
Bulgaria
Estonia
Serbia
France

intervention_type: Drug

lead_sponsor_type: industriel

status_simplified: Completed


title: A Randomised, Double-blind, Multi-centre Study to Evaluate the Efficacy and Safety of Inhaled Fluticasone Furoate in the Treatment of Persistent Asthma in Adults and Adolescents Currently Receiving Mid to High Strength Inhaled Corticosteroids.

summary: A randomised, double-blind, multi-centre study to evaluate the efficacy and safety of two doses of inhaled fluticasone furoate in the treatment of persistent asthma in adults and adolescents currently receiving mid to high strength inhaled corticosteroids.

ReferenceType: derived

ReferenceCitation: O'Byrne PM, Jacques L, Goldfrad C, Kwon N, Perrio M, Yates LJ, Busse WW. Integrated safety and efficacy analysis of once-daily fluticasone furoate for the treatment of asthma. Respir Res. 2016 Nov 24;17(1):157. doi: 10.1186/s12931-016-0473-x.

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license: cc-by

license_normalized: cc-by

version: publishedVersion

evidence: oa repository (via OAI-PMH doi match)

host_type: repository

repository_institution: PubMed Central - Europe PMC

repository_normalized: PubMed Central

evidence: oa repository (via pmcid lookup)

license_normalized: no license

repositories_concat: PubMed Central

unpaywall_oa_status: gold

publisher_dissemination: Springer-Nature

ReferenceCitation: Woodcock A, Lotvall J, Busse WW, Bateman ED, Stone S, Ellsworth A, Jacques L. Efficacy and safety of fluticasone furoate 100 mug and 200 mug once daily in the treatment of moderate-severe asthma in adults and adolescents: a 24-week randomised study. BMC Pulm Med. 2014 Jul 9;14:113. doi: 10.1186/1471-2466-14-113.

repository_institution: University of Cape Town - Open University of Cape Town

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repositories:
PubMed Central
localhost

repositories_concat: PubMed Central;localhost

publisher_dissemination: Springer

ReferenceCitation: Svedsater H, Jacques L, Goldfrad C, Bleecker ER. Ease of use of the ELLIPTA dry powder inhaler: data from three randomised controlled trials in patients with asthma. NPJ Prim Care Respir Med. 2014 Jun 26;24:14019. doi: 10.1038/npjpcrm.2014.19. No abstract available.

ReferenceCitation: Svedsater H, Dale P, Garrill K, Walker R, Woepse MW. Qualitative assessment of attributes and ease of use of the ELLIPTA dry powder inhaler for delivery of maintenance therapy for asthma and COPD. BMC Pulm Med. 2013 Dec 7;13:72. doi: 10.1186/1471-2466-13-72.

ipd_sharing_description: Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.

location_country:
Argentina
Mexico
United States
Chile
Russian Federation
France


study_start_date_type: Actual

acronym: OPERA II

lead_sponsor: Hoffmann-La Roche

summary: This randomized, double-blind, double-dummy, parallel-group study will evaluate the efficacy and safety of ocrelizumab in comparison with interferon beta-1a (Rebif) in participants with relapsing multiple sclerosis. Participants will be randomized to receive either ocrelizumab 600 mg or matching placebo intravenous (IV) as 300 mg infusions on Days 1 and 15 for the first dose and as a single infusion of 600 mg for all subsequent infusions every 24 weeks, with placebo injections matching interferon beta-1a SC three times per week; or interferon beta-1a 44 mcg SC injections three times per week (with placebo infusions matching ocrelizumab infusions every 24 weeks).

ReferenceCitation: Arnold DL, Sprenger T, Bar-Or A, Wolinsky JS, Kappos L, Kolind S, Bonati U, Magon S, van Beek J, Koendgen H, Bortolami O, Bernasconi C, Gaetano L, Traboulsee A. Ocrelizumab reduces thalamic volume loss in patients with RMS and PPMS. Mult Scler. 2022 Oct;28(12):1927-1936. doi: 10.1177/13524585221097561. Epub 2022 Jun 7.

oa_colors: green hybrid

evidence: open (via page says license)

unpaywall_oa_status: hybrid

publisher_dissemination: SAGE Publications

ReferenceCitation: Krishnan AP, Song Z, Clayton D, Gaetano L, Jia X, de Crespigny A, Bengtsson T, Carano RAD. Joint MRI T1 Unenhancing and Contrast-enhancing Multiple Sclerosis Lesion Segmentation with Deep Learning in OPERA Trials. Radiology. 2022 Mar;302(3):662-673. doi: 10.1148/radiol.211528. Epub 2021 Dec 14.

oa_host_type: closed

repositories_concat: closed

publisher_dissemination: Radiological Society of North America (RSNA)

ReferenceCitation: Giovannoni G, Kappos L, de Seze J, Hauser SL, Overell J, Koendgen H, Manfrini M, Wang Q, Wolinsky JS. Risk of requiring a walking aid after 6.5 years of ocrelizumab treatment in patients with relapsing multiple sclerosis: Data from the OPERA I and OPERA II trials. Eur J Neurol. 2022 Apr;29(4):1238-1242. doi: 10.1111/ene.14823. Epub 2021 May 5.

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evidence: oa repository (via OAI-PMH title and first author match)

repository_institution: University of California - eScholarship University of California

repositories_concat: PubMed Central;escholarship.org

publisher_dissemination: Wiley

ReferenceCitation: Hauser SL, Kappos L, Arnold DL, Bar-Or A, Brochet B, Naismith RT, Traboulsee A, Wolinsky JS, Belachew S, Koendgen H, Levesque V, Manfrini M, Model F, Hubeaux S, Mehta L, Montalban X. Five years of ocrelizumab in relapsing multiple sclerosis: OPERA studies open-label extension. Neurology. 2020 Sep 29;95(13):e1854-e1867. doi: 10.1212/WNL.0000000000010376. Epub 2020 Jul 20.

license: cc-by-nc-nd

license_normalized: cc-by-nc-nd

repository_institution: Universitat Autònoma de Barcelona - Dipòsit Digital de Documents de la UAB

repositories_concat: PubMed Central;ddd.uab.cat

publisher_dissemination: Wolters Kluwer Health

ReferenceCitation: Kappos L, Wolinsky JS, Giovannoni G, Arnold DL, Wang Q, Bernasconi C, Model F, Koendgen H, Manfrini M, Belachew S, Hauser SL. Contribution of Relapse-Independent Progression vs Relapse-Associated Worsening to Overall Confirmed Disability Accumulation in Typical Relapsing Multiple Sclerosis in a Pooled Analysis of 2 Randomized Clinical Trials. JAMA Neurol. 2020 Sep 1;77(9):1132-1140. doi: 10.1001/jamaneurol.2020.1568.

evidence: open (via free pdf)

publisher_dissemination: American Medical Association

ReferenceCitation: Hauser SL, Bar-Or A, Comi G, Giovannoni G, Hartung HP, Hemmer B, Lublin F, Montalban X, Rammohan KW, Selmaj K, Traboulsee A, Wolinsky JS, Arnold DL, Klingelschmitt G, Masterman D, Fontoura P, Belachew S, Chin P, Mairon N, Garren H, Kappos L; OPERA I and OPERA II Clinical Investigators. Ocrelizumab versus Interferon Beta-1a in Relapsing Multiple Sclerosis. N Engl J Med. 2017 Jan 19;376(3):221-234. doi: 10.1056/NEJMoa1601277. Epub 2016 Dec 21.

oa_colors: green other

evidence: open (via free article)

license: public-domain

license_normalized: public-domain

repository_institution: Queen Mary University of London - Queen Mary Research Online

repository_institution: Tampere University - Tampere University Institutional Repository

repositories_institution: Universitat de Barcelona - Dipòsit Digital de la Universitat de Barcelona

location_facility: Samodz.Publi.Szpital Kliniczny; nr 4 w Lublinie

location_facility: Associated Neurologists of Southern CT PC

location_facility: Wojewodzki Specjalistyczny Szpital w Olsztynie; Oddzial Neurologiczny z Pododdzialem Udarowym

location_facility: University of Miami; Dept. of Neurology MS Center

location_facility: State autonomous institution of healthcare Inter-regional clinical and diagnostic center

location_facility: Josephson Wallack Munshower Neurology PC

location_facility: Hospital Mexico Americano SC; Departamento de Electroencefalografía

location_facility: Wayne State University; Department of Neurology

location_facility: Saratov State Medical University of RosZdrav; Neurology

location_facility: Vseobecna nemocnica s poliklinikou Levoca a.s.

location_facility: Hospital Universitari de Girona Dr Josep Trueta

location_facility: Sankt Gertrauden Krankenhaus; Neurologisches Facharztzentrum

location_facility: Hospital Clinico Universitario de Valencia; Servicio de Neurologia

location_facility: MHAT National Cardiology Hospital, EAD; Neurology

location_facility: University of Texas Southwestern Medical Center

location_facility: Azienda Ospedaliera Universitaria Policlinico Tor Vergata

location_facility: SBHI of Nizhny Novgorod region City Clinical Hospital #3; neurology department

location_facility: Karadeniz Tecnical Uni. Med. Fac.; Neurology

location_facility: CHU toulouse - Hôpital Purpan; Departement de Neurologie

location_facility: Hospital Universitario Clinico San Carlos

location_facility: Hôpital Maisonneuve - Rosemont; Recherche Clinique de Neurologie

location_facility: Kings College Hospital; Neurosciences Clinical Trials Office

location_facility: Ospedale Casa Sollievo Della Sofferenza IRCCS

location_facility: Montreal Neurological Institute and Hospital

location_facility: Universitätsklinikum Düsseldorf; Klinik für Neurologie

location_facility: Karolinska Universitetssjukhuset Solna Neurology

location_facility: MHATNP Sv.Naum EAD; Clinic for intensive treatment of neurology diseases

location_facility: Hôpital General - Service de neurologie; Service de neurologie

location_facility: Azienda Ospedaliero Universitaria Ospedali Riuniti Umberto I-G.M. Lancisi-G. Salesi Di Ancona

location_facility: Kirov City Clinical Hospital #1; Neurology Department

location_facility: Hacettepe University Medical Faculty; Neurology

location_facility: University of Alberta; Northern Alberta Trials & Research Centre

