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

23 avril 2014 mis à jour par: 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.

Aperçu de l'étude

Statut

Complété

Les conditions

La polyarthrite rhumatoïde

Description détaillée

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.

Type d'étude

Observationnel

Inscription (Réel)

5745

Contacts et emplacements

Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.

Lieux d'étude

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

Critères de participation

Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.

Critère d'éligibilité

Âges éligibles pour étudier

18 ans et plus (Adulte, Adulte plus âgé)

Accepte les volontaires sains

Non

Sexes éligibles pour l'étude

Tout

Méthode d'échantillonnage

Échantillon non probabiliste

Population étudiée

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.

La 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

Plan d'étude

Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.

Comment l'étude est-elle conçue ?

Détails de conception

Nombre de groupes / cohortes

Cohortes et interventions

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

Que mesure l'étude ?

Principaux critères de jugement

Mesure des résultats	Description de la mesure	Délai
Change From Baseline in Disease Activity Score (DAS) 28 Délai: 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 Délai: 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

Mesures de résultats secondaires

Mesure des résultats	Description de la mesure	Délai
Percentage of Participants With a Significant Therapeutic Response Délai: 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 Délai: 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 Délai: 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 Délai: 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 Délai: 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 Délai: 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 Délai: 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 Délai: 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 Délai: 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 Délai: 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 Délai: 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 Délai: 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 Délai: 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 Délai: 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

Collaborateurs et enquêteurs

C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.

Parrainer

AbbVie (prior sponsor, Abbott)

Les enquêteurs

Directeur d'études: Bianca Wittig, MD, AbbVie Deutschland GmbH & Co. KG, Medical Department

Publications et liens utiles

La personne responsable de la saisie des informations sur l'étude fournit volontairement ces publications. Il peut s'agir de tout ce qui concerne l'étude.

Publications générales

Liens utiles

Related Info

Dates d'enregistrement des études

Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.

Dates principales de l'étude

Début de l'étude

1 avril 2003

Achèvement primaire (Réel)

1 mars 2013

Achèvement de l'étude (Réel)