title: A Five-year, Post-marketing Observational Study to Follow-up Patients With Rheumatoid Arthritis Formerly Treated in Study M02-497 (ReAct) and Subsequently Prescribed Humira

acronym: ReAlise

summary: The purpose of this observational study was to observe and assess the long term use, safety, and effectiveness of adalimumab in a normal clinical setting.

ReferenceCitation: Burmester GR, Matucci-Cerinic M, Mariette X, Navarro-Blasco F, Kary S, Unnebrink K, Kupper H. Safety and effectiveness of adalimumab in patients with rheumatoid arthritis over 5 years of therapy in a phase 3b and subsequent postmarketing observational study. Arthritis Res Ther. 2014 Jan 27;16(1):R24. doi: 10.1186/ar4452.

lead_sponsor: Abbott

location_country:
Portugal
Spain
Greece
Austria
Australia
Italy
Netherlands
United Kingdom
France
Belgium
Germany

location_facility:
Site Ref # / Investigator 49355
Site Ref # / Investigator 49835
Site Ref # / Investigator 49560
Site Ref # / Investigator 49581
Site Ref # / Investigator 50052
Site Ref # / Investigator 49600
Site Ref # / Investigator 49746
Site Ref # / Investigator 49642
Site Ref # / Investigator 49607
Site Ref # / Investigator 49442
Site Ref # / Investigator 49512
Site Ref # / Investigator 49605
Site Ref # / Investigator 49619
Site Ref # / Investigator 49666
Site Ref # / Investigator 49515
Site Ref # / Investigator 49450
Site Ref # / Investigator 49564
Site Ref # / Investigator 49788
Site Ref # / Investigator 49329
Site Ref # / Investigator 49606
Site Ref # / Investigator 49662
Site Ref # / Investigator 49827
Site Ref # / Investigator 49697
Site Ref # / Investigator 49508
Site Ref # / Investigator 49483
Site Ref # / Investigator 50057
Site Ref # / Investigator 49909
Site Ref # / Investigator 49775
Site Ref # / Investigator 26427
Site Ref # / Investigator 49649
Site Ref # / Investigator 49683
Site Ref # / Investigator 49808
Site Ref # / Investigator 49771
Site Ref # / Investigator 50053
Site Ref # / Investigator 49331
Site Ref # / Investigator 49466
Site Ref # / Investigator 49371
Site Ref # / Investigator 49365
Site Ref # / Investigator 49978
Site Ref # / Investigator 49664
Site Ref # / Investigator 49433
Site Ref # / Investigator 49665
Site Ref # / Investigator 49322
Site Ref # / Investigator 49431
Site Ref # / Investigator 49976
Site Ref # / Investigator 49598
Site Ref # / Investigator 49451
Site Ref # / Investigator 50051
Site Ref # / Investigator 49704
Site Ref # / Investigator 49573
Site Ref # / Investigator 49903
Site Ref # / Investigator 49986
Site Ref # / Investigator 49670
Site Ref # / Investigator 49620
Site Ref # / Investigator 49602
Site Ref # / Investigator 49587
Site Ref # / Investigator 49983
Site Ref # / Investigator 49748
Site Ref # / Investigator 49509
Site Ref # / Investigator 49985
Site Ref # / Investigator 49513
Site Ref # / Investigator 49580
Site Ref # / Investigator 49824
Site Ref # / Investigator 49626
Site Ref # / Investigator 49772
Site Ref # / Investigator 49987
Site Ref # / Investigator 49809
Site Ref # / Investigator 49621
Site Ref # / Investigator 49681
Site Ref # / Investigator 49627
Site Ref # / Investigator 49455
Site Ref # / Investigator 49980
Site Ref # / Investigator 49816
Site Ref # / Investigator 5590
Site Ref # / Investigator 49337
Site Ref # / Investigator 49551
Site Ref # / Investigator 49375
Site Ref # / Investigator 49476
Site Ref # / Investigator 49472
Site Ref # / Investigator 49324
Site Ref # / Investigator 5606
Site Ref # / Investigator 49789
Site Ref # / Investigator 49629
Site Ref # / Investigator 49595
Site Ref # / Investigator 49810
Site Ref # / Investigator 49774
Site Ref # / Investigator 49557
Site Ref # / Investigator 49686
Site Ref # / Investigator 49584
Site Ref # / Investigator 49325
Site Ref # / Investigator 49454
Site Ref # / Investigator 49567
Site Ref # / Investigator 26422
Site Ref # / Investigator 49449
Site Ref # / Investigator 49763
Site Ref # / Investigator 49424
Site Ref # / Investigator 49520
Site Ref # / Investigator 49667
Site Ref # / Investigator 49705
Site Ref # / Investigator 49445
Site Ref # / Investigator 49545
Site Ref # / Investigator 49618
Site Ref # / Investigator 49947
Site Ref # / Investigator 49796
Site Ref # / Investigator 49663
Site Ref # / Investigator 49556
Site Ref # / Investigator 49549
Site Ref # / Investigator 49981
Site Ref # / Investigator 49358
Site Ref # / Investigator 49989
Site Ref # / Investigator 49376
Site Ref # / Investigator 49625
Site Ref # / Investigator 49778
Site Ref # / Investigator 49946
Site Ref # / Investigator 49623
Site Ref # / Investigator 49566
Site Ref # / Investigator 49589
Site Ref # / Investigator 49523
Site Ref # / Investigator 49910
Site Ref # / Investigator 49990
Site Ref # / Investigator 49794
Site Ref # / Investigator 49984
Site Ref # / Investigator 49359
Site Ref # / Investigator 49486
Site Ref # / Investigator 49652
Site Ref # / Investigator 49332
Site Ref # / Investigator 49813
Site Ref # / Investigator 49502
Site Ref # / Investigator 49373
Site Ref # / Investigator 49906
Site Ref # / Investigator 49471
Site Ref # / Investigator 49521
Site Ref # / Investigator 49569
Site Ref # / Investigator 49645
Site Ref # / Investigator 49679
Site Ref # / Investigator 49695
Site Ref # / Investigator 49770
Site Ref # / Investigator 49441
Site Ref # / Investigator 49340
Site Ref # / Investigator 5602
Site Ref # / Investigator 49801
Site Ref # / Investigator 49648
