Efficacy and Safety of Humira® in Patients With Psoriatic Arthritis in Normal Medical Practice

December 29, 2014 updated by: AbbVie (prior sponsor, Abbott)

A Long Term Documentation to Demonstrate Long Term Efficacy and Safety of Humira® in Patients With Psoriatic Arthritis Under Conditions of Daily Practice

This study is a documentation of effectiveness and safety of Humira in patients with psoriatic arthritis.

Study Overview

Status

Completed

Conditions

Psoriatic Arthritis

Detailed Description

Psoriatic Arthritis participants receiving adalimumab are evaluated in a prospective, non-interventional study (NIS) for 2 years. Patients receive adalimumab 40 mg every other week (eow), per its label. Efficacy and safety parameters are measured routinely at baseline and after 3, 6, 9, 12, 18 and 24 months.

Study Type

Observational

Enrollment (Actual)

4635

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Germany
- - Aachen, Germany, 52062
    - Site Reference ID/Investigator# 35035
  - Aachen, Germany, 52062
    - Site Reference ID/Investigator# 64288
  - Ahlen, Germany, 59227
    - Site Reference ID/Investigator# 35509
  - Ahrensburg, Germany, 22926
    - Site Reference ID/Investigator# 53118
  - Altenburg, Germany, 04600
    - Site Reference ID/Investigator# 35042
  - Altenholz, Germany, 24161
    - Site Reference ID/Investigator# 35045
  - Amberg, Germany, 92224
    - Site Reference ID/Investigator# 35048
  - Annaberg-Buchholz, Germany, 9456
    - Site Reference ID/Investigator# 96243
  - Arnstadt, Germany, 99310
    - Site Reference ID/Investigator# 53205
  - Artern, Germany, 06556
    - Site Reference ID/Investigator# 53091
  - Augsburg, Germany, 86150
    - Site Reference ID/Investigator# 33348
  - Bad Abbach, Germany, 93077
    - Site Reference ID/Investigator# 33357
  - Bad Aibling, Germany, 83043
    - Site Reference ID/Investigator# 35085
  - Bad Aibling, Germany, 83043
    - Site Reference ID/Investigator# 57895
  - Bad Bentheim, Germany, 48455
    - Site Reference ID/Investigator# 91097
  - Bad Bentheim, Germany, D-48455
    - Site Reference ID/Investigator# 35524
  - Bad Bramstedt, Germany, 24576
    - Site Reference ID/Investigator# 35572
  - Bad Bramstedt, Germany, 24576
    - Site Reference ID/Investigator# 64304
  - Bad Endbach, Germany, 35080
    - Site Reference ID/Investigator# 33371
  - Bad Endbach, Germany, 63065
    - Site Reference ID/Investigator# 53278
  - Bad Homburg, Germany, 61348
    - Site Reference ID/Investigator# 91084
  - Bad Iburg, Germany, 49186
    - Site Reference ID/Investigator# 33377
  - Bad Iburg, Germany, 49186
    - Site Reference ID/Investigator# 33381
  - Bad Kissingen, Germany, 97688
    - Site Reference ID/Investigator# 53068
  - Bad Kreuznach, Germany, 55543
    - Site Reference ID/Investigator# 33386
  - Bad Kreuznach, Germany, 55543
    - Site Reference ID/Investigator# 35574
  - Bad Liebenwerda, Germany, 04924
    - Site Reference ID/Investigator# 33390
  - Bad Muender, Germany, 31848
    - Site Reference ID/Investigator# 33395
  - Bad Muender, Germany, 31848
    - Site Reference ID/Investigator# 96245
  - Bad Nauheim, Germany, 61231
    - Site Reference ID/Investigator# 91094
  - Bad Neuenahr, Germany, 53474
    - Site Reference ID/Investigator# 35577
  - Bad Neuenahr, Germany, 53474
    - Site Reference ID/Investigator# 53181
  - Bad Oeynhausen, Germany, 32545
    - Site Reference ID/Investigator# 57885
  - Bad Rappenau, Germany, 74906
    - Site Reference ID/Investigator# 33403
  - Bad Salzungen, Germany, 36433
    - Site Reference ID/Investigator# 53060
  - Bad Salzungen, Germany, 36433
    - Site Reference ID/Investigator# 91079
  - Bad Schlema, Germany, 8301
    - Site Reference ID/Investigator# 53254
  - Bad Staffelstein, Germany, 96231
    - Site Reference ID/Investigator# 33416
  - Bad Sulze, Germany, 18334
    - Site Reference ID/Investigator# 33420
  - Bad Toelz, Germany, 83646
    - Site Reference ID/Investigator# 57890
  - Baden-Baden, Germany, 76530
    - Site Reference ID/Investigator# 33424
  - Bamberg, Germany, 96047
    - Site Reference ID/Investigator# 33428
  - Bautzen, Germany, 02625
    - Site Reference ID/Investigator# 33434
  - Bautzen, Germany, 02625
    - Site Reference ID/Investigator# 33437
  - Bayreuth, Germany, 95444
    - Site Reference ID/Investigator# 53231
  - Bayreuth, Germany, 95445
    - Site Reference ID/Investigator# 33441
  - Bayreuth, Germany, 95445
    - Site Reference ID/Investigator# 33445
  - Bergen, Germany, 18528
    - Site Reference ID/Investigator# 68595
  - Berlin, Germany, 10117
    - Site Reference ID/Investigator# 33459
  - Berlin, Germany, 10117
    - Site Reference ID/Investigator# 35087
  - Berlin, Germany, 10117
    - Site Reference ID/Investigator# 53058
  - Berlin, Germany, 10117
    - Site Reference ID/Investigator# 53241
  - Berlin, Germany, 10117
    - Site Reference ID/Investigator# 53242
  - Berlin, Germany, 10178
    - Site Reference ID/Investigator# 33647
  - Berlin, Germany, 10178
    - Site Reference ID/Investigator# 57909
  - Berlin, Germany, 10243
    - Site Reference ID/Investigator# 53061
  - Berlin, Germany, 10369
    - Site Reference ID/Investigator# 53059
  - Berlin, Germany, 10369
    - Site Reference ID/Investigator# 68842
  - Berlin, Germany, 10435
    - Site Reference ID/Investigator# 33657
  - Berlin, Germany, 10709
    - Site Reference ID/Investigator# 53105
  - Berlin, Germany, 10713
    - Site Reference ID/Investigator# 98535
  - Berlin, Germany, 10719
    - Site Reference ID/Investigator# 34245
  - Berlin, Germany, 10777
    - Site Reference ID/Investigator# 33682
  - Berlin, Germany, 10827
    - Site Reference ID/Investigator# 68594
  - Berlin, Germany, 10961
    - Site Reference ID/Investigator# 34268
  - Berlin, Germany, 12159
    - Site Reference ID/Investigator# 33654
  - Berlin, Germany, 12159
    - Site Reference ID/Investigator# 64284
  - Berlin, Germany, 12161
    - Site Reference ID/Investigator# 35596
  - Berlin, Germany, 12161
    - Site Reference ID/Investigator# 35600
  - Berlin, Germany, 12353
    - Site Reference ID/Investigator# 53081
  - Berlin, Germany, 12435
    - Site Reference ID/Investigator# 53244
  - Berlin, Germany, 12435
    - Site Reference ID/Investigator# 91075
  - Berlin, Germany, 12437
    - Site Reference ID/Investigator# 64287
  - Berlin, Germany, 12681
    - Site Reference ID/Investigator# 34261
