Post-marketing Observational Study in Subjects With Rheumatoid Arthritis (ReAlise)

August 25, 2011 updated by: Abbott

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

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.

Study Overview

Status

Completed

Conditions

Rheumatoid Arthritis

Intervention / Treatment

Biological: adalimumab

Detailed Description

This was a multicenter, uncontrolled, 5-year observational study of adalimumab in the treatment of patients with rheumatoid arthritis (RA) who had received adalimumab for at least 3 months in NCT00448383 (Study M02-497), an interventional study that ended when adalimumab became commercially available for the treatment of RA. Participants had to have been receiving ongoing adalimumab treatment at the time NCT00448383 (Study M02-497) ended and been prescribed commercial adalimumab, and could have received commercial adalimumab for up to 1 year afterward prior to enrollment in NCT00234884 (Study M03-634).

Physician investigators were encouraged to treat participants as they would any other patient with RA in their routine clinical practice, and were free to determine the appropriate therapy for each patient. Concomitant treatment with disease-modifying antirheumatic drugs (DMARDs), including methotrexate, could be continued while receiving adalimumab. If treatment with adalimumab was permanently discontinued for any reason, participants were discontinued from the study and the reason was recorded. Investigators were asked to record adverse events up to 3 months after last administration of adalimumab.

Study Type

Observational

Enrollment (Actual)