location_facility: Ondokuz Mayis Univ. Med. Fac.; Neurology

location_facility: Weill Cornell MC-NY Presbyter; Dept. of Neurology/Neuroscience, Judith Jaffe Multiple Sclerosis Ctr

location_facility: Hospital General Universitario Gregorio Marañon; Servicio de Neurologia

location_facility: Istanbul Universitesi - Cerrahpasa Cerrahpasa Tip Fakultesi; Noroloji Anabilim Dali

location_facility: Hospital Angeles Culiacan; Neurociencias

location_facility: Fifth MHAT-Sofia AD; Neuro Dept with Vascular Unit

location_facility: Krajska zdravotni, a. s. ? Nemocnice Teplice, o. z.; Neurologicke oddeleni

location_facility: Klinikum rechts der Isar der TU Muenchen; Neurologische Klinik und Poliklinik im Neuro-Kopf-Zentrum

location_facility: Hôpital Maison Blanche; Service de Neurologie

location_facility: St. Petersburg State Medical University n.a. I.P. Pavlov; Hematology, transfusiology and transplanta

location_facility: Hospital Regional Universitario de Malaga

location_facility: Regional Clinical Hospital; Neurology Department

location_facility: ALPI-Inst. de Rehabilitacion Marcelo Fitte

location_facility: Royal Devon and Exeter Hospital (Wonford)

location_facility: Policlinico Universitario Agostino Gemelli

location_facility: Mun.Med.Proph.Inst.?Chernihiv Reg.Hosp.?; Neurology Department

location_facility: State institution of health care - Territorial Clinical Hospital

location_facility: Santa Casa de Misericordia; de Belo Horizonte

location_facility: Krakowska Akademia Neurologii Sp z o.o. Centrum Neurologii K

location_facility: University of Massachusetts Memorial Medical Center

location_facility: City General Hospital; Department of Neurology

location_facility: Neurologische Gemeinschaftspraxis Dr. Lang, Prof. Schreiber, Dr. Krauß, Dr. Kornhuber

location_facility: Territory Neurology and Research Institute

location_facility: Pardubicka Krajska Nemocnice; Department of Neurology

location_facility: State Institution V.K. Gusak Institute of Urgent and Recover; Dep of Reconstructive Angioneurology a

location_facility: Fondazione IRCCS Istituto Neurologico Carlo Besta; Farmacia Interna

location_facility: MUDr. Beata Dupejova Neurologicka ambulancia s.r.o

location_facility: Collaborative Neuroscience Research, LLC

location_facility: Institut Catala d?Oncologia Hospital Germans Trias i Pujol

location_facility: SPZOZ Uniwersytecki Szp. Klin. nr1 im.N.Barlickiego UM;Oddzial Kliniczny Neurologii

location_facility: Universitaetsklinikum Frankfurt; Klinik für Neurologie

location_facility: Clinical Hospital Centre Zagreb;Clinic for Neurology

location_facility: Hospital Universitari de Bellvitge; Servicio de Neurologia

location_facility: Road Clinical Hospital of Donetsk Station; Neurology Department

location_facility: Instituto Biomedico De Investigacion A.C.

location_facility: Hospital CIMA Chihuahua; Centro de Investigación Clínicatorre de Consultoriospiso 4

location_facility: Ospedale Civile di Montichiari; Centro Sclerosi Multipla

title: A Randomized, Double-Blind, Double-Dummy, Parallel-Group Study To Evaluate the Efficacy and Safety of Ocrelizumab in Comparison to Interferon Beta-1a (Rebif) in Patients With Relapsing Multiple Sclerosis

location_country:
Germany
Ireland
Poland
Argentina
Brazil
Bosnia and Herzegovina
Turkey
Croatia
Czechia
Canada
France
Belarus
Slovakia
United States
Ukraine
Belgium
Italy
Norway
United Kingdom
Mexico
Spain
Bulgaria
Russian Federation
Sweden


title: A Phase 3, Multicenter, Open-label, Extension Study to Assess the Safety and Tolerability of Epratuzumab Treatment in Systemic Lupus Erythematosus Subjects

summary: The primary objective of the study is assess the safety and tolerability of long-term epratuzumab treatment in subjects with Systemic Lupus Erythematosus (SLE)

lead_sponsor: UCB Pharma

location_country:
Germany
Poland
Australia
Brazil
Czechia
Canada
France
Lithuania
Hungary
Hong Kong
United States
Ukraine
Romania
Belgium
Estonia
Italy
United Kingdom
Mexico
Korea, Republic of
Spain
South Africa
Taiwan
Bulgaria
Russian Federation
Israel


title: Safety and Efficacy of 120mg and 240mg BI 201335 Once Daily in Combination With Pegylated Interferon Alpha and Ribavirin for Treatment of Chronic Hepatitis C (HCV) Genotype 1 Infection in HIV/HCV Co-infected Patients. A Multinational, Randomised, Parallel Group, Open-label Trial.

summary: the aim of this trial is to evaluate the efficacy and the safety of BI 201335 given for 12 or 24 weeks in combination with PegIFN/RBV given for 24-48 weeks, according to re-randomisation of Early Treatment Success (ETS) patients at 24 weeks to stop PegIFN/RBV or continue PegIFN/RBV until week 48. If no ETS, then PegIFN/RB for 48 weeks, in HCV treatment-naive or relapsers patients coinfected with HIV

ReferenceCitation: Dieterich D, Nelson M, Soriano V, Arasteh K, Guardiola JM, Rockstroh JK, Bhagani S, Laguno M, Tural C, Ingiliz P, Jain MK, Stern JO, Manero M, Vinisko R, Kort J; STARTVerso4 study group. Faldaprevir and pegylated interferon alpha-2a/ribavirin in individuals co-infected with hepatitis C virus genotype-1 and HIV. AIDS. 2015 Mar 13;29(5):571-81. doi: 10.1097/QAD.0000000000000579.

lead_sponsor: Boehringer Ingelheim

location_country:
Germany
Italy
United Kingdom
Brazil
Switzerland
United States
Spain
France