  - Berlin, Germany, 13055
    - Site Reference ID/Investigator# 33686
  - Berlin, Germany, 13407
    - Site Reference ID/Investigator# 64286
  - Berlin, Germany, 13507
    - Site Reference ID/Investigator# 52990
  - Berlin, Germany, 13507
    - Site Reference ID/Investigator# 52995
  - Berlin, Germany, 13595
    - Site Reference ID/Investigator# 35549
  - Berlin, Germany, 14129
    - Site Reference ID/Investigator# 53090
  - Berlin, Germany, 14163
    - Site Reference ID/Investigator# 35553
  - Berlin-Buch, Germany, 13125
    - Site Reference ID/Investigator# 34265
  - Berlin-Buch, Germany, 13125
    - Site Reference ID/Investigator# 64291
  - Berlin-Wannsee, Germany, 14109
    - Site Reference ID/Investigator# 53243
  - Berlin-Weissensee, Germany, 13086
    - Site Reference ID/Investigator# 57893
  - Bernau, Germany, 16321
    - Site Reference ID/Investigator# 35555
  - Bernsbach, Germany, 8315
    - Site Reference ID/Investigator# 53213
  - Beverungen, Germany, 37688
    - Site Reference ID/Investigator# 34274
  - Bietigheim-Bissingen, Germany, 74321
    - Site Reference ID/Investigator# 53085
  - Bietigheim-Bissingen, Germany, 74321
    - Site Reference ID/Investigator# 53268
  - Blankenburg/Hart, Germany, 38889
    - Site Reference ID/Investigator# 34284
  - Blaubeuren, Germany, 89143
    - Site Reference ID/Investigator# 34287
  - Bocholt, Germany, 46399
    - Site Reference ID/Investigator# 34290
  - Bochum, Germany, 44789
    - Site Reference ID/Investigator# 35640
  - Bochum, Germany, 44789
    - Site Reference ID/Investigator# 53196
  - Bochum, Germany, 44791
    - Site Reference ID/Investigator# 53179
  - Bochum, Germany, 44803
    - Site Reference ID/Investigator# 57908
  - Bogen, Germany, 94327
    - Site Reference ID/Investigator# 35643
  - Bonn, Germany, 53111
    - Site Reference ID/Investigator# 34301
  - Bonn, Germany, 53177
    - Site Reference ID/Investigator# 34295
  - Braunschweig, Germany, 38100
    - Site Reference ID/Investigator# 34306
  - Breitenbrunn, Germany, 08359
    - Site Reference ID/Investigator# 53234
  - Bremen, Germany, 28209
    - Site Reference ID/Investigator# 35608
  - Bremen, Germany, 28209
    - Site Reference ID/Investigator# 52987
  - Bremen, Germany, 28209
    - Site Reference ID/Investigator# 53107
  - Bremen, Germany, 28239
    - Site Reference ID/Investigator# 53247
  - Bremerhaven, Germany, 27572
    - Site Reference ID/Investigator# 91073
  - Burgstaedt, Germany, 09217
    - Site Reference ID/Investigator# 68584
  - Chemnitz, Germany, 09119
    - Site Reference ID/Investigator# 81599
  - Chemnitz, Germany, 09126
    - Site Reference ID/Investigator# 34698
  - Chemnitz, Germany, 9116
    - Site Reference ID/Investigator# 57902
  - Chemnitz, Germany, D-09130
    - Site Reference ID/Investigator# 35094
  - Cologne, Germany, 50679
    - Site Reference ID/Investigator# 53262
  - Cologne, Germany, 50679
    - Site Reference ID/Investigator# 64298
  - Cologne, Germany, 50733
    - Site Reference ID/Investigator# 64293
  - Cologne, Germany, 50823
    - Site Reference ID/Investigator# 33988
  - Cologne, Germany, 50931
    - Site Reference ID/Investigator# 53193
  - Cologne, Germany, 50937
    - Site Reference ID/Investigator# 53071
  - Cologne, Germany, 51067
    - Site Reference ID/Investigator# 35236
  - Cologne, Germany, 51103
    - Site Reference ID/Investigator# 64300
  - Cologne, Germany, 51109
    - Site Reference ID/Investigator# 72857
  - Cottbus, Germany, 03046
    - Site Reference ID/Investigator# 34710
  - Cottbus, Germany, 3048
    - Site Reference ID/Investigator# 53184
  - Darmstadt, Germany, 64283
    - Site Reference ID/Investigator# 64303
  - Darmstadt, Germany, 64295
    - Site Reference ID/Investigator# 35620
  - Deggendorf, Germany, 94469
    - Site Reference ID/Investigator# 34724
  - Delmenhorst, Germany, 27749
    - Site Reference ID/Investigator# 53209
  - Delmenhorst, Germany, 27753
    - Site Reference ID/Investigator# 53089
  - Dinslaken, Germany, 46535
    - Site Reference ID/Investigator# 91077
  - Dortmund, Germany, 44147
    - Site Reference ID/Investigator# 34741
  - Dortmund, Germany, 44147
    - Site Reference ID/Investigator# 35637
  - Dortmund, Germany, 44263
    - Site Reference ID/Investigator# 35633
  - Dresden, Germany, 01067
    - Site Reference ID/Investigator# 57899
  - Dresden, Germany, 01097
    - Site Reference ID/Investigator# 35172
  - Dresden, Germany, 01109
    - Site Reference ID/Investigator# 34753
  - Dresden, Germany, 01219
    - Site Reference ID/Investigator# 53069
  - Dresden, Germany, 01277
    - Site Reference ID/Investigator# 34747
  - Dresden, Germany, 01277
    - Site Reference ID/Investigator# 34750
  - Dresden, Germany, 01277
    - Site Reference ID/Investigator# 34759
  - Dresden, Germany, 01277
    - Site Reference ID/Investigator# 68590
  - Dresden, Germany, 01307
    - Site Reference ID/Investigator# 53182
  - Dresden, Germany, 1109
    - Site Reference ID/Investigator# 91081
  - Dresden, Germany, 1217
    - Site Reference ID/Investigator# 68592
  - Dresden, Germany, 1309
    - Site Reference ID/Investigator# 57904
  - Dueren, Germany, 52349
    - Site Reference ID/Investigator# 53266
  - Duesseldorf, Germany, 40211
    - Site Reference ID/Investigator# 34772
  - Duesseldorf, Germany, 40225
    - Site Reference ID/Investigator# 64302
  - Duisburg, Germany, 47055
    - Site Reference ID/Investigator# 34777
  - Duisburg, Germany, 47249
    - Site Reference ID/Investigator# 53072
  - Duisburg, Germany, 47249
    - Site Reference ID/Investigator# 98537
  - Eberswalde, Germany, 16225
    - Site Reference ID/Investigator# 34783
  - Eberswalde, Germany, 16225
    - Site Reference ID/Investigator# 53194
  - Eisenach, Germany, 99817
    - Site Reference ID/Investigator# 53065
  - Eisenach, Germany, 99817
    - Site Reference ID/Investigator# 72856
  - Elmshorn, Germany, 25335
    - Site Reference ID/Investigator# 35181
  - Eppstein, Germany, 65817
    - Site Reference ID/Investigator# 53114
  - Erftstadt, Germany, 50374
    - Site Reference ID/Investigator# 53221
  - Erfurt, Germany, 99084
    - Site Reference ID/Investigator# 53070
  - Erfurt, Germany, 99084
    - Site Reference ID/Investigator# 53258
  - Erfurt, Germany, 99084
    - Site Reference ID/Investigator# 53259
  - Erfurt, Germany, 99084
    - Site Reference ID/Investigator# 57900
