NCT01078090

Brief Summary

Observation of safety, tolerability and effectiveness of adalimumab (Humira) therapy in a large patient collective under everyday clinical conditions over a 5-year period.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
5,745

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Apr 2003

Longer than P75 for all trials

Geographic Reach
1 country

370 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2003

Completed
6.9 years until next milestone

First Submitted

Initial submission to the registry

February 26, 2010

Completed
4 days until next milestone

First Posted

Study publicly available on registry

March 2, 2010

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2013

Completed
1.1 years until next milestone

Results Posted

Study results publicly available

April 23, 2014

Completed
Last Updated

May 8, 2014

Status Verified

April 1, 2014

Enrollment Period

9.9 years

First QC Date

February 26, 2010

Results QC Date

March 19, 2014

Last Update Submit

April 23, 2014

Conditions

Keywords

SafetyRheumatoid ArthritisEffectiveness

Outcome Measures

Primary Outcomes (2)

  • Change From Baseline in Disease Activity Score (DAS) 28

    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

    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

Secondary Outcomes (14)

  • Percentage of Participants With a Significant Therapeutic Response

    Baseline and Months 3, 6, 12, 18, 24, 30, 36, 48, and 60

  • Percentage of Participants With Low, Moderate and High Disease Activity

    Baseline and Months 3, 6, 12, 18, 24, 30, 36, 48, and 60

  • Erythrocyte Sedimentation Rate (ESR) Over Time

    Baseline and Months 3, 6, 12, 18, 24, 30, 36, 48, and 60

  • C-Reactive Protein (CRP) Levels Over Time

    Baseline and Months 3, 6, 12, 18, 24, 30, 36, 48, and 60

  • Tender Joint Count (TJC) Over Time

    Baseline and Months 3, 6, 12, 18, 24, 30, 36, 48, and 60

  • +9 more secondary outcomes

Study Arms (1)

Rheumatoid arthritis

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

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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.

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (370)

