Efficacy and Safety of Adalimumab in Patients With Rheumatoid Arthritis in Routine Clinical Practice
NCT ID: NCT01077258
Last Updated: 2014-04-25
Study Results
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View full resultsBasic Information
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COMPLETED
4208 participants
OBSERVATIONAL
2004-04-30
2013-02-28
Brief Summary
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Detailed Description
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Conditions
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Study Design
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CASE_ONLY
PROSPECTIVE
Study Groups
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Rheumatoid arthritis
Participants with rheumatoid arthritis prescribed adalimumab in routine clinical practice were observed from the first dose for up to 24 months.
No interventions assigned to this group
Eligibility Criteria
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Inclusion Criteria
* Moderate to severe active rheumatoid arthritis in adults who have not been treated with methotrexate before. In case of incompatibility with methotrexate, Humira can be used as monotherapy
Exclusion Criteria
* Active tuberculosis or other severe infections (e.g. sepsis and opportunistic infections)
* Moderate to severe cardiac insufficiency
18 Years
ALL
No
Sponsors
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AbbVie (prior sponsor, Abbott)
INDUSTRY
Responsible Party
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Principal Investigators
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Bianca Wittig, MD
Role: STUDY_DIRECTOR
AbbVie Deutschland GmbH & Co. KG, Medical Department
Locations
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Site Reference ID/Investigator# 35036
Aachen, , Germany
Site Reference ID/Investigator# 35510
Ahlen, , Germany
Site Reference ID/Investigator# 35040
Ahrensburg, , Germany
Site Reference ID/Investigator# 35043
Altenburg, , Germany
Site Reference ID/Investigator# 35046
Altenholz, , Germany
Site Reference ID/Investigator# 35049
Amberg, , Germany
Site Reference ID/Investigator# 35057
Arnstadt, , Germany
Site Reference ID/Investigator# 35520
Attendorn, , Germany
Site Reference ID/Investigator# 33349
Augsburg, , Germany
Site Reference ID/Investigator# 33358
Bad Abbach, , Germany
Site Reference ID/Investigator# 33361
Bad Abbach, , Germany
Site Reference ID/Investigator# 35142
Bad Aibling, , Germany
Site Reference ID/Investigator# 35570
Bad Brambach, , Germany
Site Reference ID/Investigator# 35573
Bad Bramstedt, , Germany
Site Reference ID/Investigator# 33372
Bad Endbach, , Germany
Site Reference ID/Investigator# 33378
Bad Iburg, , Germany
Site Reference ID/Investigator# 33382
Bad Iburg, , Germany
Site Reference ID/Investigator# 33387
Bad Kreuznach, , Germany
Site Reference ID/Investigator# 35575
Bad Kreuznach, , Germany
Site Reference ID/Investigator# 33391
Bad Liebenwerda, , Germany
Site Reference ID/Investigator# 33396
Bad Münder am Deister, , Germany
Site Reference ID/Investigator# 102216
Bad Nauheim, , Germany
Site Reference ID/Investigator# 35578
Bad Neuenahr, , Germany
Site Reference ID/Investigator# 33404
Bad Rappenau, , Germany
Site Reference ID/Investigator# 51883
Bad Salzungen, , Germany
Site Reference ID/Investigator# 33412