  - Erfurt, Germany, 99096
    - Site Reference ID/Investigator# 34808
  - Erfurt, Germany, 99096
    - Site Reference ID/Investigator# 35095
  - Erkrath, Germany, 40699
    - Site Reference ID/Investigator# 57901
  - Erlangen, Germany, 91056
    - Site Reference ID/Investigator# 34820
  - Erlangen, Germany, D-91054
    - Site Reference ID/Investigator# 57896
  - Essen, Germany, 45326
    - Site Reference ID/Investigator# 35195
  - Essen, Germany, 45356
    - Site Reference ID/Investigator# 35198
  - Esslingen, Germany, 73732
    - Site Reference ID/Investigator# 53219
  - Feldafing, Germany, 82340
    - Site Reference ID/Investigator# 35201
  - Flensburg, Germany, 24937
    - Site Reference ID/Investigator# 35204
  - Forchheim, Germany, 91301
    - Site Reference ID/Investigator# 34832
  - Frankenberg, Germany, 09669
    - Site Reference ID/Investigator# 35209
  - Frankfurt, Germany, 60590
    - Site Reference ID/Investigator# 64283
  - Frankfurt, Germany, 60596
    - Site Reference ID/Investigator# 34839
  - Fraureuth, Germany, 08427
    - Site Reference ID/Investigator# 35212
  - Frechen, Germany, 50226
    - Site Reference ID/Investigator# 91078
  - Freiberg, Germany, 09599
    - Site Reference ID/Investigator# 35218
  - Freiburg, Germany, 79098
    - Site Reference ID/Investigator# 34853
  - Freiburg, Germany, 79098
    - Site Reference ID/Investigator# 34856
  - Freiburg, Germany, 79106
    - Site Reference ID/Investigator# 34860
  - Freystadt, Germany, 92342
    - Site Reference ID/Investigator# 35100
  - Friedrichroda, Germany, 99894
    - Site Reference ID/Investigator# 35223
  - Garching, Germany, 85748
    - Site Reference ID/Investigator# 68843
  - Gelsenkirchen, Germany, 45881
    - Site Reference ID/Investigator# 34878
  - Gelsenkirchen, Germany, 45897
    - Site Reference ID/Investigator# 68591
  - Gera, Germany, 07545
    - Site Reference ID/Investigator# 34882
  - Gera, Germany, 07545
    - Site Reference ID/Investigator# 57907
  - Gera, Germany, 07545
    - Site Reference ID/Investigator# 64285
  - Gera, Germany, 07545
    - Site Reference ID/Investigator# 64294
  - Gera, Germany, 07548
    - Site Reference ID/Investigator# 57897
  - Gera, Germany, 7546
    - Site Reference ID/Investigator# 53222
  - Giessen, Germany, 35392
    - Site Reference ID/Investigator# 34886
  - Goettingen, Germany, 37075
    - Site Reference ID/Investigator# 52998
  - Gornau, Germany, 09405
    - Site Reference ID/Investigator# 53116
  - Goslar, Germany, 38642
    - Site Reference ID/Investigator# 34895
  - Gotha, Germany, 99867
    - Site Reference ID/Investigator# 68589
  - Graefelfing, Germany, 82166
    - Site Reference ID/Investigator# 35493
  - Greifswald, Germany, 17489
    - Site Reference ID/Investigator# 53224
  - Greifswald, Germany, 17489
    - Site Reference ID/Investigator# 57889
  - Greifswald, Germany, 17489
    - Site Reference ID/Investigator# 64289
  - Greifswald, Germany, 17491
    - Site Reference ID/Investigator# 34903
  - Greifswald, Germany, 17491
    - Site Reference ID/Investigator# 58122
  - Gronau, Germany, 48599
    - Site Reference ID/Investigator# 53106
  - Grossenhain, Germany, 01558
    - Site Reference ID/Investigator# 91070
  - Guestrow, Germany, 18273
    - Site Reference ID/Investigator# 34911
  - Halle, Germany, 06108
    - Site Reference ID/Investigator# 34936
  - Halle, Germany, 06108
    - Site Reference ID/Investigator# 34939
  - Halle, Germany, 06108
    - Site Reference ID/Investigator# 53067
  - Halle, Germany, 06108
    - Site Reference ID/Investigator# 53236
  - Halle, Germany, 06108
    - Site Reference ID/Investigator# 81601
  - Halle, Germany, 06112
    - Site Reference ID/Investigator# 34921
  - Halle, Germany, 06120
    - Site Reference ID/Investigator# 34943
  - Halle, Germany, 06128
    - Site Reference ID/Investigator# 34931
  - Hamburg, Germany, 20144
    - Site Reference ID/Investigator# 53063
  - Hamburg, Germany, 20246
    - Site Reference ID/Investigator# 53183
  - Hamburg, Germany, 20246
    - Site Reference ID/Investigator# 96237
  - Hamburg, Germany, 20251
    - Site Reference ID/Investigator# 34969
  - Hamburg, Germany, 20354
    - Site Reference ID/Investigator# 53073
  - Hamburg, Germany, 20355
    - Site Reference ID/Investigator# 34951
  - Hamburg, Germany, 21031
    - Site Reference ID/Investigator# 53276
  - Hamburg, Germany, 21075
    - Site Reference ID/Investigator# 34957
  - Hamburg, Germany, 21109
    - Site Reference ID/Investigator# 96242
  - Hamburg, Germany, 22081
    - Site Reference ID/Investigator# 35451
  - Hamburg, Germany, 22081
    - Site Reference ID/Investigator# 53198
  - Hamburg, Germany, 22087
    - Site Reference ID/Investigator# 35113
  - Hamburg, Germany, 22089
    - Site Reference ID/Investigator# 35006
  - Hamburg, Germany, 22089
    - Site Reference ID/Investigator# 53186
  - Hamburg, Germany, 22111
    - Site Reference ID/Investigator# 53212
  - Hamburg, Germany, 22119
    - Site Reference ID/Investigator# 53206
  - Hamburg, Germany, 22147
    - Site Reference ID/Investigator# 34960
  - Hamburg, Germany, 22147
    - Site Reference ID/Investigator# 53199
  - Hamburg, Germany, 22179
    - Site Reference ID/Investigator# 35448
  - Hamburg, Germany, 22415
    - Site Reference ID/Investigator# 34954
  - Hamburg, Germany, 22459
    - Site Reference ID/Investigator# 34997
  - Hamburg, Germany, 22523
    - Site Reference ID/Investigator# 34993
  - Hamburg, Germany, 22529
    - Site Reference ID/Investigator# 53098
  - Hamburg, Germany, 22529
    - Site Reference ID/Investigator# 53279
  - Hamburg, Germany, 22607
    - Site Reference ID/Investigator# 72854
  - Hamburg, Germany, 22609
    - Site Reference ID/Investigator# 34982
  - Hamburg, Germany, 22609
    - Site Reference ID/Investigator# 34985
  - Hamburg, Germany, 22609
    - Site Reference ID/Investigator# 35110
  - Hamburg, Germany, 22609
    - Site Reference ID/Investigator# 53066
  - Hamburg, Germany, 22761
    - Site Reference ID/Investigator# 53248
  - Hamburg, Germany, 22767
    - Site Reference ID/Investigator# 34973
  - Hanau, Germany, 63450
    - Site Reference ID/Investigator# 35018
  - Hannover, Germany, 30625
    - Site Reference ID/Investigator# 64301
  - Hanover, Germany, 30159
    - Site Reference ID/Investigator# 33711
  - Hanover, Germany, 30159
    - Site Reference ID/Investigator# 53100
