Effectiveness and Safety of Adalimumab in Rheumatoid Arthritis Patients in Routine Clinical Practice

April 23, 2014 updated by: AbbVie (prior sponsor, Abbott)

Observation of safety, tolerability and effectiveness of adalimumab (Humira) therapy in a large patient collective under everyday clinical conditions over a 5-year period.

Study Overview

Status

Completed

Conditions

Rheumatoid Arthritis

Detailed Description

Patients with Rheumatoid Arthritis and started treatment with adalimumab in a normal clinical setting according to the label were documented. The follow-up observation period was for 5 years and focused on safety information and maintenance of efficacy during the normal clinical setting. Follow-up with participants was via regular office visits at intervals as determined by routine clinical practice or as recommended by national guidelines.

Study Type

Observational

Enrollment (Actual)

5745

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

Germany
- - Aachen, Germany, 52062
    - Site Reference ID/Investigator# 35034
  - Aachen, Germany, 52064
    - Site Reference ID/Investigator# 35033
  - Achern, Germany, 77855
    - Site Reference ID/Investigator# 53919
  - Aichhalden, Germany, 78733
    - Site Reference ID/Investigator# 53883
  - Altenburg, Germany, 04600
    - Site Reference ID/Investigator# 35041
  - Amberg, Germany, 92224
    - Site Reference ID/Investigator# 35050
  - Amberg, Germany, 92224
    - Site Reference ID/Investigator# 53974
  - Augsburg, Germany, 86150
    - Site Reference ID/Investigator# 33347
  - Bad Abbach, Germany, 93077
    - Site Reference ID/Investigator# 33356
  - Bad Abbach, Germany, 93077
    - Site Reference ID/Investigator# 33359
  - Bad Aibling, Germany, 83043
    - Site Reference ID/Investigator# 33362
  - Bad Aibling, Germany, 83043
    - Site Reference ID/Investigator# 35084
  - Bad Aibling, Germany, 83043
    - Site Reference ID/Investigator# 53968
  - Bad Bellingen, Germany, 79415
    - Site Reference ID/Investigator# 53966
  - Bad Bentheim, Germany, D-48455
    - Site Reference ID/Investigator# 35523
  - Bad Bramstedt, Germany, 24576
    - Site Reference ID/Investigator# 35571
  - Bad Bramstedt, Germany, 24576
    - Site Reference ID/Investigator# 53903
  - Bad Buchau, Germany, 88422
    - Site Reference ID/Investigator# 53929
  - Bad Endbach, Germany, 35080
    - Site Reference ID/Investigator# 33370
  - Bad Endbach, Germany, 63065
    - Site Reference ID/Investigator# 33369
  - Bad Iburg, Germany, 49186
    - Site Reference ID/Investigator# 33380
  - Bad Kissingen, Germany, 97688
    - Site Reference ID/Investigator# 33384
  - Bad Kreuznach, Germany, 55543
    - Site Reference ID/Investigator# 33385
  - Bad Liebenwerda, Germany, 04924
    - Site Reference ID/Investigator# 33389
  - Bad Mergentheim, Germany, 97980
    - Site Reference ID/Investigator# 53942
  - Bad Muender, Germany, 31848
    - Site Reference ID/Investigator# 33394
  - Bad Nauheim, Germany, 61231
    - Site Reference ID/Investigator# 33398
  - Bad Neuenahr, Germany, 53474
    - Site Reference ID/Investigator# 33399
  - Bad Neuenahr, Germany, 53474
    - Site Reference ID/Investigator# 35576
  - Bad Pyrmont, Germany, 31812
    - Site Reference ID/Investigator# 53980
  - Bad Rappenau, Germany, 74906
    - Site Reference ID/Investigator# 33402
  - Bad Soden-Salmuenster, Germany, 63628
    - Site Reference ID/Investigator# 33410
  - Bad Staffelstein, Germany, 96231
    - Site Reference ID/Investigator# 33415
  - Bad Toelz, Germany, 83646
    - Site Reference ID/Investigator# 54804
  - Baden-Baden, Germany, 76530
    - Site Reference ID/Investigator# 33423
  - Bamberg, Germany, 96047
    - Site Reference ID/Investigator# 33427
  - Bautzen, Germany, 02625
    - Site Reference ID/Investigator# 33436
  - Bayreuth, Germany, 95445
    - Site Reference ID/Investigator# 33440
  - Belm, Germany, 49191
    - Site Reference ID/Investigator# 53978
  - Bensheim, Germany, 64625
    - Site Reference ID/Investigator# 33449
  - Berlin, Germany, 10178
    - Site Reference ID/Investigator# 33646
  - Berlin, Germany, 10247
    - Site Reference ID/Investigator# 53902
  - Berlin, Germany, 10367
    - Site Reference ID/Investigator# 33662
  - Berlin, Germany, 10711
    - Site Reference ID/Investigator# 33695
  - Berlin, Germany, 10719
    - Site Reference ID/Investigator# 34243
  - Berlin, Germany, 10777
    - Site Reference ID/Investigator# 33681
  - Berlin, Germany, 12161
    - Site Reference ID/Investigator# 35599
  - Berlin, Germany, 12200
    - Site Reference ID/Investigator# 53959
  - Berlin, Germany, 12435
    - Site Reference ID/Investigator# 33688
  - Berlin, Germany, 12681
    - Site Reference ID/Investigator# 34260
