Effectiveness and Safety of Adalimumab in Rheumatoid Arthritis Patients in Routine Clinical Practice
23 aprile 2014 aggiornato da: 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.
Panoramica dello studio
Stato
Completato
Condizioni
Descrizione dettagliata
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.
Tipo di studio
Osservativo
Iscrizione (Effettivo)
5745
Contatti e Sedi
Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.
Luoghi di studio
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Aachen, Germania, 52062
- Site Reference ID/Investigator# 35034
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Aachen, Germania, 52064
- Site Reference ID/Investigator# 35033
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Achern, Germania, 77855
- Site Reference ID/Investigator# 53919
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Aichhalden, Germania, 78733
- Site Reference ID/Investigator# 53883
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Altenburg, Germania, 04600
- Site Reference ID/Investigator# 35041
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Amberg, Germania, 92224
- Site Reference ID/Investigator# 35050
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Amberg, Germania, 92224
- Site Reference ID/Investigator# 53974
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Augsburg, Germania, 86150
- Site Reference ID/Investigator# 33347
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Bad Abbach, Germania, 93077
- Site Reference ID/Investigator# 33356
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Bad Abbach, Germania, 93077
- Site Reference ID/Investigator# 33359
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Bad Aibling, Germania, 83043
- Site Reference ID/Investigator# 33362
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Bad Aibling, Germania, 83043
- Site Reference ID/Investigator# 35084
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Bad Aibling, Germania, 83043
- Site Reference ID/Investigator# 53968
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Bad Bellingen, Germania, 79415
- Site Reference ID/Investigator# 53966
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Bad Bentheim, Germania, D-48455
- Site Reference ID/Investigator# 35523
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Bad Bramstedt, Germania, 24576
- Site Reference ID/Investigator# 35571
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Bad Bramstedt, Germania, 24576
- Site Reference ID/Investigator# 53903
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Bad Buchau, Germania, 88422
- Site Reference ID/Investigator# 53929
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Bad Endbach, Germania, 35080
- Site Reference ID/Investigator# 33370
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Bad Endbach, Germania, 63065
- Site Reference ID/Investigator# 33369
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Bad Iburg, Germania, 49186
- Site Reference ID/Investigator# 33380
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Bad Kissingen, Germania, 97688
- Site Reference ID/Investigator# 33384
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Bad Kreuznach, Germania, 55543
- Site Reference ID/Investigator# 33385
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Bad Liebenwerda, Germania, 04924
- Site Reference ID/Investigator# 33389
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Bad Mergentheim, Germania, 97980
- Site Reference ID/Investigator# 53942
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Bad Muender, Germania, 31848
- Site Reference ID/Investigator# 33394
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Bad Nauheim, Germania, 61231
- Site Reference ID/Investigator# 33398
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Bad Neuenahr, Germania, 53474
- Site Reference ID/Investigator# 33399
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Bad Neuenahr, Germania, 53474
- Site Reference ID/Investigator# 35576
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Bad Pyrmont, Germania, 31812
- Site Reference ID/Investigator# 53980
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Bad Rappenau, Germania, 74906
- Site Reference ID/Investigator# 33402
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Bad Soden-Salmuenster, Germania, 63628
- Site Reference ID/Investigator# 33410
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Bad Staffelstein, Germania, 96231
- Site Reference ID/Investigator# 33415
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Bad Toelz, Germania, 83646
- Site Reference ID/Investigator# 54804
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Baden-Baden, Germania, 76530
- Site Reference ID/Investigator# 33423
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Bamberg, Germania, 96047
- Site Reference ID/Investigator# 33427
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Bautzen, Germania, 02625
- Site Reference ID/Investigator# 33436
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Bayreuth, Germania, 95445
- Site Reference ID/Investigator# 33440
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Belm, Germania, 49191
- Site Reference ID/Investigator# 53978
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Bensheim, Germania, 64625
- Site Reference ID/Investigator# 33449
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Berlin, Germania, 10178
- Site Reference ID/Investigator# 33646
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Berlin, Germania, 10247
- Site Reference ID/Investigator# 53902
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Berlin, Germania, 10367
- Site Reference ID/Investigator# 33662
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Berlin, Germania, 10711
- Site Reference ID/Investigator# 33695
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Berlin, Germania, 10719
- Site Reference ID/Investigator# 34243
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Berlin, Germania, 10777