  - Hanover, Germany, 30159
    - Site Reference ID/Investigator# 68582
  - Hanover, Germany, 30161
    - Site Reference ID/Investigator# 53083
  - Harrislee, Germany, 24955
    - Site Reference ID/Investigator# 53256
  - Heidelberg, Germany, 69120
    - Site Reference ID/Investigator# 33797
  - Heidelberg, Germany, 69120
    - Site Reference ID/Investigator# 33804
  - Heidelberg, Germany, 69120
    - Site Reference ID/Investigator# 35118
  - Heidelberg, Germany, 69120
    - Site Reference ID/Investigator# 91083
  - Heidelberg, Germany, 69121
    - Site Reference ID/Investigator# 33800
  - Heidelberg, Germany, 69121
    - Site Reference ID/Investigator# 33807
  - Heilbad Heiligenstadt, Germany, 37308
    - Site Reference ID/Investigator# 33817
  - Heilbad Heiligenstadt, Germany, 37308
    - Site Reference ID/Investigator# 53057
  - Herne, Germany, 44623
    - Site Reference ID/Investigator# 64297
  - Herrsching, Germany, 82211
    - Site Reference ID/Investigator# 57894
  - Herten, Germany, 45699
    - Site Reference ID/Investigator# 68586
  - Hildburghausen, Germany, 98646
    - Site Reference ID/Investigator# 53272
  - Hilden, Germany, 40721
    - Site Reference ID/Investigator# 53080
  - Hildesheim, Germany, 31124
    - Site Reference ID/Investigator# 53097
  - Hof, Germany, 95028
    - Site Reference ID/Investigator# 33833
  - Hofheim, Germany, 65719
    - Site Reference ID/Investigator# 33841
  - Hohen Neuendorf, Germany, 16540
    - Site Reference ID/Investigator# 114015
  - Hohenfelde, Germany, 18209
    - Site Reference ID/Investigator# 33844
  - Holzkirchen, Germany, 83607
    - Site Reference ID/Investigator# 53084
  - Homburg, Germany, 66424
    - Site Reference ID/Investigator# 53092
  - Homburg, Germany, 66424
    - Site Reference ID/Investigator# 91085
  - Hoyerswerda, Germany, 02977
    - Site Reference ID/Investigator# 53109
  - Immenstadt, Germany, 87509
    - Site Reference ID/Investigator# 33857
  - Ingoldstadt, Germany, 85049
    - Site Reference ID/Investigator# 98538
  - Ingolstadt, Germany, 85049
    - Site Reference ID/Investigator# 33934
  - Ingolstadt, Germany, 85049
    - Site Reference ID/Investigator# 53111
  - Jena, Germany, 07740
    - Site Reference ID/Investigator# 53053
  - Jena, Germany, 07743
    - Site Reference ID/Investigator# 53055
  - Jena, Germany, 07745
    - Site Reference ID/Investigator# 5305
  - Juelich, Germany, 52428
    - Site Reference ID/Investigator# 33941
  - Kahla, Germany, 07768
    - Site Reference ID/Investigator# 33945
  - Kahla, Germany, 07768
    - Site Reference ID/Investigator# 35123
  - Kaiserslautern, Germany, 67655
    - Site Reference ID/Investigator# 33949
  - Kamenz, Germany, 01917
    - Site Reference ID/Investigator# 52992
  - Karlsruhe, Germany, 76133
    - Site Reference ID/Investigator# 33960
  - Karlstadt, Germany, 97753
    - Site Reference ID/Investigator# 35483
  - Kassel, Germany, 34117
    - Site Reference ID/Investigator# 53192
  - Kassel, Germany, 34131
    - Site Reference ID/Investigator# 33963
  - Katzhuette, Germany, 98746
    - Site Reference ID/Investigator# 33967
  - Kiel, Germany, 24105
    - Site Reference ID/Investigator# 53229
  - Kleinmachnow, Germany, 14532
    - Site Reference ID/Investigator# 72859
  - Koblenz, Germany, 56068
    - Site Reference ID/Investigator# 53233
  - Koenigs Wusterhausen, Germany, 15711
    - Site Reference ID/Investigator# 34001
  - Krefeld, Germany, 47798
    - Site Reference ID/Investigator# 91076
  - Krefeld, Germany, 47798
    - Site Reference ID/Investigator# 91093
  - Krefeld, Germany, 47802
    - Site Reference ID/Investigator# 53108
  - Kressbronn, Germany, 88079
    - Site Reference ID/Investigator# 34007
  - Kronach, Germany, 96317
    - Site Reference ID/Investigator# 34083
  - Kyritz, Germany, 16866
    - Site Reference ID/Investigator# 53101
  - Lahr, Germany, 77933
    - Site Reference ID/Investigator# 34004
  - Landau, Germany, 76829
    - Site Reference ID/Investigator# 35244
  - Langenfeld, Germany, 40764
    - Site Reference ID/Investigator# 64290
  - Leinefelde, Germany, 37327
    - Site Reference ID/Investigator# 53245
  - Leipzig, Germany, 04103
    - Site Reference ID/Investigator# 53115
  - Leipzig, Germany, 04109
    - Site Reference ID/Investigator# 53087
  - Leipzig, Germany, 04129
    - Site Reference ID/Investigator# 34105
  - Leipzig, Germany, 04207
    - Site Reference ID/Investigator# 34108
  - Leipzig, Germany, 04207
    - Site Reference ID/Investigator# 53197
  - Leipzig, Germany, 04289
    - Site Reference ID/Investigator# 53052
  - Leipzig, Germany, 04299
    - Site Reference ID/Investigator# 53211
  - Leverkusen, Germany, 51373
    - Site Reference ID/Investigator# 53088
  - Lichtenstein, Germany, 09350
    - Site Reference ID/Investigator# 34122
  - Lingen, Germany, 49809
    - Site Reference ID/Investigator# 53180
  - Lippstadt, Germany, 59555
    - Site Reference ID/Investigator# 35253
  - Loebau, Germany, 02708
    - Site Reference ID/Investigator# 96240
  - Ludwigsfelde, Germany, 14974
    - Site Reference ID/Investigator# 35259
  - Ludwigshafen, Germany, 67063
    - Site Reference ID/Investigator# 53195
  - Ludwigslust, Germany, 19288
    - Site Reference ID/Investigator# 53249
  - Luebeck, Germany, 23538
    - Site Reference ID/Investigator# 53110
  - Luebeck, Germany, 23564
    - Site Reference ID/Investigator# 34135
  - Luedenscheid, Germany, 58515
    - Site Reference ID/Investigator# 53074
  - Lueneburg, Germany, 21335
    - Site Reference ID/Investigator# 96239
  - Lutherstadt Eisleben, Germany, 06295
    - Site Reference ID/Investigator# 53000
  - Magdeburg, Germany, 39104
    - Site Reference ID/Investigator# 34146
  - Magdeburg, Germany, 39104
    - Site Reference ID/Investigator# 34149
  - Magdeburg, Germany, 39104
    - Site Reference ID/Investigator# 91082
  - Magdeburg, Germany, 39108
    - Site Reference ID/Investigator# 64292
  - Magdeburg, Germany, 39108
    - Site Reference ID/Investigator# 68583
  - Magdeburg, Germany, 39120
    - Site Reference ID/Investigator# 53230
  - Magdeburg, Germany, 39124
    - Site Reference ID/Investigator# 64305
  - Mainz, Germany, 55131
    - Site Reference ID/Investigator# 53075
  - Mainz, Germany, 55131
    - Site Reference ID/Investigator# 68593
  - Mannheim, Germany, 68165
    - Site Reference ID/Investigator# 34179
  - Marktredwitz, Germany, 95615