Site Reference ID/Investigator# 35034

Aachen, 52062, Germany

Location

Site Reference ID/Investigator# 35033

Aachen, 52064, Germany

Location

Site Reference ID/Investigator# 53919

Achern, 77855, Germany

Location

Site Reference ID/Investigator# 53883

Aichhalden, 78733, Germany

Location

Site Reference ID/Investigator# 35041

Altenburg, 04600, Germany

Location

Site Reference ID/Investigator# 35050

Amberg, 92224, Germany

Location

Site Reference ID/Investigator# 53974

Amberg, 92224, Germany

Location

Site Reference ID/Investigator# 33347

Augsburg, 86150, Germany

Location

Site Reference ID/Investigator# 33356

Bad Abbach, 93077, Germany

Location

Site Reference ID/Investigator# 33359

Bad Abbach, 93077, Germany

Location

Site Reference ID/Investigator# 33362

Bad Aibling, 83043, Germany

Location

Site Reference ID/Investigator# 35084

Bad Aibling, 83043, Germany

Location

Site Reference ID/Investigator# 53968

Bad Aibling, 83043, Germany

Location

Site Reference ID/Investigator# 53966

Bad Bellingen, 79415, Germany

Location

Site Reference ID/Investigator# 35523

Bad Bentheim, D-48455, Germany

Location

Site Reference ID/Investigator# 35571

Bad Bramstedt, 24576, Germany

Location

Site Reference ID/Investigator# 53903

Bad Bramstedt, 24576, Germany

Location

Site Reference ID/Investigator# 53929

Bad Buchau, 88422, Germany

Location

Site Reference ID/Investigator# 33370

Bad Endbach, 35080, Germany

Location

Site Reference ID/Investigator# 33369

Bad Endbach, 63065, Germany

Location

Site Reference ID/Investigator# 33380

Bad Iburg, 49186, Germany

Location

Site Reference ID/Investigator# 33384

Bad Kissingen, 97688, Germany

Location

Site Reference ID/Investigator# 33385

Bad Kreuznach, 55543, Germany

Location

Site Reference ID/Investigator# 33389

Bad Liebenwerda, 04924, Germany

Location

Site Reference ID/Investigator# 53942

Bad Mergentheim, 97980, Germany

Location

Site Reference ID/Investigator# 33394

Bad Münder am Deister, 31848, Germany

Location

Site Reference ID/Investigator# 33398

Bad Nauheim, 61231, Germany

Location

Site Reference ID/Investigator# 33399

Bad Neuenahr, 53474, Germany

Location

Site Reference ID/Investigator# 35576

Bad Neuenahr, 53474, Germany

Location

Site Reference ID/Investigator# 53980

Bad Pyrmont, 31812, Germany

Location

Site Reference ID/Investigator# 33402

Bad Rappenau, 74906, Germany

Location

Site Reference ID/Investigator# 33410

Bad Soden-Salmünster, 63628, Germany

Location

Site Reference ID/Investigator# 33415

Bad Staffelstein, 96231, Germany

Location

Site Reference ID/Investigator# 54804

Bad Tölz, 83646, Germany

Location

Site Reference ID/Investigator# 33423

Baden-Baden, 76530, Germany

Location

Site Reference ID/Investigator# 33427

Bamberg, 96047, Germany

Location

Site Reference ID/Investigator# 33436

Bautzen, 02625, Germany

Location

Site Reference ID/Investigator# 33440

Bayreuth, 95445, Germany

Location

Site Reference ID/Investigator# 53978

Belm, 49191, Germany

Location

Site Reference ID/Investigator# 33449

Bensheim, 64625, Germany

Location

Site Reference ID/Investigator# 33646

Berlin, 10178, Germany

Location

Site Reference ID/Investigator# 53902

Berlin, 10247, Germany

Location

Site Reference ID/Investigator# 33662

Berlin, 10367, Germany

Location

Site Reference ID/Investigator# 33695

Berlin, 10711, Germany

Location

Site Reference ID/Investigator# 34243

Berlin, 10719, Germany

Location

Site Reference ID/Investigator# 33681

Berlin, 10777, Germany

Location

Site Reference ID/Investigator# 35599

Berlin, 12161, Germany

Location

Site Reference ID/Investigator# 53959

Berlin, 12200, Germany

Location

Site Reference ID/Investigator# 33688

Berlin, 12435, Germany

Location

Site Reference ID/Investigator# 34260

Berlin, 12681, Germany

Location

Site Reference ID/Investigator# 33685

Berlin, 13055, Germany

Location

Site Reference ID/Investigator# 53948

Berlin, 13055, Germany

Location

Site Reference ID/Investigator# 53939

Berlin, 13589, Germany

Location

Site Reference ID/Investigator# 53971

Berlin, 13595, Germany

Location