3435

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Australia
- - Cairns, Australia, 4870
    - Site Ref # / Investigator 49502
- New South Wales
  - Camperdown, New South Wales, Australia, 2050
    - Site Ref # / Investigator 5606
  - New Lambton, New South Wales, Australia, 2305
    - Site Ref # / Investigator 49504
- Queensland
  - Brisbane, Queensland, Australia, 4102
    - Site Ref # / Investigator 49508
- South Australia
  - Woodville, South Australia, Australia, 5011
    - Site Ref # / Investigator 49505
- Victoria
  - West Heidelberg, Victoria, Australia, 3081
    - Site Ref # / Investigator 49503
Austria
- - Bad Schallerbach, Austria, 4701
    - Site Ref # / Investigator 49747
  - Graz, Austria, 8036
    - Site Ref # / Investigator 49517
  - Graz, Austria, A-8020
    - Site Ref # / Investigator 49521
  - Innsbruck, Austria, A-6020
    - Site Ref # / Investigator 49518
  - Klagenfurt, Austria, 9020
    - Site Ref # / Investigator 49746
  - Laab im Walde, Austria, 2381
    - Site Ref # / Investigator 49748
  - Linz, Austria, 4020
    - Site Ref # / Investigator 49516
  - Oberpullendorf, Austria, 7350
    - Site Ref # / Investigator 49523
  - St. Poelten, Austria, 3100
    - Site Ref # / Investigator 49745
  - Stockerau, Austria, 2000
    - Site Ref # / Investigator 49519
  - Vienna, Austria, 1090
    - Site Ref # / Investigator 49520
  - Vienna, Austria, 1130
    - Site Ref # / Investigator 4961
Belgium
- - Aalst, Belgium, 9300
    - Site Ref # / Investigator 49794
  - Antwerp, Belgium, 2020
    - Site Ref # / Investigator 49817
  - Assebroek, Belgium, 8310
    - Site Ref # / Investigator 49788
  - Baudour, Belgium, 7331
    - Site Ref # / Investigator 49764
  - Belsele, Belgium, 9111
    - Site Ref # / Investigator 49808
  - Bonheiden, Belgium, 2820
    - Site Ref # / Investigator 49806
  - Bonheiden, Belgium, 2820
    - Site Ref # / Investigator 49809
  - Braine-l'Alleud, Belgium, 1421
    - Site Ref # / Investigator 49798
  - Bruges, Belgium, 8000
    - Site Ref # / Investigator 49773
  - Brussels, Belgium, 1000
    - Site Ref # / Investigator 49774
  - Brussels, Belgium, 1020
    - Site Ref # / Investigator 49763
  - Brussels, Belgium, 1050
    - Site Ref # / Investigator 49791
  - Brussels, Belgium, 1070
    - Site Ref # / Investigator 49762
  - Brussels, Belgium, 1090
    - Site Ref # / Investigator 49811
  - Brussels, Belgium, 1180
    - Site Ref # / Investigator 49807
  - Brussels, Belgium, 1200
    - Site Ref # / Investigator 49772
  - Chimay, Belgium, 6460
    - Site Ref # / Investigator 49780
  - Destelbergen, Belgium, 9070
    - Site Ref # / Investigator 49795
  - Edegem, Belgium, 2650
    - Site Ref # / Investigator 49768
  - Genk, Belgium, 3600
    - Site Ref # / Investigator 49776
  - Genk, Belgium, 3600
    - Site Ref # / Investigator 49813
  - Ghent, Belgium, 9000
    - Site Ref # / Investigator 26424
  - Gosselies, Belgium, 6041
    - Site Ref # / Investigator 49766
  - Hamme, Belgium, 9220
    - Site Ref # / Investigator 49781
  - Hasselt, Belgium, 3500
    - Site Ref # / Investigator 49814
  - Hasselt, Belgium, B-3500
    - Site Ref # / Investigator 49810
  - Kortrijk, Belgium, 8500
    - Site Ref # / Investigator 49777
  - La Louviere, Belgium, 7100
    - Site Ref # / Investigator 49767
  - La Louviere, Belgium, 7100
    - Site Ref # / Investigator 49801
  - Leuven, Belgium, 3000
    - Site Ref # / Investigator 49816
  - Liege, Belgium, 4000
    - Site Ref # / Investigator 49789
  - Lier, Belgium, 2500
