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

23 апреля 2014 г. обновлено: 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.

Обзор исследования

Статус

Завершенный

Условия

Ревматоидный артрит

Подробное описание

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.

Тип исследования

Наблюдательный

Регистрация (Действительный)

5745

Контакты и местонахождение

В этом разделе приведены контактные данные лиц, проводящих исследование, и информация о том, где проводится это исследование.

Места учебы

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

Критерии участия

Исследователи ищут людей, которые соответствуют определенному описанию, называемому критериям приемлемости. Некоторыми примерами этих критериев являются общее состояние здоровья человека или предшествующее лечение.

Критерии приемлемости

Возраст, подходящий для обучения

18 лет и старше (Взрослый, Пожилой взрослый)

Принимает здоровых добровольцев

Нет

Полы, имеющие право на обучение

Все

Метод выборки

Невероятностная выборка

Исследуемая популяция

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.

Описание

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

Учебный план

В этом разделе представлена подробная информация о плане исследования, в том числе о том, как планируется исследование и что оно измеряет.

Как устроено исследование?

Детали дизайна

Количество групп / когорт

Когорты и вмешательства

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

Что измеряет исследование?

Первичные показатели результатов

Мера результата	Мера Описание	Временное ограничение
Change From Baseline in Disease Activity Score (DAS) 28 Временное ограничение: 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 Временное ограничение: 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

Вторичные показатели результатов

Мера результата	Мера Описание	Временное ограничение
Percentage of Participants With a Significant Therapeutic Response Временное ограничение: 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 Временное ограничение: 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 Временное ограничение: 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 Временное ограничение: 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 Временное ограничение: 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 Временное ограничение: 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 Временное ограничение: 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 Временное ограничение: 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 Временное ограничение: 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 Временное ограничение: 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 Временное ограничение: 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 Временное ограничение: 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 Временное ограничение: 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 Временное ограничение: 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

Соавторы и исследователи

Здесь вы найдете людей и организации, участвующие в этом исследовании.

Спонсор

AbbVie (prior sponsor, Abbott)

Следователи

Директор по исследованиям: Bianca Wittig, MD, AbbVie Deutschland GmbH & Co. KG, Medical Department

Публикации и полезные ссылки

Лицо, ответственное за внесение сведений об исследовании, добровольно предоставляет эти публикации. Это может быть что угодно, связанное с исследованием.

Общие публикации

Полезные ссылки

Related Info

Даты записи исследования

Эти даты отслеживают ход отправки отчетов об исследованиях и сводных результатов на сайт ClinicalTrials.gov. Записи исследований и сообщаемые результаты проверяются Национальной медицинской библиотекой (NLM), чтобы убедиться, что они соответствуют определенным стандартам контроля качества, прежде чем публиковать их на общедоступном веб-сайте.

Изучение основных дат

Начало исследования

1 апреля 2003 г.

Первичное завершение (Действительный)

1 марта 2013 г.

Завершение исследования (Действительный)