Site Reference ID/Investigator# 53933

Berlin, 14059, Germany

Location

Site Reference ID/Investigator# 53884

Berlin, 14089, Germany

Location

Site Reference ID/Investigator# 33672

Berlin, 14109, Germany

Location

Site Reference ID/Investigator# 35552

Berlin, 14163, Germany

Location

Site Reference ID/Investigator# 35554

Bernau, 16321, Germany

Location

Site Reference ID/Investigator# 53899

Biberach, 88400, Germany

Location

Site Reference ID/Investigator# 34279

Bielefeld, 33611, Germany

Location

Site Reference ID/Investigator# 54810

Bielefeld, 33617, Germany

Location

Site Reference ID/Investigator# 35559

Bietigheim-Bissingen, 74321, Germany

Location

Site Reference ID/Investigator# 35560

Bietigheim-Bissingen, 74321, Germany

Location

Site Reference ID/Investigator# 34283

Blankenburg/Hart, 38889, Germany

Location

Site Reference ID/Investigator# 34286

Blaubeuren Abbey, 89143, Germany

Location

Site Reference ID/Investigator# 34289

Bocholt, 46399, Germany

Location

Site Reference ID/Investigator# 53946

Bocholt, 46399, Germany

Location

Site Reference ID/Investigator# 35567

Bochum, 44789, Germany

Location

Site Reference ID/Investigator# 35642

Bogen, 94327, Germany

Location

Site Reference ID/Investigator# 34300

Bonn, 53111, Germany

Location

Site Reference ID/Investigator# 53969

Bonn, 53129, Germany

Location

Site Reference ID/Investigator# 35647

Bonn, 53175, Germany

Location

Site Reference ID/Investigator# 35648

Bonn, 53175, Germany

Location

Site Reference ID/Investigator# 34294

Bonn, 53177, Germany

Location

Site Reference ID/Investigator# 34305

Braunschweig, 38100, Germany

Location

Site Reference ID/Investigator# 34310

Braunschweig, 38100, Germany

Location

Site Reference ID/Investigator# 35601

Breitenbrunn, 08359, Germany

Location

Site Reference ID/Investigator# 35607

Bremen, 28209, Germany

Location

Site Reference ID/Investigator# 53975

Bremen, 28329, Germany

Location

Site Reference ID/Investigator# 34264

Buch, 13125, Germany

Location

Site Reference ID/Investigator# 53934

Büchen, 21514, Germany

Location

Site Reference ID/Investigator# 34696

Celle, 29221, Germany

Location

Site Reference ID/Investigator# 34700

Chemnitz, 09126, Germany

Location

Site Reference ID/Investigator# 35092

Chemnitz, D-09130, Germany

Location

Site Reference ID/Investigator# 33990

Cologne, 50679, Germany

Location

Site Reference ID/Investigator# 33987

Cologne, 50823, Germany

Location

Site Reference ID/Investigator# 33996

Cologne, 50931, Germany

Location

Site Reference ID/Investigator# 33993

Cologne, 50969, Germany

Location

Site Reference ID/Investigator# 35238

Cologne, 51067, Germany

Location

Site Reference ID/Investigator# 35617

Cottbus, 3048, Germany

Location

Site Reference ID/Investigator# 53987

Cuxhaven, 27474, Germany

Location

Site Reference ID/Investigator# 53889

Cuxhaven, 27476, Germany

Location

Site Reference ID/Investigator# 35622

Darmstadt, 64295, Germany

Location

Site Reference ID/Investigator# 53885

Delmenhorst, 27749, Germany

Location

Site Reference ID/Investigator# 34726

Demmin, 17109, Germany

Location

Site Reference ID/Investigator# 53932

Denkendorf, 73770, Germany

Location

Site Reference ID/Investigator# 35636

Dortmund, 44147, Germany

Location

Site Reference ID/Investigator# 35632

Dortmund, 44263, Germany

Location

Site Reference ID/Investigator# 35171

Dresden, 01097, Germany

Location

Site Reference ID/Investigator# 34762

Dresden, 01109, Germany

Location

Site Reference ID/Investigator# 53958

Dresden, 01159, Germany

Location

Site Reference ID/Investigator# 34749

Dresden, 01277, Germany

Location

Site Reference ID/Investigator# 34763

Dresden, 01307, Germany

Location

Site Reference ID/Investigator# 34776

Duisburg, 47055, Germany

Location

Site Reference ID/Investigator# 53897

Duisburg, 47167, Germany

Location

Site Reference ID/Investigator# 34771

Düsseldorf, 40211, Germany

Location

Site Reference ID/Investigator# 34774

Düsseldorf, 40225, Germany

Location

Site Reference ID/Investigator# 34779

Ebensfeld, 96250, Germany

Location

Site Reference ID/Investigator# 34782