  - Berlin, Germany, 13055
    - Site Reference ID/Investigator# 33685
  - Berlin, Germany, 13055
    - Site Reference ID/Investigator# 53948
  - Berlin, Germany, 13589
    - Site Reference ID/Investigator# 53939
  - Berlin, Germany, 13595
    - Site Reference ID/Investigator# 53971
  - Berlin, Germany, 14059
    - Site Reference ID/Investigator# 53933
  - Berlin, Germany, 14089
    - Site Reference ID/Investigator# 53884
  - Berlin, Germany, 14109
    - Site Reference ID/Investigator# 33672
  - Berlin, Germany, 14163
    - Site Reference ID/Investigator# 35552
  - Berlin-Buch, Germany, 13125
    - Site Reference ID/Investigator# 34264
  - Berlin-Wannsee, Germany, 14109
    - Site Reference ID/Investigator# 34250
  - Bernau, Germany, 16321
    - Site Reference ID/Investigator# 35554
  - Biberach, Germany, 88400
    - Site Reference ID/Investigator# 53899
  - Bielefeld, Germany, 33611
    - Site Reference ID/Investigator# 34279
  - Bielefeld, Germany, 33617
    - Site Reference ID/Investigator# 54810
  - Bietigheim-Bissingen, Germany, 74321
    - Site Reference ID/Investigator# 35559
  - Bietigheim-Bissingen, Germany, 74321
    - Site Reference ID/Investigator# 35560
  - Blankenburg/Hart, Germany, 38889
    - Site Reference ID/Investigator# 34283
  - Blaubeuren, Germany, 89143
    - Site Reference ID/Investigator# 34286
  - Bocholt, Germany, 46399
    - Site Reference ID/Investigator# 34289
  - Bocholt, Germany, 46399
    - Site Reference ID/Investigator# 53946
  - Bochum, Germany, 44789
    - Site Reference ID/Investigator# 35567
  - Bogen, Germany, 94327
    - Site Reference ID/Investigator# 35642
  - Bonn, Germany, 53111
    - Site Reference ID/Investigator# 34300
  - Bonn, Germany, 53129
    - Site Reference ID/Investigator# 53969
  - Bonn, Germany, 53175
    - Site Reference ID/Investigator# 35647
  - Bonn, Germany, 53175
    - Site Reference ID/Investigator# 35648
  - Bonn, Germany, 53177
    - Site Reference ID/Investigator# 34294
  - Braunschweig, Germany, 38100
    - Site Reference ID/Investigator# 34305
  - Braunschweig, Germany, 38100
    - Site Reference ID/Investigator# 34310
  - Breitenbrunn, Germany, 08359
    - Site Reference ID/Investigator# 35601
  - Bremen, Germany, 28209
    - Site Reference ID/Investigator# 35607
  - Bremen, Germany, 28329
    - Site Reference ID/Investigator# 53975
  - Buechen, Germany, 21514
    - Site Reference ID/Investigator# 53934
  - Celle, Germany, 29221
    - Site Reference ID/Investigator# 34696
  - Chemnitz, Germany, 09126
    - Site Reference ID/Investigator# 34700
  - Chemnitz, Germany, D-09130
    - Site Reference ID/Investigator# 35092
  - Cologne, Germany, 50679
    - Site Reference ID/Investigator# 33990
  - Cologne, Germany, 50823
    - Site Reference ID/Investigator# 33987
  - Cologne, Germany, 50931
    - Site Reference ID/Investigator# 33996
  - Cologne, Germany, 50969
    - Site Reference ID/Investigator# 33993
  - Cologne, Germany, 51067
    - Site Reference ID/Investigator# 35238
  - Cottbus, Germany, 3048
    - Site Reference ID/Investigator# 35617
  - Cuxhaven, Germany, 27474
    - Site Reference ID/Investigator# 53987
  - Cuxhaven, Germany, 27476
    - Site Reference ID/Investigator# 53889
  - Darmstadt, Germany, 64295
    - Site Reference ID/Investigator# 35622
  - Delmenhorst, Germany, 27749
    - Site Reference ID/Investigator# 53885
  - Demmin, Germany, 17109
    - Site Reference ID/Investigator# 34726
  - Denkendorf, Germany, 73770
    - Site Reference ID/Investigator# 53932
  - Dortmund, Germany, 44147
    - Site Reference ID/Investigator# 35636
  - Dortmund, Germany, 44263
    - Site Reference ID/Investigator# 35632
  - Dresden, Germany, 01097
    - Site Reference ID/Investigator# 35171
  - Dresden, Germany, 01109
    - Site Reference ID/Investigator# 34762
  - Dresden, Germany, 01159
    - Site Reference ID/Investigator# 53958
  - Dresden, Germany, 01277
    - Site Reference ID/Investigator# 34749
  - Dresden, Germany, 01307
    - Site Reference ID/Investigator# 34763
  - Duesseldorf, Germany, 40211
    - Site Reference ID/Investigator# 34771
  - Duesseldorf, Germany, 40225
    - Site Reference ID/Investigator# 34774
  - Duisburg, Germany, 47055
    - Site Reference ID/Investigator# 34776
  - Duisburg, Germany, 47167
    - Site Reference ID/Investigator# 53897
  - Ebensfeld, Germany, 96250
    - Site Reference ID/Investigator# 34779
  - Eberswalde, Germany, 16225
    - Site Reference ID/Investigator# 34782
  - Eisenberg, Germany, 07607
    - Site Reference ID/Investigator# 54805
  - Elmshorn, Germany, 25335
    - Site Reference ID/Investigator# 35180
  - Erftstadt, Germany, 50374
    - Site Reference ID/Investigator# 34802