Site Ref # / Investigator 49552
Site Ref # / Investigator 49345
Site Ref # / Investigator 49780
Site Ref # / Investigator 49609
Site Ref # / Investigator 49592
Site Ref # / Investigator 49514
Site Ref # / Investigator 49548
Site Ref # / Investigator 49814
Site Ref # / Investigator 49601
Site Ref # / Investigator 49616
Site Ref # / Investigator 49481
Site Ref # / Investigator 26424
Site Ref # / Investigator 49905
Site Ref # / Investigator 49920
Site Ref # / Investigator 49691
Site Ref # / Investigator 49806
Site Ref # / Investigator 49351
Site Ref # / Investigator 49344
Site Ref # / Investigator 49798
Site Ref # / Investigator 49330
Site Ref # / Investigator 49689
Site Ref # / Investigator 50055
Site Ref # / Investigator 49518
Site Ref # / Investigator 49617
Site Ref # / Investigator 49994
Site Ref # / Investigator 49363
Site Ref # / Investigator 49711
Site Ref # / Investigator 49482
Site Ref # / Investigator 49991
Site Ref # / Investigator 49680
Site Ref # / Investigator 49360
Site Ref # / Investigator 49948
Site Ref # / Investigator 49902
Site Ref # / Investigator 49503
Site Ref # / Investigator 49339
Site Ref # / Investigator 49469
Site Ref # / Investigator 49767
Site Ref # / Investigator 49440
Site Ref # / Investigator 49708
Site Ref # / Investigator 49781
Site Ref # / Investigator 49802
Site Ref # / Investigator 49336
Site Ref # / Investigator 49334
Site Ref # / Investigator 49694
Site Ref # / Investigator 49480
Site Ref # / Investigator 49764
Site Ref # / Investigator 49519
Site Ref # / Investigator 49829
Site Ref # / Investigator 49783
Site Ref # / Investigator 49361
Site Ref # / Investigator 49547
Site Ref # / Investigator 49822
Site Ref # / Investigator 49596
Site Ref # / Investigator 49817
Site Ref # / Investigator 49517
Site Ref # / Investigator 49795
Site Ref # / Investigator 49777
Site Ref # / Investigator 49362
Site Ref # / Investigator 49687
Site Ref # / Investigator 49793
Site Ref # / Investigator 26426
Site Ref # / Investigator 49327
Site Ref # / Investigator 49831
Site Ref # / Investigator 49825
Site Ref # / Investigator 49356
Site Ref # / Investigator 49374
Site Ref # / Investigator 49612
Site Ref # / Investigator 49326
Site Ref # / Investigator 49353
Site Ref # / Investigator 49685
Site Ref # / Investigator 49653
Site Ref # / Investigator 49797
Site Ref # / Investigator 49579
Site Ref # / Investigator 49583
Site Ref # / Investigator 49588
Site Ref # / Investigator 49350
Site Ref # / Investigator 49624
Site Ref # / Investigator 49585
Site Ref # / Investigator 49992
Site Ref # / Investigator 49974
Site Ref # / Investigator 49470
Site Ref # / Investigator 49787
Site Ref # / Investigator 49460
Site Ref # / Investigator 49447
Site Ref # / Investigator 49762
Site Ref # / Investigator 49553
Site Ref # / Investigator 49593
Site Ref # / Investigator 49805
Site Ref # / Investigator 49565
Site Ref # / Investigator 49811
Site Ref # / Investigator 49830
Site Ref # / Investigator 49591
Site Ref # / Investigator 49949
Site Ref # / Investigator 49328
Site Ref # / Investigator 49614
Site Ref # / Investigator 49544
Site Ref # / Investigator 49646
Site Ref # / Investigator 49651
Site Ref # / Investigator 49366
Site Ref # / Investigator 49352
Site Ref # / Investigator 49693
Site Ref # / Investigator 49370
Site Ref # / Investigator 49563
Site Ref # / Investigator 49510
Site Ref # / Investigator 49615
Site Ref # / Investigator 49333
Site Ref # / Investigator 49558
Site Ref # / Investigator 49904
Site Ref # / Investigator 49504
Site Ref # / Investigator 49745
Site Ref # / Investigator 49349
Site Ref # / Investigator 49474
Site Ref # / Investigator 49669
Site Ref # / Investigator 49692
Site Ref # / Investigator 49815
Site Ref # / Investigator 49608
Site Ref # / Investigator 49613
Site Ref # / Investigator 49577
Site Ref # / Investigator 49382
Site Ref # / Investigator 4961
Site Ref # / Investigator 49907
Site Ref # / Investigator 49603
Site Ref # / Investigator 49647
Site Ref # / Investigator 49908
Site Ref # / Investigator 49696
Site Ref # / Investigator 49807
Site Ref # / Investigator 49604
Site Ref # / Investigator 49348
Site Ref # / Investigator 49611
Site Ref # / Investigator 49437
Site Ref # / Investigator 49594
Site Ref # / Investigator 49768
Site Ref # / Investigator 50056
Site Ref # / Investigator 49468
Site Ref # / Investigator 49485
Site Ref # / Investigator 49766
Site Ref # / Investigator 49747
Site Ref # / Investigator 49554
Site Ref # / Investigator 49379
Site Ref # / Investigator 49610
Site Ref # / Investigator 49568
Site Ref # / Investigator 5594
Site Ref # / Investigator 49372
Site Ref # / Investigator 49346
Site Ref # / Investigator 49364
Site Ref # / Investigator 49776
Site Ref # / Investigator 49773
Site Ref # / Investigator 49785
Site Ref # / Investigator 49456
Site Ref # / Investigator 49516
Site Ref # / Investigator 49628
Site Ref # / Investigator 49323
Site Ref # / Investigator 49475
Site Ref # / Investigator 49422
Site Ref # / Investigator 26425
Site Ref # / Investigator 49582
Site Ref # / Investigator 49505
Site Ref # / Investigator 49622
Site Ref # / Investigator 49650
Site Ref # / Investigator 49342
Site Ref # / Investigator 49343
Site Ref # / Investigator 49950
Site Ref # / Investigator 49688
Site Ref # / Investigator 49654
Site Ref # / Investigator 49891
Site Ref # / Investigator 49684
Site Ref # / Investigator 49597
Site Ref # / Investigator 49791
Site Ref # / Investigator 49446