Eberswalde, 16225, Germany

Location

Site Reference ID/Investigator# 54805

Eisenberg, 07607, Germany

Location

Site Reference ID/Investigator# 35180

Elmshorn, 25335, Germany

Location

Site Reference ID/Investigator# 34802

Erftstadt, 50374, Germany

Location

Site Reference ID/Investigator# 34807

Erfurt, 99096, Germany

Location

Site Reference ID/Investigator# 35097

Erfurt, 99096, Germany

Location

Site Reference ID/Investigator# 35189

Erfurt, 99096, Germany

Location

Site Reference ID/Investigator# 54811

Erlangen, 91054, Germany

Location

Site Reference ID/Investigator# 34815

Erlangen, 91056, Germany

Location

Site Reference ID/Investigator# 53925

Essen, 45128, Germany

Location

Site Reference ID/Investigator# 34823

Essen, 45239, Germany

Location

Site Reference ID/Investigator# 35194

Essen, 45326, Germany

Location

Site Reference ID/Investigator# 53931

Essen, 45329, Germany

Location

Site Reference ID/Investigator# 53945

Essen, 45359, Germany

Location

Site Reference ID/Investigator# 34829

Esslingen am Neckar, 73732, Germany

Location

Site Reference ID/Investigator# 35200

Feldafing, 82340, Germany

Location

Site Reference ID/Investigator# 35203

Flensburg, 24937, Germany

Location

Site Reference ID/Investigator# 34831

Forchheim, 91301, Germany

Location

Site Reference ID/Investigator# 34851

Frankfurt, 60590, Germany

Location

Site Reference ID/Investigator# 34838

Frankfurt, 60596, Germany

Location

Site Reference ID/Investigator# 35211

Fraureuth, 08427, Germany

Location

Site Reference ID/Investigator# 35217

Freiberg, 09599, Germany

Location

Site Reference ID/Investigator# 34852

Freiburg im Breisgau, 79098, Germany

Location

Site Reference ID/Investigator# 34855

Freiburg im Breisgau, 79098, Germany

Location

Site Reference ID/Investigator# 53926

Freiburg im Breisgau, 79098, Germany

Location

Site Reference ID/Investigator# 34859

Freiburg im Breisgau, 79106, Germany

Location

Site Reference ID/Investigator# 35099

Freystadt, 92342, Germany

Location

Site Reference ID/Investigator# 53960

Friedberg, 61169, Germany

Location

Site Reference ID/Investigator# 35222

Friedrichroda, 99894, Germany

Location

Site Reference ID/Investigator# 53976

Geesthacht, 21502, Germany

Location

Site Reference ID/Investigator# 53890

Geilenkirchen, 52511, Germany

Location

Site Reference ID/Investigator# 34877

Gelsenkirchen, 45881, Germany

Location

Site Reference ID/Investigator# 53909

Giessen, 35392, Germany

Location

Site Reference ID/Investigator# 53922

Gladbeck, 45964, Germany

Location

Site Reference ID/Investigator# 34894

Goslar, 38642, Germany

Location

Site Reference ID/Investigator# 35231

Göttingen, 37073, Germany

Location

Site Reference ID/Investigator# 65622

Göttingen, 37075, Germany

Location

Site Reference ID/Investigator# 34902

Greifswald, 17491, Germany

Location

Site Reference ID/Investigator# 53957

Groß Reken, 48734, Germany

Location

Site Reference ID/Investigator# 34910

Güstrow, 18273, Germany

Location

Site Reference ID/Investigator# 35501

Hagen, 58089, Germany

Location

Site Reference ID/Investigator# 34924

Halle, 06108, Germany

Location

Site Reference ID/Investigator# 34935

Halle, 06108, Germany

Location

Site Reference ID/Investigator# 34938

Halle, 06108, Germany

Location

Site Reference ID/Investigator# 34920

Halle, 06112, Germany

Location

Site Reference ID/Investigator# 34942

Halle, 06120, Germany

Location

Site Reference ID/Investigator# 33819

Halle, 06128, Germany

Location

Site Reference ID/Investigator# 35442

Hamburg, 20144, Germany

Location

Site Reference ID/Investigator# 53984

Hamburg, 20355, Germany

Location

Site Reference ID/Investigator# 33367

Hamburg, 21031, Germany

Location

Site Reference ID/Investigator# 53900

Hamburg, 21073, Germany

Location

Site Reference ID/Investigator# 34956

Hamburg, 21075, Germany

Location

Site Reference ID/Investigator# 34962

Hamburg, 22081, Germany

Location

Site Reference ID/Investigator# 35450

Hamburg, 22081, Germany

Location

Site Reference ID/Investigator# 35112

Hamburg, 22087, Germany

Location