  - Erfurt, Germany, 99096
    - Site Reference ID/Investigator# 34807
  - Erfurt, Germany, 99096
    - Site Reference ID/Investigator# 35097
  - Erfurt, Germany, 99096
    - Site Reference ID/Investigator# 35189
  - Erlangen, Germany, 91054
    - Site Reference ID/Investigator# 54811
  - Erlangen, Germany, 91056
    - Site Reference ID/Investigator# 34815
  - Essen, Germany, 45128
    - Site Reference ID/Investigator# 53925
  - Essen, Germany, 45239
    - Site Reference ID/Investigator# 34823
  - Essen, Germany, 45326
    - Site Reference ID/Investigator# 35194
  - Essen, Germany, 45329
    - Site Reference ID/Investigator# 53931
  - Essen, Germany, 45359
    - Site Reference ID/Investigator# 53945
  - Esslingen, Germany, 73732
    - Site Reference ID/Investigator# 34829
  - Feldafing, Germany, 82340
    - Site Reference ID/Investigator# 35200
  - Flensburg, Germany, 24937
    - Site Reference ID/Investigator# 35203
  - Forchheim, Germany, 91301
    - Site Reference ID/Investigator# 34831
  - Frankfurt, Germany, 60590
    - Site Reference ID/Investigator# 34851
  - Frankfurt, Germany, 60596
    - Site Reference ID/Investigator# 34838
  - Fraureuth, Germany, 08427
    - Site Reference ID/Investigator# 35211
  - Freiberg, Germany, 09599
    - Site Reference ID/Investigator# 35217
  - Freiburg, Germany, 79098
    - Site Reference ID/Investigator# 34852
  - Freiburg, Germany, 79098
    - Site Reference ID/Investigator# 34855
  - Freiburg, Germany, 79098
    - Site Reference ID/Investigator# 53926
  - Freiburg, Germany, 79106
    - Site Reference ID/Investigator# 34859
  - Freystadt, Germany, 92342
    - Site Reference ID/Investigator# 35099
  - Friedberg, Germany, 61169
    - Site Reference ID/Investigator# 53960
  - Friedrichroda, Germany, 99894
    - Site Reference ID/Investigator# 35222
  - Geesthacht, Germany, 21502
    - Site Reference ID/Investigator# 53976
  - Geilenkirchen, Germany, 52511
    - Site Reference ID/Investigator# 53890
  - Gelsenkirchen, Germany, 45881
    - Site Reference ID/Investigator# 34877
  - Giessen, Germany, 35392
    - Site Reference ID/Investigator# 53909
  - Gladbeck, Germany, 45964
    - Site Reference ID/Investigator# 53922
  - Goettingen, Germany, 37073
    - Site Reference ID/Investigator# 35231
  - Goettingen, Germany, 37075
    - Site Reference ID/Investigator# 65622
  - Goslar, Germany, 38642
    - Site Reference ID/Investigator# 34894
  - Greifswald, Germany, 17491
    - Site Reference ID/Investigator# 34902
  - Guestrow, Germany, 18273
    - Site Reference ID/Investigator# 34910
  - Hagen, Germany, 58089
    - Site Reference ID/Investigator# 35501
  - Halle, Germany, 06108
    - Site Reference ID/Investigator# 34924
  - Halle, Germany, 06108
    - Site Reference ID/Investigator# 34935
  - Halle, Germany, 06108
    - Site Reference ID/Investigator# 34938
  - Halle, Germany, 06112
    - Site Reference ID/Investigator# 34920
  - Halle, Germany, 06120
    - Site Reference ID/Investigator# 34942
  - Halle, Germany, 06128
    - Site Reference ID/Investigator# 33819
  - Hamburg, Germany, 20144
    - Site Reference ID/Investigator# 35442
  - Hamburg, Germany, 20355
    - Site Reference ID/Investigator# 53984
  - Hamburg, Germany, 21031
    - Site Reference ID/Investigator# 33367
  - Hamburg, Germany, 21073
    - Site Reference ID/Investigator# 53900
  - Hamburg, Germany, 21075
    - Site Reference ID/Investigator# 34956
  - Hamburg, Germany, 22081
    - Site Reference ID/Investigator# 34962
  - Hamburg, Germany, 22081
    - Site Reference ID/Investigator# 35450
  - Hamburg, Germany, 22087
    - Site Reference ID/Investigator# 35112
  - Hamburg, Germany, 22089
    - Site Reference ID/Investigator# 34946
  - Hamburg, Germany, 22119
    - Site Reference ID/Investigator# 35001
  - Hamburg, Germany, 22147
    - Site Reference ID/Investigator# 34959
  - Hamburg, Germany, 22147
    - Site Reference ID/Investigator# 34977
  - Hamburg, Germany, 22391
    - Site Reference ID/Investigator# 34965
  - Hamburg, Germany, 22399
    - Site Reference ID/Investigator# 54806
  - Hamburg, Germany, 22529
    - Site Reference ID/Investigator# 33578
  - Hamburg, Germany, 22529
    - Site Reference ID/Investigator# 34967
  - Hamburg, Germany, 22529
    - Site Reference ID/Investigator# 34989
  - Hamburg, Germany, 22609
    - Site Reference ID/Investigator# 34981
  - Hamburg, Germany, 22609
    - Site Reference ID/Investigator# 34984
  - Hamburg, Germany, 22609
    - Site Reference ID/Investigator# 34996
  - Hamm, Germany, 59065
    - Site Reference ID/Investigator# 53953
  - Hanau, Germany, 63450
    - Site Reference ID/Investigator# 35017
  - Hannover, Germany, 30625
    - Site Reference ID/Investigator# 33788