intervention_type: Biological


title: Pompe Disease Registry

summary:
The Pompe Registry is a global, multicenter, international, longitudinal, observational, and voluntary program for patients with Pompe disease, designed to track the disease's natural history and outcomes in patients, both treated and not. Data from the Registry are also used to fulfill various global regulatory commitments, to support product development/reimbursement, and for other research and non-research related purposes.

The objectives of the Registry are:

To enhance understanding of the variability, progression, identification, and natural history of Pompe disease, with the ultimate goal of better guiding and assessing therapeutic intervention.
To assist the Pompe medical community with the development of recommendations for monitoring patients, and to provide reports on patient outcomes, to optimize patient care.
To characterize the Pompe disease population.
To evaluate the long-term effectiveness of alglucosidase alfa.

study_start_date_type: Actual

status: Recruiting

study_completion_date_type: Anticipated

study_type: Observational

time_perspective: Other

enrollment_type: Anticipated

ReferenceType: background

ReferenceCitation: Kishnani PS, Amartino HM, Lindberg C, Miller TM, Wilson A, Keutzer J. Methods of diagnosis of patients with Pompe disease: Data from the Pompe Registry. Mol Genet Metab. 2014 Sep-Oct;113(1-2):84-91. doi: 10.1016/j.ymgme.2014.07.014. Epub 2014 Jul 16.

ReferenceCitation: Kishnani PS, Amartino HM, Lindberg C, Miller TM, Wilson A, Keutzer J; Pompe Registry Boards of Advisors. Timing of diagnosis of patients with Pompe disease: data from the Pompe registry. Am J Med Genet A. 2013 Oct;161A(10):2431-43. doi: 10.1002/ajmg.a.36110. Epub 2013 Aug 30.

ReferenceCitation: Byrne BJ, Kishnani PS, Case LE, Merlini L, Müller-Felber W, Prasad S, van der Ploeg A. Pompe disease: design, methodology, and early findings from the Pompe Registry. Mol Genet Metab. 2011 May;103(1):1-11. doi: 10.1016/j.ymgme.2011.02.004. Epub 2011 Feb 11. Erratum in: Mol Genet Metab. 2011 Nov;104(3):424.

ReferenceType: derived

ReferenceCitation: Zhao Y, Wang Z, Lu J, Gu X, Huang Y, Qiu Z, Wei Y, Yan C. Characteristics of Pompe disease in China: a report from the Pompe registry. Orphanet J Rare Dis. 2019 Apr 3;14(1):78. doi: 10.1186/s13023-019-1054-0.

lead_sponsor: Genzyme, a Sanofi Company

location_country:
Croatia
Serbia
Saudi Arabia
Italy
United Kingdom
United States
Belgium
Japan
Philippines
Romania
Czechia
Poland
Portugal
Russian Federation
Australia
Argentina
Indonesia
India
Israel
Malaysia
Singapore
Slovakia
Kuwait
Brazil
Lebanon
Canada
Hungary
China
Germany
Bulgaria
Denmark
Taiwan
Jordan
Greece
Thailand
Vietnam
Korea, Republic of
France
Chile
Colombia
Netherlands
Pakistan
United Arab Emirates

location_facility: Metropolitan Hospital Center-Site Number:840110

location_facility: University of Rochester Medical Center SOM-Site Number:840105

location_facility: Arkansas Childrens Hospital-Site Number:840109

location_facility: University of Florida-Genetics-Site Number:840012

location_facility: Oregon Health & Science University-Site Number:840095

location_facility: University of Florida Pediatrics Genetics-Site Number:840121

location_facility: Baylor Research Center-Site Number:840058

location_facility: University of Virginia School of Medicine-Pediatrics-Site Number:840078

location_facility: University of Missouri Health System Department of Genetics-Site Number:840031

location_facility: University of Utah Department of Medical Genetics-Site Number:840043

location_facility: Massachusetts General Hospital-Genetics-Site Number:840062

location_facility: University of Louisville- Genetics-Site Number:840030

location_facility: New York Medical College-Site Number:840039

location_facility: Children's Specialty Center of Nevada-Site Number:840008

location_facility: Barrow Neurological Institute-Site Number:840087

location_facility: University Alabama at Birmingham-Site Number:840106

location_facility: Cincinnati Children's Hospital-Genetics-Site Number:840041

location_facility: Indianapolis University School of Medicine-Site Number:840027

location_facility: Rush University Medical Center Genetics-Site Number:840079

location_facility: Atlantic Health System-Site Number:840099

location_facility: USC Health Sciences Center Dept of Genetics-Site Number:840082