location_facility: 1220.19.0021 Boehringer Ingelheim Investigational Site

location_facility: 1220.19.0029 Boehringer Ingelheim Investigational Site

location_facility: 1220.19.3305 Boehringer Ingelheim Investigational Site

location_facility: 1220.19.0027 Boehringer Ingelheim Investigational Site

location_facility: 1220.19.0079 Boehringer Ingelheim Investigational Site

location_facility: 1220.19.3901 Boehringer Ingelheim Investigational Site

location_facility: 1220.19.0026 Boehringer Ingelheim Investigational Site

location_facility: 1220.19.3405 Boehringer Ingelheim Investigational Site

location_facility: 1220.19.4923 Boehringer Ingelheim Investigational Site

location_facility: 1220.19.3906 Boehringer Ingelheim Investigational Site

location_facility: 1220.19.5502 Boehringer Ingelheim Investigational Site

location_facility: 1220.19.3903 Boehringer Ingelheim Investigational Site

location_facility: 1220.19.4921 Boehringer Ingelheim Investigational Site

location_facility: 1220.19.3407 Boehringer Ingelheim Investigational Site

location_facility: 1220.19.3902 Boehringer Ingelheim Investigational Site

location_facility: 1220.19.4402 Boehringer Ingelheim Investigational Site

location_facility: 1220.19.4101 Boehringer Ingelheim Investigational Site

location_facility: 1220.19.0004 Boehringer Ingelheim Investigational Site

location_facility: 1220.19.3406 Boehringer Ingelheim Investigational Site

location_facility: 1220.19.3402 Boehringer Ingelheim Investigational Site

location_facility: 1220.19.4104 Boehringer Ingelheim Investigational Site

location_facility: 1220.19.0005 Boehringer Ingelheim Investigational Site

location_facility: 1220.19.0011 Boehringer Ingelheim Investigational Site

location_facility: 1220.19.5508 Boehringer Ingelheim Investigational Site

location_facility: 1220.19.3301 Boehringer Ingelheim Investigational Site

location_facility: 1220.19.0031 Boehringer Ingelheim Investigational Site

location_facility: 1220.19.0007 Boehringer Ingelheim Investigational Site

location_facility: 1220.19.0008 Boehringer Ingelheim Investigational Site

location_facility: 1220.19.3907 Boehringer Ingelheim Investigational Site

location_facility: 1220.19.0012 Boehringer Ingelheim Investigational Site

location_facility: 1220.19.3304 Boehringer Ingelheim Investigational Site

location_facility: 1220.19.3403 Boehringer Ingelheim Investigational Site

location_facility: 1220.19.4403 Boehringer Ingelheim Investigational Site

location_facility: 1220.19.5505 Boehringer Ingelheim Investigational Site

location_facility: 1220.19.4102 Boehringer Ingelheim Investigational Site

location_facility: 1220.19.3307 Boehringer Ingelheim Investigational Site

location_facility: 1220.19.0084 Boehringer Ingelheim Investigational Site

location_facility: 1220.19.4924 Boehringer Ingelheim Investigational Site

location_facility: 1220.19.4404 Boehringer Ingelheim Investigational Site

location_facility: 1220.19.3905 Boehringer Ingelheim Investigational Site

location_facility: 1220.19.0006 Boehringer Ingelheim Investigational Site

location_facility: 1220.19.3303 Boehringer Ingelheim Investigational Site

location_facility: 1220.19.5501 Boehringer Ingelheim Investigational Site

location_facility: 1220.19.0013 Boehringer Ingelheim Investigational Site

location_facility: 1220.19.0086 Boehringer Ingelheim Investigational Site

location_facility: 1220.19.4922 Boehringer Ingelheim Investigational Site

location_facility: 1220.19.0045 Boehringer Ingelheim Investigational Site

location_facility: 1220.19.0014 Boehringer Ingelheim Investigational Site

location_facility: 1220.19.0016 Boehringer Ingelheim Investigational Site

location_facility: 1220.19.4103 Boehringer Ingelheim Investigational Site

location_facility: 1220.19.5506 Boehringer Ingelheim Investigational Site

location_facility: 1220.19.4919 Boehringer Ingelheim Investigational Site

location_facility: 1220.19.3306 Boehringer Ingelheim Investigational Site

location_facility: 1220.19.4901 Boehringer Ingelheim Investigational Site

location_facility: 1220.19.4920 Boehringer Ingelheim Investigational Site

location_facility: 1220.19.3408 Boehringer Ingelheim Investigational Site

location_facility: 1220.19.3904 Boehringer Ingelheim Investigational Site

location_facility: 1220.19.0060 Boehringer Ingelheim Investigational Site

location_facility: 1220.19.4408 Boehringer Ingelheim Investigational Site

location_facility: 1220.19.3401 Boehringer Ingelheim Investigational Site

location_facility: 1220.19.0009 Boehringer Ingelheim Investigational Site

location_facility: 1220.19.3404 Boehringer Ingelheim Investigational Site

location_facility: 1220.19.4905 Boehringer Ingelheim Investigational Site

location_facility: 1220.19.3409 Boehringer Ingelheim Investigational Site

location_facility: 1220.19.5503 Boehringer Ingelheim Investigational Site

location_facility: 1220.19.4406 Boehringer Ingelheim Investigational Site

location_facility: 1220.19.4405 Boehringer Ingelheim Investigational Site

location_facility: 1220.19.4407 Boehringer Ingelheim Investigational Site

location_facility: 1220.19.0044 Boehringer Ingelheim Investigational Site

location_facility: 1220.19.4401 Boehringer Ingelheim Investigational Site

location_facility: 1220.19.4902 Boehringer Ingelheim Investigational Site


title: A 12 Week Study to Evaluate the Effect of Fluticasone Furoate (FF, GW685698)/Vilanterol (VI, GW642444) 100/25 mcg Inhalation Powder Delivered Once Daily Via a Novel Dry Powder Inhaler (NDPI) on Arterial Stiffness Compared With Tiotropium Bromide 18 mcg Delivered Once Daily Via a HandiHaler in Subjects With Chronic Obstructive Pulmonary Disease (COPD).

summary: This study is designed to evaluate the effect of fluticasone furoate (FF, GW685698)/vilanterol (VI, GW642444) Inhalation Powder once daily (QD) on arterial stiffness compared with Tiotropium QD over 12 week treatment period in subjects with COPD and aortic pulse wave velocity (aPWV) > 12.0 m/s at Visit 1. Arterial stiffness will be measured as aPWV. This is a comparator, randomised, double-blind, double-dummy, parallel group, multi-centre study. Subjects who meet the eligibility criteria at Screening and meet the randomization criteria at the end of a 2-week Run-In period will enter a 12-week treatment period. There will be an approximate 7-day Follow-up period after the treatment period.

ReferenceCitation: Pepin JL, Cockcroft JR, Midwinter D, Sharma S, Rubin DB, Andreas S. Long-acting bronchodilators and arterial stiffness in patients with COPD: a comparison of fluticasone furoate/vilanterol with tiotropium. Chest. 2014 Dec;146(6):1521-1530. doi: 10.1378/chest.13-2859.

oa_host_type: publisher

publisher_dissemination: Elsevier

ipd_sharing: Yes

lead_sponsor: GlaxoSmithKline

location_country:
Germany
Italy
Norway
Argentina
Ukraine
Russian Federation
France


title: A Randomized, Double-blind, Multicenter, Phase III Study to Evaluate the Efficacy and Safety of Pasireotide LAR in Patients With Cushing's Disease

summary: This is a randomized, double-blind, multicenter, phase III study to evaluate the safety and efficacy of 2 dosing regiments of Pasireotide long acting release (LAR) in patients with Cushing's disease.

ReferenceCitation: Lacroix A, Bronstein MD, Schopohl J, Delibasi T, Salvatori R, Li Y, Barkan A, Suzaki N, Tauchmanova L, Ortmann CE, Ravichandran S, Petersenn S, Pivonello R. Long-acting pasireotide improves clinical signs and quality of life in Cushing's disease: results from a phase III study. J Endocrinol Invest. 2020 Nov;43(11):1613-1622. doi: 10.1007/s40618-020-01246-0. Epub 2020 May 8.

ReferenceCitation: Newell-Price J, Pivonello R, Tabarin A, Fleseriu M, Witek P, Gadelha MR, Petersenn S, Tauchmanova L, Ravichandran S, Gupta P, Lacroix A, Biller BMK. Use of late-night salivary cortisol to monitor response to medical treatment in Cushing's disease. Eur J Endocrinol. 2020 Feb;182(2):207-217. doi: 10.1530/EJE-19-0695.

version: acceptedVersion

repositories_concat: PubMed Central;eprints.whiterose.ac.uk

publisher_dissemination: Oxford University Press

ReferenceCitation: Fleseriu M, Petersenn S, Biller BMK, Kadioglu P, De Block C, T'Sjoen G, Vantyghem MC, Tauchmanova L, Wojna J, Roughton M, Lacroix A, Newell-Price J. Long-term efficacy and safety of once-monthly pasireotide in Cushing's disease: A Phase III extension study. Clin Endocrinol (Oxf). 2019 Dec;91(6):776-785. doi: 10.1111/cen.14081. Epub 2019 Oct 1.

repository_institution: Ghent University - Ghent University Academic Bibliography

repository_institution: University of Antwerp - Institutional Repository University of Antwerp

repository_normalized: irua

repository_institution: University of Leeds, The University of Sheffield, University of York - White Rose Research Online

ReferenceCitation: Lacroix A, Gu F, Gallardo W, Pivonello R, Yu Y, Witek P, Boscaro M, Salvatori R, Yamada M, Tauchmanova L, Roughton M, Ravichandran S, Petersenn S, Biller BMK, Newell-Price J; Pasireotide G2304 Study Group. Efficacy and safety of once-monthly pasireotide in Cushing's disease: a 12 month clinical trial. Lancet Diabetes Endocrinol. 2018 Jan;6(1):17-26. doi: 10.1016/S2213-8587(17)30326-1. Epub 2017 Oct 12. Erratum In: Lancet Diabetes Endocrinol. 2018 Jan;6(1):e1.

ReferenceCitation: Silverstein JM. Hyperglycemia induced by pasireotide in patients with Cushing's disease or acromegaly. Pituitary. 2016 Oct;19(5):536-43. doi: 10.1007/s11102-016-0734-1.

repositories_institution: Washington University School of Medicine - Digital Commons@Becker

ipd_sharing_description:
Novartis is committed to sharing with qualified external researchers, access to patient-level data and supporting clinical documents from eligible studies. These requests are reviewed and approved by an independent review panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations.

This trial data availability is according to the criteria and process described on www.clinicalstudydatarequest.com

location_country:
Germany
Poland
Argentina
Japan
Brazil
Thailand
Turkey
Canada
France
United States
India
Belgium
China
Peru
Italy
United Kingdom
Netherlands
Spain
Russian Federation
Israel

location_facility: Emory University School of Medicine/Winship Cancer Institute G2304 - C2301

location_facility: University of Michigan Comprehensive Cancer Center SC-2

location_facility: Oregon Health & Sciences University DeptofOregonHealth&Sciences(2)

location_facility: Pituitary Center, Division of Endocrinology SC

location_facility: Mount Sinai School of Medicine Mt. Sinai Medical Center

location_facility: University of Pennsylvania - Clinical Studies Unit Unniv SC

location_facility: Vanderbilt University Medical Center CSOM230G2304

location_facility: University of California at Los Angeles UCLA Tiverton


type: Other Identifier

title: A Prospective 3-Year Follow-up Study in Subjects Previously Treated in a Phase IIb or Phase III Study With a TMC435-Containing Regimen for the Treatment of Hepatitis C Virus (HCV) Infection

summary: The purpose of this study is to investigate durability of SVR in chronic HCV patients who achieved SVR in the previous study with TMC435-containing regimen and time for resistance associated mutations to return to baseline in chronic HCV patients who did not achieve SVR in the previous study with TMC435-containing regimen.

design_allocation: Non-Randomized

primary_purpose: Other

ReferenceCitation: Zoulim F, Moreno C, Lee SS, Buggisch P, Horban A, Lawitz E, Corbett C, Lenz O, Fevery B, Verbinnen T, Shukla U, Jessner W. A 3-year follow-up study after treatment with simeprevir in combination with pegylated interferon-alpha and ribavirin for chronic hepatitis C virus infection. Virol J. 2018 Jan 30;15(1):26. doi: 10.1186/s12985-018-0936-4.

repository_institution: Le Centre pour la Communication Scientifique Directe - HAL - Inria

repository_normalized: HAL

repository_institution: Le Centre pour la Communication Scientifique Directe - HAL - Université Paris Descartes

repositories:
HAL
PubMed Central

repositories_concat: HAL;PubMed Central

lead_sponsor: Janssen R&D Ireland

location_country:
Germany
Poland
Belgium
United States
Canada
Russian Federation
France


title: Multicenter, Open-label Study to Evaluate the Safety and Efficacy (by Blinded Reading) of Gadobutrol-enhanced Magnetic Resonance Angiography (MRA) After a Single Injection of 0.1 mmol/kg of Gadobutrol in Subjects With Known or Suspected Renal Artery Disease

acronym: GRAMS

summary:
Subjects referred for a routine CTA (computed tomography angiography) or MRA (magnetic resonance angiography) will be invited to participate in the study and subjects will be involved in the study for between 2 and 12 days. Two to three visits to the study doctor will be required.

This study will compare the diagnostic results of Gadobutrol enhanced MRA images with MRA images taken without contrast agent using images from a CTA as the standard of reference, which may have been performed up to 60 days prior to enrolment. If a CTA has not been performed in this prior time period, a CTA is required for the study.

MRA and CTA images will be collected for an independent review (blinded read).

primary_purpose: Diagnostic

lead_sponsor: Bayer

location_country:
France
Germany
Poland
Colombia
Argentina
Brazil
Switzerland
Austria
United States
Korea, Republic of
Turkey
Taiwan
Czech Republic


title: A 52 Weeks, Double Blind, Randomized, Placebo-controlled Trial Evaluating the Effect of Oral BIBF 1120, 150 mg Twice Daily, on Annual Forced Vital Capacity Decline, in Patients With Idiopathic Pulmonary Fibrosis (IPF)

summary:
Idiopathic Pulmonary Fibrosis (IPF) is a chronic disease of unknown cause that results in scarring of the lung and there is a high unmet medical need for effective treatment to halt lung function decline, delay or avoid exacerbation (flare-ups), and ultimately to reduce the death rate.