  - Hanover, Germany, 30159
    - Site Reference ID/Investigator# 33713
  - Hanover, Germany, 30159
    - Site Reference ID/Investigator# 35032
  - Hanover, Germany, 30161
    - Site Reference ID/Investigator# 35021
  - Harrislee, Germany, 24955
    - Site Reference ID/Investigator# 33790
  - Haseluenne, Germany, 49740
    - Site Reference ID/Investigator# 65629
  - Hattingen, Germany, 45525
    - Site Reference ID/Investigator# 33795
  - Heidelberg, Germany, 69120
    - Site Reference ID/Investigator# 33796
  - Heidelberg, Germany, 69121
    - Site Reference ID/Investigator# 33806
  - Heidelberg, Germany, D-69115
    - Site Reference ID/Investigator# 33811
  - Heilbad Heiligenstadt, Germany, 37308
    - Site Reference ID/Investigator# 33816
  - Herne, Germany, 44623
    - Site Reference ID/Investigator# 53911
  - Herne, Germany, 44625
    - Site Reference ID/Investigator# 53910
  - Herne, Germany, 44652
    - Site Reference ID/Investigator# 65623
  - Herrsching, Germany, 82211
    - Site Reference ID/Investigator# 33823
  - Hildesheim, Germany, 31124
    - Site Reference ID/Investigator# 33831
  - Hof, Germany, 95028
    - Site Reference ID/Investigator# 33836
  - Hofheim, Germany, 65719
    - Site Reference ID/Investigator# 33840
  - Hohenfelde, Germany, 18209
    - Site Reference ID/Investigator# 33843
  - Homburg, Germany, 66424
    - Site Reference ID/Investigator# 54807
  - Illingen, Germany, 66557
    - Site Reference ID/Investigator# 53985
  - Ingolstadt, Germany, 85049
    - Site Reference ID/Investigator# 33933
  - Jena, Germany, 07743
    - Site Reference ID/Investigator# 53938
  - Jena, Germany, 07745
    - Site Reference ID/Investigator# 5323
  - Juelich, Germany, 52428
    - Site Reference ID/Investigator# 33940
  - Kahla, Germany, 07768
    - Site Reference ID/Investigator# 33944
  - Kahla, Germany, 07768
    - Site Reference ID/Investigator# 35124
  - Kaiserslautern, Germany, 67655
    - Site Reference ID/Investigator# 33948
  - Kaltenkirchen, Germany, 24568
    - Site Reference ID/Investigator# 53935
  - Karlsruhe, Germany, 76133
    - Site Reference ID/Investigator# 33397
  - Karlsruhe, Germany, 76133
    - Site Reference ID/Investigator# 33954
  - Karlstadt, Germany, 97753
    - Site Reference ID/Investigator# 35482
  - Kassel, Germany, 34131
    - Site Reference ID/Investigator# 33962
  - Koenigs Wusterhausen, Germany, 15711
    - Site Reference ID/Investigator# 34000
  - Kolkwitz, Germany, 3099
    - Site Reference ID/Investigator# 35239
  - Kressbronn, Germany, 88079
    - Site Reference ID/Investigator# 34006
  - Kronach, Germany, 96317
    - Site Reference ID/Investigator# 34009
  - Kyritz, Germany, 16866
    - Site Reference ID/Investigator# 34086
  - Lahr, Germany, 77933
    - Site Reference ID/Investigator# 34003
  - Leipzig, Germany, 04103
    - Site Reference ID/Investigator# 53937
  - Leipzig, Germany, 04109
    - Site Reference ID/Investigator# 65628
  - Leipzig, Germany, 04207
    - Site Reference ID/Investigator# 34107
  - Leipzig, Germany, 04299
    - Site Reference ID/Investigator# 34098
  - Leverkusen, Germany, 51373
    - Site Reference ID/Investigator# 34119
  - Lichtenstein, Germany, 09350
    - Site Reference ID/Investigator# 34121
  - Lippstadt, Germany, 59555
    - Site Reference ID/Investigator# 35252
  - Lohne, Germany, 49393
    - Site Reference ID/Investigator# 53882
  - Ludwigsburg, Germany, 71638
    - Site Reference ID/Investigator# 53886
  - Ludwigsfelde, Germany, 14974
    - Site Reference ID/Investigator# 35257
  - Ludwigslust, Germany, 19288
    - Site Reference ID/Investigator# 53906
  - Luebeck, Germany, 23552
    - Site Reference ID/Investigator# 34133
  - Luedenscheid, Germany, 58311
    - Site Reference ID/Investigator# 53943
  - Lueneburg, Germany, 21335
    - Site Reference ID/Investigator# 33407
  - Lueneburg, Germany, 21335
    - Site Reference ID/Investigator# 53888
  - Magdeburg, Germany, 39104
    - Site Reference ID/Investigator# 34148
  - Magdeburg, Germany, 39110
    - Site Reference ID/Investigator# 53981
  - Magdeburg, Germany, 39120
    - Site Reference ID/Investigator# 53913
  - Mainz, Germany, 55116
    - Site Reference ID/Investigator# 53928
  - Mainz, Germany, 55116
    - Site Reference ID/Investigator# 65631
  - Mannheim, Germany, 68165
    - Site Reference ID/Investigator# 34184
  - Marl, Germany, 45768
    - Site Reference ID/Investigator# 34194
  - Menz, Germany, 39175
    - Site Reference ID/Investigator# 35283
  - Merxheim, Germany, 55627
    - Site Reference ID/Investigator# 53896
  - Minden, Germany, 32429
    - Site Reference ID/Investigator# 33418
  - Mittelherwigsdorf, Germany, 02763
    - Site Reference ID/Investigator# 34206