Site Reference ID/Investigator# 34946

Hamburg, 22089, Germany

Location

Site Reference ID/Investigator# 35001

Hamburg, 22119, Germany

Location

Site Reference ID/Investigator# 34959

Hamburg, 22147, Germany

Location

Site Reference ID/Investigator# 34977

Hamburg, 22147, Germany

Location

Site Reference ID/Investigator# 34965

Hamburg, 22391, Germany

Location

Site Reference ID/Investigator# 54806

Hamburg, 22399, Germany

Location

Site Reference ID/Investigator# 33578

Hamburg, 22529, Germany

Location

Site Reference ID/Investigator# 34967

Hamburg, 22529, Germany

Location

Site Reference ID/Investigator# 34989

Hamburg, 22529, Germany

Location

Site Reference ID/Investigator# 34981

Hamburg, 22609, Germany

Location

Site Reference ID/Investigator# 34984

Hamburg, 22609, Germany

Location

Site Reference ID/Investigator# 34996

Hamburg, 22609, Germany

Location

Site Reference ID/Investigator# 53953

Hamm, 59065, Germany

Location

Site Reference ID/Investigator# 35017

Hanau, 63450, Germany

Location

Site Reference ID/Investigator# 33713

Hanover, 30159, Germany

Location

Site Reference ID/Investigator# 35032

Hanover, 30159, Germany

Location

Site Reference ID/Investigator# 35021

Hanover, 30161, Germany

Location

Site Reference ID/Investigator# 33788

Hanover, 30625, Germany

Location

Site Reference ID/Investigator# 33790

Harrislee, 24955, Germany

Location

Site Reference ID/Investigator# 65629

Haselünne, 49740, Germany

Location

Site Reference ID/Investigator# 33795

Hattingen, 45525, Germany

Location

Site Reference ID/Investigator# 33796

Heidelberg, 69120, Germany

Location

Site Reference ID/Investigator# 33806

Heidelberg, 69121, Germany

Location

Site Reference ID/Investigator# 33811

Heidelberg, D-69115, Germany

Location

Site Reference ID/Investigator# 33816

Heilbad Heiligenstadt, 37308, Germany

Location

Site Reference ID/Investigator# 53911

Herne, 44623, Germany

Location

Site Reference ID/Investigator# 53910

Herne, 44625, Germany

Location

Site Reference ID/Investigator# 65623

Herne, 44652, Germany

Location

Site Reference ID/Investigator# 33823

Herrsching am Ammersee, 82211, Germany

Location

Site Reference ID/Investigator# 33831

Hildesheim, 31124, Germany

Location

Site Reference ID/Investigator# 33836

Hof, 95028, Germany

Location

Site Reference ID/Investigator# 33840

Hofheim, 65719, Germany

Location

Site Reference ID/Investigator# 33843

Hohenfelde, 18209, Germany

Location

Site Reference ID/Investigator# 54807

Homburg, 66424, Germany

Location

Site Reference ID/Investigator# 53985

Illingen, 66557, Germany

Location

Site Reference ID/Investigator# 33933

Ingolstadt, 85049, Germany

Location

Site Reference ID/Investigator# 53938

Jena, 07743, Germany

Location

Site Reference ID/Investigator# 5323

Jena, 07745, Germany

Location

Site Reference ID/Investigator# 33940

Jülich, 52428, Germany

Location

Site Reference ID/Investigator# 33944

Kahla, 07768, Germany

Location

Site Reference ID/Investigator# 35124

Kahla, 07768, Germany

Location

Site Reference ID/Investigator# 33948

Kaiserslautern, 67655, Germany

Location

Site Reference ID/Investigator# 53935

Kaltenkirchen, 24568, Germany

Location

Site Reference ID/Investigator# 33397

Karlsruhe, 76133, Germany

Location

Site Reference ID/Investigator# 33954

Karlsruhe, 76133, Germany

Location

Site Reference ID/Investigator# 35482

Karlstadt am Main, 97753, Germany

Location

Site Reference ID/Investigator# 33962

Kassel, 34131, Germany

Location

Site Reference ID/Investigator# 35239

Kolkwitz, 3099, Germany

Location

Site Reference ID/Investigator# 34000

Königs Wusterhausen, 15711, Germany

Location

Site Reference ID/Investigator# 34006

Kressbronn, 88079, Germany

Location

Site Reference ID/Investigator# 34009

Kronach, 96317, Germany

Location

Site Reference ID/Investigator# 34086

Kyritz, 16866, Germany

Location

Site Reference ID/Investigator# 34003

Lahr, 77933, Germany

Location

Site Reference ID/Investigator# 53937

Leipzig, 04103, Germany

Location

Site Reference ID/Investigator# 65628

Leipzig, 04109, Germany

Location