    - Site Ref # / Investigator 49775
  - Lokeren, Belgium, 9160
    - Site Ref # / Investigator 49778
  - Mechelen, Belgium, 2800
    - Site Ref # / Investigator 49771
  - Mechelen, Belgium, 2800
    - Site Ref # / Investigator 49815
  - Merksem, Belgium, 2170
    - Site Ref # / Investigator 49796
  - Mons, Belgium, 7000
    - Site Ref # / Investigator 49785
  - Montignies-sur-Sambre, Belgium, 6061
    - Site Ref # / Investigator 49891
  - Namur, Belgium, 5000
    - Site Ref # / Investigator 49770
  - Namur, Belgium, 5000
    - Site Ref # / Investigator 49783
  - Nukerke, Belgium, 9681
    - Site Ref # / Investigator 49797
  - Oostende, Belgium, 8400
    - Site Ref # / Investigator 49787
  - Ottignies, Belgium, 1340
    - Site Ref # / Investigator 49802
  - Sijsele, Belgium, 8340
    - Site Ref # / Investigator 49793
  - Sint-Niklaas, Belgium, 9100
    - Site Ref # / Investigator 49805
France
- - Aix Les Bains, France, 73106
    - Site Ref # / Investigator 49332
  - Aix en Provence, France, 13616
    - Site Ref # / Investigator 49615
  - Angers, France, 49033
    - Site Ref # / Investigator 49350
  - Aulnay Sous Bois, France, 93602
    - Site Ref # / Investigator 49604
  - Belfort, France, 90016
    - Site Ref # / Investigator 49340
  - Berck, France, 62608
    - Site Ref # / Investigator 49621
  - Besancon, France, 25030
    - Site Ref # / Investigator 49339
  - Bobigny, France, 93009
    - Site Ref # / Investigator 49351
  - Bordeaux, France, 33076
    - Site Ref # / Investigator 49365
  - Boulogne Billancourt, France, 92100
    - Site Ref # / Investigator 49611
  - Bourg en Bresse, France, 01012
    - Site Ref # / Investigator 49622
  - Brest, France, 29609
    - Site Ref # / Investigator 49329
  - Caen, France, 14033
    - Site Ref # / Investigator 49334
  - Cahors, France, 46005
    - Site Ref # / Investigator 49358
  - Cannes, France, 06400
    - Site Ref # / Investigator 49607
  - Carcassonne, France, 11012
    - Site Ref # / Investigator 49612
  - Cherbourg, France, 50102
    - Site Ref # / Investigator 49628
  - Clermont-Ferrand, France, 63003
    - Site Ref # / Investigator 49613
  - Colombes, France, 92701
    - Site Ref # / Investigator 49624
  - Compiegne, France, 60200
    - Site Ref # / Investigator 49376
  - Corbeil Essonnes, France, 91108
    - Site Ref # / Investigator 49356
  - Creteil, France, 94010
    - Site Ref # / Investigator 49370
  - Dijon, France, 21033
    - Site Ref # / Investigator 49605
  - Gleize, France, 69400
    - Site Ref # / Investigator 49608
  - Gonesse, France, 95503
    - Site Ref # / Investigator 49610
  - Grenoble, France, 38000
    - Site Ref # / Investigator 49379
  - Grenoble, France, 38042
    - Site Ref # / Investigator 49361
  - La Roche sur Yon, France, 85925
    - Site Ref # / Investigator 49614
  - La Rochelle, France, 17019
    - Site Ref # / Investigator 49601
  - Le Kremlin Bicetre, France, 94275
    - Site Ref # / Investigator 49373
  - Le Mans, France, 72037
    - Site Ref # / Investigator 49375
  - Libourne, France, 33505
    - Site Ref # / Investigator 49325
  - Lievin, France, 62806
    - Site Ref # / Investigator 49620
  - Lille, France, 59037
    - Site Ref # / Investigator 49360
  - Limoges, France, 87042
    - Site Ref # / Investigator 49623
  - Lomme, France, 59462
    - Site Ref # / Investigator 49333
  - Lunel, France, 34400
    - Site Ref # / Investigator 49355
  - Lyon, France, 69310
    - Site Ref # / Investigator 49337
  - Lyon, France, 69365
    - Site Ref # / Investigator 49363
  - Lyon, France, 69437