  - Moenchengladbach, Germany, 41061
    - Site Reference ID/Investigator# 34216
  - Moenchengladbach, Germany, 41061
    - Site Reference ID/Investigator# 53915
  - Moenchengladbach, Germany, 41199
    - Site Reference ID/Investigator# 34211
  - Moenchengladbach, Germany, 41199
    - Site Reference ID/Investigator# 34214
  - Moenkeberg, Germany, 24248
    - Site Reference ID/Investigator# 34219
  - Muehlhausen, Germany, 99974
    - Site Reference ID/Investigator# 34222
  - Muenster, Germany, 48143
    - Site Reference ID/Investigator# 34044
  - Muenster, Germany, 48143
    - Site Reference ID/Investigator# 53970
  - Muenster, Germany, 48149
    - Site Reference ID/Investigator# 34046
  - Munich, Germany, 80331
    - Site Reference ID/Investigator# 53904
  - Munich, Germany, 80336
    - Site Reference ID/Investigator# 53956
  - Munich, Germany, 80639
    - Site Reference ID/Investigator# 34037
  - Munich, Germany, 80798
    - Site Reference ID/Investigator# 53962
  - Munich, Germany, 81547
    - Site Reference ID/Investigator# 53912
  - Munich, Germany, 81667
    - Site Reference ID/Investigator# 35296
  - Munich, Germany, 81667
    - Site Reference ID/Investigator# 53924
  - Munich, Germany, 81925
    - Site Reference ID/Investigator# 34041
  - Munich, Germany, D-81541
    - Site Reference ID/Investigator# 34035
  - Naunhof, Germany, 04683
    - Site Reference ID/Investigator# 34050
  - Neubrandenburg, Germany, 17033
    - Site Reference ID/Investigator# 34059
  - Neuburg, Germany, 86633
    - Site Reference ID/Investigator# 34062
  - Neunkirchen, Germany, 66538
    - Site Reference ID/Investigator# 34980
  - Neuss, Germany, 41460
    - Site Reference ID/Investigator# 35311
  - Neustadt, Germany, 67434
    - Site Reference ID/Investigator# 34072
  - Neuwied, Germany, 56564
    - Site Reference ID/Investigator# 65630
  - Niederbrombach, Germany, 55767
    - Site Reference ID/Investigator# 82694
  - Niefern-Oeschelbronn, Germany, 75223
    - Site Reference ID/Investigator# 34078
  - Nienburg, Germany, 31582
    - Site Reference ID/Investigator# 34081
  - Nienburg, Germany, 31582
    - Site Reference ID/Investigator# 34082
  - Nuremberg, Germany, 90402
    - Site Reference ID/Investigator# 53923
  - Oberguenzburg, Germany, 87634
    - Site Reference ID/Investigator# 34168
  - Offenburg, Germany, 77652
    - Site Reference ID/Investigator# 34174
  - Oldenburg, Germany, 26121
    - Site Reference ID/Investigator# 33490
  - Olsberg, Germany, 59939
    - Site Reference ID/Investigator# 53950
  - Osnabrueck, Germany, D-49074
    - Site Reference ID/Investigator# 33499
  - Osnabrueck, Germany, D-49074
    - Site Reference ID/Investigator# 54803
  - Ostseebad Damp, Germany, 24351
    - Site Reference ID/Investigator# 34715
  - Paderborn, Germany, 33098
    - Site Reference ID/Investigator# 35333
  - Papenburg, Germany, 26871
    - Site Reference ID/Investigator# 33503
  - Parchim, Germany, 19370
    - Site Reference ID/Investigator# 33506
  - Parsberg, Germany, 92331
    - Site Reference ID/Investigator# 33509
  - Passau, Germany, 94032
    - Site Reference ID/Investigator# 35338
  - Petershagen, Germany, 32469
    - Site Reference ID/Investigator# 33511
  - Pinneberg, Germany, 25421
    - Site Reference ID/Investigator# 33519
  - Pirna, Germany, 01796
    - Site Reference ID/Investigator# 33520
  - Planegg, Germany, 82152
    - Site Reference ID/Investigator# 33521
  - Plauen, Germany, 08523
    - Site Reference ID/Investigator# 33526
  - Potsdam, Germany, 14467
    - Site Reference ID/Investigator# 33468
  - Potsdam, Germany, 14469
    - Site Reference ID/Investigator# 33464
  - Pulheim, Germany, 50259
    - Site Reference ID/Investigator# 53940
  - Radebeul, Germany, 01445
    - Site Reference ID/Investigator# 33482
  - Raststatt, Germany, 76437
    - Site Reference ID/Investigator# 53964
  - Ratingen, Germany, 40882
    - Site Reference ID/Investigator# 33485
  - Ratingen, Germany, 40882
    - Site Reference ID/Investigator# 35134
  - Ratingen, Germany, 40882
    - Site Reference ID/Investigator# 54812
  - Regensburg, Germany, 93049
    - Site Reference ID/Investigator# 33888
  - Regensburg, Germany, 93049
    - Site Reference ID/Investigator# 33891
  - Regensburg, Germany, 93051
    - Site Reference ID/Investigator# 33881
  - Regensburg, Germany, 93051
    - Site Reference ID/Investigator# 33884
  - Regensburg, Germany, 93059
    - Site Reference ID/Investigator# 53930
  - Reichenbach, Germany, 08468
    - Site Reference ID/Investigator# 53986
  - Reken, Germany, 48734
    - Site Reference ID/Investigator# 53957
  - Remscheid, Germany, 42864
    - Site Reference ID/Investigator# 53920
  - Rendsburg, Germany, 24768