- Site Reference ID/Investigator# 33681
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Berlin, Germania, 12161
- Site Reference ID/Investigator# 35599
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Berlin, Germania, 12200
- Site Reference ID/Investigator# 53959
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Berlin, Germania, 12435
- Site Reference ID/Investigator# 33688
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Berlin, Germania, 12681
- Site Reference ID/Investigator# 34260
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Berlin, Germania, 13055
- Site Reference ID/Investigator# 33685
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Berlin, Germania, 13055
- Site Reference ID/Investigator# 53948
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Berlin, Germania, 13589
- Site Reference ID/Investigator# 53939
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Berlin, Germania, 13595
- Site Reference ID/Investigator# 53971
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Berlin, Germania, 14059
- Site Reference ID/Investigator# 53933
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Berlin, Germania, 14089
- Site Reference ID/Investigator# 53884
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Berlin, Germania, 14109
- Site Reference ID/Investigator# 33672
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Berlin, Germania, 14163
- Site Reference ID/Investigator# 35552
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Berlin-Buch, Germania, 13125
- Site Reference ID/Investigator# 34264
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Berlin-Wannsee, Germania, 14109
- Site Reference ID/Investigator# 34250
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Bernau, Germania, 16321
- Site Reference ID/Investigator# 35554
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Biberach, Germania, 88400
- Site Reference ID/Investigator# 53899
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Bielefeld, Germania, 33611
- Site Reference ID/Investigator# 34279
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Bielefeld, Germania, 33617
- Site Reference ID/Investigator# 54810
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Bietigheim-Bissingen, Germania, 74321
- Site Reference ID/Investigator# 35559
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Bietigheim-Bissingen, Germania, 74321
- Site Reference ID/Investigator# 35560
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Blankenburg/Hart, Germania, 38889
- Site Reference ID/Investigator# 34283
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Blaubeuren, Germania, 89143
- Site Reference ID/Investigator# 34286
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Bocholt, Germania, 46399
- Site Reference ID/Investigator# 34289
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Bocholt, Germania, 46399
- Site Reference ID/Investigator# 53946
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Bochum, Germania, 44789
- Site Reference ID/Investigator# 35567
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Bogen, Germania, 94327
- Site Reference ID/Investigator# 35642
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Bonn, Germania, 53111
- Site Reference ID/Investigator# 34300
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Bonn, Germania, 53129
- Site Reference ID/Investigator# 53969
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Bonn, Germania, 53175
- Site Reference ID/Investigator# 35647
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Bonn, Germania, 53175
- Site Reference ID/Investigator# 35648
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Bonn, Germania, 53177
- Site Reference ID/Investigator# 34294
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Braunschweig, Germania, 38100
- Site Reference ID/Investigator# 34305
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Braunschweig, Germania, 38100
- Site Reference ID/Investigator# 34310
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Breitenbrunn, Germania, 08359
- Site Reference ID/Investigator# 35601
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Bremen, Germania, 28209
- Site Reference ID/Investigator# 35607
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Bremen, Germania, 28329
- Site Reference ID/Investigator# 53975
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Buechen, Germania, 21514
- Site Reference ID/Investigator# 53934
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Celle, Germania, 29221
- Site Reference ID/Investigator# 34696
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Chemnitz, Germania, 09126
- Site Reference ID/Investigator# 34700
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Chemnitz, Germania, D-09130
- Site Reference ID/Investigator# 35092
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Cologne, Germania, 50679
- Site Reference ID/Investigator# 33990
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Cologne, Germania, 50823
- Site Reference ID/Investigator# 33987
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Cologne, Germania, 50931
- Site Reference ID/Investigator# 33996
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Cologne, Germania, 50969
- Site Reference ID/Investigator# 33993
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Cologne, Germania, 51067
- Site Reference ID/Investigator# 35238
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Cottbus, Germania, 3048
- Site Reference ID/Investigator# 35617
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Cuxhaven, Germania, 27474
- Site Reference ID/Investigator# 53987
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Cuxhaven, Germania, 27476
- Site Reference ID/Investigator# 53889
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Darmstadt, Germania, 64295
- Site Reference ID/Investigator# 35622
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Delmenhorst, Germania, 27749
- Site Reference ID/Investigator# 53885