location_facility: State University of New York-Site Number:840052

location_facility: Boston Children's Hospital-Site Number:840092

location_facility: University of California at San Francisco-Site Number:840051

location_facility: LSD Data Registry Site LLC-Site Number:840094

location_facility: Children's Hospital and Clinics of Minnesota-Site Number:840046

location_facility: UC Davis MIND Institute-Site Number:840010

location_facility: Phoenix Children's Hospital-Site Number:840003

location_facility: Loma Linda University Children's Hospital-Site Number:840117

location_facility: University Of Kansas Medical Center-Site Number:840020

location_facility: Oregon Health & Sciences University-Site Number:840080

location_facility: University Of Miami SOM-Site Number:840006

location_facility: Southern California Permanente Medical Group-Site Number:840108

location_facility: St. Peter's University Hospital-Site Number:840016

location_facility: Ann and Robert Lurie Children's Hospital-Site Number:840013

location_facility: Hackensack University Medical Center-Site Number:840101

location_facility: Cleveland Clinic Foundation Pediatrics-Site Number:840048

location_facility: Children's Hospital of Philadelphia-Site Number:840034

location_facility: Washington University of St. Louis-Site Number:840100

location_facility: Loma Linda University- Genetics-Site Number:840070

location_facility: Vanderbilt University Hospital-Pediatrics-Site Number:840049

location_facility: Carolinas Medical Center Hospital-Site Number:840065

location_facility: University of Nebraska Medical Center- Pediatrics-Site Number:840084

location_facility: Children's National Medical Center-Site Number:840067

location_facility: St. Joseph's Children's Hospital-Site Number:840057

location_facility: University of Pittsburgh-Site Number:840023

location_facility: University Of Washington Medical Center-Site Number:840059

location_facility: Duke University Medical Center Genetics Dept-Site Number:840037

location_facility: Ochsner Medical Center-Site Number:840120

location_facility: Emory University School of Medicine- Human Genetics-Site Number:840060

location_facility: University of Michigan Pediatrics-Site Number:840107

location_facility: University of California at San Diego-Site Number:840007

location_facility: Children's Health Care-Site Number:840114

location_facility: Children's Hospital of Orange County-Site Number:840074

location_facility: University of California at Irvine-Site Number:840036

location_facility: Children's Mercy Hospital- Pediatrics-Site Number:840063

location_facility: Children's Hospital of Philadelphia HUP Medical Genetics-Site Number:840089

location_facility: Children's Hospital of the Kings Daughters-Site Number:840072

location_facility: Mt. Sinai School of Medicine-Site Number:840005

location_facility: Children's Hospital IMD Clinic-Site Number:840069

location_facility: Children's Hospital Oakland-Site Number:840029

location_facility: Nationwide Children's Hospital-Site Number:840091

location_facility: Rhode Island Hospital Genetics-Site Number:840053

location_facility: University of Minnesota Medical Center Pediatrics-Site Number:840035

location_facility: University of Colorado at Denver Genetics-Site Number:840068

location_facility: Penn Hershey Medical Center-Site Number:840061

location_facility: University of Minnesota Medical Center Pediatrics-Site Number:840076

location_facility: Maine Medical Center Pediatrics-Site Number:840064

location_facility: Ann and Robert Lurie Children's Hospital-Site Number:840011

location_facility: New York University School Of Medicine-Site Number:840040

location_facility: Seattle Children's Hospital-Site Number:840028

location_facility: University of Arizona-Site Number:840015

location_facility: Multicare Health System � Mary Bridge Childrens Hospital-Site Number:840115

location_facility: Children's Hospital of Wisconsin-Pediatrics-Site Number:840054

location_facility: Stanford University Pediatrics-Site Number:840021

location_facility: Oregon Health and Scinece University-Site Number:840038

location_facility: Cook Children's Health Care System-Site Number:840024

location_facility: University of Arkansas for Medical Sciences-Site Number:840113

location_facility: University of Florida-Genetics-Site Number:840096

location_facility: Children's Hospital of Michigan-Site Number:840066

lead_sponsor_type: industriel

status_simplified: Ongoing


type: Other Identifier

title: A Randomized, Double-blind, Placebo-controlled, Multicenter Parallel Group Phase III Study Measuring Effects on Intima Media Thickness: an Evaluation Of Rosuvastatin 40 mg (METEOR)

summary: The purpose of this trial is to see if rosuvastatin will be effective in decreasing the thickness of the walls of the arteries in the neck for people who already have some evidence of thickening of these walls.

status: Completed

study_completion_date_type: Actual

study_type: Interventional

design_allocation: Randomized

ReferenceCitation: Peters SA, Bots ML, Lind L, Groenewegen KA, de Korte C, den Ruijter HM; METEOR study group. The impact of variability in ultrasound settings on the measured echolucency of the carotid intima-media. J Hypertens. 2013 Sep;31(9):1861-7. doi: 10.1097/HJH.0b013e3283623548.

ReferenceCitation: Lind L, Peters SA, den Ruijter HM, Palmer MK, Grobbee DE, Crouse JR 3rd, O'Leary DH, Evans GW, Raichlen JS, Bots ML; METEOR Study Group. Effect of rosuvastatin on the echolucency of the common carotid intima-media in low-risk individuals: the METEOR trial. J Am Soc Echocardiogr. 2012 Oct;25(10):1120-1127.e1. doi: 10.1016/j.echo.2012.07.004. Epub 2012 Aug 9.