    - Site Reference ID/Investigator# 33900
  - Reutlingen, Germany, 72764
    - Site Reference ID/Investigator# 33903
  - Rheinfelden, Germany, 79618
    - Site Reference ID/Investigator# 53982
  - Rickenbach, Germany, 79736
    - Site Reference ID/Investigator# 53908
  - Riesa, Germany, 01589
    - Site Reference ID/Investigator# 33393
  - Rinteln, Germany, 31737
    - Site Reference ID/Investigator# 33912
  - Rostock, Germany, 18059
    - Site Reference ID/Investigator# 33921
  - Rothenburg, Germany, 02929
    - Site Reference ID/Investigator# 33929
  - Saarbruecken, Germany, 66111
    - Site Reference ID/Investigator# 34014
  - Salzwedel, Germany, 29410
    - Site Reference ID/Investigator# 34021
  - Schlangenbad, Germany, 65388
    - Site Reference ID/Investigator# 53916
  - Schneeberg, Germany, 08289
    - Site Reference ID/Investigator# 34030
  - Schwerin, Germany, 19053
    - Site Reference ID/Investigator# 33550
  - Schwerin, Germany, 19053
    - Site Reference ID/Investigator# 35374
  - Schwerte, Germany, 58239
    - Site Reference ID/Investigator# 33553
  - Seesen, Germany, 38723
    - Site Reference ID/Investigator# 33557
  - Siegen, Germany, 57072
    - Site Reference ID/Investigator# 53944
  - Sinsheim, Germany, 74889
    - Site Reference ID/Investigator# 33565
  - Solingen, Germany, 42651
    - Site Reference ID/Investigator# 53927
  - Soltau, Germany, 29614
    - Site Reference ID/Investigator# 33570
  - Stadtbergen, Germany, 86391
    - Site Reference ID/Investigator# 33583
  - Stadthagen, Germany, 31655
    - Site Reference ID/Investigator# 33586
  - Steinhagen, Germany, 33803
    - Site Reference ID/Investigator# 53936
  - Stuttgart, Germany, 70178
    - Site Reference ID/Investigator# 33602
  - Stuttgart, Germany, 70199
    - Site Reference ID/Investigator# 33609
  - Stuttgart, Germany, 70372
    - Site Reference ID/Investigator# 33596
  - Suhl, Germany, 98529
    - Site Reference ID/Investigator# 35387
  - Tarp, Germany, 24963
    - Site Reference ID/Investigator# 54808
  - Thum-Jahnsbach, Germany, 9419
    - Site Reference ID/Investigator# 35433
  - Tischenreuth, Germany, 95643
    - Site Reference ID/Investigator# 53951
  - Torgelow, Germany, 17358
    - Site Reference ID/Investigator# 33623
  - Treuenbrietzen, Germany, 14929
    - Site Reference ID/Investigator# 33628
  - Tuebingen, Germany, 72072
    - Site Reference ID/Investigator# 53907
  - Twistringen, Germany, 27239
    - Site Reference ID/Investigator# 53893
  - Ueberlingen-Nussdorf, Germany, 88662
    - Site Reference ID/Investigator# 33635
  - Uhlstaedt-Kirchhasel, Germany, 07407
    - Site Reference ID/Investigator# 53898
  - Ulm, Germany, 89073
    - Site Reference ID/Investigator# 33722
  - Ulm, Germany, 89073
    - Site Reference ID/Investigator# 65626
  - Verden, Germany, 27283
    - Site Reference ID/Investigator# 33732
  - Viersen, Germany, 41747
    - Site Reference ID/Investigator# 53965
  - Villingen-Schwenningen, Germany, 78054
    - Site Reference ID/Investigator# 33735
  - Vogelsang-Gommern, Germany, 39245
    - Site Reference ID/Investigator# 53914
  - Vreden, Germany, 48691
    - Site Reference ID/Investigator# 53952
  - Waldbronn, Germany, 76337
    - Site Reference ID/Investigator# 54809
  - Waltrop, Germany, 45731
    - Site Reference ID/Investigator# 33740
  - Weener, Germany, 26826
    - Site Reference ID/Investigator# 33747
  - Weiden i.d. Oberpfalz, Germany, 92637
    - Site Reference ID/Investigator# 53891
  - Weissenfels, Germany, 06667
    - Site Reference ID/Investigator# 53921
  - Welzow, Germany, 03119
    - Site Reference ID/Investigator# 33753
  - Wiesbaden, Germany, 65189
    - Site Reference ID/Investigator# 35406
  - Wiesbaden, Germany, 65189
    - Site Reference ID/Investigator# 53941
  - Wiesbaden, Germany, 65191
    - Site Reference ID/Investigator# 33762
  - Wilhelmshaven, Germany, 26382
    - Site Reference ID/Investigator# 33770
  - Winsen, Germany, 21423
    - Site Reference ID/Investigator# 53954
  - Winsen (Luhe), Germany, 21423
    - Site Reference ID/Investigator# 53977
  - Wittlich, Germany, 54516
    - Site Reference ID/Investigator# 33778
  - Wolfsburg, Germany, 38440
    - Site Reference ID/Investigator# 33783
  - Wuerzburg, Germany, 97070
    - Site Reference ID/Investigator# 33716
  - Wuppertal, Germany, 42103
    - Site Reference ID/Investigator# 53917
  - Wuppertal, Germany, 42105
    - Site Reference ID/Investigator# 35418
  - Zerbst, Germany, 39261
    - Site Reference ID/Investigator# 33862
  - Zeven, Germany, 27404
    - Site Reference ID/Investigator# 33865
  - Zwickau, Germany, 08060
    - Site Reference ID/Investigator# 33870
  - Zwiesel, Germany, 94227
    - Site Reference ID/Investigator# 33878