    - Site Ref # / Investigator 49364
  - Mantes La Jolie, France, 78201
    - Site Ref # / Investigator 49603
  - Marseilles, France, 13274
    - Site Ref # / Investigator 49626
  - Marseilles, France, 13285
    - Site Ref # / Investigator 49342
  - Marseilles, France, 13385
    - Site Ref # / Investigator 49345
  - Marseilles, France, 13385
    - Site Ref # / Investigator 49362
  - Montivilliers, France, 76290
    - Site Ref # / Investigator 49330
  - Montpellier Cedex 5, France, 34295
    - Site Ref # / Investigator 49323
  - Mulhouse, France, 68070
    - Site Ref # / Investigator 5590
  - Nantes Cedex 1, France, 44035
    - Site Ref # / Investigator 49374
  - Narbonne, France, 11108
    - Site Ref # / Investigator 49642
  - Nice, France, 06200
    - Site Ref # / Investigator 49353
  - Orange, France, 84106
    - Site Ref # / Investigator 49618
  - Orleans, France, 45032
    - Site Ref # / Investigator 49331
  - Paris, France, 75014
    - Site Ref # / Investigator 49326
  - Paris, France, 75016
    - Site Ref # / Investigator 49600
  - Paris, France, 75475
    - Site Ref # / Investigator 49625
  - Paris, France, 75651
    - Site Ref # / Investigator 49359
  - Paris Cedex 14, France, 75679
    - Site Ref # / Investigator 49352
  - Pau, France, 64046
    - Site Ref # / Investigator 49343
  - Pessac, France, 33604
    - Site Ref # / Investigator 49344
  - Pierre Benite, France, 69495
    - Site Ref # / Investigator 49606
  - Poissy, France, 78303
    - Site Ref # / Investigator 49602
  - Poitiers, France, 86021
    - Site Ref # / Investigator 49349
  - Provins, France, 77488
    - Site Ref # / Investigator 49627
  - Reims, France, 51100
    - Site Ref # / Investigator 49382
  - Rennes, France, 35056
    - Site Ref # / Investigator 49328
  - Roubaix, France, 59056
    - Site Ref # / Investigator 49619
  - Rouen, France, 76031
    - Site Ref # / Investigator 49372
  - Saint Aubin Les Elbeuf, France, 76410
    - Site Ref # / Investigator 49609
  - Saint Brieuc, France, 22023
    - Site Ref # / Investigator 49327
  - Saint Maurice, France, 94415
    - Site Ref # / Investigator 49336
  - Saint-Etienne, France, 42055
    - Site Ref # / Investigator 49598
  - Strasbourg, France, 67098
    - Site Ref # / Investigator 49346
  - Thionville, France, 57126
    - Site Ref # / Investigator 49366
  - Toulon, France, 83800
    - Site Ref # / Investigator 49616
  - Toulouse, France, 31059
    - Site Ref # / Investigator 49322
  - Toulouse, France, 31059
    - Site Ref # / Investigator 49348
  - Tours, France, 37044
    - Site Ref # / Investigator 49324
  - Valence, France, 26953
    - Site Ref # / Investigator 49617
  - Valenciennes, France, 59322
    - Site Ref # / Investigator 49371
  - Vannes, France, 56017
    - Site Ref # / Investigator 49629
Germany
- - Aachen, Germany, 52064
    - Site Ref # / Investigator 49573
  - Berlin, Germany, 12163
    - Site Ref # / Investigator 49454
  - Berlin, Germany, 12627
    - Site Ref # / Investigator 49705
  - Berlin, Germany, 14163
    - Site Ref # / Investigator 49480
  - Berlin, Germany, D-10117
    - Site Ref # / Investigator 49433
  - Bremen, Germany, 28209
    - Site Ref # / Investigator 49577
  - Chemnitz, Germany, D-09130
    - Site Ref # / Investigator 49451
  - Cologne, Germany, 50823
    - Site Ref # / Investigator 49551
  - Cottbus, Germany, 3048
    - Site Ref # / Investigator 5602
  - Damp, Germany, 24351
    - Site Ref # / Investigator 49441
  - Dresden, Germany, 01277
    - Site Ref # / Investigator 49446