ReferenceCitation: Peters SA, den Ruijter HM, Palmer MK, Grobbee DE, Crouse JR 3rd, O'Leary DH, Evans GW, Raichlen JS, Bots ML; METEOR Study Group. Biologically implausible carotid intima-media thickness measurement values: effects on rate of change over time. Curr Med Res Opin. 2012 Jun;28(6):891-9. doi: 10.1185/03007995.2012.689255. Epub 2012 Jun 6.

ReferenceCitation: Stein EA, Vidt DG, Shepherd J, Cain VA, Anzalone D, Cressman MD. Renal safety of intensive cholesterol-lowering treatment with rosuvastatin: a retrospective analysis of renal adverse events among 40,600 participants in the rosuvastatin clinical development program. Atherosclerosis. 2012 Apr;221(2):471-7. doi: 10.1016/j.atherosclerosis.2011.12.011. Epub 2012 Jan 3.

ReferenceCitation: Peters SA, den Ruijter HM, Palmer MK, Grobbee DE, Crouse JR 3rd, O'Leary DH, Evans GW, Raichlen JS, Lind L, Bots ML; METEOR Study Group. Manual or semi-automated edge detection of the maximal far wall common carotid intima-media thickness: a direct comparison. J Intern Med. 2012 Mar;271(3):247-56. doi: 10.1111/j.1365-2796.2011.02422.x. Epub 2011 Aug 11.

ReferenceCitation: Peters SA, Dogan S, Meijer R, Palmer MK, Grobbee DE, Crouse JR 3rd, O'Leary DH, Evans GW, Raichlen JS, Bots ML. The use of plaque score measurements to assess changes in atherosclerotic plaque burden induced by lipid-lowering therapy over time: the METEOR study. J Atheroscler Thromb. 2011;18(9):784-95. Epub 2011 May 27.

ReferenceCitation: Peters SA, Palmer MK, Grobbee DE, Crouse JR 3rd, Evans GW, Raichlen JS, Bots ML; METEOR Study Group. Effect of number of ultrasound examinations on the assessment of carotid intima-media thickness changes over time: the example of the METEOR study. J Hypertens. 2011 Jun;29(6):1145-54. doi: 10.1097/HJH.0b013e328345d85e.

ReferenceCitation: Peters SA, Palmer MK, Grobbee DE, Crouse JR 3rd, O'Leary DH, Raichlen JS, Bots ML. C-reactive protein lowering with rosuvastatin in the METEOR study. J Intern Med. 2010 Aug;268(2):155-61. doi: 10.1111/j.1365-2796.2010.02230.x. Epub 2010 Mar 6.

ReferenceCitation: Bots ML, Palmer MK, Dogan S, Plantinga Y, Raichlen JS, Evans GW, O'Leary DH, Grobbee DE, Crouse JR 3rd; METEOR Study Group. Intensive lipid lowering may reduce progression of carotid atherosclerosis within 12 months of treatment: the METEOR study. J Intern Med. 2009 Jun;265(6):698-707. doi: 10.1111/j.1365-2796.2009.02073.x. Epub 2009 Mar 2.

ReferenceCitation: Crouse JR 3rd, Raichlen JS, Riley WA, Evans GW, Palmer MK, O'Leary DH, Grobbee DE, Bots ML; METEOR Study Group. Effect of rosuvastatin on progression of carotid intima-media thickness in low-risk individuals with subclinical atherosclerosis: the METEOR Trial. JAMA. 2007 Mar 28;297(12):1344-53. Epub 2007 Mar 25.

ReferenceCitation: Crouse JR 3rd, Grobbee DE, O'Leary DH, Bots ML, Evans GW, Palmer MK, Riley WA, Raichlen JS; METEOR Study Group. Carotid intima-media thickness in low-risk individuals with asymptomatic atherosclerosis: baseline data from the METEOR study. Curr Med Res Opin. 2007 Mar;23(3):641-8.

lead_sponsor: AstraZeneca

location_country:
Netherlands
Finland
Czech Republic
France
United States
Belgium
Norway
Germany

intervention_type: Drug

status_simplified: Completed


title: Controlled Rosuvastatin Multinational Study in Heart Failure CORONA A Randomized, Double-Blind, Placebo Controlled Phase III Study With Rosuvastatin in Subjects With Chronic Symptomatic Systolic Heart Failure

summary: The purpose of the study is to investigate if rosuvastatin, added on top of all other medicines prescribed to subjects with symptomatic systolic heart failure, reduces the combined endpoint of cardiovascular death or non-fatal myocardial infarction or non-fatal stroke (time to first event)

primary_purpose: Prevention

ReferenceCitation: Askevold ET, Gullestad L, Nymo S, Kjekshus J, Yndestad A, Latini R, Cleland JG, McMurray JJ, Aukrust P, Ueland T. Secreted Frizzled Related Protein 3 in Chronic Heart Failure: Analysis from the Controlled Rosuvastatin Multinational Trial in Heart Failure (CORONA). PLoS One. 2015 Aug 19;10(8):e0133970. doi: 10.1371/journal.pone.0133970. eCollection 2015.

ReferenceCitation: Perez AC, Jhund PS, Stott DJ, Gullestad L, Cleland JG, van Veldhuisen DJ, Wikstrand J, Kjekshus J, McMurray JJ. Thyroid-stimulating hormone and clinical outcomes: the CORONA trial (controlled rosuvastatin multinational study in heart failure). JACC Heart Fail. 2014 Feb;2(1):35-40. doi: 10.1016/j.jchf.2013.07.008. Epub 2014 Jan 25.