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Demmin, Germania, 17109
- Site Reference ID/Investigator# 34726
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Denkendorf, Germania, 73770
- Site Reference ID/Investigator# 53932
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Dortmund, Germania, 44147
- Site Reference ID/Investigator# 35636
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Dortmund, Germania, 44263
- Site Reference ID/Investigator# 35632
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Dresden, Germania, 01097
- Site Reference ID/Investigator# 35171
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Dresden, Germania, 01109
- Site Reference ID/Investigator# 34762
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Dresden, Germania, 01159
- Site Reference ID/Investigator# 53958
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Dresden, Germania, 01277
- Site Reference ID/Investigator# 34749
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Dresden, Germania, 01307
- Site Reference ID/Investigator# 34763
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Duesseldorf, Germania, 40211
- Site Reference ID/Investigator# 34771
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Duesseldorf, Germania, 40225
- Site Reference ID/Investigator# 34774
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Duisburg, Germania, 47055
- Site Reference ID/Investigator# 34776
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Duisburg, Germania, 47167
- Site Reference ID/Investigator# 53897
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Ebensfeld, Germania, 96250
- Site Reference ID/Investigator# 34779
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Eberswalde, Germania, 16225
- Site Reference ID/Investigator# 34782
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Eisenberg, Germania, 07607
- Site Reference ID/Investigator# 54805
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Elmshorn, Germania, 25335
- Site Reference ID/Investigator# 35180
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Erftstadt, Germania, 50374
- Site Reference ID/Investigator# 34802
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Erfurt, Germania, 99096
- Site Reference ID/Investigator# 34807
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Erfurt, Germania, 99096
- Site Reference ID/Investigator# 35097
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Erfurt, Germania, 99096
- Site Reference ID/Investigator# 35189
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Erlangen, Germania, 91054
- Site Reference ID/Investigator# 54811
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Erlangen, Germania, 91056
- Site Reference ID/Investigator# 34815
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Essen, Germania, 45128
- Site Reference ID/Investigator# 53925
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Essen, Germania, 45239
- Site Reference ID/Investigator# 34823
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Essen, Germania, 45326
- Site Reference ID/Investigator# 35194
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Essen, Germania, 45329
- Site Reference ID/Investigator# 53931
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Essen, Germania, 45359
- Site Reference ID/Investigator# 53945
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Esslingen, Germania, 73732
- Site Reference ID/Investigator# 34829
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Feldafing, Germania, 82340
- Site Reference ID/Investigator# 35200
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Flensburg, Germania, 24937
- Site Reference ID/Investigator# 35203
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Forchheim, Germania, 91301
- Site Reference ID/Investigator# 34831
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Frankfurt, Germania, 60590
- Site Reference ID/Investigator# 34851
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Frankfurt, Germania, 60596
- Site Reference ID/Investigator# 34838
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Fraureuth, Germania, 08427
- Site Reference ID/Investigator# 35211
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Freiberg, Germania, 09599
- Site Reference ID/Investigator# 35217
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Freiburg, Germania, 79098
- Site Reference ID/Investigator# 34852
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Freiburg, Germania, 79098
- Site Reference ID/Investigator# 34855
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Freiburg, Germania, 79098
- Site Reference ID/Investigator# 53926
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Freiburg, Germania, 79106
- Site Reference ID/Investigator# 34859
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Freystadt, Germania, 92342
- Site Reference ID/Investigator# 35099
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Friedberg, Germania, 61169
- Site Reference ID/Investigator# 53960
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Friedrichroda, Germania, 99894
- Site Reference ID/Investigator# 35222
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Geesthacht, Germania, 21502
- Site Reference ID/Investigator# 53976
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Geilenkirchen, Germania, 52511
- Site Reference ID/Investigator# 53890
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Gelsenkirchen, Germania, 45881
- Site Reference ID/Investigator# 34877
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Giessen, Germania, 35392
- Site Reference ID/Investigator# 53909
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Gladbeck, Germania, 45964
- Site Reference ID/Investigator# 53922
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Goettingen, Germania, 37073
- Site Reference ID/Investigator# 35231
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Goettingen, Germania, 37075
- Site Reference ID/Investigator# 65622
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Goslar, Germania, 38642