In a large Phase 2 trial (1199.30) (NCT00514683), investigating the effects of 52 weeks of treatment with BIBF 1120 in patients with IPF, a positive effect was seen on lung function of patients treated with high dose of BIBF 1120 compared to placebo.

Hence it is the purpose of this trial to investigate and confirm the efficacy and safety of BIBF 1120 at a high dose in treating patients with IPF, compared with placebo. The trial will be conducted as a prospective, randomised design with the aim to collect safety and efficacy data.

Respiratory function is globally accepted for assessment of treatment effects in IPF patients. The chosen endpoint (Forced Vital Capacity (FVC) decline) is easy to obtain and is part of the usual examinations done in IPF patients.

ReferenceCitation: Glaspole I, Bonella F, Bargagli E, Glassberg MK, Caro F, Stansen W, Quaresma M, Orsatti L, Bendstrup E. Efficacy and safety of nintedanib in patients with idiopathic pulmonary fibrosis who are elderly or have comorbidities. Respir Res. 2021 Apr 26;22(1):125. doi: 10.1186/s12931-021-01695-y.

ReferenceCitation: Jouneau S, Crestani B, Thibault R, Lederlin M, Vernhet L, Valenzuela C, Wijsenbeek M, Kreuter M, Stansen W, Quaresma M, Cottin V. Analysis of body mass index, weight loss and progression of idiopathic pulmonary fibrosis. Respir Res. 2020 Nov 25;21(1):312. doi: 10.1186/s12931-020-01528-4.

repository_institution: DANS - Data Archiving and Networked Services - NARCIS - National Academic Research and Collaborations Information System

repository_institution: Erasmus University Rotterdam - EUR Research Repository

repository_institution: Le Centre pour la Communication Scientifique Directe - HAL - Diderot

repository_institution: Le Centre pour la Communication Scientifique Directe - HAL - Inserm

repository_institution: Le Centre pour la Communication Scientifique Directe - HAL - Hospices Civils de Lyon

repositories_institution: Erasmus University Rotterdam - EUR Research Repository

repositories_institution: Le Centre pour la Communication Scientifique Directe - HAL - Université Paris Descartes

ReferenceCitation: Brown KK, Martinez FJ, Walsh SLF, Thannickal VJ, Prasse A, Schlenker-Herceg R, Goeldner RG, Clerisme-Beaty E, Tetzlaff K, Cottin V, Wells AU. The natural history of progressive fibrosing interstitial lung diseases. Eur Respir J. 2020 Jun 25;55(6):2000085. doi: 10.1183/13993003.00085-2020. Print 2020 Jun.

repository_institution: Imperial College London - Spiral

repositories_institution:
Imperial College London - Spiral
PubMed Central - Europe PMC

ReferenceCitation: Richeldi L, Kolb M, Jouneau S, Wuyts WA, Schinzel B, Stowasser S, Quaresma M, Raghu G. Efficacy and safety of nintedanib in patients with advanced idiopathic pulmonary fibrosis. BMC Pulm Med. 2020 Jan 8;20(1):3. doi: 10.1186/s12890-019-1030-4.

repository_institution: Università Cattolica del Sacro Cuore - PubliCatt

repositories:
HAL
LIRIAS (KU Leuven)
PubMed Central
publicatt.unicatt.it

repositories_concat: HAL;LIRIAS (KU Leuven);PubMed Central;publicatt.unicatt.it

repositories_institution: Le Centre pour la Communication Scientifique Directe - HAL - Inria

repositories_institution: Università Cattolica del Sacro Cuore - PubliCatt

ReferenceCitation: Kreuter M, Koegler H, Trampisch M, Geier S, Richeldi L. Differing severities of acute exacerbations of idiopathic pulmonary fibrosis (IPF): insights from the INPULSIS(R) trials. Respir Res. 2019 Apr 11;20(1):71. doi: 10.1186/s12931-019-1037-7.

repository_institution: Heidelberg University - heiDOK - The Heidelberg Document Repository

ReferenceCitation: Xu Z, Li H, Wen F, Bai C, Chen P, Fan F, Hu N, Stowasser S, Kang J. Subgroup Analysis for Chinese Patients Included in the INPULSIS(R) Trials on Nintedanib in Idiopathic Pulmonary Fibrosis. Adv Ther. 2019 Mar;36(3):621-631. doi: 10.1007/s12325-019-0887-1. Epub 2019 Feb 7.

ReferenceCitation: Costabel U, Behr J, Crestani B, Stansen W, Schlenker-Herceg R, Stowasser S, Raghu G. Anti-acid therapy in idiopathic pulmonary fibrosis: insights from the INPULSIS(R) trials. Respir Res. 2018 Sep 3;19(1):167. doi: 10.1186/s12931-018-0866-0.

ReferenceCitation: Collard HR, Richeldi L, Kim DS, Taniguchi H, Tschoepe I, Luisetti M, Roman J, Tino G, Schlenker-Herceg R, Hallmann C, du Bois RM. Acute exacerbations in the INPULSIS trials of nintedanib in idiopathic pulmonary fibrosis. Eur Respir J. 2017 May 19;49(5):1601339. doi: 10.1183/13993003.01339-2016. Print 2017 May.

ReferenceCitation: Paterniti MO, Bi Y, Rekic D, Wang Y, Karimi-Shah BA, Chowdhury BA. Acute Exacerbation and Decline in Forced Vital Capacity Are Associated with Increased Mortality in Idiopathic Pulmonary Fibrosis. Ann Am Thorac Soc. 2017 Sep;14(9):1395-1402. doi: 10.1513/AnnalsATS.201606-458OC.

ReferenceCitation: Rinciog C, Watkins M, Chang S, Maher TM, LeReun C, Esser D, Diamantopoulos A. A Cost-Effectiveness Analysis of Nintedanib in Idiopathic Pulmonary Fibrosis in the UK. Pharmacoeconomics. 2017 Apr;35(4):479-491. doi: 10.1007/s40273-016-0480-2.

repository_institution: University College London - UCL Discovery

repositories:
PubMed Central
UCL Discovery
spiral.imperial.ac.uk

repositories_institution: University College London - UCL Discovery

ReferenceCitation: Kolb M, Richeldi L, Behr J, Maher TM, Tang W, Stowasser S, Hallmann C, du Bois RM. Nintedanib in patients with idiopathic pulmonary fibrosis and preserved lung volume. Thorax. 2017 Apr;72(4):340-346. doi: 10.1136/thoraxjnl-2016-208710. Epub 2016 Sep 26.

repository_institution: University of Oxford - Oxford Academic Notes & Queries

repository_institution: Ludwid Maxmilian's Universitat Munchen - Open access LMU

repository_institution: University of Southampton - ePrints Soton

repositories_institution: University of Oxford - Oxford Academic Notes & Queries

repositories_institution: University of Southampton - ePrints Soton

ReferenceCitation: Corte T, Bonella F, Crestani B, Demedts MG, Richeldi L, Coeck C, Pelling K, Quaresma M, Lasky JA. Safety, tolerability and appropriate use of nintedanib in idiopathic pulmonary fibrosis. Respir Res. 2015 Sep 24;16:116. doi: 10.1186/s12931-015-0276-5.

ReferenceCitation: Richeldi L, du Bois RM, Raghu G, Azuma A, Brown KK, Costabel U, Cottin V, Flaherty KR, Hansell DM, Inoue Y, Kim DS, Kolb M, Nicholson AG, Noble PW, Selman M, Taniguchi H, Brun M, Le Maulf F, Girard M, Stowasser S, Schlenker-Herceg R, Disse B, Collard HR; INPULSIS Trial Investigators. Efficacy and safety of nintedanib in idiopathic pulmonary fibrosis. N Engl J Med. 2014 May 29;370(22):2071-82. doi: 10.1056/NEJMoa1402584. Epub 2014 May 18. Erratum In: N Engl J Med. 2015 Aug 20;373(8):782.

ReferenceCitation: Richeldi L, Cottin V, Flaherty KR, Kolb M, Inoue Y, Raghu G, Taniguchi H, Hansell DM, Nicholson AG, Le Maulf F, Stowasser S, Collard HR. Design of the INPULSIS trials: two phase 3 trials of nintedanib in patients with idiopathic pulmonary fibrosis. Respir Med. 2014 Jul;108(7):1023-30. doi: 10.1016/j.rmed.2014.04.011. Epub 2014 Apr 29.

location_country:
Finland
Germany
India
Portugal
Japan
Netherlands
Mexico
United States
China
Korea, Republic of
Spain
Greece
Turkey
Chile
Canada
Russian Federation
France