ReferenceCitation: Gravning J, Askevold ET, Nymo SH, Ueland T, Wikstrand J, McMurray JJ, Aukrust P, Gullestad L, Kjekshus J; CORONA Study Group. Prognostic effect of high-sensitive troponin T assessment in elderly patients with chronic heart failure: results from the CORONA trial. Circ Heart Fail. 2014 Jan;7(1):96-103. doi: 10.1161/CIRCHEARTFAILURE.113.000450. Epub 2013 Nov 27.

ReferenceCitation: Perez AC, Jhund P, Preiss D, Kjekshus J, McMurray JJ. Effect of rosuvastatin on fatigue in patients with heart failure. J Am Coll Cardiol. 2013 Mar 12;61(10):1121-2. doi: 10.1016/j.jacc.2012.12.004.

ReferenceCitation: van der Velde AR, Gullestad L, Ueland T, Aukrust P, Guo Y, Adourian A, Muntendam P, van Veldhuisen DJ, de Boer RA. Prognostic value of changes in galectin-3 levels over time in patients with heart failure: data from CORONA and COACH. Circ Heart Fail. 2013 Mar;6(2):219-26. doi: 10.1161/CIRCHEARTFAILURE.112.000129. Epub 2013 Feb 8.

ReferenceCitation: Askevold ET, Nymo S, Ueland T, Gravning J, Wergeland R, Kjekshus J, Yndestad A, Cleland JG, McMurray JJ, Aukrust P, Gullestad L. Soluble glycoprotein 130 predicts fatal outcomes in chronic heart failure: analysis from the Controlled Rosuvastatin Multinational Trial in Heart Failure (CORONA). Circ Heart Fail. 2013 Jan;6(1):91-8. doi: 10.1161/CIRCHEARTFAILURE.112.972653. Epub 2012 Dec 10.

ReferenceCitation: Gullestad L, Ueland T, Kjekshus J, Nymo SH, Hulthe J, Muntendam P, McMurray JJ, Wikstrand J, Aukrust P. The predictive value of galectin-3 for mortality and cardiovascular events in the Controlled Rosuvastatin Multinational Trial in Heart Failure (CORONA). Am Heart J. 2012 Dec;164(6):878-83. doi: 10.1016/j.ahj.2012.08.021. Epub 2012 Oct 29.

ReferenceCitation: Latini R, Gullestad L, Masson S, Nymo SH, Ueland T, Cuccovillo I, Vårdal M, Bottazzi B, Mantovani A, Lucci D, Masuda N, Sudo Y, Wikstrand J, Tognoni G, Aukrust P, Tavazzi L; Investigators of the Controlled Rosuvastatin Multinational Trial in Heart Failure (CORONA) and GISSI-Heart Failure (GISSI-HF) trials. Pentraxin-3 in chronic heart failure: the CORONA and GISSI-HF trials. Eur J Heart Fail. 2012 Sep;14(9):992-9. Epub 2012 Jun 27.

ReferenceCitation: Ueland T, Dahl CP, Kjekshus J, Hulthe J, Böhm M, Mach F, Goudev A, Lindberg M, Wikstrand J, Aukrust P, Gullestad L. Osteoprotegerin predicts progression of chronic heart failure: results from CORONA. Circ Heart Fail. 2011 Mar;4(2):145-52. doi: 10.1161/CIRCHEARTFAILURE.110.957332. Epub 2011 Jan 7.

ReferenceCitation: McMurray JJ, Dunselman P, Wedel H, Cleland JG, Lindberg M, Hjalmarson A, Kjekshus J, Waagstein F, Apetrei E, Barrios V, Böhm M, Kamenský G, Komajda M, Mareev V, Wikstrand J; CORONA Study Group. Coenzyme Q10, rosuvastatin, and clinical outcomes in heart failure: a pre-specified substudy of CORONA (controlled rosuvastatin multinational study in heart failure). J Am Coll Cardiol. 2010 Oct 5;56(15):1196-204. doi: 10.1016/j.jacc.2010.02.075.

ReferenceCitation: Inglis SC, McMurray JJ, Böhm M, Schaufelberger M, van Veldhuisen DJ, Lindberg M, Dunselman P, Hjalmarson A, Kjekshus J, Waagstein F, Wedel H, Wikstrand J; CORONA Study Group. Intermittent claudication as a predictor of outcome in patients with ischaemic systolic heart failure: analysis of the Controlled Rosuvastatin Multinational Trial in Heart Failure trial (CORONA). Eur J Heart Fail. 2010 Jul;12(7):698-705. doi: 10.1093/eurjhf/hfq070. Epub 2010 May 25.

ReferenceCitation: McMurray JJ, Kjekshus J, Gullestad L, Dunselman P, Hjalmarson A, Wedel H, Lindberg M, Waagstein F, Grande P, Hradec J, Kamenský G, Korewicki J, Kuusi T, Mach F, Ranjith N, Wikstrand J; CORONA Study Group. Effects of statin therapy according to plasma high-sensitivity C-reactive protein concentration in the Controlled Rosuvastatin Multinational Trial in Heart Failure (CORONA): a retrospective analysis. Circulation. 2009 Dec 1;120(22):2188-96. doi: 10.1161/CIRCULATIONAHA.109.849117. Epub 2009 Nov 16. Erratum in: Circulation. 2010 Jun 29;121(25):e461.