- Site Reference ID/Investigator# 34894
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Greifswald, Germania, 17491
- Site Reference ID/Investigator# 34902
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Guestrow, Germania, 18273
- Site Reference ID/Investigator# 34910
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Hagen, Germania, 58089
- Site Reference ID/Investigator# 35501
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Halle, Germania, 06108
- Site Reference ID/Investigator# 34924
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Halle, Germania, 06108
- Site Reference ID/Investigator# 34935
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Halle, Germania, 06108
- Site Reference ID/Investigator# 34938
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Halle, Germania, 06112
- Site Reference ID/Investigator# 34920
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Halle, Germania, 06120
- Site Reference ID/Investigator# 34942
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Halle, Germania, 06128
- Site Reference ID/Investigator# 33819
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Hamburg, Germania, 20144
- Site Reference ID/Investigator# 35442
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Hamburg, Germania, 20355
- Site Reference ID/Investigator# 53984
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Hamburg, Germania, 21031
- Site Reference ID/Investigator# 33367
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Hamburg, Germania, 21073
- Site Reference ID/Investigator# 53900
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Hamburg, Germania, 21075
- Site Reference ID/Investigator# 34956
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Hamburg, Germania, 22081
- Site Reference ID/Investigator# 34962
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Hamburg, Germania, 22081
- Site Reference ID/Investigator# 35450
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Hamburg, Germania, 22087
- Site Reference ID/Investigator# 35112
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Hamburg, Germania, 22089
- Site Reference ID/Investigator# 34946
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Hamburg, Germania, 22119
- Site Reference ID/Investigator# 35001
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Hamburg, Germania, 22147
- Site Reference ID/Investigator# 34959
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Hamburg, Germania, 22147
- Site Reference ID/Investigator# 34977
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Hamburg, Germania, 22391
- Site Reference ID/Investigator# 34965
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Hamburg, Germania, 22399
- Site Reference ID/Investigator# 54806
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Hamburg, Germania, 22529
- Site Reference ID/Investigator# 33578
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Hamburg, Germania, 22529
- Site Reference ID/Investigator# 34967
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Hamburg, Germania, 22529
- Site Reference ID/Investigator# 34989
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Hamburg, Germania, 22609
- Site Reference ID/Investigator# 34981
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Hamburg, Germania, 22609
- Site Reference ID/Investigator# 34984
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Hamburg, Germania, 22609
- Site Reference ID/Investigator# 34996
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Hamm, Germania, 59065
- Site Reference ID/Investigator# 53953
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Hanau, Germania, 63450
- Site Reference ID/Investigator# 35017
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Hannover, Germania, 30625
- Site Reference ID/Investigator# 33788
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Hanover, Germania, 30159
- Site Reference ID/Investigator# 33713
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Hanover, Germania, 30159
- Site Reference ID/Investigator# 35032
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Hanover, Germania, 30161
- Site Reference ID/Investigator# 35021
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Harrislee, Germania, 24955
- Site Reference ID/Investigator# 33790
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Haseluenne, Germania, 49740
- Site Reference ID/Investigator# 65629
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Hattingen, Germania, 45525
- Site Reference ID/Investigator# 33795
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Heidelberg, Germania, 69120
- Site Reference ID/Investigator# 33796
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Heidelberg, Germania, 69121
- Site Reference ID/Investigator# 33806
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Heidelberg, Germania, D-69115
- Site Reference ID/Investigator# 33811
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Heilbad Heiligenstadt, Germania, 37308
- Site Reference ID/Investigator# 33816
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Herne, Germania, 44623
- Site Reference ID/Investigator# 53911
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Herne, Germania, 44625
- Site Reference ID/Investigator# 53910
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Herne, Germania, 44652
- Site Reference ID/Investigator# 65623
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Herrsching, Germania, 82211
- Site Reference ID/Investigator# 33823
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Hildesheim, Germania, 31124
- Site Reference ID/Investigator# 33831
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Hof, Germania, 95028
- Site Reference ID/Investigator# 33836
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Hofheim, Germania, 65719
- Site Reference ID/Investigator# 33840
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Hohenfelde, Germania, 18209
- Site Reference ID/Investigator# 33843