Bad Soden-Salmünster, , Germany
Site Reference ID/Investigator# 33425
Baden-Baden, , Germany
Site Reference ID/Investigator# 33429
Bamberg, , Germany
Site Reference ID/Investigator# 33438
Bautzen, , Germany
Site Reference ID/Investigator# 33442
Bayreuth, , Germany
Site Reference ID/Investigator# 33446
Bayreuth, , Germany
Site Reference ID/Investigator# 33641
Berlin, , Germany
Site Reference ID/Investigator# 35089
Berlin, , Germany
Site Reference ID/Investigator# 33648
Berlin, , Germany
Site Reference ID/Investigator# 33693
Berlin, , Germany
Site Reference ID/Investigator# 33670
Berlin, , Germany
Site Reference ID/Investigator# 33658
Berlin, , Germany
Site Reference ID/Investigator# 33697
Berlin, , Germany
Site Reference ID/Investigator# 34246
Berlin, , Germany
Site Reference ID/Investigator# 33683
Berlin, , Germany
Site Reference ID/Investigator# 34269
Berlin, , Germany
Site Reference ID/Investigator# 35527
Berlin, , Germany
Site Reference ID/Investigator# 35597
Berlin, , Germany
Site Reference ID/Investigator# 33620
Berlin, , Germany
Site Reference ID/Investigator# 33690
Berlin, , Germany
Site Reference ID/Investigator# 33704
Berlin, , Germany
Site Reference ID/Investigator# 33687
Berlin, , Germany
Site Reference ID/Investigator# 33661
Berlin, , Germany
Site Reference ID/Investigator# 35550
Berlin, , Germany
Site Reference ID/Investigator# 33674
Berlin, , Germany
Site Reference ID/Investigator# 35551
Berlin, , Germany
Site Reference ID/Investigator# 34238
Berlin, , Germany
Site Reference ID/Investigator# 35556
Bernau, , Germany
Site Reference ID/Investigator# 34277
Biberach, , Germany
Site Reference ID/Investigator# 35562
Binzen, , Germany
Site Reference ID/Investigator# 34285
Blankenburg/Hart, , Germany
Site Reference ID/Investigator# 34288
Blaubeuren Abbey, , Germany
Site Reference ID/Investigator# 34291
Bocholt, , Germany
Site Reference ID/Investigator# 35566
Bocholt, , Germany
Site Reference ID/Investigator# 35641
Bochum, , Germany
Site Reference ID/Investigator# 35644
Bogen, , Germany
Site Reference ID/Investigator# 34302
Bonn, , Germany
Site Reference ID/Investigator# 35646
Bonn, , Germany
Site Reference ID/Investigator# 34296
Bonn, , Germany
Site Reference ID/Investigator# 35652
Bottrop, , Germany
Site Reference ID/Investigator# 34307
Braunschweig, , Germany
Site Reference ID/Investigator# 35603
Breitenbrunn, , Germany
Site Reference ID/Investigator# 35609
Bremen, , Germany
Site Reference ID/Investigator# 34266
Buch, , Germany
Site Reference ID/Investigator# 35611
Celle, , Germany
Site Reference ID/Investigator# 34699
Chemnitz, , Germany
Site Reference ID/Investigator# 35093
Chemnitz, , Germany
Site Reference ID/Investigator# 35615
Coesfeld, , Germany
Site Reference ID/Investigator# 33989
Cologne, , Germany
Site Reference ID/Investigator# 35237
Cologne, , Germany
Site Reference ID/Investigator# 34708
Cottbus, , Germany
Site Reference ID/Investigator# 34711
Cottbus, , Germany
Site Reference ID/Investigator# 35621
Darmstadt, , Germany
Site Reference ID/Investigator# 34725
Deggendorf, , Germany
Site Reference ID/Investigator# 35631
Dessau, , Germany
Site Reference ID/Investigator# 34742
Dortmund, , Germany
Site Reference ID/Investigator# 35635
Dortmund, , Germany
Site Reference ID/Investigator# 35634
Dortmund, , Germany
Site Reference ID/Investigator# 35170