Site Reference ID/Investigator# 34107

Leipzig, 04207, Germany

Location

Site Reference ID/Investigator# 34098

Leipzig, 04299, Germany

Location

Site Reference ID/Investigator# 34119

Leverkusen, 51373, Germany

Location

Site Reference ID/Investigator# 34121

Lichtenstein, 09350, Germany

Location

Site Reference ID/Investigator# 35252

Lippstadt, 59555, Germany

Location

Site Reference ID/Investigator# 53882

Löhne, 49393, Germany

Location

Site Reference ID/Investigator# 53886

Ludwigsburg, 71638, Germany

Location

Site Reference ID/Investigator# 35257

Ludwigsfelde, 14974, Germany

Location

Site Reference ID/Investigator# 53906

Ludwigslust, 19288, Germany

Location

Site Reference ID/Investigator# 34133

Lübeck, 23552, Germany

Location

Site Reference ID/Investigator# 53943

Lüdenscheid, 58311, Germany

Location

Site Reference ID/Investigator# 33407

Lüneburg, 21335, Germany

Location

Site Reference ID/Investigator# 53888

Lüneburg, 21335, Germany

Location

Site Reference ID/Investigator# 34148

Magdeburg, 39104, Germany

Location

Site Reference ID/Investigator# 53981

Magdeburg, 39110, Germany

Location

Site Reference ID/Investigator# 53913

Magdeburg, 39120, Germany

Location

Site Reference ID/Investigator# 53928

Mainz, 55116, Germany

Location

Site Reference ID/Investigator# 65631

Mainz, 55116, Germany

Location

Site Reference ID/Investigator# 34184

Mannheim, 68165, Germany

Location

Site Reference ID/Investigator# 34194

Marl, 45768, Germany

Location

Site Reference ID/Investigator# 35283

Menz, 39175, Germany

Location

Site Reference ID/Investigator# 53896

Merxheim, 55627, Germany

Location

Site Reference ID/Investigator# 33418

Minden, 32429, Germany

Location

Site Reference ID/Investigator# 34206

Mittelherwigsdorf, 02763, Germany

Location

Site Reference ID/Investigator# 34219

Moenkeberg, 24248, Germany

Location

Site Reference ID/Investigator# 34216

Mönchengladbach, 41061, Germany

Location

Site Reference ID/Investigator# 53915

Mönchengladbach, 41061, Germany

Location

Site Reference ID/Investigator# 34211

Mönchengladbach, 41199, Germany

Location

Site Reference ID/Investigator# 34214

Mönchengladbach, 41199, Germany

Location

Site Reference ID/Investigator# 53904

Munich, 80331, Germany

Location

Site Reference ID/Investigator# 53956

Munich, 80336, Germany

Location

Site Reference ID/Investigator# 34037

Munich, 80639, Germany

Location

Site Reference ID/Investigator# 53962

Munich, 80798, Germany

Location

Site Reference ID/Investigator# 53912

Munich, 81547, Germany

Location

Site Reference ID/Investigator# 35296

Munich, 81667, Germany

Location

Site Reference ID/Investigator# 53924

Munich, 81667, Germany

Location

Site Reference ID/Investigator# 34041

Munich, 81925, Germany

Location

Site Reference ID/Investigator# 34035

Munich, D-81541, Germany

Location

Site Reference ID/Investigator# 34222

Mühlhausen, 99974, Germany

Location

Site Reference ID/Investigator# 34044

Münster, 48143, Germany

Location

Site Reference ID/Investigator# 53970

Münster, 48143, Germany

Location

Site Reference ID/Investigator# 34046

Münster, 48149, Germany

Location

Site Reference ID/Investigator# 34050

Naunhof, 04683, Germany

Location

Site Reference ID/Investigator# 34059

Neubrandenburg, 17033, Germany

Location

Site Reference ID/Investigator# 34062

Neuburg am Inn, 86633, Germany

Location

Site Reference ID/Investigator# 34980

Neunkirchen, 66538, Germany

Location

Site Reference ID/Investigator# 35311

Neuss, 41460, Germany

Location

Site Reference ID/Investigator# 34072

Neustadt, 67434, Germany

Location

Site Reference ID/Investigator# 65630

Neuwied, 56564, Germany

Location

Site Reference ID/Investigator# 82694

Niederbrombach, 55767, Germany

Location

Site Reference ID/Investigator# 34078

Niefern-Öschelbronn, 75223, Germany

Location

Site Reference ID/Investigator# 34081

Nienburg, 31582, Germany

Location

Site Reference ID/Investigator# 34082

Nienburg, 31582, Germany

Location

Site Reference ID/Investigator# 53923

Nuremberg, 90402, Germany

Location

Site Reference ID/Investigator# 34168