ReferenceCitation: Kjekshus J, Apetrei E, Barrios V, Böhm M, Cleland JG, Cornel JH, Dunselman P, Fonseca C, Goudev A, Grande P, Gullestad L, Hjalmarson A, Hradec J, Jánosi A, Kamenský G, Komajda M, Korewicki J, Kuusi T, Mach F, Mareev V, McMurray JJ, Ranjith N, Schaufelberger M, Vanhaecke J, van Veldhuisen DJ, Waagstein F, Wedel H, Wikstrand J; CORONA Group. Rosuvastatin in older patients with systolic heart failure. N Engl J Med. 2007 Nov 29;357(22):2248-61. Epub 2007 Nov 5.

location_country:
Spain
United Kingdom
Romania
South Africa
Belgium
Poland
Portugal
Russian Federation
Norway
Sweden
Slovakia
Switzerland
Hungary
Germany
Bulgaria
Denmark
Ireland
Finland
Czech Republic
France
Netherlands


title: A Randomized, Open Label Study to Evaluate the Safety and Efficacy of Etanercept in the Treatment of Subjects With Psoriasis

summary: This study will provide a direct comparison of 'continuous therapy' and 'intermittent therapy' with withdrawal and retreatment upon return of psoriasis.

primary_purpose: Treatment

enrollment_type: Actual

ReferenceCitation: Griffiths CE, Christophers E, Szumski A, Jones H, Mallbris L. Impact of early vs. late disease onset on treatment response to etanercept in patients with psoriasis. Br J Dermatol. 2015 Nov;173(5):1271-3. doi: 10.1111/bjd.13865. Epub 2015 Aug 17.

ReferenceCitation: Griffiths CE, Luger TA, Brault Y, Germain JM, Mallbris L. Retreatment in patients with psoriasis achieving response with etanercept after relapse due to treatment interruption: results from the CRYSTEL study. J Eur Acad Dermatol Venereol. 2015 Mar;29(3):468-73. doi: 10.1111/jdv.12585. Epub 2014 Aug 4.

lead_sponsor: Wyeth is now a wholly owned subsidiary of Pfizer

location_country:
Denmark
Poland
Portugal
Spain
Greece
Austria
Italy
Netherlands
Finland
Czech Republic
Switzerland
United Kingdom
Sweden
Hungary
France
Turkey
Belgium
Norway
Germany


type: EudraCT Number

title: A Therapeutic Confirmatory, Open-label, Multi-center, Randomized 2 Parallel Groups, Community-based Trial Studying the Efficacy and Safety of Levetiracetam (1000 to 3000 mg/Day Oral Tablets 250-500 mg b.i.d.) Compared to Sodium Valproate (1000 to 2000 mg/Day Oral ER Tablets 300-500 mg b.i.d.) and Carbamazepine (600 to 1600 mg/Day Oral CR Tablets 200-400 mg b.i.d.) as Monotherapy in Subjects With Newly Diagnosed Epilepsy.

summary: Study N01175 was to compare overall effectiveness (efficacy and safety) of levetiracetam (LEV) versus the 2 older antiepileptic drugs (AEDs), sodium valproate extended release (VPA-ER) and carbamazepine controlled release (CBZ-CR) in the treatment of subjects with newly diagnosed epilepsy.

ReferenceCitation: Pohlmann-Eden B, Marson AG, Noack-Rink M, Ramirez F, Tofighy A, Werhahn KJ, Wild I, Trinka E. Comparative effectiveness of levetiracetam, valproate and carbamazepine among elderly patients with newly diagnosed epilepsy: subgroup analysis of the randomized, unblinded KOMET study. BMC Neurol. 2016 Aug 23;16(1):149. doi: 10.1186/s12883-016-0663-7.

ReferenceCitation: Trinka E, Marson AG, Van Paesschen W, Kälviäinen R, Marovac J, Duncan B, Buyle S, Hallström Y, Hon P, Muscas GC, Newton M, Meencke HJ, Smith PE, Pohlmann-Eden B; KOMET Study Group. KOMET: an unblinded, randomised, two parallel-group, stratified trial comparing the effectiveness of levetiracetam with controlled-release carbamazepine and extended-release sodium valproate as monotherapy in patients with newly diagnosed epilepsy. J Neurol Neurosurg Psychiatry. 2013 Oct;84(10):1138-47. doi: 10.1136/jnnp-2011-300376. Epub 2012 Aug 29.

lead_sponsor: UCB Pharma

location_country:
Spain
Italy
United Kingdom
Romania
Belgium
Poland
Austria
Australia
Russian Federation
Turkey
Norway
Sweden
Slovakia
Switzerland
Hungary
Germany
Bulgaria
Denmark
Greece
Ireland
Finland
Czech Republic
France
Netherlands


title: A Phase IIIb - IV, Randomised, Open Label Trial Evaluating the Efficacy and Safety of Tenecteplase Together With Unfractionated Heparin Prior to Early PCI as Compared to Standard Primary PCI in Patients With Acute Myocardial Infarction. ASSENT 4 PCI (Assessment of the Safety and Efficacy of a New Treatment Strategy for Acute Myocardial Infarction.)

summary: To show whether addition of thrombolytic treatment by a single bolus injection of tenecteplase prior to early standard PCI (percutaneous coronary intervention) will improve the clinical outcome in patients with large acute myocardial infarcts as compared to primary PCI alone.

status: Terminated

ReferenceType: result

ReferenceCitation: Assessment of the Safety and Efficacy of a New Treatment Strategy with Percutaneous Coronary Intervention (ASSENT-4 PCI) investigators. Primary versus tenecteplase-facilitated percutaneous coronary intervention in patients with ST-segment elevation acute myocardial infarction (ASSENT-4 PCI): randomised trial. Lancet. 2006 Feb 18;367(9510):569-78.