location_facility: 1199.34.30005 Boehringer Ingelheim Investigational Site

location_facility: 1199.34.91054 Boehringer Ingelheim Investigational Site

location_facility: 1199.34.10087 Boehringer Ingelheim Investigational Site

location_facility: 1199.34.82003 Boehringer Ingelheim Investigational Site

location_facility: 1199.34.35101 Boehringer Ingelheim Investigational Site

location_facility: 1199.34.81052 Boehringer Ingelheim Investigational Site

location_facility: 1199.34.34005 Boehringer Ingelheim Investigational Site

location_facility: 1199.34.90001 Boehringer Ingelheim Investigational Site

location_facility: 1199.34.02001 Boehringer Ingelheim Investigational Site

location_facility: 1199.34.82004 Boehringer Ingelheim Investigational Site

location_facility: 1199.34.90003 Boehringer Ingelheim Investigational Site

location_facility: 1199.34.49002 Boehringer Ingelheim Investigational Site

location_facility: 1199.34.10070 Boehringer Ingelheim Investigational Site

location_facility: 1199.34.91055 Boehringer Ingelheim Investigational Site

location_facility: 1199.34.82001 Boehringer Ingelheim Investigational Site

location_facility: 1199.34.90004 Boehringer Ingelheim Investigational Site

location_facility: 1199.34.82007 Boehringer Ingelheim Investigational Site

location_facility: 1199.34.49004 Boehringer Ingelheim Investigational Site

location_facility: 1199.34.34004 Boehringer Ingelheim Investigational Site

location_facility: 1199.34.86058 Boehringer Ingelheim Investigational Site

location_facility: 1199.34.10083 Boehringer Ingelheim Investigational Site

location_facility: 1199.34.49003 Boehringer Ingelheim Investigational Site

location_facility: 1199.34.34008 Boehringer Ingelheim Investigational Site

location_facility: 1199.34.86057 Boehringer Ingelheim Investigational Site

location_facility: 1199.34.10093 Boehringer Ingelheim Investigational Site

location_facility: 1199.34.10073 Boehringer Ingelheim Investigational Site

location_facility: 1199.34.81056 Boehringer Ingelheim Investigational Site

location_facility: 1199.34.91051 Boehringer Ingelheim Investigational Site

location_facility: 1199.34.31001 Boehringer Ingelheim Investigational Site

location_facility: 1199.34.34001 Boehringer Ingelheim Investigational Site

location_facility: 1199.34.86054 Boehringer Ingelheim Investigational Site

location_facility: 1199.34.34003 Boehringer Ingelheim Investigational Site

location_facility: 1199.34.49006 Boehringer Ingelheim Investigational Site

location_facility: 1199.34.10089 Boehringer Ingelheim Investigational Site

location_facility: 1199.34.33004 Boehringer Ingelheim Investigational Site

location_facility: 1199.34.81058 Boehringer Ingelheim Investigational Site

location_facility: 1199.34.30003 Boehringer Ingelheim Investigational Site

location_facility: 1199.34.10100 Boehringer Ingelheim Investigational Site

location_facility: 1199.34.34009 Boehringer Ingelheim Investigational Site

location_facility: 1199.34.10084 Boehringer Ingelheim Investigational Site

location_facility: 1199.34.10074 Boehringer Ingelheim Investigational Site

location_facility: 1199.34.10075 Boehringer Ingelheim Investigational Site

location_facility: 1199.34.33002 Boehringer Ingelheim Investigational Site

location_facility: 1199.34.82006 Boehringer Ingelheim Investigational Site

location_facility: 1199.34.81059 Boehringer Ingelheim Investigational Site

location_facility: 1199.34.49005 Boehringer Ingelheim Investigational Site

location_facility: 1199.34.91056 Boehringer Ingelheim Investigational Site

location_facility: 1199.34.86055 Boehringer Ingelheim Investigational Site

location_facility: 1199.34.10095 Boehringer Ingelheim Investigational Site

location_facility: 1199.34.10064 Boehringer Ingelheim Investigational Site

location_facility: 1199.34.81053 Boehringer Ingelheim Investigational Site

location_facility: 1199.34.31003 Boehringer Ingelheim Investigational Site

location_facility: 1199.34.10060 Boehringer Ingelheim Investigational Site

location_facility: 1199.34.81055 Boehringer Ingelheim Investigational Site

location_facility: 1199.34.35106 Boehringer Ingelheim Investigational Site

location_facility: 1199.34.81054 Boehringer Ingelheim Investigational Site

location_facility: 1199.34.81051 Boehringer Ingelheim Investigational Site

location_facility: 1199.34.81060 Boehringer Ingelheim Investigational Site

location_facility: 1199.34.10067 Boehringer Ingelheim Investigational Site

location_facility: 1199.34.81063 Boehringer Ingelheim Investigational Site

location_facility: 1199.34.49001 Boehringer Ingelheim Investigational Site

location_facility: 1199.34.91053 Boehringer Ingelheim Investigational Site

location_facility: 1199.34.10066 Boehringer Ingelheim Investigational Site

location_facility: 1199.34.33007 Boehringer Ingelheim Investigational Site

location_facility: 1199.34.35102 Boehringer Ingelheim Investigational Site

location_facility: 1199.34.35801 Boehringer Ingelheim Investigational Site

location_facility: 1199.34.10079 Boehringer Ingelheim Investigational Site

location_facility: 1199.34.10090 Boehringer Ingelheim Investigational Site

location_facility: 1199.34.33005 Boehringer Ingelheim Investigational Site

location_facility: 1199.34.82002 Boehringer Ingelheim Investigational Site

location_facility: 1199.34.07001 Boehringer Ingelheim Investigational Site

location_facility: 1199.34.10101 Boehringer Ingelheim Investigational Site

location_facility: 1199.34.49010 Boehringer Ingelheim Investigational Site

location_facility: 1199.34.10085 Boehringer Ingelheim Investigational Site

location_facility: 1199.34.30001 Boehringer Ingelheim Investigational Site

location_facility: 1199.34.35105 Boehringer Ingelheim Investigational Site

location_facility: 1199.34.86053 Boehringer Ingelheim Investigational Site

location_facility: 1199.34.02002 Boehringer Ingelheim Investigational Site

location_facility: 1199.34.52001 Boehringer Ingelheim Investigational Site

location_facility: 1199.34.10092 Boehringer Ingelheim Investigational Site

location_facility: 1199.34.86051 Boehringer Ingelheim Investigational Site

location_facility: 1199.34.10082 Boehringer Ingelheim Investigational Site

location_facility: 1199.34.10088 Boehringer Ingelheim Investigational Site

location_facility: 1199.34.86056 Boehringer Ingelheim Investigational Site

location_facility: 1199.34.30004 Boehringer Ingelheim Investigational Site

location_facility: 1199.34.81061 Boehringer Ingelheim Investigational Site

location_facility: 1199.34.02003 Boehringer Ingelheim Investigational Site

location_facility: 1199.34.81062 Boehringer Ingelheim Investigational Site

location_facility: 1199.34.07003 Boehringer Ingelheim Investigational Site

location_facility: 1199.34.35103 Boehringer Ingelheim Investigational Site

location_facility: 1199.34.56001 Boehringer Ingelheim Investigational Site

location_facility: 1199.34.10077 Boehringer Ingelheim Investigational Site

location_facility: 1199.34.10069 Boehringer Ingelheim Investigational Site

location_facility: 1199.34.33003 Boehringer Ingelheim Investigational Site

location_facility: 1199.34.33006 Boehringer Ingelheim Investigational Site

location_facility: 1199.34.49011 Boehringer Ingelheim Investigational Site

location_facility: 1199.34.90005 Boehringer Ingelheim Investigational Site

location_facility: 1199.34.10086 Boehringer Ingelheim Investigational Site

location_facility: 1199.34.35107 Boehringer Ingelheim Investigational Site

location_facility: 1199.34.31002 Boehringer Ingelheim Investigational Site

location_facility: 1199.34.81057 Boehringer Ingelheim Investigational Site

location_facility: 1199.34.49007 Boehringer Ingelheim Investigational Site

location_facility: 1199.34.86052 Boehringer Ingelheim Investigational Site

location_facility: 1199.34.49009 Boehringer Ingelheim Investigational Site

location_facility: 1199.34.10078 Boehringer Ingelheim Investigational Site

location_facility: 1199.34.10080 Boehringer Ingelheim Investigational Site

location_facility: 1199.34.30002 Boehringer Ingelheim Investigational Site

location_facility: 1199.34.90002 Boehringer Ingelheim Investigational Site


title: An Open-Label, Randomized Study Evaluating a Switch From a Regimen of Two Nucleoside Reverse Transcriptase Inhibitors Regimen Plus Any Third Agent to Either a Regimen of Atazanavir/Ritonavir Once Daily and Raltegravir Twice Daily or to a Regimen of Atazanavir/Ritonavir Once Daily and Tenofovir/Emtricitabine Once Daily in Virologically Suppressed HIV-1 Infected Subjects With Safety and/or Tolerability Issues on Their Present Treatment Regimen.

acronym: SPARTAN

summary: The purpose of this study is to determine whether HIV-1-infected patients, who are virologically suppressed on a regimen of 2 nucleoside reverse transcriptase inhibitors plus any third agent but are experiencing safety and/or tolerability issues, will maintain virologic suppression after switching to a regimen of heat-stable ritonavir boosted atazanavir, 300/100 mg, once daily plus raltegravir, 400 mg, twice daily.

lead_sponsor: Bristol-Myers Squibb

location_country:
Germany
Italy
Poland
United Kingdom
United States
Spain
France

location_facility:
Consultive Medicine
The Research Institute
Aids Care
Health For Life Clinic Pllc
Triple O Medical Services, P.A.
Metropolis Medical Pc
Local Institution
Orange County Health Dept.
Eisenhower Medical Center


title: A Randomized, Double Masked, Active Controlled, Phase III Study of the Efficacy and Safety of Repeated Doses of Intravitreal VEGF Trap-Eye in Subjects With Diabetic Macular Edema

acronym: VIVID-DME

summary: To determine the efficacy of intravitreally (IVT) administered VEGF Trap-Eye on the best-corrected visual acuity (BCVA) assessed by the early treatment diabetic retinopathy study (ETDRS) chart in subjects with diabetic macular edema (DME) with central involvement

ReferenceType: background

ReferenceCitation: Nanegrungsunk O, Gu SZ, Bressler SB, Du W, Amer F, Moini H, Bressler NM. Correlation of Change in Macular Thickness With Change in Visual Acuity in Diabetic Macular Edema: Post Hoc Analysis of VISTA and VIVID Trials. J Vitreoretin Dis. 2022 Jul 27;6(4):284-289. doi: 10.1177/24741264221099429. eCollection 2022 Jul-Aug.

ReferenceCitation: Valentim CCS, Singh RP, Du W, Moini H, Talcott KE. Time to Resolution of Diabetic Macular Edema after Treatment with Intravitreal Aflibercept Injection or Laser in VISTA and VIVID. Ophthalmol Retina. 2023 Jan;7(1):24-32. doi: 10.1016/j.oret.2022.07.004. Epub 2022 Jul 14.

ReferenceCitation: Dhoot DS, Moini H, Reed K, Du W, Vitti R, Berliner AJ, Singh RP. Functional outcomes of sustained improvement on Diabetic Retinopathy Severity Scale with intravitreal aflibercept in the VISTA and VIVID trials. Eye (Lond). 2023 Jul;37(10):2020-2025. doi: 10.1038/s41433-022-02058-7. Epub 2022 Apr 19.