Obergünzburg, 87634, Germany

Location

Site Reference ID/Investigator# 34174

Offenburg, 77652, Germany

Location

Site Reference ID/Investigator# 33490

Oldenburg, 26121, Germany

Location

Site Reference ID/Investigator# 53950

Olsberg, 59939, Germany

Location

Site Reference ID/Investigator# 33499

Osnabrück, D-49074, Germany

Location

Site Reference ID/Investigator# 54803

Osnabrück, D-49074, Germany

Location

Site Reference ID/Investigator# 34715

Ostseebad Damp, 24351, Germany

Location

Site Reference ID/Investigator# 35333

Paderborn, 33098, Germany

Location

Site Reference ID/Investigator# 33503

Papenburg, 26871, Germany

Location

Site Reference ID/Investigator# 33506

Parchim, 19370, Germany

Location

Site Reference ID/Investigator# 33509

Parsberg, 92331, Germany

Location

Site Reference ID/Investigator# 35338

Passau, 94032, Germany

Location

Site Reference ID/Investigator# 33511

Petershagen, 32469, Germany

Location

Site Reference ID/Investigator# 33519

Pinneberg, 25421, Germany

Location

Site Reference ID/Investigator# 33520

Pirna, 01796, Germany

Location

Site Reference ID/Investigator# 33521

Planegg, 82152, Germany

Location

Site Reference ID/Investigator# 33526

Plauen, 08523, Germany

Location

Site Reference ID/Investigator# 33468

Potsdam, 14467, Germany

Location

Site Reference ID/Investigator# 33464

Potsdam, 14469, Germany

Location

Site Reference ID/Investigator# 53940

Pulheim, 50259, Germany

Location

Site Reference ID/Investigator# 33482

Radebeul, 01445, Germany

Location

Site Reference ID/Investigator# 53964

Raststatt, 76437, Germany

Location

Site Reference ID/Investigator# 33485

Ratingen, 40882, Germany

Location

Site Reference ID/Investigator# 35134

Ratingen, 40882, Germany

Location

Site Reference ID/Investigator# 54812

Ratingen, 40882, Germany

Location

Site Reference ID/Investigator# 33888

Regensburg, 93049, Germany

Location

Site Reference ID/Investigator# 33891

Regensburg, 93049, Germany

Location

Site Reference ID/Investigator# 33881

Regensburg, 93051, Germany

Location

Site Reference ID/Investigator# 33884

Regensburg, 93051, Germany

Location

Site Reference ID/Investigator# 53930

Regensburg, 93059, Germany

Location

Site Reference ID/Investigator# 53986

Reichenbach, 08468, Germany

Location

Site Reference ID/Investigator# 53920

Remscheid, 42864, Germany

Location

Site Reference ID/Investigator# 33900

Rendsburg, 24768, Germany

Location

Site Reference ID/Investigator# 33903

Reutlingen, 72764, Germany

Location

Site Reference ID/Investigator# 53982

Rheinfelden, 79618, Germany

Location

Site Reference ID/Investigator# 53908

Rickenbach, 79736, Germany

Location

Site Reference ID/Investigator# 33393

Riesa, 01589, Germany

Location

Site Reference ID/Investigator# 33912

Rinteln, 31737, Germany

Location

Site Reference ID/Investigator# 33921

Rostock, 18059, Germany

Location

Site Reference ID/Investigator# 33929

Rothenburg, 02929, Germany

Location

Site Reference ID/Investigator# 34014

Saarbrücken, 66111, Germany

Location

Site Reference ID/Investigator# 34021

Salzwedel, 29410, Germany

Location

Site Reference ID/Investigator# 53916

Schlangenbad, 65388, Germany

Location

Site Reference ID/Investigator# 34030

Schneeberg, 08289, Germany

Location

Site Reference ID/Investigator# 33550

Schwerin, 19053, Germany

Location

Site Reference ID/Investigator# 35374

Schwerin, 19053, Germany

Location

Site Reference ID/Investigator# 33553

Schwerte, 58239, Germany

Location

Site Reference ID/Investigator# 33557

Seesen, 38723, Germany

Location

Site Reference ID/Investigator# 53944

Siegen, 57072, Germany

Location

Site Reference ID/Investigator# 33565

Sinsheim, 74889, Germany

Location

Site Reference ID/Investigator# 53927

Solingen, 42651, Germany

Location

Site Reference ID/Investigator# 33570

Soltau, 29614, Germany

Location

Site Reference ID/Investigator# 33583

Stadtbergen, 86391, Germany

Location

Site Reference ID/Investigator# 33586

Stadthagen, 31655, Germany

Location

Site Reference ID/Investigator# 53936

Steinhagen, 33803, Germany

Location