  - Dresden, Germany, 01307
    - Site Ref # / Investigator 49474
  - Duisburg, Germany, 47055
    - Site Ref # / Investigator 49483
  - Erfurt, Germany, 99096
    - Site Ref # / Investigator 49455
  - Erlangen, Germany, 91054
    - Site Ref # / Investigator 49579
  - Erlangen, Germany, 91056
    - Site Ref # / Investigator 49475
  - Essen, Germany, 45239
    - Site Ref # / Investigator 49481
  - Freiburg, Germany, 79098
    - Site Ref # / Investigator 49469
  - Freiburg, Germany, 79106
    - Site Ref # / Investigator 49711
  - Fuerth, Germany, 90766
    - Site Ref # / Investigator 49556
  - Gyhum, Germany, 27404
    - Site Ref # / Investigator 49482
  - Halle, Germany, 06128
    - Site Ref # / Investigator 49422
  - Hamburg, Germany, 20246
    - Site Ref # / Investigator 49468
  - Hamburg, Germany, 22081
    - Site Ref # / Investigator 49552
  - Hattingen, Germany, 45525
    - Site Ref # / Investigator 49466
  - Herrsching, Germany, 82211
    - Site Ref # / Investigator 49544
  - Hildesheim, Germany, 31134
    - Site Ref # / Investigator 49548
  - Hofheim, Germany, 65719
    - Site Ref # / Investigator 49587
  - Jena, Germany, 07747
    - Site Ref # / Investigator 49447
  - Leipzig, Germany, 04207
    - Site Ref # / Investigator 49431
  - Ludwigsburg, Germany, 71638
    - Site Ref # / Investigator 49424
  - Ludwigshafen, Germany, 67065
    - Site Ref # / Investigator 49557
  - Marl, Germany, 45770
    - Site Ref # / Investigator 49704
  - Moenchengladbach, Germany, 41199
    - Site Ref # / Investigator 49547
  - Muenster, Germany, 48129
    - Site Ref # / Investigator 49440
  - Munich, Germany, 80331
    - Site Ref # / Investigator 49450
  - Munich, Germany, 81667
    - Site Ref # / Investigator 49563
  - Passau, Germany, 94032
    - Site Ref # / Investigator 49442
  - Ratingen, Germany, 40882
    - Site Ref # / Investigator 49549
  - Rostock, Germany, 18059
    - Site Ref # / Investigator 49708
  - Schlangenbad, Germany, 65388
    - Site Ref # / Investigator 49558
  - Sendenhorst, Germany, 48324
    - Site Ref # / Investigator 49445
  - Stuttgart, Germany, 70178
    - Site Ref # / Investigator 49437
  - Tuebingen, Germany, 72076
    - Site Ref # / Investigator 49560
  - Villingen, Germany, 78054
    - Site Ref # / Investigator 49460
  - Vogelsang-Gommern, Germany, 39245
    - Site Ref # / Investigator 49456
  - Wuerzburg, Germany, 97070
    - Site Ref # / Investigator 49545
  - Wuppertal, Germany, 42117
    - Site Ref # / Investigator 49449
Greece
- - Athens, Greece, 10682
    - Site Ref # / Investigator 49580
  - Athens, Greece, 11521
    - Site Ref # / Investigator 49568
  - Athens, Greece, 11521
    - Site Ref # / Investigator 49584
  - Athens, Greece, 11526
    - Site Ref # / Investigator 49554
  - Athens, Greece, 11527
    - Site Ref # / Investigator 49565
  - Athens, Greece, 11527
    - Site Ref # / Investigator 49583
  - Athens, Greece, 14500
    - Site Ref # / Investigator 49585
  - Heraklion, Greece, 81352
    - Site Ref # / Investigator 49564
  - Ioannina, Greece, 45500
    - Site Ref # / Investigator 49567
  - Larisa, Greece, 41110
    - Site Ref # / Investigator 49581
  - Patras, Greece, 26500
    - Site Ref # / Investigator 26425
  - Thessaloniki, Greece, 54625
    - Site Ref # / Investigator 49566
  - Thessaloniki, Greece, 54636
    - Site Ref # / Investigator 49582
  - Thessaloniki, Greece, 54642
    - Site Ref # / Investigator 49553
  - Thessaloniki, Greece, 57010
    - Site Ref # / Investigator 49569
Italy
- - Acqui Terme (AL), Italy, 15011