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

General population: patients with rheumatoid arthritis who resided in Germany. German regulations state that all patients are eligible for non-interventional studies; there are no exclusions. Adult patients (≥ 18 years of age) with RA who were preparing to initiate adalimumab therapy according to the product label were eligible for study enrollment. The eligibility criteria below reflect the approved label as stated in the German Summary of Product Characteristics (SPC) for Humira.

Description

Inclusion Criteria:

Moderate to severe active rheumatoid arthritis in adults with insufficient response to disease-modifying antirheumatic drugs, including methotrexate.
Moderate to severe active rheumatoid arthritis in adults who have not been treated with methotrexate before.
In case of incompatibility with methotrexate, adalimumab can be used as monotherapy

Exclusion Criteria:

Hypersensitivity against the drug or one of the other ingredients; active tuberculosis or other severe infections (e.g. sepsis and opportunistic infections); moderate to severe cardiac insufficiency

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
Rheumatoid arthritis Participants with rheumatoid arthritis prescribed adalimumab in routine clinical practice were observed from the first dose for up to 5 years.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change From Baseline in Disease Activity Score (DAS) 28 Time Frame: Baseline and Months 3, 6, 12, 18, 24, 30, 36, 48, and 60	The DAS28 is a validated index of rheumatoid arthritis disease activity. Twenty-eight tender joint counts, 28 swollen joint counts, the erythrocyte sedimentation rate (ESR), and general health (measured on a visual analog scale [VAS] from 0 to 10 cm) are included in the DAS28 score. Scores on the DAS28 range from 0 to 10. A DAS28 score >5.1 indicates high disease activity, a DAS28 score <3.2 indicates low disease activity, and a DAS28 score <2.6 indicates clinical remission.	Baseline and Months 3, 6, 12, 18, 24, 30, 36, 48, and 60
Percentage of Participants in DAS28 Remission Time Frame: Months 3, 6, 12, 18, 24, 30, 36, 48, and 60	Clinical remission is defined as a DAS28 score of < 2.6. The Disease Activity Score (DAS28) is a validated index of rheumatoid arthritis disease activity calculated from the 28 tender joint count, 28 swollen joint count, the erythrocyte sedimentation rate (ESR), and the patient's assessment of global disease activity (measured on a visual analog scale [VAS] from 0 to 10 cm). Scores on the DAS28 range from 0 to 10; higher scores indicate more disease activity.	Months 3, 6, 12, 18, 24, 30, 36, 48, and 60

