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

2014년 4월 23일 업데이트: 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.

연구 개요

상태

완전한

상세 설명

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.

연구 유형

관찰

등록 (실제)

5745

연락처 및 위치

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연구 장소

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

참여기준

연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.

자격 기준

공부할 수 있는 나이

18년 이상 (성인, 고령자)

건강한 자원 봉사자를 받아들입니다

아니

연구 대상 성별

모두

샘플링 방법

비확률 샘플

연구 인구

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.

설명

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

공부 계획

이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.

연구는 어떻게 설계됩니까?

디자인 세부사항

코호트 및 개입

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

연구는 무엇을 측정합니까?

주요 결과 측정

결과 측정
측정값 설명
기간
Change From Baseline in Disease Activity Score (DAS) 28
기간: 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
기간: 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

2차 결과 측정

결과 측정
측정값 설명
기간
Percentage of Participants With a Significant Therapeutic Response
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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

공동 작업자 및 조사자

여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.

수사관

  • 연구 책임자: Bianca Wittig, MD, AbbVie Deutschland GmbH & Co. KG, Medical Department

간행물 및 유용한 링크

연구에 대한 정보 입력을 담당하는 사람이 자발적으로 이러한 간행물을 제공합니다. 이것은 연구와 관련된 모든 것에 관한 것일 수 있습니다.

유용한 링크

연구 기록 날짜

이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.

연구 주요 날짜

연구 시작

2003년 4월 1일

기본 완료 (실제)

2013년 3월 1일

연구 완료 (실제)

2013년 3월 1일

연구 등록 날짜

최초 제출

2010년 2월 26일

QC 기준을 충족하는 최초 제출

2010년 2월 26일

처음 게시됨 (추정)

2010년 3월 2일

연구 기록 업데이트

마지막 업데이트 게시됨 (추정)

2014년 5월 8일

QC 기준을 충족하는 마지막 업데이트 제출

2014년 4월 23일

마지막으로 확인됨

2014년 4월 1일

추가 정보

이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .

류마티스 관절염에 대한 임상 시험

구독하다