    - Site Reference ID/Investigator# 34191
  - Marl, Germany, 45768
    - Site Reference ID/Investigator# 34195
  - Meissen, Germany, 01662
    - Site Reference ID/Investigator# 34199
  - Melsungen, Germany, 34212
    - Site Reference ID/Investigator# 53269
  - Memmingen, Germany, 87700
    - Site Reference ID/Investigator# 53078
  - Menz, Germany, 39175
    - Site Reference ID/Investigator# 35284
  - Minden, Germany, 32429
    - Site Reference ID/Investigator# 35286
  - Mittelherwigsdorf, Germany, 02763
    - Site Reference ID/Investigator# 34207
  - Moenchengladbach, Germany, 41061
    - Site Reference ID/Investigator# 34217
  - Moenchengladbach, Germany, 41199
    - Site Reference ID/Investigator# 34212
  - Moenchengladbach, Germany, 41199
    - Site Reference ID/Investigator# 53095
  - Moenchengladbach, Germany, 41236
    - Site Reference ID/Investigator# 53261
  - Moenkeburg, Germany, 24248
    - Site Reference ID/Investigator# 57883
  - Muehlhausen, Germany, 99974
    - Site Reference ID/Investigator# 34223
  - Muelheim, Germany, 45468
    - Site Reference ID/Investigator# 35291
  - Muelheim, Germany, 45468
    - Site Reference ID/Investigator# 53235
  - Muellheim, Germany, 79379
    - Site Reference ID/Investigator# 34228
  - Muenster, Germany, 48143
    - Site Reference ID/Investigator# 53062
  - Muenster, Germany, 48143
    - Site Reference ID/Investigator# 68587
  - Muenster, Germany, 48149
    - Site Reference ID/Investigator# 34047
  - Muenster, Germany, 48149
    - Site Reference ID/Investigator# 53093
  - Muenster, Germany, 48149
    - Site Reference ID/Investigator# 91096
  - Munich, Germany, 80634
    - Site Reference ID/Investigator# 64282
  - Munich, Germany, 80639
    - Site Reference ID/Investigator# 34039
  - Munich, Germany, 80802
    - Site Reference ID/Investigator# 57892
  - Munich, Germany, 80802
    - Site Reference ID/Investigator# 64295
  - Munich, Germany, 81377
    - Site Reference ID/Investigator# 35294
  - Munich, Germany, 81547
    - Site Reference ID/Investigator# 34234
  - Munich, Germany, 81667
    - Site Reference ID/Investigator# 91080
  - Munich, Germany, 81925
    - Site Reference ID/Investigator# 34042
  - Munich, Germany, D-81541
    - Site Reference ID/Investigator# 53270
  - Naila, Germany, 95119
    - Site Reference ID/Investigator# 53246
  - Nastaetten, Germany, 56355
    - Site Reference ID/Investigator# 53271
  - Naumburg, Germany, 06618
    - Site Reference ID/Investigator# 35305
  - Naunhof, Germany, 04683
    - Site Reference ID/Investigator# 34051
  - Neubrandenburg, Germany, 17033
    - Site Reference ID/Investigator# 34060
  - Neuburg, Germany, 86633
    - Site Reference ID/Investigator# 34063
  - Neunkirchen, Germany, 66538
    - Site Reference ID/Investigator# 53220
  - Neuss, Germany, 41460
    - Site Reference ID/Investigator# 35312
  - Neustadt, Germany, 67434
    - Site Reference ID/Investigator# 34075
  - Niefern-Oeschelbronn, Germany, 75223
    - Site Reference ID/Investigator# 34079
  - Nienburg, Germany, 31582
    - Site Reference ID/Investigator# 34157
  - Nienburg, Germany, 31582
    - Site Reference ID/Investigator# 57891
  - Nordhausen, Germany, 99734
    - Site Reference ID/Investigator# 52997
  - Nordhausen, Germany, 99734
    - Site Reference ID/Investigator# 52999
  - Nordhausen, Germany, 99734
    - Site Reference ID/Investigator# 53277
  - Nuremberg, Germany, 90429
    - Site Reference ID/Investigator# 53054
  - Nuremberg, Germany, 90429
    - Site Reference ID/Investigator# 68588
  - Nuremberg, Germany, 90482
    - Site Reference ID/Investigator# 53112
  - Oberhausen, Germany, 46145
    - Site Reference ID/Investigator# 96244
  - Oelsnitz, Germany, 09376
    - Site Reference ID/Investigator# 34172
  - Oelsnitz, Germany, 09376
    - Site Reference ID/Investigator# 53104
  - Offenburg, Germany, 77652
    - Site Reference ID/Investigator# 34175
  - Oldenburg, Germany, 26121
    - Site Reference ID/Investigator# 33491
  - Oldenburg, Germany, 26133
    - Site Reference ID/Investigator# 57886
  - Oschatz, Germany, 04758
    - Site Reference ID/Investigator# 91067
  - Osnabrueck, Germany, 49074
    - Site Reference ID/Investigator# 53207
  - Osnabrueck, Germany, 49076
    - Site Reference ID/Investigator# 81600
  - Ostseebad Damp, Germany, 24351
    - Site Reference ID/Investigator# 53228
  - Paderborn, Germany, 33098
    - Site Reference ID/Investigator# 35334
  - Parchim, Germany, 19370
    - Site Reference ID/Investigator# 33507
  - Passau, Germany, 94032
    - Site Reference ID/Investigator# 35339
  - Peitz, Germany, 03185
    - Site Reference ID/Investigator# 72858
  - Petershagen, Germany, 32469
    - Site Reference ID/Investigator# 53096
  - Pinneberg, Germany, 25421
    - Site Reference ID/Investigator# 53086
  - Pirna, Germany, 01796
    - Site Reference ID/Investigator# 53232
  - Planegg, Germany, 82152
    - Site Reference ID/Investigator# 33522
  - Plauen, Germany, 08523
    - Site Reference ID/Investigator# 33527
  - Plochingen, Germany, 73207
    - Site Reference ID/Investigator# 96278
  - Potsdam, Germany, 14467
    - Site Reference ID/Investigator# 33469
  - Potsdam, Germany, 14469
    - Site Reference ID/Investigator# 33465
  - Potsdam, Germany, 14471
    - Site Reference ID/Investigator# 96236
  - Potsdam, Germany, 14480
    - Site Reference ID/Investigator# 53281
  - Pruem, Germany, 54595
    - Site Reference ID/Investigator# 33475
  - Puettlingen, Germany, 66346
    - Site Reference ID/Investigator# 33478
  - Puettlingen, Germany, 66346
    - Site Reference ID/Investigator# 53257
  - Puettlingen, Germany, 66346
    - Site Reference ID/Investigator# 91120
  - Quedlinburg, Germany, 06484
    - Site Reference ID/Investigator# 53094
  - Querfurt, Germany, 6268
    - Site Reference ID/Investigator# 53265
  - Radebeul, Germany, 01445
    - Site Reference ID/Investigator# 33483
  - Radebeul, Germany, 01445
    - Site Reference ID/Investigator# 35346
  - Ratingen, Germany, 40882
    - Site Reference ID/Investigator# 53280
  - Ratingen, Germany, 40882
    - Site Reference ID/Investigator# 57888
  - Ratzeburg, Germany, 23909
    - Site Reference ID/Investigator# 33487
  - Regensburg, Germany, 93049
    - Site Reference ID/Investigator# 33889
  - Regensburg, Germany, 93049
    - Site Reference ID/Investigator# 57912
  - Regensburg, Germany, 93051
    - Site Reference ID/Investigator# 57911