ReferenceCitation: Zalewski J, Bogaerts K, Desmet W, Sinnaeve P, Berger P, Grines C, Danays T, Armstrong P, Van de Werf F. Intraluminal thrombus in facilitated versus primary percutaneous coronary intervention: an angiographic substudy of the ASSENT-4 PCI (Assessment of the Safety and Efficacy of a New Treatment Strategy with Percutaneous Coronary Intervention) trial. J Am Coll Cardiol. 2011 May 10;57(19):1867-73. doi: 10.1016/j.jacc.2010.10.061.

ReferenceCitation: Jarai R, Huber K, Bogaerts K, Sinnaeve PR, Ezekowitz J, Ross AM, Zeymer U, Armstrong PW, Van de Werf FJ; ASSENT-4 PCI investigators. Prediction of cardiogenic shock using plasma B-type natriuretic peptide and the N-terminal fragment of its pro-hormone [corrected] concentrations in ST elevation myocardial infarction: an analysis from the ASSENT-4 Percutaneous Coronary Intervention Trial. Crit Care Med. 2010 Sep;38(9):1793-801. doi: 10.1097/CCM.0b013e3181eaaf2a. Erratum in: Crit Care Med. 2010 Dec;38(12):2430.

lead_sponsor: Boehringer Ingelheim

location_country:
Poland
Brazil
Portugal
Greece
Austria
Ireland
Italy
Canada
Czech Republic
Mexico
Thailand
Hungary
United States
France
Turkey
Belgium
Norway
Germany

location_facility: Boehringer Ingelheim Investigational Site

intervention_type: Procedure

status_simplified: Unknown


title: A Prospective Registry of European Hemophilia B Patients Receiving BeneFIX®(Nonacog Alfa, Recombinant Human Factor IX) for Usual Use

summary: This is an open-label multi-center Registry in patients with hemophilia B receiving BeneFIX. All patients who begin treatment with BeneFIX in European Union countries, will be eligible for participation. Patient demographics will be collected at baseline for all patients. A baseline FIX activity and Bethesda assay for inhibitor based on historical data should be recorded if available. Adverse events as defined in the protocol will also be reported on the appropriate forms. Data will be collected from patients on an ongoing basis to ensure that information is being captured for each patient being treated with BeneFIX.

time_perspective: Prospective

ReferenceCitation: Rendo P, Smith L, Lee HY, Shafer F. Nonacog alfa: an analysis of safety data from six prospective clinical studies in different patient populations with haemophilia B treated with different therapeutic modalities. Blood Coagul Fibrinolysis. 2015 Dec;26(8):912-8. doi: 10.1097/MBC.0000000000000359.

location_country:
Portugal
Spain
Italy
Austria
Netherlands
United Kingdom
Sweden
France
Belgium
Germany


title: A Double-Blind, Placebo-Controlled, Randomized 24-Month Study, Assessing The Effect Of Celecoxib (Celebrex) Long Term Treatment On Hip Osteoarthritis (OA) Progression OSCARE

summary:
Objectives of the study:

Primary: Assess the ability of a continuous treatment of celecoxib 200 mg versus placebo administered once daily (QD) for 24 months in slowing disease progression as assessed radiographically in subjects with osteoarthritis (OA) of the hipSecondary:Assess the ability of a continuous treatment of celecoxib 200 mg versus placebo administered QD for 24 months in treating disease signs and symptoms in subjects with OA of the hip.Evaluate the ability of a continuous 24-month intake of celecoxib 200 mg QD versus placebo to reduce number of subjects eligible for hip replacement according to the investigator.Evaluate the tolerability and safety of a continuous 24-month intake of celecoxib 200 mg QD versus placebo in subjects with OA of the hip.

lead_sponsor: Pfizer's Upjohn has merged with Mylan to form Viatris Inc.

location_country: Canada France


title: A Multicenter, Randomized Double-Blind Study Comparing The Pleiotropic Effects Of Atorvastatin 10 Mg And 80 Mg Over A 26-Week Period In Subjects With Coronary Atherosclerosis

acronym: CAP

summary: The primary objective of the study is to evaluate the efficacy of atorvastatin 80 mg daily as compared to atorvastatin 10 mg daily in reducing C-reactive protein levels over a 26-week treatment period in subjects with documented coronary artery disease.

ReferenceCitation: Bonnet J, McPherson R, Tedgui A, Simoneau D, Nozza A, Martineau P, Davignon J; CAP Investigators. Comparative effects of 10-mg versus 80-mg Atorvastatin on high-sensitivity C-reactive protein in patients with stable coronary artery disease: results of the CAP (Comparative Atorvastatin Pleiotropic effects) study. Clin Ther. 2008 Dec;30(12):2298-313. doi: 10.1016/j.clinthera.2008.12.023.

location_country:
Poland
Russian Federation
Canada
France
Romania
Slovakia
Czechia


title: Carotid Atorvastatin Study In Hyperlipidemic Post-Menopausal Women: A Randomized Evaluation of Atorvastatin, Versus Placebo (CASHMERE)

summary: To evaluate the effect of atorvastatin 80 mg, versus placebo, given for 12 months on carotid intima-media thickness in postmenopausal women with moderate hypercholesterolemia.

ReferenceCitation: Gompel A, Boutouyrie P, Joannides R, Christin-Maitre S, Kearny-Schwartz A, Kunz K, Laurent S, Boivin JM, Pannier B, Pornel B, Struijker-Boudier HA, Thuillez C, Van Bortel L, Zannad F, Pithois-Merli I, Jaillon P, Simon T. Association of menopause and hormone replacement therapy with large artery remodeling. Fertil Steril. 2011 Dec;96(6):1445-50. doi: 10.1016/j.fertnstert.2011.09.010. Epub 2011 Oct 6.

location_country: Netherlands France Belgium