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Homburg, Germania, 66424
- Site Reference ID/Investigator# 54807
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Illingen, Germania, 66557
- Site Reference ID/Investigator# 53985
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Ingolstadt, Germania, 85049
- Site Reference ID/Investigator# 33933
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Jena, Germania, 07743
- Site Reference ID/Investigator# 53938
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Jena, Germania, 07745
- Site Reference ID/Investigator# 5323
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Juelich, Germania, 52428
- Site Reference ID/Investigator# 33940
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Kahla, Germania, 07768
- Site Reference ID/Investigator# 33944
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Kahla, Germania, 07768
- Site Reference ID/Investigator# 35124
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Kaiserslautern, Germania, 67655
- Site Reference ID/Investigator# 33948
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Kaltenkirchen, Germania, 24568
- Site Reference ID/Investigator# 53935
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Karlsruhe, Germania, 76133
- Site Reference ID/Investigator# 33397
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Karlsruhe, Germania, 76133
- Site Reference ID/Investigator# 33954
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Karlstadt, Germania, 97753
- Site Reference ID/Investigator# 35482
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Kassel, Germania, 34131
- Site Reference ID/Investigator# 33962
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Koenigs Wusterhausen, Germania, 15711
- Site Reference ID/Investigator# 34000
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Kolkwitz, Germania, 3099
- Site Reference ID/Investigator# 35239
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Kressbronn, Germania, 88079
- Site Reference ID/Investigator# 34006
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Kronach, Germania, 96317
- Site Reference ID/Investigator# 34009
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Kyritz, Germania, 16866
- Site Reference ID/Investigator# 34086
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Lahr, Germania, 77933
- Site Reference ID/Investigator# 34003
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Leipzig, Germania, 04103
- Site Reference ID/Investigator# 53937
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Leipzig, Germania, 04109
- Site Reference ID/Investigator# 65628
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Leipzig, Germania, 04207
- Site Reference ID/Investigator# 34107
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Leipzig, Germania, 04299
- Site Reference ID/Investigator# 34098
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Leverkusen, Germania, 51373
- Site Reference ID/Investigator# 34119
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Lichtenstein, Germania, 09350
- Site Reference ID/Investigator# 34121
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Lippstadt, Germania, 59555
- Site Reference ID/Investigator# 35252
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Lohne, Germania, 49393
- Site Reference ID/Investigator# 53882
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Ludwigsburg, Germania, 71638
- Site Reference ID/Investigator# 53886
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Ludwigsfelde, Germania, 14974
- Site Reference ID/Investigator# 35257
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Ludwigslust, Germania, 19288
- Site Reference ID/Investigator# 53906
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Luebeck, Germania, 23552
- Site Reference ID/Investigator# 34133
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Luedenscheid, Germania, 58311
- Site Reference ID/Investigator# 53943
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Lueneburg, Germania, 21335
- Site Reference ID/Investigator# 33407
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Lueneburg, Germania, 21335
- Site Reference ID/Investigator# 53888
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Magdeburg, Germania, 39104
- Site Reference ID/Investigator# 34148
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Magdeburg, Germania, 39110
- Site Reference ID/Investigator# 53981
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Magdeburg, Germania, 39120
- Site Reference ID/Investigator# 53913
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Mainz, Germania, 55116
- Site Reference ID/Investigator# 53928
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Mainz, Germania, 55116
- Site Reference ID/Investigator# 65631
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Mannheim, Germania, 68165
- Site Reference ID/Investigator# 34184
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Marl, Germania, 45768
- Site Reference ID/Investigator# 34194
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Menz, Germania, 39175
- Site Reference ID/Investigator# 35283
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Merxheim, Germania, 55627
- Site Reference ID/Investigator# 53896
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Minden, Germania, 32429
- Site Reference ID/Investigator# 33418
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Mittelherwigsdorf, Germania, 02763
- Site Reference ID/Investigator# 34206
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Moenchengladbach, Germania, 41061
- Site Reference ID/Investigator# 34216
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Moenchengladbach, Germania, 41061
- Site Reference ID/Investigator# 53915
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Moenchengladbach, Germania, 41199
- Site Reference ID/Investigator# 34211
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Moenchengladbach, Germania, 41199
- Site Reference ID/Investigator# 34214