    - Site Ref # / Investigator 49990
  - Arenzano (GE), Italy, 16011
    - Site Ref # / Investigator 49591
  - Bari, Italy, 70124
    - Site Ref # / Investigator 49983
  - Bologna, Italy, 40138
    - Site Ref # / Investigator 49593
  - Brescia, Italy, 25123
    - Site Ref # / Investigator 49980
  - Cagliari, Italy, 09042
    - Site Ref # / Investigator 49986
  - Ferrara, Italy, 44100
    - Site Ref # / Investigator 50056
  - Florence, Italy, 50100
    - Site Ref # / Investigator 49987
  - Foggia, Italy, 71100
    - Site Ref # / Investigator 49597
  - Genoa, Italy, 16132
    - Site Ref # / Investigator 49824
  - Genoa, Italy, 16148
    - Site Ref # / Investigator 50051
  - Jesi (Ancona), Italy, 60035
    - Site Ref # / Investigator 49981
  - Messina, Italy, 98125
    - Site Ref # / Investigator 49588
  - Milano, Italy, 20122
    - Site Ref # / Investigator 49976
  - Milano, Italy, 20132
    - Site Ref # / Investigator 50052
  - Milano, Italy, 20162
    - Site Ref # / Investigator 49596
  - Modena, Italy, 41100
    - Site Ref # / Investigator 49985
  - Naples, Italy, 80135
    - Site Ref # / Investigator 49949
  - Novara, Italy, 28100
    - Site Ref # / Investigator 49595
  - Padova, Italy, 35128
    - Site Ref # / Investigator 49947
  - Palermo, Italy, 90127
    - Site Ref # / Investigator 49948
  - Perugia, Italy, 06126
    - Site Ref # / Investigator 49978
  - Pescara, Italy, 65126
    - Site Ref # / Investigator 49974
  - Pisa, Italy, 56126
    - Site Ref # / Investigator 49592
  - Potenza, Italy, 85100
    - Site Ref # / Investigator 49992
  - Prato, Italy, 59100
    - Site Ref # / Investigator 49822
  - Reggio Emilia, Italy, 42100
    - Site Ref # / Investigator 49946
  - Rome, Italy, 00152
    - Site Ref # / Investigator 49989
  - Rome, Italy, 00161
    - Site Ref # / Investigator 49950
  - Rome, Italy, 00168
    - Site Ref # / Investigator 50057
  - Rozzano, Italy, 20089
    - Site Ref # / Investigator 49984
  - San Cesario Lecce, Italy, 73016
    - Site Ref # / Investigator 49991
  - Torino, Italy, 10128
    - Site Ref # / Investigator 49994
  - Udine, Italy, 33100
    - Site Ref # / Investigator 49825
  - Valeggio sul Mincio Verona, Italy, 37067
    - Site Ref # / Investigator 26422
  - Varese, Italy, 21100
    - Site Ref # / Investigator 49594
  - Verbania Pallanza, Italy, 28048
    - Site Ref # / Investigator 50055
  - Verona, Italy, 37134
    - Site Ref # / Investigator 49589
  - Vimercate, Italy, 20059
    - Site Ref # / Investigator 50053
Netherlands
- - Alkmaar, Netherlands, 1815 JD
    - Site Ref # / Investigator 49904
  - Almere, Netherlands, 1315 RA
    - Site Ref # / Investigator 49909
  - Amersfoort, Netherlands, 3818 ES
    - Site Ref # / Investigator 49831
  - Bergen op Zoom, Netherlands, 4624 VT
    - Site Ref # / Investigator 49906
  - Breda, Netherlands, 4818 CK
    - Site Ref # / Investigator 49907
  - Den Haag, Netherlands, 2545 CH
    - Site Ref # / Investigator 49905
  - Den Haag, Netherlands, 2597 AX
    - Site Ref # / Investigator 49920
  - Den Helder, Netherlands, 1780 AT
    - Site Ref # / Investigator 49910
  - Goes, Netherlands, 4462 RA
    - Site Ref # / Investigator 49902
  - Leeuwarden, Netherlands, 8934 AD
    - Site Ref # / Investigator 49829
  - Rotterdam, Netherlands, 3015 GD
    - Site Ref # / Investigator 26426
  - Rotterdam, Netherlands, 3078 HT
    - Site Ref # / Investigator 49830
  - Schiedam, Netherlands, 3118 JH
    - Site Ref # / Investigator 49908
  - Utrecht, Netherlands, GA 3508