ReferenceType: result

ReferenceCitation: Korobelnik JF, Do DV, Schmidt-Erfurth U, Boyer DS, Holz FG, Heier JS, Midena E, Kaiser PK, Terasaki H, Marcus DM, Nguyen QD, Jaffe GJ, Slakter JS, Simader C, Soo Y, Schmelter T, Yancopoulos GD, Stahl N, Vitti R, Berliner AJ, Zeitz O, Metzig C, Brown DM. Intravitreal aflibercept for diabetic macular edema. Ophthalmology. 2014 Nov;121(11):2247-54. doi: 10.1016/j.ophtha.2014.05.006. Epub 2014 Jul 8.

unpaywall_oa_status: bronze

ReferenceCitation: Brown DM, Schmidt-Erfurth U, Do DV, Holz FG, Boyer DS, Midena E, Heier JS, Terasaki H, Kaiser PK, Marcus DM, Nguyen QD, Jaffe GJ, Slakter JS, Simader C, Soo Y, Schmelter T, Yancopoulos GD, Stahl N, Vitti R, Berliner AJ, Zeitz O, Metzig C, Korobelnik JF. Intravitreal Aflibercept for Diabetic Macular Edema: 100-Week Results From the VISTA and VIVID Studies. Ophthalmology. 2015 Oct;122(10):2044-52. doi: 10.1016/j.ophtha.2015.06.017. Epub 2015 Jul 18.

ReferenceCitation: Keating GM. Aflibercept: A Review of Its Use in Diabetic Macular Oedema. Drugs. 2015 Jul;75(10):1153-60. doi: 10.1007/s40265-015-0421-y.

ReferenceCitation: Do DV, Gordon C, Suner IJ, Reed K, Moini H, Gibson A, Du W, Shah CP. Proliferative Diabetic Retinopathy Events in Patients With Diabetic Macular Edema: Post Hoc Analysis of VISTA and VIVID Trials. J Vitreoretin Dis. 2022 Jun 4;6(4):295-301. doi: 10.1177/24741264221093914. eCollection 2022 Jul-Aug.

ReferenceCitation: Midena E, Gillies M, Katz TA, Metzig C, Lu C, Ogura Y. Impact of Baseline Central Retinal Thickness on Outcomes in the VIVID-DME and VISTA-DME Studies. J Ophthalmol. 2018 Mar 29;2018:3640135. doi: 10.1155/2018/3640135. eCollection 2018.

repository_institution: Hindawi - Hindawi

repository_institution: PubMed Central - Europe PMC

evidence: oa repository (semantic scholar lookup)

version: submittedVersion

repositories_institution:
Hindawi - Hindawi
PubMed Central - Europe PMC

publisher_dissemination: Hindawi

ReferenceCitation: Staurenghi G, Feltgen N, Arnold JJ, Katz TA, Metzig C, Lu C, Holz FG; VIVID-DME and VISTA-DME study investigators. Impact of baseline Diabetic Retinopathy Severity Scale scores on visual outcomes in the VIVID-DME and VISTA-DME studies. Br J Ophthalmol. 2018 Jul;102(7):954-958. doi: 10.1136/bjophthalmol-2017-310664. Epub 2017 Oct 19.

repository_institution: Universita Degli Studi Di Milano - Archivio Istituzionale della Ricerca

ReferenceCitation: Wykoff CC, Marcus DM, Midena E, Korobelnik JF, Saroj N, Gibson A, Vitti R, Berliner AJ, Williams Liu Z, Zeitz O, Metzig C, Schmelter T, Heier JS. Intravitreal Aflibercept Injection in Eyes With Substantial Vision Loss After Laser Photocoagulation for Diabetic Macular Edema: Subanalysis of the VISTA and VIVID Randomized Clinical Trials. JAMA Ophthalmol. 2017 Feb 1;135(2):107-114. doi: 10.1001/jamaophthalmol.2016.4912.

ReferenceCitation: Ziemssen F, Schlottman PG, Lim JI, Agostini H, Lang GE, Bandello F. Initiation of intravitreal aflibercept injection treatment in patients with diabetic macular edema: a review of VIVID-DME and VISTA-DME data. Int J Retina Vitreous. 2016 Jul 11;2:16. doi: 10.1186/s40942-016-0041-z. eCollection 2016.

location_country: Germany Italy Poland Hungary Denmark Australia Japan Austria Spain Czechia France

location_facility: IRCCS Fondazione Ca' Granda Ospedale Maggiore Policlinico

location_facility: Klinikum der Stadt Ludwigshafen am Rhein gGmbH


summary: This randomized, multicenter, open label study will evaluate the safety and efficacy of RO5083945 in combination with FOLFIRI as compared to FOLFIRI plus cetuximab or FOLFIRI alone as second line treatment in patients with metastatic colorectal cancer. Patients will be randomized to receive RO5083945 (1400 mg intravenously on Day 1 and Day 8 and every 2 weeks thereafter) plus FOLFIRI standard iv chemotherapy or FOLFIRI plus cetuximab (400 mg/m2 iv on Day 1 followed by 250 mg/m2 iv every week) or FOLFIRI alone. Anticipated time on study treatment is until disease progression or unacceptable toxicity occurs.

title: A Randomized, Multicenter, Open-label Phase II Study of RO5083945 in Combination With FOLFIRI Versus FOLFIRI Plus Cetuximab or FOLFIRI Alone as Second Line Treatment in Patients With KRAS Wild-type or Mutant Metastatic Colorectal Cancer

source: euctr

location_country:
Germany
Italy
Poland
United Kingdom
Australia
Belgium
United States
Spain
France


title: A Phase 3, Double-Blind, Multicenter, Randomized, Placebo-Controlled Trial Evaluating Repeated Courses of Aztreonam for Inhalation Solution/Aztreonam 75 mg Powder and Solvent for Nebuliser Solution in Subjects With Non-CF Bronchiectasis and Gram-Negative Endobronchial Infection (AIR-BX2)

summary: The AIR-BX2 study enrolled people with non-cystic fibrosis (non-CF) bronchiectasis and gram-negative airway infection. Participants received two 28-day courses of either Aztreonam for Inhalation Solution (AZLI) or placebo taken 3 times a day. Each course was followed by a 28-day off-drug period. Following the two blinded courses, all participants received a 28-day course of open-label AZLI then were followed for an additional 56 days.

ReferenceCitation: Barker AF, O'Donnell AE, Flume P, Thompson PJ, Ruzi JD, de Gracia J, Boersma WG, De Soyza A, Shao L, Zhang J, Haas L, Lewis SA, Leitzinger S, Montgomery AB, McKevitt MT, Gossage D, Quittner AL, O'Riordan TG. Aztreonam for inhalation solution in patients with non-cystic fibrosis bronchiectasis (AIR-BX1 and AIR-BX2): two randomised double-blind, placebo-controlled phase 3 trials. Lancet Respir Med. 2014 Sep;2(9):738-49. doi: 10.1016/S2213-2600(14)70165-1. Epub 2014 Aug 18.

lead_sponsor: Gilead Sciences

location_country:
Germany
Italy
United Kingdom
Australia
Netherlands
Belgium
United States
Spain
Canada
France

location_facility: Medical College of Wisconsin Froedtert Hospital

location_facility: GBS RE Sheffield Teaching Hospitals NHS Foundation Trust

location_facility: University of Texas Health Science Center at Tyler

location_facility: Kelowna Respiratory Research and Allergy Clinic

location_facility: Pulmonary Consultants & Primary Care Physicians Medical Group, Inc.

location_facility: UO Broncopneumologia IRCCS Fondazione Cà Granda Milano

location_facility: Sarasota Memorial Hospital - Clinical Research Center

location_facility: Sir William Leech Centre for Lung Research, Freeman Hospital

location_facility: The Oregon Clinic P.C./ Pulmonary Division

location_facility: University of Pennsylvania Medical Center

location_facility: CHICAS - Centre Hospitalier Intercommunal des Alpes du sud, site de GAP

location_facility: Ospendale Civile Maggiore Centro Regionale Fibrosi Cistica

location_facility: University of Miami Miller School of Medicine

location_facility: CHU de Montpellier-Hopital Arnaud de Villeneuve

location_facility: Research Center for Medical Studies (RCMS)

location_facility: Columbia University, NY Presbyterian Hospital

location_facility: Tampa General Hospital - New Lung Associates

location_facility: Service Activite Ambulatoire Pole Cardiovasculaire Hopital Nord

location_facility: Pulmonary & Critical Care Associates of Baltimore

location_facility: Royal Devon and Exeter Hospital, NHS Foundation Trust

location_facility: Universitätsklinikum Jena Clinic for Internal Medicine II

location_facility: The Lung Centre at Vancouver General Hospital

location_facility: University of Wisconsin Hospital and Clinics


title: A Phase 2B, Randomized Study to Evaluate the Safety and Efficacy of Pegylated Interferon Lambda (BMS-914143) Administered With Ribavirin Plus a Single Direct Antiviral Agent (BMS-790052 or BMS-650032) Versus Pegasys Administered With Ribavirin (Part A) and of Pegylated Interferon Lambda (BMS-914143) Administered With or Without Ribavirin Plus 2 Direct Antiviral Agents (BMS-790052 and BMS-650032) (Part B) in Chronic Hepatitis C Genotype-1 Treatment naïve Subjects

acronym: D-LITE

summary: The purpose of this study is to determine if combination therapy with Pegylated Interferon Lambda (BMS-914143) plus Ribavirin (RBV) with a single direct antiviral agent (BMS-790052 or BMS-650032) for 24 weeks is effective and safe for treatment of Chronic Hepatitis C (CHC) compared to current standard therapy with Pegylated Interferon Alpha-2a plus RBV for 48 weeks.

location_country:
Germany
Italy
New Zealand
Australia
Japan
United States
Spain
Puerto Rico
France

location_facility: University Of Colorado Denver And Hospital

location_facility: St. Luke'S Episcopal Hospital - Baylor College Of Medicine

location_facility: Bristol-Myers Squibb/David E. Bernstein, Md


title: Clinical Efficacy, Immunogenicity, Clinical Tolerability and Assessment of Safety of gpASIT+TM Administered Orally, According to Two Administration Schedules, for the Prophylaxis of Seasonal Grass Pollen Rhinoconjunctivitis

summary: The purpose of the study is to evaluate the efficacy and safety of grass pollen-derived peptides administrated orally to treat seasonal allergic rhinoconjunctivitis.

primary_purpose: Prevention

lead_sponsor: BioTech Tools S.A.

location_country: Luxembourg Belgium France

location_facility:
CHU Ambroise Paré
UCL Saint Luc
UZ Gent
CHR Citadelle
Hôpital Saint Vincent de Paul
Private practice
AZ Sint Lucas
UZ Leuven
CHU Reims
CHR Saint Joseph Warquignies
CH Luxembourg
UCL Mont Godinne
CHRU Lille
CHRU Strasbourg
UZ Antwerpen
Clinique du Parc Léopold
CHU Sart-Tilman
UZ Brussel

intervention_type: Biological


title: Multicenter, Double-blind, Placebo-controlled, Parallel-group, Phase IV Study to Assess the Effect of Rotigotine on Non-motor Symptoms in Patients With Idiopathic Parkinson's Disease

summary: The primary objective of this study was to demonstrate that Rotigotine improves non-motor symptoms compared to Placebo in subjects with Parkinson's Disease.