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Moenkeberg, Germania, 24248
- Site Reference ID/Investigator# 34219
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Muehlhausen, Germania, 99974
- Site Reference ID/Investigator# 34222
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Muenster, Germania, 48143
- Site Reference ID/Investigator# 34044
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Muenster, Germania, 48143
- Site Reference ID/Investigator# 53970
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Muenster, Germania, 48149
- Site Reference ID/Investigator# 34046
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Munich, Germania, 80331
- Site Reference ID/Investigator# 53904
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Munich, Germania, 80336
- Site Reference ID/Investigator# 53956
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Munich, Germania, 80639
- Site Reference ID/Investigator# 34037
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Munich, Germania, 80798
- Site Reference ID/Investigator# 53962
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Munich, Germania, 81547
- Site Reference ID/Investigator# 53912
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Munich, Germania, 81667
- Site Reference ID/Investigator# 35296
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Munich, Germania, 81667
- Site Reference ID/Investigator# 53924
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Munich, Germania, 81925
- Site Reference ID/Investigator# 34041
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Munich, Germania, D-81541
- Site Reference ID/Investigator# 34035
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Naunhof, Germania, 04683
- Site Reference ID/Investigator# 34050
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Neubrandenburg, Germania, 17033
- Site Reference ID/Investigator# 34059
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Neuburg, Germania, 86633
- Site Reference ID/Investigator# 34062
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Neunkirchen, Germania, 66538
- Site Reference ID/Investigator# 34980
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Neuss, Germania, 41460
- Site Reference ID/Investigator# 35311
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Neustadt, Germania, 67434
- Site Reference ID/Investigator# 34072
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Neuwied, Germania, 56564
- Site Reference ID/Investigator# 65630
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Niederbrombach, Germania, 55767
- Site Reference ID/Investigator# 82694
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Niefern-Oeschelbronn, Germania, 75223
- Site Reference ID/Investigator# 34078
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Nienburg, Germania, 31582
- Site Reference ID/Investigator# 34081
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Nienburg, Germania, 31582
- Site Reference ID/Investigator# 34082
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Nuremberg, Germania, 90402
- Site Reference ID/Investigator# 53923
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Oberguenzburg, Germania, 87634
- Site Reference ID/Investigator# 34168
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Offenburg, Germania, 77652
- Site Reference ID/Investigator# 34174
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Oldenburg, Germania, 26121
- Site Reference ID/Investigator# 33490
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Olsberg, Germania, 59939
- Site Reference ID/Investigator# 53950
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Osnabrueck, Germania, D-49074
- Site Reference ID/Investigator# 33499
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Osnabrueck, Germania, D-49074
- Site Reference ID/Investigator# 54803
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Ostseebad Damp, Germania, 24351
- Site Reference ID/Investigator# 34715
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Paderborn, Germania, 33098
- Site Reference ID/Investigator# 35333
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Papenburg, Germania, 26871
- Site Reference ID/Investigator# 33503
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Parchim, Germania, 19370
- Site Reference ID/Investigator# 33506
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Parsberg, Germania, 92331
- Site Reference ID/Investigator# 33509
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Passau, Germania, 94032
- Site Reference ID/Investigator# 35338
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Petershagen, Germania, 32469
- Site Reference ID/Investigator# 33511
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Pinneberg, Germania, 25421
- Site Reference ID/Investigator# 33519
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Pirna, Germania, 01796
- Site Reference ID/Investigator# 33520
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Planegg, Germania, 82152
- Site Reference ID/Investigator# 33521
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Plauen, Germania, 08523
- Site Reference ID/Investigator# 33526
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Potsdam, Germania, 14467
- Site Reference ID/Investigator# 33468
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Potsdam, Germania, 14469
- Site Reference ID/Investigator# 33464
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Pulheim, Germania, 50259
- Site Reference ID/Investigator# 53940
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Radebeul, Germania, 01445
- Site Reference ID/Investigator# 33482
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Raststatt, Germania, 76437
- Site Reference ID/Investigator# 53964
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Ratingen, Germania, 40882
- Site Reference ID/Investigator# 33485
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Ratingen, Germania, 40882
- Site Reference ID/Investigator# 35134