Dresden, , Germany
Site Reference ID/Investigator# 34754
Dresden, , Germany
Site Reference ID/Investigator# 34748
Dresden, , Germany
Site Reference ID/Investigator# 34751
Dresden, , Germany
Site Reference ID/Investigator# 34760
Dresden, , Germany
Site Reference ID/Investigator# 34778
Duisburg, , Germany
Site Reference ID/Investigator# 34773
Düsseldorf, , Germany
Site Reference ID/Investigator# 34768
Düsseldorf, , Germany
Site Reference ID/Investigator# 34784
Eberswalde, , Germany
Site Reference ID/Investigator# 35184
Elmshorn, , Germany
Site Reference ID/Investigator# 34809
Erfurt, , Germany
Site Reference ID/Investigator# 35096
Erfurt, , Germany
Site Reference ID/Investigator# 35191
Erfurt, , Germany
Site Reference ID/Investigator# 34821
Erlangen, , Germany
Site Reference ID/Investigator# 35196
Essen, , Germany
Site Reference ID/Investigator# 35199
Essen, , Germany
Site Reference ID/Investigator# 35202
Feldafing, , Germany
Site Reference ID/Investigator# 35205
Flensburg, , Germany
Site Reference ID/Investigator# 34833
Forchheim, , Germany
Site Reference ID/Investigator# 35210
Frankenberg, , Germany
Site Reference ID/Investigator# 34849
Frankfurt, , Germany
Site Reference ID/Investigator# 34840
Frankfurt, , Germany
Site Reference ID/Investigator# 34843
Frankfurt, , Germany
Site Reference ID/Investigator# 35213
Fraureuth, , Germany
Site Reference ID/Investigator# 35219
Freiberg, , Germany
Site Reference ID/Investigator# 34854
Freiburg im Breisgau, , Germany
Site Reference ID/Investigator# 35221
Freiburg im Breisgau, , Germany
Site Reference ID/Investigator# 34861
Freiburg im Breisgau, , Germany
Site Reference ID/Investigator# 35101
Freystadt, , Germany
Site Reference ID/Investigator# 35224
Friedrichroda, , Germany
Site Reference ID/Investigator# 34879
Gelsenkirchen, , Germany
Site Reference ID/Investigator# 34883
Gera, , Germany
Site Reference ID/Investigator# 34887
Giessen, , Germany
Site Reference ID/Investigator# 35491
Gosheim, , Germany
Site Reference ID/Investigator# 34896
Goslar, , Germany
Site Reference ID/Investigator# 34901
Greifswald, , Germany
Site Reference ID/Investigator# 35496
Greifswald, , Germany
Site Reference ID/Investigator# 34904
Greifswald, , Germany
Site Reference ID/Investigator# 102217
Groß Ammensleben, , Germany
Site Reference ID/Investigator# 33897
Groß Reken, , Germany
Site Reference ID/Investigator# 35498
Guben, , Germany
Site Reference ID/Investigator# 34912
Güstrow, , Germany
Site Reference ID/Investigator# 35503
Hagen, , Germany
Site Reference ID/Investigator# 34937
Halle, , Germany
Site Reference ID/Investigator# 34940
Halle, , Germany
Site Reference ID/Investigator# 34922
Halle, , Germany
Site Reference ID/Investigator# 34944
Halle, , Germany
Site Reference ID/Investigator# 34932
Halle, , Germany
Site Reference ID/Investigator# 35444
Hamburg, , Germany
Site Reference ID/Investigator# 35441
Hamburg, , Germany
Site Reference ID/Investigator# 34970
Hamburg, , Germany
Site Reference ID/Investigator# 34952
Hamburg, , Germany
Site Reference ID/Investigator# 34958
Hamburg, , Germany
Site Reference ID/Investigator# 35452
Hamburg, , Germany
Site Reference ID/Investigator# 35007
Hamburg, , Germany
Site Reference ID/Investigator# 35000
Hamburg, , Germany
Site Reference ID/Investigator# 34961
Hamburg, , Germany
Site Reference ID/Investigator# 35449