    - Site Ref # / Investigator 49827
  - Venlo, Netherlands, 5912 BL
    - Site Ref # / Investigator 49903
  - Vlissingen, Netherlands, 4382 EE
    - Site Ref # / Investigator 49835
Portugal
- - Coimbra, Portugal, 3000-075
    - Site Ref # / Investigator 49514
  - Lisboa, Portugal, 1050-034
    - Site Ref # / Investigator 49515
  - Lisboa, Portugal, 1200
    - Site Ref # / Investigator 49509
  - Lisbon, Portugal, 1349-019
    - Site Ref # / Investigator 49510
  - Lisbon, Portugal, 1649-035
    - Site Ref # / Investigator 49513
  - Ponta Delgada-Acores, Portugal, 9500-370
    - Site Ref # / Investigator 49512
  - Ponte de Lima, Portugal, 4990-041
    - Site Ref # / Investigator 26427
Spain
- - Alicante, Spain, 3010
    - Site Ref # / Investigator 49653
  - Asturias, Spain, 33006
    - Site Ref # / Investigator 49662
  - Barcelona, Spain, 08003
    - Site Ref # / Investigator 49684
  - Barcelona, Spain, 08022
    - Site Ref # / Investigator 49680
  - Barcelona, Spain, 08025
    - Site Ref # / Investigator 49646
  - Barcelona, Spain, 08036
    - Site Ref # / Investigator 49645
  - Barcelona, Spain, 08208
    - Site Ref # / Investigator 49649
  - Barcelona, Spain, 08221
    - Site Ref # / Investigator 49647
  - Barcelona, Spain, 08907
    - Site Ref # / Investigator 49670
  - Cadiz, Spain, 11009
    - Site Ref # / Investigator 49667
  - Cadiz, Spain, 11407
    - Site Ref # / Investigator 49693
  - Castellon de la Plana, Spain, 12004
    - Site Ref # / Investigator 5594
  - Cordoba, Spain, 14004
    - Site Ref # / Investigator 49663
  - Elche, Spain, 32032
    - Site Ref # / Investigator 49652
  - Granada, Spain, 18012
    - Site Ref # / Investigator 49651
  - Granada, Spain, 18014
    - Site Ref # / Investigator 49681
  - Guadalajara, Spain, 19002
    - Site Ref # / Investigator 49695
  - Jaen, Spain, 23007
    - Site Ref # / Investigator 49669
  - Lerida, Spain, 25198
    - Site Ref # / Investigator 49689
  - Madrid, Spain, 28007
    - Site Ref # / Investigator 49686
  - Madrid, Spain, 28034
    - Site Ref # / Investigator 49697
  - Madrid, Spain, 28040
    - Site Ref # / Investigator 49679
  - Madrid, Spain, 28041
    - Site Ref # / Investigator 49650
  - Madrid, Spain, 28046
    - Site Ref # / Investigator 49683
  - Madrid, Spain, 28222
    - Site Ref # / Investigator 49687
  - Madrid, Spain, 28905
    - Site Ref # / Investigator 49692
  - Madrid, Spain, 28911
    - Site Ref # / Investigator 49664
  - Madrid, Spain, 28922
    - Site Ref # / Investigator 49696
  - Malaga, Spain, 29010
    - Site Ref # / Investigator 49665
  - Malaga, Spain, 29010
    - Site Ref # / Investigator 49691
  - Mostoles-Madrid, Spain, 28935
    - Site Ref # / Investigator 49685
  - Sant Joan Despi (Barcelona), Spain, 08970
    - Site Ref # / Investigator 49666
  - Seville, Spain, 41071
    - Site Ref # / Investigator 49688
  - Toledo, Spain, 45004
    - Site Ref # / Investigator 49694
  - Valencia, Spain, 46017
    - Site Ref # / Investigator 49654
  - Vic (Barcelona), Spain, 08500
    - Site Ref # / Investigator 49648
United Kingdom
- - Brighton, United Kingdom, BN2 5BE
    - Site Ref # / Investigator 49485
  - Greater Manchester, United Kingdom, M6 8HD
    - Site Ref # / Investigator 49470
  - Harrogate, United Kingdom, HG2 7SX
    - Site Ref # / Investigator 49471
  - Manchester, United Kingdom, M41 5SL
    - Site Ref # / Investigator 49476
  - Oxford, United Kingdom, OX3 7LD
    - Site Ref # / Investigator 49486
  - Wigan, United Kingdom, WN6 9EP
    - Site Ref # / Investigator 49472