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Ratingen, Germania, 40882
- Site Reference ID/Investigator# 54812
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Regensburg, Germania, 93049
- Site Reference ID/Investigator# 33888
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Regensburg, Germania, 93049
- Site Reference ID/Investigator# 33891
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Regensburg, Germania, 93051
- Site Reference ID/Investigator# 33881
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Regensburg, Germania, 93051
- Site Reference ID/Investigator# 33884
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Regensburg, Germania, 93059
- Site Reference ID/Investigator# 53930
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Reichenbach, Germania, 08468
- Site Reference ID/Investigator# 53986
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Reken, Germania, 48734
- Site Reference ID/Investigator# 53957
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Remscheid, Germania, 42864
- Site Reference ID/Investigator# 53920
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Rendsburg, Germania, 24768
- Site Reference ID/Investigator# 33900
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Reutlingen, Germania, 72764
- Site Reference ID/Investigator# 33903
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Rheinfelden, Germania, 79618
- Site Reference ID/Investigator# 53982
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Rickenbach, Germania, 79736
- Site Reference ID/Investigator# 53908
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Riesa, Germania, 01589
- Site Reference ID/Investigator# 33393
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Rinteln, Germania, 31737
- Site Reference ID/Investigator# 33912
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Rostock, Germania, 18059
- Site Reference ID/Investigator# 33921
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Rothenburg, Germania, 02929
- Site Reference ID/Investigator# 33929
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Saarbruecken, Germania, 66111
- Site Reference ID/Investigator# 34014
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Salzwedel, Germania, 29410
- Site Reference ID/Investigator# 34021
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Schlangenbad, Germania, 65388
- Site Reference ID/Investigator# 53916
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Schneeberg, Germania, 08289
- Site Reference ID/Investigator# 34030
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Schwerin, Germania, 19053
- Site Reference ID/Investigator# 33550
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Schwerin, Germania, 19053
- Site Reference ID/Investigator# 35374
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Schwerte, Germania, 58239
- Site Reference ID/Investigator# 33553
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Seesen, Germania, 38723
- Site Reference ID/Investigator# 33557
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Siegen, Germania, 57072
- Site Reference ID/Investigator# 53944
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Sinsheim, Germania, 74889
- Site Reference ID/Investigator# 33565
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Solingen, Germania, 42651
- Site Reference ID/Investigator# 53927
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Soltau, Germania, 29614
- Site Reference ID/Investigator# 33570
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Stadtbergen, Germania, 86391
- Site Reference ID/Investigator# 33583
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Stadthagen, Germania, 31655
- Site Reference ID/Investigator# 33586
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Steinhagen, Germania, 33803
- Site Reference ID/Investigator# 53936
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Stuttgart, Germania, 70178
- Site Reference ID/Investigator# 33602
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Stuttgart, Germania, 70199
- Site Reference ID/Investigator# 33609
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Stuttgart, Germania, 70372
- Site Reference ID/Investigator# 33596
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Suhl, Germania, 98529
- Site Reference ID/Investigator# 35387
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Tarp, Germania, 24963
- Site Reference ID/Investigator# 54808
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Thum-Jahnsbach, Germania, 9419
- Site Reference ID/Investigator# 35433
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Tischenreuth, Germania, 95643
- Site Reference ID/Investigator# 53951
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Torgelow, Germania, 17358
- Site Reference ID/Investigator# 33623
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Treuenbrietzen, Germania, 14929
- Site Reference ID/Investigator# 33628
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Tuebingen, Germania, 72072
- Site Reference ID/Investigator# 53907
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Twistringen, Germania, 27239
- Site Reference ID/Investigator# 53893
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Ueberlingen-Nussdorf, Germania, 88662
- Site Reference ID/Investigator# 33635
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Uhlstaedt-Kirchhasel, Germania, 07407
- Site Reference ID/Investigator# 53898
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Ulm, Germania, 89073
- Site Reference ID/Investigator# 33722
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Ulm, Germania, 89073
- Site Reference ID/Investigator# 65626
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Verden, Germania, 27283
- Site Reference ID/Investigator# 33732
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Viersen, Germania, 41747
- Site Reference ID/Investigator# 53965
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Villingen-Schwenningen, Germania, 78054
- Site Reference ID/Investigator# 33735