ReferenceCitation: Antonini A, Bauer L, Dohin E, Oertel WH, Rascol O, Reichmann H, Schmid M, Singh P, Tolosa E, Chaudhuri KR. Effects of rotigotine transdermal patch in patients with Parkinson's disease presenting with non-motor symptoms - results of a double-blind, randomized, placebo-controlled trial. Eur J Neurol. 2015 Oct;22(10):1400-7. doi: 10.1111/ene.12757. Epub 2015 Jun 22.

oa_host_type: repository

repository_institution: King's College London - Research Portal

unpaywall_oa_status: green

location_country:
Germany
Italy
Slovakia
Hungary
Romania
Switzerland
Austria
Belgium
Spain
Bulgaria
Czech Republic
France


title: Empirical Versus Pre-emptive (Diagnostic-driven) Antifungal Therapy of Patients Treated for Haematological Malignancies or Receiving an Allogeneic Stem Cell Transplant. A Therapeutic Open Label Phase III Strategy Study of the EORTC Infectious Diseases and Leukemia Groups

summary:
RATIONALE: Caspofungin acetate may be effective in treating fungal infections in patients with acute myeloid leukemia or myelodysplastic syndrome who are receiving treatment for their cancer. It is not yet known whether caspofungin acetate is more effective when treatment starts after development of a fever or after the infection is shown in laboratory test, chest x-ray, or CT scan.

PURPOSE: This randomized phase III trial is studying the best time to start caspofungin acetate therapy in treating patients with acute myeloid leukemia or myelodysplastic syndrome that is newly diagnosed or in first relapse.

primary_purpose: Supportive Care

lead_sponsor: European Organisation for Research and Treatment of Cancer - EORTC

location_country: Germany Slovakia Netherlands Belgium Czechia France

location_facility: Hôpitaux Universitaires Bordet-Erasme - Institut Jules Bordet

location_facility: Universitaetsklinikum Wuerzburg - Medizinische Klinik und Poliklinik II

location_facility: Radboud University Nijmegen Medical Centre


title: A Randomized, Double-Blind, Placebo-Controlled, Multi-Center Study of the Safety and Efficacy of Dexpramipexole in Subjects With Amyotrophic Lateral Sclerosis

acronym: EMPOWER

summary: The purpose of this study is to determine whether dexpramipexole (150 mg twice daily) is safe and effective in the treatment of Amyotrophic Lateral Sclerosis (ALS).

ReferenceCitation: Cudkowicz ME, van den Berg LH, Shefner JM, Mitsumoto H, Mora JS, Ludolph A, Hardiman O, Bozik ME, Ingersoll EW, Archibald D, Meyers AL, Dong Y, Farwell WR, Kerr DA; EMPOWER investigators. Dexpramipexole versus placebo for patients with amyotrophic lateral sclerosis (EMPOWER): a randomised, double-blind, phase 3 trial. Lancet Neurol. 2013 Nov;12(11):1059-67. doi: 10.1016/S1474-4422(13)70221-7. Epub 2013 Sep 23. Erratum In: Lancet Neurol. 2013 Nov;12(11):1042. Carbonell, J G [corrected to Gamez, J].

lead_sponsor: Knopp Biosciences

location_country:
Germany
Ireland
United Kingdom
Australia
Sweden
Netherlands
Belgium
United States
Spain
Canada
France

location_facility: Sheffield Institute for Transnational Neuroscience

location_facility: University of South Florida Medical Center

location_facility: Kings College Hospital NHS Foundation Trust

location_facility: University of Arkansas for Medical Sciences

location_facility: University of Miami Miller School of Medicine

location_facility: Barrow Neurological Institute - St. Joseph's Hospital

location_facility: Walton Centre for Neurology & Neurosurgery

location_facility: Washington University School of Medicine

location_facility: Sunnybrook and Women's College and Health Sciences Centre

location_facility: Johns Hopkins University School of Medicine

location_facility: University of California at San Francisco - Fresno

location_facility: Newcastle University Hospital - Clinical Ageing Research Unit

location_facility: University of Texas Health Sciences Center

location_facility: Research Foundation of the State University of New York


title: INFORM-SVR: A Randomized, Multi-Center Study of Interferon-Free Treatment With a Combination of a Polymerase Inhibitor (RO5024048) and a Ritonavir Boosted HCV Protease Inhibitor (RO5190591/r, DNV/r) With or Without Copegus® in Interferon Naïve HCV Genotype 1 Infected Patients

summary:
This multicenter, randomized, double-blind, parallel group study will evaluate the safety and efficacy of the combination RO5024048 and ritonavir-boosted danoprevir with and without Copegus (ribavirin) in patients with chronic hepatitis C genotype 1. In arm A and B, interferon treatment-naïve patients will receive 1000 mg RO5024048 orally twice daily and 100 mg danoprevir with 100 mg ritonavir orally twice daily plus either Copegus (1000 mg or 1200 mg orally daily) or placebo for 12 weeks. Depending on viral response and treatment arm patients will be re-randomized to continue assigned treatment for additional 12 weeks or stop all treatment. The anticipated time on study treatment is up to 24 weeks plus a 24-week follow-up.

As of 29. September 2011, Arm B patients (placebo-containing arm) will be offered, in conjunction with the current treatment, Pegasys (peginterferon alfa-2a) 180 mcg subcutaneously weekly plus Copegus 1000mg or 1200 mg orally daily for 24 weeks, with a 24-week follow-up.

ReferenceCitation: Tong X, Li L, Haines K, Najera I. Identification of the NS5B S282T resistant variant and two novel amino acid substitutions that affect replication capacity in hepatitis C virus-infected patients treated with mericitabine and danoprevir. Antimicrob Agents Chemother. 2014 Jun;58(6):3105-14. doi: 10.1128/AAC.02672-13. Epub 2014 Mar 17.

publisher_dissemination: American Society for Microbiology

location_country:
United States
Germany
New Zealand
France


title: A Phase 2, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Effect of Add-on AMG 747 on Schizophrenia Negative Symptoms

summary: The purpose of this study is to evaluate the effect of AMG 747 on negative symptoms of schizophrenia in patients who are stable on current antipsychotic treatment. After a run-in period on their current antipsychotic treatment, patients will be randomized to one of the four treatment arms as add-on therapy for a treatment duration of up to 3 months.

status: Terminated

ReferenceCitation: Dunayevich E, Buchanan RW, Chen CY, Yang J, Nilsen J, Dietrich JM, Sun H, Marder S. Efficacy and safety of the glycine transporter type-1 inhibitor AMG 747 for the treatment of negative symptoms associated with schizophrenia. Schizophr Res. 2017 Apr;182:90-97. doi: 10.1016/j.schres.2016.10.027. Epub 2016 Oct 24.

lead_sponsor: Amgen

location_country:
Poland
United Kingdom
United States
Malaysia
Czech Republic
France

status_simplified: Unknown


title: A Phase 2, Randomized, Open-Label Study of the Safety and Efficacy of Two Doses of Quizartinib (AC220; ASP2689) in Subjects With FLT3-ITD Positive Relapsed or Refractory Acute Myeloid Leukemia (AML)

summary: This study will evaluate two doses of Quizartinib in patients with relapsed or refractory acute myeloid leukemia who are also FMS-like tyrosine kinase - internal tandem duplication ( FLT3-ITD) positive. Patient will be randomly assigned in a 1:1 ratio to one of two treatment arms. Both treatment arms will receive Quizartinib but at different doses. The study treatment is taken orally in 28 day cycles until either disease progression occurs or an unacceptable toxicity occurs. In addition to the study assessments to evaluate the disease, blood will be drawn to measure drug levels and biomarkers. Patients will be followed for survival at three month intervals after the end of treatment.

ipd_sharing_description: De-identified individual participant data (IPD) and applicable supporting clinical trial documents may be available upon request at https://vivli.org/. In cases where clinical trial data and supporting documents are provided pursuant to our company policies and procedures, Daiichi Sankyo will continue to protect the privacy of our clinical trial participants. Details on data sharing criteria and the procedure for requesting access can be found at this web address: https://vivli.org/ourmember/daiichi-sankyo/

lead_sponsor: Daiichi Sankyo, Inc.

sponsor_collaborators:
Daiichi Sankyo, Inc.
Ambit Biosciences Corporation

location_country:
United States
Italy
United Kingdom
France

location_facility: Universitaria Policlinico S. Orsola Malpighi, Institute of Hemtology "L. & A. Seragnoli"

location_facility: University of Maryland Greenebaum Cancer Center

location_facility: Medical University of South Carolina, Hollings Cancer Center

location_facility: Penn State Milton S. Hershey Medical Center

location_facility: Tufts University School of Medicine-Tufts Medical Center

location_facility: Vanderbilt University, Vanderbilt Ingram Cancer Center

location_facility: Hospital of the University of Pennsylvania

location_facility: UT Southwestern Medical Center, Simmons Cancer Center


title: A Randomized, Double-blind, Placebo Controlled, Multicenter Study of Subcutaneous Secukinumab in Prefilled Syringes to Demonstrate Efficacy After Twelve Weeks of Treatment, and to Assess the Safety, Tolerability, Usability and Long-term Efficacy in Subjects With Chronic Plaque-type Psoriasis

acronym: FEATURE

summary: The purpose of this study is to demonstrate efficacy of secukinumab at Week 12 based on PASI and IGA response rates versus placebo in subjects with moderate to severe chronic plaque-type psoriasis.