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Participants were patients with rheumatoid arthritis (RA) who had received adalimumab for at least 3 months in NCT00448383 (Study M02-497) and had been prescribed commercial adalimumab following termination of that study. At the time of enrollment in NCT00448383 (Study M02-497), participants had failed one or more disease-modifying antirheumatic drugs (DMARDs) and had active, moderate to severe RA despite concurrent RA treatment.

Description

Inclusion Criteria:

Participants with ongoing adalimumab treatment who completed at least Month 3 (Visit 5) of NCT00448383 (Study M02-497) and who had subsequently been prescribed adalimumab according to the Summary of Product Characteristics (SmPC).
Participants must have been willing to consent to data being collected and provided to Abbott.

Exclusion Criteria:

· Participants with contraindications according to the SmPC.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Number of groups / cohorts

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Adalimumab RA patients in treatment with commercial adalimumab	Biological: adalimumab commercial adalimumab as prescribed by the rheumatologist in a normal clinical setting and in accordance with the Summary of Product Characteristics (SmPC) Other Names: HUMIRA®

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Disease Activity Score in 28 Joints (DAS28) Based on Erythrocyte Sedimentation Rate (ESR) Time Frame: Baseline, Months 12, 24, 36, 48, and 60, and Last Observed Value	DAS28 is a composite measure of disease activity in patients with rheumatoid arthritis. It is calculated on the basis of tender and swollen joint counts (each assessed in 28 joints), the patient's ESR, and the patient's subjective assessment of disease activity (assessed using a 100-mm visual analog scale). A DAS28 less than 3.2 indicates low disease activity and a DAS28 greater than 5.1 indicates high disease activity; there is no absolute range of scores due to inter-patient variability in ESR.	Baseline, Months 12, 24, 36, 48, and 60, and Last Observed Value
American College of Rheumatology 20% (ACR20) Response Rate Time Frame: Baseline, Months 12, 24, 36, 48, and 60, and Last Observed Value	ACR20 response is a 20% or better improvement from Baseline in tender joint count, swollen joint count, and at least 3 of the following 5 parameters: patient's assessment of pain, patient's global assessment of disease activity, physician's global assessment of disease activity, Health Assessment Questionnaire Disability Index (HAQ-DI), and C-reactive protein. Response was calculated based on values at Baseline of NCT00448383 (Study M02-497).	Baseline, Months 12, 24, 36, 48, and 60, and Last Observed Value
American College of Rheumatology 50% (ACR50) Response Rate Time Frame: Baseline, Months 12, 24, 36, 48, and 60, and Last Observed Value	ACR50 response is a 50% or better improvement from Baseline in tender joint count, swollen joint count, and at least 3 of the following 5 parameters: patient's assessment of pain, patient's global assessment of disease activity, physician's global assessment of disease activity, Health Assessment Questionnaire Disability Index (HAQ-DI), and C-reactive protein. Response was calculated based on values at Baseline of NCT00448383 (Study M02-497).	Baseline, Months 12, 24, 36, 48, and 60, and Last Observed Value
American College of Rheumatology 70% (ACR70) Response Rate Time Frame: Baseline, Months 12, 24, 36, 48, and 60, and Last Observed Value	ACR70 response is a 70% or better improvement from Baseline in tender joint count, swollen joint count, and at least 3 of the following 5 parameters: patient's assessment of pain, patient's global assessment of disease activity, physician's global assessment of disease activity, Health Assessment Questionnaire Disability Index (HAQ-DI), and C-reactive protein. Response was calculated based on values at Baseline of NCT00448383 (Study M02-497).	Baseline, Months 12, 24, 36, 48, and 60, and Last Observed Value
Change From Baseline in the Health Assessment Questionnaire Disability Index (HAQ-DI) Time Frame: Baseline, Months 12, 24, 36, 48, and 60, and Last Observed Value	HAQ-DI is a composite measure of physical function calculated on the basis of 20 questions in 8 domains (dressing, arising, eating, walking, hygiene, reach, grip, and common activities), each evaluated on a 4-point scale ranging from 0 (without any difficulty) to 3 (unable to do). HAQ-DI score is the sum of worst scores in each domain divided by the number of domains answered, and ranges from 0 (no difficulty) to 3 (unable to do). A mean change of -0.22 is considered the minimum clinically important change. Mean change in HAQ-DI was calculated from Baseline of NCT00448383 (Study M02-497).	Baseline, Months 12, 24, 36, 48, and 60, and Last Observed Value

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Abbott

Investigators

Study Director: Laura Redden, MD, PhD, Abbott

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2003

Primary Completion (Actual)

July 1, 2010

Study Completion (Actual)

July 1, 2010

Study Registration Dates

First Submitted

September 16, 2005

First Submitted That Met QC Criteria

October 7, 2005

First Posted (Estimate)

October 10, 2005

Study Record Updates

Last Update Posted (Estimate)

September 30, 2011

Last Update Submitted That Met QC Criteria

August 25, 2011

Last Verified

August 1, 2011

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

M03-634

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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Study Overview

Status

Conditions

Intervention / Treatment

Detailed Description

Study Type

Enrollment (Actual)

Contacts and Locations

Study Locations

Participation Criteria

Eligibility Criteria

Ages Eligible for Study

Accepts Healthy Volunteers

Genders Eligible for Study

Sampling Method

Study Population

Description

Study Plan

How is the study designed?

Design Details

Number of groups / cohorts

Cohorts and Interventions

Group / Cohort

Intervention / Treatment

What is the study measuring?

Primary Outcome Measures

Outcome Measure

Measure Description

Time Frame

Collaborators and Investigators

Sponsor

Investigators

Publications and helpful links

General Publications

Study record dates

Study Major Dates

Study Start

Primary Completion (Actual)

Study Completion (Actual)

Study Registration Dates

First Submitted

First Submitted That Met QC Criteria

First Posted (Estimate)

Study Record Updates

Last Update Posted (Estimate)

Last Update Submitted That Met QC Criteria

Last Verified

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Clinical Trials on Rheumatoid Arthritis

Clinical Trials on adalimumab

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