Hamburg, , Germany
Site Reference ID/Investigator# 34955
Hamburg, , Germany
Site Reference ID/Investigator# 34998
Hamburg, , Germany
Site Reference ID/Investigator# 34994
Hamburg, , Germany
Site Reference ID/Investigator# 34983
Hamburg, , Germany
Site Reference ID/Investigator# 34986
Hamburg, , Germany
Site Reference ID/Investigator# 35111
Hamburg, , Germany
Site Reference ID/Investigator# 34974
Hamburg, , Germany
Site Reference ID/Investigator# 35019
Hanau, , Germany
Site Reference ID/Investigator# 33712
Hanover, , Germany
Site Reference ID/Investigator# 35025
Hanover, , Germany
Site Reference ID/Investigator# 33792
Harrislee, , Germany
Site Reference ID/Investigator# 35459
Haselünne, , Germany
Site Reference ID/Investigator# 102215
Heidelberg, , Germany
Site Reference ID/Investigator# 33798
Heidelberg, , Germany
Site Reference ID/Investigator# 35119
Heidelberg, , Germany
Site Reference ID/Investigator# 33801
Heidelberg, , Germany
Site Reference ID/Investigator# 33808
Heidelberg, , Germany
Site Reference ID/Investigator# 35464
Heidenheim, , Germany
Site Reference ID/Investigator# 33818
Heilbad Heiligenstadt, , Germany
Site Reference ID/Investigator# 33825
Herrsching am Ammersee, , Germany
Site Reference ID/Investigator# 33834
Hof, , Germany
Site Reference ID/Investigator# 33842
Hofheim, , Germany
Site Reference ID/Investigator# 33845
Hohenfelde, , Germany
Site Reference ID/Investigator# 33855
Illertissen, , Germany
Site Reference ID/Investigator# 33858
Immenstadt im Allgäu, , Germany
Site Reference ID/Investigator# 35479
Ingolstadt, , Germany
Site Reference ID/Investigator# 51882
Jena, , Germany
Site Reference ID/Investigator# 33942
Jülich, , Germany
Site Reference ID/Investigator# 33946
Kahla, , Germany
Site Reference ID/Investigator# 35125
Kahla, , Germany
Site Reference ID/Investigator# 33950
Kaiserslautern, , Germany
Site Reference ID/Investigator# 33956
Karlsruhe, , Germany
Site Reference ID/Investigator# 33961
Karlsruhe, , Germany
Site Reference ID/Investigator# 33964
Kassel, , Germany
Site Reference ID/Investigator# 34002
Königs Wusterhausen, , Germany
Site Reference ID/Investigator# 34008
Kressbronn, , Germany
Site Reference ID/Investigator# 34084
Kronach, , Germany
Site Reference ID/Investigator# 34005
Lahr, , Germany
Site Reference ID/Investigator# 35245
Landau, , Germany
Site Reference ID/Investigator# 34112
Leipzig, , Germany
Site Reference ID/Investigator# 34106
Leipzig, , Germany
Site Reference ID/Investigator# 34109
Leipzig, , Germany
Site Reference ID/Investigator# 34100
Leipzig, , Germany
Site Reference ID/Investigator# 35254
Lippstadt, , Germany
Site Reference ID/Investigator# 35306
Ludwigsfelde, , Germany
Site Reference ID/Investigator# 35262
Ludwigshafen, , Germany
Site Reference ID/Investigator# 34136
Lübeck, , Germany
Site Reference ID/Investigator# 34139
Lüneburg, , Germany
Site Reference ID/Investigator# 34147
Magdeburg, , Germany
Site Reference ID/Investigator# 34150
Magdeburg, , Germany
Site Reference ID/Investigator# 35276
Mainz, , Germany
Site Reference ID/Investigator# 34192
Marktredwitz, , Germany
Site Reference ID/Investigator# 34196
Marl, , Germany
Site Reference ID/Investigator# 34200
Meissen, , Germany
Site Reference ID/Investigator# 35285
Menz, , Germany
Site Reference ID/Investigator# 35287
Minden, , Germany