ReferenceCitation: Merola JF, McInnes IB, Deodhar AA, Dey AK, Adamstein NH, Quebe-Fehling E, Aassi M, Peine M, Mehta NN. Effect of Secukinumab on Traditional Cardiovascular Risk Factors and Inflammatory Biomarkers: Post Hoc Analyses of Pooled Data Across Three Indications. Rheumatol Ther. 2022 Jun;9(3):935-955. doi: 10.1007/s40744-022-00434-z. Epub 2022 Mar 19.

repository_institution: The University of Glasgow - Enlighten: Publications

repositories_concat: PubMed Central;eprints.gla.ac.uk

ReferenceCitation: Houghton K, Patil D, Gomez B, Feldman SR. Correlation Between Change in Psoriasis Area and Severity Index and Dermatology Life Quality Index in Patients with Psoriasis: Pooled Analysis from Four Phase 3 Clinical Trials of Secukinumab. Dermatol Ther (Heidelb). 2021 Aug;11(4):1373-1384. doi: 10.1007/s13555-021-00564-2. Epub 2021 Jun 10.

ReferenceCitation: Menter A, Cather JC, Jarratt M, Meng X, Guana A, Nyirady J. Efficacy of Secukinumab on Moderate-to-severe Plaque Psoriasis Affecting Different Body Regions: a Pooled Analysis of Four Phase 3 Studies. Dermatol Ther (Heidelb). 2016 Dec;6(4):639-647. doi: 10.1007/s13555-016-0140-7. Epub 2016 Aug 30.

ReferenceCitation: Kircik L, Fowler J, Weiss J, Meng X, Guana A, Nyirady J. Efficacy of Secukinumab for Moderate-to-Severe Head and Neck Psoriasis Over 52 Weeks: Pooled Analysis of Four Phase 3 Studies. Dermatol Ther (Heidelb). 2016 Dec;6(4):627-638. doi: 10.1007/s13555-016-0139-0. Epub 2016 Aug 30.

lead_sponsor: Novartis Pharmaceuticals

location_country:
Germany
United States
Canada
Estonia
France


title: Randomized, Multicenter, Double-blind, Placebo-controlled, Parallel-group Phase III Study to Investigate the Efficacy, Safety, and Tolerability of 2 Different Doses of IgPro20 (Subcutaneous Immunoglobulin) for the Treatment of Chronic Inflammatory Demyelinating Polyneuropathy (CIDP) - the PATH Study

summary:
This is a prospective, multicenter, randomized, double-blind, placebo-controlled, parallel-group 3-arm study to investigate 2 different doses of subcutaneous (SC) IgPro20 compared with placebo for maintenance treatment of patients with CIDP.

Patients who received at lease 1 dose of intravenous immunoglobulin (IVIG) within 8 weeks before screening will be assessed during 4 separate study periods. Patients first undergo a Screening Period, followed by an IgG Dependency Test Period of up to 12 weeks to test for ongoing need of IgG. Those patients experiencing CIDP relapse during this test period will be administered a standardized IVIG regimen during an IVIG Re-stabilization Period. Patients with improved and maintained adjusted inflammatory neuropathy cause and treatment scale (INCAT) in the IVIG Re-stabilization Period will continue to the SC Treatment Period of the study. Patients entering the 24 week SC Treatment Period will be randomized to receive weekly infusions of 1 of 2 IgPro20 doses (0.2 or 0.4 g/kg body weight) or placebo.

The overall study duration is up to 52 weeks. Clinical outcomes will be assessed by the Inflammatory Neuropathy Cause and Treatment (INCAT) score, maximum grip strength, the Medical Research Council (MRC) sum score, the Rasch-built Overall Disability Scale (R-ODS), and electrophysiological evaluations.

ReferenceCitation: van Schaik IN, Bril V, van Geloven N, Hartung HP, Lewis RA, Sobue G, Lawo JP, Praus M, Mielke O, Durn BL, Cornblath DR, Merkies ISJ; PATH study group. Subcutaneous immunoglobulin for maintenance treatment in chronic inflammatory demyelinating polyneuropathy (PATH): a randomised, double-blind, placebo-controlled, phase 3 trial. Lancet Neurol. 2018 Jan;17(1):35-46. doi: 10.1016/S1474-4422(17)30378-2. Epub 2017 Nov 6. Erratum In: Lancet Neurol. 2018 Jan;17 (1):26. Lancet Neurol. 2018 Aug;17(8):661.

repository_institution: Maastricht University - Research Publications

repository_institution: DANS - Data Archiving and Networked Services - NARCIS - National Academic Research and Collaborations Information System

repositories_institution: Universita Degli Studi Di Milano - Archivio Istituzionale della Ricerca

ReferenceCitation: van Schaik IN, van Geloven N, Bril V, Hartung HP, Lewis RA, Sobue G, Lawo JP, Mielke O, Cornblath DR, Merkies IS; PATH study group. Subcutaneous immunoglobulin for maintenance treatment in chronic inflammatory demyelinating polyneuropathy (The PATH Study): study protocol for a randomized controlled trial. Trials. 2016 Jul 25;17(1):345. doi: 10.1186/s13063-016-1466-2.

repository_institution: University of Toronto - TSpace

repositories_institution:
PubMed Central - Europe PMC
University of Toronto - TSpace

lead_sponsor: CSL Behring

sponsor_collaborators:
CSL Behring
ICON Clinical Research

location_country:
Finland
Germany
Italy
Poland
Israel
United Kingdom
Australia
Japan
Netherlands
Belgium
United States
Spain
Czechia
Canada
Estonia
France

location_facility:
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acronym: not applicable

summary:
The purpose of this study is to determine if everolimus combined with reduced exposure CNI (TAC) is efficacious and safe and will support corticosteroid elimination compared to a standard exposure CNI (TAC) + MMF + steroid regimen after paediatric kidney transplantation. An additional purpose of the study is to assess the effect of the combination of EVR and reduced exposure CNI (TAC) on renal function.

This study is part of the requirements of the Paediatric Investigational Plan approved by Paediatric Committee at the European Medicines Agency (PDCO/EMA) on September 10, 2010, and is intended to support the indication of everolimus in the prevention of acute rejection in paediatric recipients of a renal transplant.

ReferenceCitation: Patry C, Sauer LD, Sander A, Krupka K, Fichtner A, Brezinski J, Geissbuhler Y, Aubrun E, Grinienko A, Strologo LD, Haffner D, Oh J, Grenda R, Pape L, Topaloglu R, Weber LT, Bouts A, Kim JJ, Prytula A, Konig J, Shenoy M, Hocker B, Tonshoff B. Emulation of the control cohort of a randomized controlled trial in pediatric kidney transplantation with Real-World Data from the CERTAIN Registry. Pediatr Nephrol. 2023 May;38(5):1621-1632. doi: 10.1007/s00467-022-05777-x. Epub 2022 Oct 20.

repository_institution: Ghent University - Ghent University Academic Bibliography

repositories_concat: PubMed Central;archive.ugent.be

ReferenceCitation: Tonshoff B, Tedesco-Silva H, Ettenger R, Christian M, Bjerre A, Dello Strologo L, Marks SD, Pape L, Veldandi U, Lopez P, Cousin M, Pandey P, Meier M. Three-year outcomes from the CRADLE study in de novo pediatric kidney transplant recipients receiving everolimus with reduced tacrolimus and early steroid withdrawal. Am J Transplant. 2021 Jan;21(1):123-137. doi: 10.1111/ajt.16005. Epub 2020 Jun 27.

title: A 12-month, Multicenter, Open Label, Randomized, Controlled Study to Evaluate the Efficacy, Tolerability and Safety of Early Introduction of Everolimus, Reduced CNI, and Early Steroid Elimination Compared to Standard CNI, Mycophenolate Mofetil and Steroid Regimen in Paediatric Renal Transplant Recipients With a 24-month Additional Safety Follow-up.

ipd_sharing_description:
Novartis is committed to sharing access to patient-level data and supporting clinical documents from eligible studies with qualified external researchers. Requests are reviewed and approved by an independent review panel on the basis of scientific merit. All data provided is anonymized to protect the privacy of patients who have participated in the trial in line with applicable laws and regulations.

This trial data availability is according to the criteria and process described on www.clinicalstudydatarequest.com

location_country:
Germany
Italy
Poland
Hungary
Argentina
Norway
United Kingdom
Brazil
Sweden
United States
Spain
Turkey
France

ipd_sharing: Undecided


title: A Randomised, Double-blind, Active Treatment Study to Induce Clinical Response and/or Remission With GSK1605786A in Subjects With Moderately-to-Severely Active Crohn's Disease

summary: This is a multi-centre, randomised, double-blind, active treatment, parallel group induction study in subjects with moderately-to-severely active Crohn's disease. Subjects will receive one of two doses (500 milligrams once daily, 500 milligrams twice daily) of GSK1605786A for 12 weeks. The primary objective of the study is to induce clinical response (Crohn's Disease Activity Index [CDAI] decrease from baseline of at least 100 points) and/or remission (CDAI score less than 150) with GSK1605786A at Week 12 in subjects with active Crohn's disease to qualify subjects for enrolment into a 52 week maintenance study (CCX114157). Secondary objectives will include assessment of the safety and evaluation of the efficacy in induction of clinical response or remission. Safety will be assessed by recording of adverse events and assessment of changes in clinical laboratory parameters, vital signs and electrocardiogram. Population pharmacokinetics will evaluate the two doses of GSK1605786A. Health outcomes assessments will include changes in Inflammatory Bowel Disease Questionnaire, SF-36, EQ-5D, and Work Productivity and Activity Impairment-Crohn's Disease.

location_country:
Germany
Poland
New Zealand
Australia
Japan
Turkey
Chile
Czechia
Canada
France
Portugal
Slovakia
Hungary
Hong Kong
Denmark
Switzerland
United States
Ukraine
Belgium
Estonia
Italy
United Kingdom
Netherlands
Austria
Korea, Republic of
Spain
Greece
Taiwan
Bulgaria
Russian Federation
Israel