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

23. april 2014 opdateret af: 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.

Studieoversigt

Status

Afsluttet

Betingelser

Detaljeret beskrivelse

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.

Undersøgelsestype

Observationel

Tilmelding (Faktiske)

5745

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

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

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

18 år og ældre (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Prøveudtagningsmetode

Ikke-sandsynlighedsprøve

Studiebefolkning

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.

Beskrivelse

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

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

Kohorter og interventioner

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

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Change From Baseline in Disease Activity Score (DAS) 28
Tidsramme: 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
Tidsramme: 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

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Percentage of Participants With a Significant Therapeutic Response
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Efterforskere

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

Publikationer og nyttige links

Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.

Hjælpsomme links

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart

1. april 2003

Primær færdiggørelse (Faktiske)

1. marts 2013

Studieafslutning (Faktiske)

1. marts 2013

Datoer for studieregistrering

Først indsendt

26. februar 2010

Først indsendt, der opfyldte QC-kriterier

26. februar 2010

Først opslået (Skøn)

2. marts 2010

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Skøn)

8. maj 2014

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

23. april 2014

Sidst verificeret

1. april 2014

Mere information

Begreber relateret til denne undersøgelse

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

Kliniske forsøg med Rheumatoid arthritis

Abonner