Site Reference ID/Investigator# 34208
Mittelherwigsdorf, , Germany
Site Reference ID/Investigator# 34221
Moenkeberg, , Germany
Site Reference ID/Investigator# 34218
Mönchengladbach, , Germany
Site Reference ID/Investigator# 34213
Mönchengladbach, , Germany
Site Reference ID/Investigator# 34040
Munich, , Germany
Site Reference ID/Investigator# 35295
Munich, , Germany
Site Reference ID/Investigator# 34232
Munich, , Germany
Site Reference ID/Investigator# 34235
Munich, , Germany
Site Reference ID/Investigator# 35298
Munich, , Germany
Site Reference ID/Investigator# 34043
Munich, , Germany
Site Reference ID/Investigator# 34224
Mühlhausen, , Germany
Site Reference ID/Investigator# 35292
Mülheim, , Germany
Site Reference ID/Investigator# 34229
Müllheim, , Germany
Site Reference ID/Investigator# 34048
Münster, , Germany
Site Reference ID/Investigator# 34052
Naunhof, , Germany
Site Reference ID/Investigator# 34061
Neubrandenburg, , Germany
Site Reference ID/Investigator# 34064
Neuburg am Inn, , Germany
Site Reference ID/Investigator# 34071
Neumünster, , Germany
Site Reference ID/Investigator# 35313
Neuss, , Germany
Site Reference ID/Investigator# 34076
Neustadt, , Germany
Site Reference ID/Investigator# 35321
Niederbrombach, , Germany
Site Reference ID/Investigator# 34080
Niefern-Öschelbronn, , Germany
Site Reference ID/Investigator# 34158
Nienburg, , Germany
Site Reference ID/Investigator# 34173
Oelsnitz, , Germany
Site Reference ID/Investigator# 34176
Offenburg, , Germany
Site Reference ID/Investigator# 33492
Oldenburg, , Germany
Site Reference ID/Investigator# 34718
Ostseebad Damp, , Germany
Site Reference ID/Investigator# 35335
Paderborn, , Germany
Site Reference ID/Investigator# 33508
Parchim, , Germany
Site Reference ID/Investigator# 35340
Passau, , Germany
Site Reference ID/Investigator# 33517
Pfullendorf, , Germany
Site Reference ID/Investigator# 67482
Pirna, , Germany
Site Reference ID/Investigator# 33523
Planegg, , Germany
Site Reference ID/Investigator# 33528
Plauen, , Germany
Site Reference ID/Investigator# 33470
Potsdam, , Germany
Site Reference ID/Investigator# 33466
Potsdam, , Germany
Site Reference ID/Investigator# 33476
Prüm, , Germany
Site Reference ID/Investigator# 33479
Püttlingen, , Germany
Site Reference ID/Investigator# 33484
Radebeul, , Germany
Site Reference ID/Investigator# 35347
Radebeul, , Germany
Site Reference ID/Investigator# 35136
Ratingen, , Germany
Site Reference ID/Investigator# 33488
Ratzeburg, , Germany
Site Reference ID/Investigator# 33890
Regensburg, , Germany
Site Reference ID/Investigator# 33883
Regensburg, , Germany
Site Reference ID/Investigator# 33886
Regensburg, , Germany
Site Reference ID/Investigator# 33902
Rendsburg, , Germany
Site Reference ID/Investigator# 33907
Rheine, , Germany
Site Reference ID/Investigator# 35355
Rickenbach, , Germany
Site Reference ID/Investigator# 33911
Riesa, , Germany
Site Reference ID/Investigator# 33914
Rinteln, , Germany
Site Reference ID/Investigator# 33923
Rostock, , Germany
Site Reference ID/Investigator# 33927
Rostock, , Germany
Site Reference ID/Investigator# 33931
Rothenburg, , Germany
Site Reference ID/Investigator# 35362
Rüdersdorf, , Germany
Site Reference ID/Investigator# 34016
Saarbrücken, , Germany
Site Reference ID/Investigator# 35383
Saint Martin, , Germany
Site Reference ID/Investigator# 34023