Site Reference ID/Investigator# 33602

Stuttgart, 70178, Germany

Location

Site Reference ID/Investigator# 33609

Stuttgart, 70199, Germany

Location

Site Reference ID/Investigator# 33596

Stuttgart, 70372, Germany

Location

Site Reference ID/Investigator# 35387

Suhl, 98529, Germany

Location

Site Reference ID/Investigator# 54808

Tarp, 24963, Germany

Location

Site Reference ID/Investigator# 35433

Thum-Jahnsbach, 9419, Germany

Location

Site Reference ID/Investigator# 53951

Tischenreuth, 95643, Germany

Location

Site Reference ID/Investigator# 33623

Torgelow, 17358, Germany

Location

Site Reference ID/Investigator# 33628

Treuenbrietzen, 14929, Germany

Location

Site Reference ID/Investigator# 53907

Tübingen, 72072, Germany

Location

Site Reference ID/Investigator# 53893

Twistringen, 27239, Germany

Location

Site Reference ID/Investigator# 33635

Ueberlingen-Nussdorf, 88662, Germany

Location

Site Reference ID/Investigator# 53898

Uhlstaedt-Kirchhasel, 07407, Germany

Location

Site Reference ID/Investigator# 33722

Ulm, 89073, Germany

Location

Site Reference ID/Investigator# 65626

Ulm, 89073, Germany

Location

Site Reference ID/Investigator# 33732

Verden an der Aller, 27283, Germany

Location

Site Reference ID/Investigator# 53965

Viersen, 41747, Germany

Location

Site Reference ID/Investigator# 33735

Villingen-Schwenningen, 78054, Germany

Location

Site Reference ID/Investigator# 53914

Vogelsang-Gommern, 39245, Germany

Location

Site Reference ID/Investigator# 53952

Vreden, 48691, Germany

Location

Site Reference ID/Investigator# 54809

Waldbronn, 76337, Germany

Location

Site Reference ID/Investigator# 33740

Waltrop, 45731, Germany

Location

Site Reference ID/Investigator# 34250

Wannsee, 14109, Germany

Location

Site Reference ID/Investigator# 33747

Weener, 26826, Germany

Location

Site Reference ID/Investigator# 53891

Weiden I.d. Oberpfalz, 92637, Germany

Location

Site Reference ID/Investigator# 53921

Weißenfels, 06667, Germany

Location

Site Reference ID/Investigator# 33753

Welzow, 03119, Germany

Location

Site Reference ID/Investigator# 35406

Wiesbaden, 65189, Germany

Location

Site Reference ID/Investigator# 53941

Wiesbaden, 65189, Germany

Location

Site Reference ID/Investigator# 33762

Wiesbaden, 65191, Germany

Location

Site Reference ID/Investigator# 33770

Wilhelmshaven, 26382, Germany

Location

Site Reference ID/Investigator# 53954

Winsen, 21423, Germany

Location

Site Reference ID/Investigator# 53977

Winsen, 21423, Germany

Location

Site Reference ID/Investigator# 33778

Wittlich, 54516, Germany

Location

Site Reference ID/Investigator# 33783

Wolfsburg, 38440, Germany

Location

Site Reference ID/Investigator# 53917

Wuppertal, 42103, Germany

Location

Site Reference ID/Investigator# 35418

Wuppertal, 42105, Germany

Location

Site Reference ID/Investigator# 33716

Würzburg, 97070, Germany

Location

Site Reference ID/Investigator# 33862

Zerbst, 39261, Germany

Location

Site Reference ID/Investigator# 33865

Zeven, 27404, Germany

Location

Site Reference ID/Investigator# 33870

Zwickau, 08060, Germany

Location

Site Reference ID/Investigator# 33878

Zwiesel, 94227, Germany

Location

Related Publications (2)

  • 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

MeSH Terms

Conditions

Arthritis, Rheumatoid

Condition Hierarchy (Ancestors)

ArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic DiseasesConnective Tissue DiseasesSkin and Connective Tissue DiseasesAutoimmune DiseasesImmune System Diseases

Results Point of Contact

Title
Global Medical Services
Organization
AbbVie (prior sponsor, Abbott)

Study Officials

  • Bianca Wittig, MD

    AbbVie Deutschland GmbH & Co. KG, Medical Department

    STUDY DIRECTOR

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
OTHER
Restrictive Agreement
Yes

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 26, 2010

First Posted

March 2, 2010

Study Start

April 1, 2003

Primary Completion

March 1, 2013

Study Completion

March 1, 2013

Last Updated

May 8, 2014

Results First Posted

April 23, 2014

Record last verified: 2014-04

Locations