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percentage of Participants With a Significant Therapeutic Response Time Frame: Baseline and Months 3, 6, 12, 18, 24, 30, 36, 48, and 60	Significant therapeutic response was determined by DAS28 critical difference (Dcrit). A Dcrit response is a statistically determined value that exceeds the threshold of random fluctuation and signifies a positive individual response during treatment. A DAS28-Dcrit individual therapeutic response is defined as a decrease (improvement) in DAS28 from Baseline of ≥ 1.8. The Disease Activity Score (DAS28) is a validated index of rheumatoid arthritis disease activity calculated from the 28 tender joint count, 28 swollen joint count, the erythrocyte sedimentation rate (ESR), and the patient's assessment of global disease activity (measured on a visual analog scale [VAS] from 0 to 10 cm). Scores on the DAS28 range from 0 to 10; higher scores indicate more disease activity.	Baseline and Months 3, 6, 12, 18, 24, 30, 36, 48, and 60
Percentage of Participants With Low, Moderate and High Disease Activity Time Frame: Baseline and Months 3, 6, 12, 18, 24, 30, 36, 48, and 60	Low disease activity is defined as a DAS28 score ≤ 3.2; Moderate disease activity as a DAS28 >3.2 to ≤5.1; High disease activity as a DAS28 >5.1. The Disease Activity Score (DAS28) is a validated index of rheumatoid arthritis disease activity calculated from the 28 tender joint count, 28 swollen joint count, the erythrocyte sedimentation rate (ESR), and the patient's assessment of global disease activity (measured on a visual analog scale [VAS] from 0 to 10 cm). Scores on the DAS28 range from 0 to 10; higher scores indicate more disease activity.	Baseline and Months 3, 6, 12, 18, 24, 30, 36, 48, and 60
Erythrocyte Sedimentation Rate (ESR) Over Time Time Frame: Baseline and Months 3, 6, 12, 18, 24, 30, 36, 48, and 60	Erythrocyte sedimentation rate (ESR) indirectly measures how much inflammation is in the body. A higher ESR is indicative of increased inflammation.	Baseline and Months 3, 6, 12, 18, 24, 30, 36, 48, and 60
C-Reactive Protein (CRP) Levels Over Time Time Frame: Baseline and Months 3, 6, 12, 18, 24, 30, 36, 48, and 60	C-reactive protein (CRP) was measured from blood samples as a marker for inflammation. Higher levels are indicative of more inflammation. Normal concentration in healthy human serum is usually lower than 10 mg/L, slightly increasing with age.	Baseline and Months 3, 6, 12, 18, 24, 30, 36, 48, and 60
Tender Joint Count (TJC) Over Time Time Frame: Baseline and Months 3, 6, 12, 18, 24, 30, 36, 48, and 60	Twenty-eight joints were assessed and classified as tender/not tender by pressure and joint manipulation on physical examination.	Baseline and Months 3, 6, 12, 18, 24, 30, 36, 48, and 60
Swollen Joint Count (SJC) Over Time Time Frame: Baseline and Months 3, 6, 12, 18, 24, 30, 36, 48, and 60	Twenty-eight joints were assessed and classified as swollen/not swollen by pressure and joint manipulation on physical examination.	Baseline and Months 3, 6, 12, 18, 24, 30, 36, 48, and 60
Hannover Functional Questionnaire (FFbH) Over Time Time Frame: Baseline and Months 3, 6, 12, 18, 24, 30, 36, 48, and 60	A self-administered patient questionnaire used to assess patient function based on 18 questions. The numerically coded responses to the questions are added to provide a total patient score. The FFbH was calculated from this patient score by the following formula: FFbH = (patient score x 100) ÷ 2 (number of valid responses). The resulting FFbH score reflects the degree of remaining functional capacity where 0% indicates maximal impairment and 100% indicates maximal functional capacity.	Baseline and Months 3, 6, 12, 18, 24, 30, 36, 48, and 60
Patients Global Assessment of Disease Activity Over Time Time Frame: Baseline and Months 3, 6, 12, 18, 24, 30, 36, 48, and 60	Participants indicated their global assessment of disease activity over the last 7 days on a visual analog scale (VAS) ranging from 0 (best) to 10 (worst) cm; lower scores indicate better patient status.	Baseline and Months 3, 6, 12, 18, 24, 30, 36, 48, and 60
Participants Assessment of Pain Over Time Time Frame: Baseline and Months 3, 6, 12, 18, 24, 30, 36, 48, and 60	Participants indicated their level of pain over the last 7 days on a visual analog scale (VAS) ranging from 0 (best) to 10 (worst) cm; lower scores indicate better patient status.	Baseline and Months 3, 6, 12, 18, 24, 30, 36, 48, and 60
Participants Assessment of Fatigue Over Time Time Frame: Baseline and Months 3, 6, 12, 18, 24, 30, 36, 48, and 60	Participants indicated their level of fatigue over the last 7 days on a visual analog scale (VAS) ranging from 0 (best) to 10 (worst) cm; lower scores indicate better patient status.	Baseline and Months 3, 6, 12, 18, 24, 30, 36, 48, and 60
Percentage of Participants With Impairment in Daily Activities Time Frame: Baseline and Months 6, 18, 24, and 30	Participants were asked to report how many days of impairment in daily activities they had experienced in the last 4 weeks.	Baseline and Months 6, 18, 24, and 30
Number of Days Missed From Work Due to Rheumatoid Arthritis Time Frame: Baseline and Months 6, 12, 18, 24, 30, 36, 48, and 60	Participants reported the number of days they had missed from work in the prior 6 months due to rheumatoid arthritis. The Baseline measurement includes data for the prior 12 months.	Baseline and Months 6, 12, 18, 24, 30, 36, 48, and 60
Percentage of Participants With In-patient Hospitalization Time Frame: Baseline and Months 6, 12, 18, 24, 30, 36, 48, and 60	The percentage of participants with in-patient hospitalization in the prior 6 months. Baseline data includes in-patient hospitalizations that occurred within the prior 12 months.	Baseline and Months 6, 12, 18, 24, 30, 36, 48, and 60
Percentage of Participants on Concomitant Rheumatoid Arthritis and Pain Relief/Anti-inflammatory Medication Time Frame: Baseline and Months 3, 6, 12, 18, 24, 30, 36, 48, and 60		Baseline and Months 3, 6, 12, 18, 24, 30, 36, 48, and 60

Collaborators and Investigators

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

Sponsor

AbbVie (prior sponsor, Abbott)

Investigators

Study Director: Bianca Wittig, MD, AbbVie Deutschland GmbH & Co. KG, Medical Department

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

Helpful Links

Related Info

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

April 1, 2003

Primary Completion (Actual)

March 1, 2013

Study Completion (Actual)

March 1, 2013

Study Registration Dates

First Submitted

February 26, 2010

First Submitted That Met QC Criteria

February 26, 2010

First Posted (Estimate)

March 2, 2010

Study Record Updates

Last Update Posted (Estimate)

May 8, 2014

Last Update Submitted That Met QC Criteria

April 23, 2014

Last Verified

April 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

HUM 03-1

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

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure

Measure Description

Time Frame

Secondary Outcome Measures

Outcome Measure

Measure Description

Time Frame

Collaborators and Investigators

Sponsor

Investigators

Publications and helpful links

General Publications

Helpful Links

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

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