Salzwedel, , Germany
Site Reference ID/Investigator# 34027
Sande, , Germany
Site Reference ID/Investigator# 33534
Schneeberg, , Germany
Site Reference ID/Investigator# 33539
Schramberg, , Germany
Site Reference ID/Investigator# 33542
Schutterwald, , Germany
Site Reference ID/Investigator# 35371
Schwandorf in Bayern, , Germany
Site Reference ID/Investigator# 33549
Schwerin, , Germany
Site Reference ID/Investigator# 35376
Schwerin, , Germany
Site Reference ID/Investigator# 33555
Schwerte, , Germany
Site Reference ID/Investigator# 33559
Seesen, , Germany
Site Reference ID/Investigator# 33563
Senden, , Germany
Site Reference ID/Investigator# 35380
Singen, , Germany
Site Reference ID/Investigator# 33567
Sinsheim, , Germany
Site Reference ID/Investigator# 33572
Soltau, , Germany
Site Reference ID/Investigator# 33577
Spremberg, , Germany
Site Reference ID/Investigator# 33588
Stadthagen, , Germany
Site Reference ID/Investigator# 33592
Steinhagen, , Germany
Site Reference ID/Investigator# 33604
Stuttgart, , Germany
Site Reference ID/Investigator# 33607
Stuttgart, , Germany
Site Reference ID/Investigator# 33611
Stuttgart, , Germany
Site Reference ID/Investigator# 33598
Stuttgart, , Germany
Site Reference ID/Investigator# 35389
Suhl, , Germany
Site Reference ID/Investigator# 35391
Tegernau, , Germany
Site Reference ID/Investigator# 33625
Torgelow, , Germany
Site Reference ID/Investigator# 33637
Ueberlingen-Nussdorf, , Germany
Site Reference ID/Investigator# 35395
Uffenheim, , Germany
Site Reference ID/Investigator# 33721
Ulm, , Germany
Site Reference ID/Investigator# 33724
Ulm, , Germany
Site Reference ID/Investigator# 33734
Viersen, , Germany
Site Reference ID/Investigator# 33737
Villingen-Schwenningen, , Germany
Site Reference ID/Investigator# 35397
Vöhringen, , Germany
Site Reference ID/Investigator# 33742
Waltrop, , Germany
Site Reference ID/Investigator# 34252
Wannsee, , Germany
Site Reference ID/Investigator# 33749
Weener, , Germany
Site Reference ID/Investigator# 33751
Weißenfels, , Germany
Site Reference ID/Investigator# 33852
Welzow, , Germany
Site Reference ID/Investigator# 35404
Wiefelstede, , Germany
Site Reference ID/Investigator# 33761
Wiesbaden, , Germany
Site Reference ID/Investigator# 35408
Wiesbaden, , Germany
Site Reference ID/Investigator# 33765
Wiesbaden, , Germany
Site Reference ID/Investigator# 35413
Wiesbaden, , Germany
Site Reference ID/Investigator# 33772
Wilhelmshaven, , Germany
Site Reference ID/Investigator# 33780
Wittlich, , Germany
Site Reference ID/Investigator# 35420
Wuppertal, , Germany
Site Reference ID/Investigator# 33718
Würzburg, , Germany
Site Reference ID/Investigator# 33864
Zerbst, , Germany
Site Reference ID/Investigator# 33867
Zeven, , Germany
Site Reference ID/Investigator# 33873
Zwickau, , Germany
Site Reference ID/Investigator# 33876
Zwickau, , Germany
Site Reference ID/Investigator# 33880
Zwiesel, , Germany
Countries
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References
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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.
Related Links
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Related Info
Other Identifiers
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P10-448
Identifier Type: -
Identifier Source: org_study_id
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