  - Regensburg, Germany, 93053
    - Site Reference ID/Investigator# 53264
  - Rendsburg, Germany, 24768
    - Site Reference ID/Investigator# 33901
  - Ribnitz-Damgarten, Germany, 18311
    - Site Reference ID/Investigator# 52991
  - Riesa, Germany, 01587
    - Site Reference ID/Investigator# 53267
  - Riesa, Germany, 01589
    - Site Reference ID/Investigator# 33910
  - Rinteln, Germany, 31737
    - Site Reference ID/Investigator# 33913
  - Rostock, Germany, 18059
    - Site Reference ID/Investigator# 33922
  - Rostock, Germany, 18059
    - Site Reference ID/Investigator# 33926
  - Rothenburg, Germany, 02929
    - Site Reference ID/Investigator# 33930
  - Rudolstadt, Germany, 07407
    - Site Reference ID/Investigator# 53113
  - Ruedersdorf, Germany, 15562
    - Site Reference ID/Investigator# 35361
  - Saarbruecken, Germany, 66111
    - Site Reference ID/Investigator# 34015
  - Saarlouis, Germany, 66740
    - Site Reference ID/Investigator# 91071
  - Salzwedel, Germany, 29410
    - Site Reference ID/Investigator# 34022
  - Sande, Germany, 26452
    - Site Reference ID/Investigator# 34026
  - Schleiz, Germany, 7907
    - Site Reference ID/Investigator# 53208
  - Schlettau, Germany, 09487
    - Site Reference ID/Investigator# 91074
  - Schneeberg, Germany, 08289
    - Site Reference ID/Investigator# 33533
  - Schramberg, Germany, 78713
    - Site Reference ID/Investigator# 33538
  - Schutterwald, Germany, 77746
    - Site Reference ID/Investigator# 33541
  - Schwandorf, Germany, 92421
    - Site Reference ID/Investigator# 35370
  - Schwandorf, Germany, 92421
    - Site Reference ID/Investigator# 91072
  - Schwedt, Germany, 16303
    - Site Reference ID/Investigator# 57905
  - Schweina, Germany, 36448
    - Site Reference ID/Investigator# 72855
  - Schwerin, Germany, 19053
    - Site Reference ID/Investigator# 33548
  - Schwerin, Germany, 19053
    - Site Reference ID/Investigator# 35375
  - Schwerte, Germany, 58239
    - Site Reference ID/Investigator# 33554
  - Seesen, Germany, 38723
    - Site Reference ID/Investigator# 33558
  - Sinsheim, Germany, 74889
    - Site Reference ID/Investigator# 33566
  - Soltau, Germany, 29614
    - Site Reference ID/Investigator# 33571
  - Spelle, Germany, 48480
    - Site Reference ID/Investigator# 53255
  - St. Martin, Germany, 67487
    - Site Reference ID/Investigator# 35382
  - Stadtbergen, Germany, 86391
    - Site Reference ID/Investigator# 33584
  - Stolberg, Germany, 52222
    - Site Reference ID/Investigator# 98539
  - Storkow, Germany, 15859
    - Site Reference ID/Investigator# 53218
  - Straubing, Germany, 94315
    - Site Reference ID/Investigator# 53082
  - Stuttgart, Germany, 70178
    - Site Reference ID/Investigator# 33603
  - Stuttgart, Germany, 70178
    - Site Reference ID/Investigator# 33606
  - Stuttgart, Germany, 70199
    - Site Reference ID/Investigator# 33610
  - Stuttgart, Germany, 70372
    - Site Reference ID/Investigator# 33597
  - Suhl, Germany, 98527
    - Site Reference ID/Investigator# 53210
  - Suhl, Germany, 98527
    - Site Reference ID/Investigator# 53223
  - Suhl, Germany, 98529
    - Site Reference ID/Investigator# 35388
  - Torgelow, Germany, 17358
    - Site Reference ID/Investigator# 33624
  - Treuenbrietzen, Germany, 14929
    - Site Reference ID/Investigator# 53077
  - Treuenbrietzen, Germany, 14929
    - Site Reference ID/Investigator# 57906
  - Tuttlingen, Germany, 78532
    - Site Reference ID/Investigator# 53200
  - Ueberlingen-Nussdorf, Germany, 88662
    - Site Reference ID/Investigator# 57910
  - Ulm, Germany, 89073
    - Site Reference ID/Investigator# 33640
  - Ulm, Germany, 89073
    - Site Reference ID/Investigator# 33723
  - Unna, Germany, 59423
    - Site Reference ID/Investigator# 81602
  - Varel, Germany, 26316
    - Site Reference ID/Investigator# 96241
  - Verden, Germany, 27283
    - Site Reference ID/Investigator# 98536
  - Viersen, Germany, 41749
    - Site Reference ID/Investigator# 72860
  - Villingen-Schwenningen, Germany, 78054
    - Site Reference ID/Investigator# 33736
  - Waltrop, Germany, 45731
    - Site Reference ID/Investigator# 33741
  - Wasserburg, Germany, 83512
    - Site Reference ID/Investigator# 72853
  - Weener, Germany, 26826
    - Site Reference ID/Investigator# 33748
  - Welzow, Germany, 03119
    - Site Reference ID/Investigator# 33851
  - Wiesbaden, Germany, 65189
    - Site Reference ID/Investigator# 35407
  - Wiesbaden, Germany, 65191
    - Site Reference ID/Investigator# 33764
  - Wiesbaden, Germany, 65191
    - Site Reference ID/Investigator# 52989
  - Wilhelmshaven, Germany, 26382
    - Site Reference ID/Investigator# 33771
  - Winsen, Germany, 21423
    - Site Reference ID/Investigator# 53076
  - Wismar, Germany, 23966
    - Site Reference ID/Investigator# 33775
  - Wittlich, Germany, 54516
    - Site Reference ID/Investigator# 33779
  - Wittmund, Germany, 26409
    - Site Reference ID/Investigator# 91095
  - Wolfenbuettel, Germany, 38300
    - Site Reference ID/Investigator# 96235
  - Wuerzburg, Germany, 97070
    - Site Reference ID/Investigator# 33717
  - Wuerzburg, Germany, 97070
    - Site Reference ID/Investigator# 57903
  - Wuppertal, Germany, 42103
    - Site Reference ID/Investigator# 91068
  - Wuppertal, Germany, 42103
    - Site Reference ID/Investigator# 91069
  - Wuppertal, Germany, 42105
    - Site Reference ID/Investigator# 35419
  - Wurzen, Germany, 04808
    - Site Reference ID/Investigator# 57884
  - Zeitz, Germany, 06712
    - Site Reference ID/Investigator# 53064
  - Zerbst, Germany, 39261
    - Site Reference ID/Investigator# 33863
  - Zeven, Germany, 27404
    - Site Reference ID/Investigator# 33866
  - Zschopau, Germany, 9405
    - Site Reference ID/Investigator# 64299
  - Zwickau, Germany, 08056
    - Site Reference ID/Investigator# 52996
  - Zwickau, Germany, 08060
    - Site Reference ID/Investigator# 33875
  - Zwickau, Germany, 08060
    - Site Reference ID/Investigator# 52993
  - Zwickau, Germany, 08060
    - Site Reference ID/Investigator# 53056
  - Zwickau, Germany, 08060
    - Site Reference ID/Investigator# 53102
  - Zwickau, Germany, 08066
    - Site Reference ID/Investigator# 52994
  - Zwickau, Germany, 8058
    - Site Reference ID/Investigator# 53226
  - Zwickau, Germany, 8060
    - Site Reference ID/Investigator# 53260
  - Zwiesel, Germany, 94227
    - Site Reference ID/Investigator# 33879

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Clinical routine patients with psoriatic arthritis

Description

Inclusion:

18 years of age or older (younger patients may be enrolled at the discretion of physician)
Diagnosis of Psoriatic Arthritis (or any indication at the discretion of physician) and initiating adalimumab therapy
Signed/dated Informed Consent

Exclusion:

-None

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Number of groups / cohorts

Cohorts and Interventions

Group / Cohort
Psoriatic Arthritis Participants with Psoriatic Arthritis prescribed adalimumab in routine clinical practice were observed from the first dose for up to 24 months.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Mean Change From Baseline in Disease Activity Score (DAS)28 Time Frame: Baseline and Months 3, 6, 9, 12, 18, and 24	The DAS28 is a validated index of rheumatoid arthritis disease activity. Twenty-eight tender joint counts, 28 swollen joint counts, C-reactive protein, and general health are included in the DAS28 score. Scores on the DAS28 range from 0 to 10. A DAS28 score greater than 5.1 indicates high disease activity, a DAS28 score less than 3.2 indicates low disease activity, and a DAS28 score less than 2.6 indicates clinical remission.	Baseline and Months 3, 6, 9, 12, 18, and 24
Mean Tender Joint Count (TJC) Over Time Time Frame: Baseline, and Months 3, 6, 9, 12, 18, and 24	Tender joint count represents the number of joints displaying tenderness. Although the DAS28 includes assessments of 28 joints, additional joints are typically evaluated in examinations of participants with Psoriatic Arthritis (PsA) as the joints typically affected in these participants differ from those commonly involved in Rheumatoid Arthritis (RA). Specifically, PsA often involves distal interphalangeal joints (DIP), whereas RA does not.	Baseline, and Months 3, 6, 9, 12, 18, and 24
Mean Swollen Joint Count (SJC) Over Time Time Frame: Baseline, and Months 3, 6, 9, 12, 18, and 24	Swollen joint count represents the number of joints displaying swelling. Although the DAS28 includes assessments of 28 joints, additional joints are typically evaluated in examinations of participants with Psoriatic Arthritis (PsA) as the joints typically affected in these participants differ from those commonly involved in Rheumatoid Arthritis (RA). Specifically, PsA often involves distal interphalangeal joints (DIP), whereas RA does not.	Baseline, and Months 3, 6, 9, 12, 18, and 24
Mean Percent Body Surface Area (BSA) Affected by Psoriasis Over Time Time Frame: Baseline, and Months 3, 6, 9, 12, 18, and 24	Body surface area was used to evaluate the extent of psoriatic skin involvement. At baseline, investigators classified participants as having BSA less than 3%, 3 to 10%, 11 to 20%, or greater than 20%. At all post-baseline time points, clinicians were asked to estimate BSA on a scale of 0% to 100% rather than as categories. BSA was visually determined by the investigator using the 'rule of nines' and estimating that the palm of the patient's hand was equal to 1% BSA.	Baseline, and Months 3, 6, 9, 12, 18, and 24
Mean Target Lesion Score (TLS) Over Time Time Frame: Baseline, and Months 3, 6, 9, 12, 18, and 24	The Target Lesion Score (TLS) was based on the severity of erythema, scaling, and infiltration of a prospectively-defined psoriasis target lesion of at least 2 cm in width that was considered to be representative of all other affected areas. Each of the three characteristics was evaluated by the clinician on a scale of 0 (absent) to 5 (maximal expression), and these scores were totaled to provide a TLS ranging from 0 (lowest severity) to 15 (highest severity).	Baseline, and Months 3, 6, 9, 12, 18, and 24
Number of Participants With Adverse Events (AEs) Time Frame: Baseline up to 24 months	Adverse Events (AEs) were reported that clinicians considered to be related to the study drug. An AE was considered to be a serious adverse event (SAE) if any of the following criteria were met: Death of participant, life-threatening event, hospitalization, prolongation of hospitalization, congenital anomaly, persistent or significant disability or incapacity, important medical event requiring medical or surgical intervention to prevent serious outcome, or spontaneous or elective abortion.	Baseline up to 24 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Participants by Severity of Enthesitis Over Time Time Frame: Baseline, and Months 3, 6, 9, 12, 18, and 24	Enthesitis is a distinguishing characteristic of PsA. Enthesitis involves inflammation at the site where tendons and other connective tissues enter the bone. Investigators reported the presence or absence of enthesitis on the basis of their clinical evaluation; no specific scale or score was used. If present, the severity of each condition was graded by the investigator on a scale of mild, moderate, and severe based on their clinical impression.	Baseline, and Months 3, 6, 9, 12, 18, and 24
Number of Participants by Severity of Dactylitis Over Time Time Frame: Baseline, and Months 3, 6, 9, 12, 18, and 24	Dactylitis is a distinguishing characteristic of PsA. Dactylitis, sometimes referred to "sausage digit," involves swelling of the entire finger. Investigators reported the presence or absence of dactylitis on the basis of their clinical evaluation; no specific scale or score was used. If present, the severity of each condition was graded by the investigator on a scale of mild, moderate, and severe based on their clinical impression.	Baseline, and Months 3, 6, 9, 12, 18, and 24
Number of Participants by Severity of Nail Psoriasis Levels Over Time Time Frame: Baseline, and Months 3, 6, 9, 12, 18, and 24	Nail psoriasis is a distinguishing characteristic of PsA. Nail psoriasis is characterized by changes in the nail and nail matrix, including pitting, onycholysis (painless separation of the nail from the nail bed), and reddish spots. Investigators reported the presence or absence of nail psoriasis on the basis of their clinical evaluation; no specific scale or score was used. If present, the severity of this condition was graded by the investigator on a scale of mild, moderate, and severe based on their clinical impression.	Baseline, and Months 3, 6, 9, 12, 18, and 24
Mean Erythrocyte Sedimentation Rate (ESR) Over Time Time Frame: Baseline, and Months 3, 6, 9, 12, 18, and 24	The Erythrocyte Sedimentation Rate (ESR) is a practicable and sensitive but not specific parameter for measuring disease progression. By means of the ESR it can be generally distinguished between an active and nonactive rheumatic disease. The normal reference range is, as a rule, 0 to 10 mm/h for men and 0 to 15 mm/h for women. The higher the ESR value out of the normal range, the higher is the disease activity.	Baseline, and Months 3, 6, 9, 12, 18, and 24
Mean C-Reactive Protein (CRP) Levels Over Time Time Frame: Baseline, and Months 3, 6, 9, 12, 18, and 24	The C-Reactive Protein (CRP) is an acute phase reactant plasma protein, normally produced by the liver, which is commonly used as an indirect measure of the extent and activity of an inflammation. The CRP normal reference range in the blood is, as a rule, from 0 to 1.0 mg/dL.	Baseline, and Months 3, 6, 9, 12, 18, and 24
Patients Global Assessment of Disease Activity Over Time Time Frame: Baseline, and Months 3, 6, 9, 12, 18, and 24	Measured on a visual analog scale (VAS) of 0 to 10 cm; lower scores indicate better participant's status.	Baseline, and Months 3, 6, 9, 12, 18, and 24
Participants Assessment of Fatigue Over Time Time Frame: Baseline, and Months 3, 6, 9, 12, 18, and 24	Measured on a visual analog scale (VAS) of 0 to 10 cm; lower scores indicate better participant's status.	Baseline, and Months 3, 6, 9, 12, 18, and 24
Participants Assessment of Pain Over Time Time Frame: Baseline, and Months 3, 6, 9, 12, 18, and 24	Measured on a visual analog scale (VAS) of 0 to 10 cm; lower scores indicate better participant's status.	Baseline, and Months 3, 6, 9, 12, 18, and 24
Mean Funktionsfragebogen Hannover (FFbH) Questionnaire Scores Over Time Time Frame: Baseline, and Months 3, 6, 9, 12, 18, and 24	A self-administered participant questionnaire used to assess patient function on a scale of 0 (total loss of functional capacity) to 100 (maximal functional capacity) units; the FFbH score indicates the remaining percentage of participant function.	Baseline, and Months 3, 6, 9, 12, 18, and 24
Percentage of Participants With Impairment in Daily Activities During the Last 4 Weeks of Each Visit Time Frame: Baseline, and Months 3, 6, 9, 12, 18, and 24		Baseline, and Months 3, 6, 9, 12, 18, and 24
Mean Number of Days Missed From Work Due to Psoriatic Arthritis Time Frame: Baseline, and Months 3, 6, 9, 12, 18, and 24	Mean number of days missed from work were derived from patient recall of events in the preceding 12 months (at baseline), in the preceding 3 months (at months 3, 6, 9, and 12), or in the preceding 6 months (at months 18 and 24).	Baseline, and Months 3, 6, 9, 12, 18, and 24
Percentage of Participants With In-Patient Hospitalization Time Frame: Baseline, and Months 3, 6, 9, 12, 18, and 24	Percentage of participants with in-patient hospitalization were derived from patient recall of events in the preceding 12 months (at Baseline), in the preceding 3 months (at months 3, 6, 9, and 12), or in the preceding 6 months (at months 18 and 24).	Baseline, and Months 3, 6, 9, 12, 18, and 24
Percentage of Participants on Concomitant Systemic Rheumatic and Pain Relief Medication Time Frame: Baseline, and Months 6 and 24	Prior and concomitant non-biologic disease-modifying antirheumatic drugs (DMARDs): methotrexate (MTX) and other DMARDs	Baseline, and Months 6 and 24

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

AbbVie (prior sponsor, Abbott)

Investigators

Study Director: Bianca Wittig, MD, AbbVie Deutschland GmbH & Co. KG, Medical Department

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Related Info

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2005

Primary Completion (Actual)

December 1, 2013

Study Completion (Actual)

December 1, 2013

Study Registration Dates

First Submitted

February 26, 2010

First Submitted That Met QC Criteria

April 26, 2010

First Posted (Estimate)

April 27, 2010

Study Record Updates

Last Update Posted (Estimate)

December 30, 2014

Last Update Submitted That Met QC Criteria

December 29, 2014

Last Verified

December 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

HUM 05-3

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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Medical College of Wisconsin

Not yet recruiting

Impact of Glucagon-like Peptide-1 (GLP-1) Analogs on Disease Outcomes in Psoriatic Arthritis: A Pragmatic Randomized Controlled Trial

Psoriatic Arthritis (PsA)

United States
Sun Pharmaceutical Industries Limited

Active, not recruiting

Efficacy and Safety of Tildrakizumab Compared to Placebo in Anti-TNF naïve Subjects With Active Psoriatic Arthritis II (INSPIRE 2)

Active Psoriatic Arthritis

United States, Australia, Czechia, Germany, India, Japan, Poland, Spain, South Korea
AbbVie

Active, not recruiting

A Study Comparing Risankizumab to Placebo in Participants With Active Psoriatic Arthritis Including Those Who Have a History of Inadequate Response or Intolerance to Biologic Therapy(Ies) (KEEPsAKE2)

Psoriatic Arthritis (PsA)

United States, Australia, Belgium, Canada, Estonia, Finland, France, Germany, Greece, Hungary, Israel, Italy, Netherlands, New Zealand, Puerto Rico, Singapore, South Africa, Spain, Sweden, United Kingdom, Argentina, Brazil, Denmark, P... and more
Chao Ji

Enrolling by invitation

A Real-World Study of Biologic Therapy for Subclinical Psoriatic Arthritis

Subclinical Psoriatic Arthritis

China
Sun Pharmaceutical Industries Limited

Completed

Efficacy and Safety Study of SUNPG1623

Active Psoriatic Arthritis

United States
Bristol-Myers Squibb

Completed

Efficacy and Safety of BMS-986165 Compared With Placebo in Participants With Active Psoriatic Arthritis (PsA)

Active Psoriatic Arthritis

Spain, United States, Hungary, Germany, Poland, United Kingdom, Russian Federation, Italy, Czechia
Sun Pharmaceutical Industries Limited

Completed

Efficacy and Safety of Tildrakizumab Compared to Placebo in Subjects With Active Psoriatic Arthritis I (INSPIRE 1)

Active Psoriatic Arthritis

United States, Spain, Canada, Czechia, Estonia, Germany, India, Italy, Poland, Slovakia, Taiwan, South Korea
Dr. Schär AG / SPA
ASST Gaetano Pini-CTO

Completed

A Randomized, Double-blind Clinical Trial on the Efficacy of a Dietary Formulation Containing Medium-chain Triglycerides (MCT) and Fiber in Patients With Psoriatic Arthritis (CALIPSO)

Psoriatic Arthritis (PsA)

Italy

Efficacy and Safety of Humira® in Patients With Psoriatic Arthritis in Normal Medical Practice

A Long Term Documentation to Demonstrate Long Term Efficacy and Safety of Humira® in Patients With Psoriatic Arthritis Under Conditions of Daily Practice

Study Overview

Status

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Detailed Description

Study Type

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Contacts and Locations

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Accepts Healthy Volunteers

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Primary Outcome Measures

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Secondary Outcome Measures

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Last Verified

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Clinical Trials on Psoriatic Arthritis

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