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Vogelsang-Gommern, Germania, 39245
- Site Reference ID/Investigator# 53914
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Vreden, Germania, 48691
- Site Reference ID/Investigator# 53952
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Waldbronn, Germania, 76337
- Site Reference ID/Investigator# 54809
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Waltrop, Germania, 45731
- Site Reference ID/Investigator# 33740
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Weener, Germania, 26826
- Site Reference ID/Investigator# 33747
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Weiden i.d. Oberpfalz, Germania, 92637
- Site Reference ID/Investigator# 53891
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Weissenfels, Germania, 06667
- Site Reference ID/Investigator# 53921
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Welzow, Germania, 03119
- Site Reference ID/Investigator# 33753
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Wiesbaden, Germania, 65189
- Site Reference ID/Investigator# 35406
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Wiesbaden, Germania, 65189
- Site Reference ID/Investigator# 53941
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Wiesbaden, Germania, 65191
- Site Reference ID/Investigator# 33762
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Wilhelmshaven, Germania, 26382
- Site Reference ID/Investigator# 33770
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Winsen, Germania, 21423
- Site Reference ID/Investigator# 53954
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Winsen (Luhe), Germania, 21423
- Site Reference ID/Investigator# 53977
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Wittlich, Germania, 54516
- Site Reference ID/Investigator# 33778
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Wolfsburg, Germania, 38440
- Site Reference ID/Investigator# 33783
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Wuerzburg, Germania, 97070
- Site Reference ID/Investigator# 33716
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Wuppertal, Germania, 42103
- Site Reference ID/Investigator# 53917
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Wuppertal, Germania, 42105
- Site Reference ID/Investigator# 35418
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Zerbst, Germania, 39261
- Site Reference ID/Investigator# 33862
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Zeven, Germania, 27404
- Site Reference ID/Investigator# 33865
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Zwickau, Germania, 08060
- Site Reference ID/Investigator# 33870
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Zwiesel, Germania, 94227
- Site Reference ID/Investigator# 33878
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Criteri di partecipazione
I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.
Criteri di ammissibilità
Età idonea allo studio
18 anni e precedenti (Adulto, Adulto più anziano)
Accetta volontari sani
No
Sessi ammissibili allo studio
Tutto
Metodo di campionamento
Campione non probabilistico
Popolazione di studio
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.
Descrizione
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
Piano di studio
Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.
Come è strutturato lo studio?
Dettagli di progettazione
Coorti e interventi
Gruppo / Coorte |
|---|
|
Rheumatoid arthritis
Participants with rheumatoid arthritis prescribed adalimumab in routine clinical practice were observed from the first dose for up to 5 years.
|
Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
|
Change From Baseline in Disease Activity Score (DAS) 28
Lasso di tempo: 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
Lasso di tempo: 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
|
Misure di risultato secondarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
|
Percentage of Participants With a Significant Therapeutic Response
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
|
Collaboratori e investigatori
Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.
Sponsor
Investigatori
- Direttore dello studio: Bianca Wittig, MD, AbbVie Deutschland GmbH & Co. KG, Medical Department
Pubblicazioni e link utili
La persona responsabile dell'inserimento delle informazioni sullo studio fornisce volontariamente queste pubblicazioni. Questi possono riguardare qualsiasi cosa relativa allo studio.
Pubblicazioni generali
- Behrens F, Koehm M, Schwaneck EC, Schmalzing M, Wittig BM, Gnann H, Greger G, Tony HP, Burkhardt H. Addition or removal of concomitant methotrexate alters adalimumab effectiveness in rheumatoid arthritis but not psoriatic arthritis. Scand J Rheumatol. 2019 Sep;48(5):375-382. doi: 10.1080/03009742.2019.1600717. Epub 2019 Jul 16.
- Scharbatke EC, Behrens F, Schmalzing M, Koehm M, Greger G, Gnann H, Burkhardt H, Tony HP. Association of Improvement in Pain With Therapeutic Response as Determined by Individual Improvement Criteria in Patients With Rheumatoid Arthritis. Arthritis Care Res (Hoboken). 2016 Nov;68(11):1607-1615. doi: 10.1002/acr.22884. Epub 2016 Oct 1.
Collegamenti utili
Studiare le date dei record
Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.
Studia le date principali
Inizio studio
1 aprile 2003
Completamento primario (Effettivo)
1 marzo 2013
Completamento dello studio (Effettivo)
1 marzo 2013
Date di iscrizione allo studio
Primo inviato
26 febbraio 2010
Primo inviato che soddisfa i criteri di controllo qualità
26 febbraio 2010
Primo Inserito (Stima)
2 marzo 2010
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Stima)
8 maggio 2014
Ultimo aggiornamento inviato che soddisfa i criteri QC
23 aprile 2014
Ultimo verificato
1 aprile 2014
Maggiori informazioni
Termini relativi a questo studio
Parole chiave
Termini MeSH pertinenti aggiuntivi
Altri numeri di identificazione dello studio
- HUM 03-1
Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .