AzTrials
AzTrials

Rheumatoid ArthritisNCT01078090

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

An observational study of Rheumatoid Arthritis, run by AbbVie (prior sponsor, Abbott) at 370 sites in Germany.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Rheumatoid Arthritis
How many people
5,745 participants
Where
370 sitesGermany
Study dates
Apr 2003to Mar 2013
Phase
Observational
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

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.

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

370 sites in 1 country.

300 sites in 1 country

Germany300 sites

  • Site Reference ID/Investigator# 35034

    Aachen, 52062

  • Site Reference ID/Investigator# 35033

    Aachen, 52064

  • Site Reference ID/Investigator# 53919

    Achern, 77855

  • Site Reference ID/Investigator# 53883

    Aichhalden, 78733

  • Site Reference ID/Investigator# 35041

    Altenburg, 04600

  • Site Reference ID/Investigator# 35050

    Amberg, 92224

  • Site Reference ID/Investigator# 53974

    Amberg, 92224

  • Site Reference ID/Investigator# 33347

    Augsburg, 86150

  • Site Reference ID/Investigator# 33356

    Bad Abbach, 93077

  • Site Reference ID/Investigator# 33359

    Bad Abbach, 93077

  • Site Reference ID/Investigator# 33362

    Bad Aibling, 83043

  • Site Reference ID/Investigator# 35084

    Bad Aibling, 83043

  • Site Reference ID/Investigator# 53968

    Bad Aibling, 83043

  • Site Reference ID/Investigator# 53966

    Bad Bellingen, 79415

  • Site Reference ID/Investigator# 35523

    Bad Bentheim, D-48455

  • Site Reference ID/Investigator# 35571

    Bad Bramstedt, 24576

  • Site Reference ID/Investigator# 53903

    Bad Bramstedt, 24576

  • Site Reference ID/Investigator# 53929

    Bad Buchau, 88422

  • Site Reference ID/Investigator# 33370

    Bad Endbach, 35080

  • Site Reference ID/Investigator# 33369

    Bad Endbach, 63065

  • Site Reference ID/Investigator# 33380

    Bad Iburg, 49186

  • Site Reference ID/Investigator# 33384

    Bad Kissingen, 97688

  • Site Reference ID/Investigator# 33385

    Bad Kreuznach, 55543

  • Site Reference ID/Investigator# 33389

    Bad Liebenwerda, 04924

  • Site Reference ID/Investigator# 53942

    Bad Mergentheim, 97980

  • Site Reference ID/Investigator# 33394

    Bad Münder am Deister, 31848

  • Site Reference ID/Investigator# 33398

    Bad Nauheim, 61231

  • Site Reference ID/Investigator# 33399

    Bad Neuenahr, 53474

  • Site Reference ID/Investigator# 35576

    Bad Neuenahr, 53474

  • Site Reference ID/Investigator# 53980

    Bad Pyrmont, 31812

  • Site Reference ID/Investigator# 33402

    Bad Rappenau, 74906

  • Site Reference ID/Investigator# 33410

    Bad Soden-Salmünster, 63628

  • Site Reference ID/Investigator# 33415

    Bad Staffelstein, 96231

  • Site Reference ID/Investigator# 54804

    Bad Tölz, 83646

  • Site Reference ID/Investigator# 33423

    Baden-Baden, 76530

  • Site Reference ID/Investigator# 33427

    Bamberg, 96047

  • Site Reference ID/Investigator# 33436

    Bautzen, 02625

  • Site Reference ID/Investigator# 33440

    Bayreuth, 95445

  • Site Reference ID/Investigator# 53978

    Belm, 49191

  • Site Reference ID/Investigator# 33449

    Bensheim, 64625

  • Site Reference ID/Investigator# 33646

    Berlin, 10178

  • Site Reference ID/Investigator# 53902

    Berlin, 10247

  • Site Reference ID/Investigator# 33662

    Berlin, 10367

  • Site Reference ID/Investigator# 33695

    Berlin, 10711

  • Site Reference ID/Investigator# 34243

    Berlin, 10719

  • Site Reference ID/Investigator# 33681

    Berlin, 10777

  • Site Reference ID/Investigator# 35599

    Berlin, 12161

  • Site Reference ID/Investigator# 53959

    Berlin, 12200

  • Site Reference ID/Investigator# 33688

    Berlin, 12435

  • Site Reference ID/Investigator# 34260

    Berlin, 12681

  • Site Reference ID/Investigator# 33685

    Berlin, 13055

  • Site Reference ID/Investigator# 53948

    Berlin, 13055

  • Site Reference ID/Investigator# 53939

    Berlin, 13589

  • Site Reference ID/Investigator# 53971

    Berlin, 13595

  • Site Reference ID/Investigator# 53933

    Berlin, 14059

  • Site Reference ID/Investigator# 53884

    Berlin, 14089

  • Site Reference ID/Investigator# 33672

    Berlin, 14109

  • Site Reference ID/Investigator# 35552

    Berlin, 14163

  • Site Reference ID/Investigator# 35554

    Bernau, 16321

  • Site Reference ID/Investigator# 53899

    Biberach, 88400

  • Site Reference ID/Investigator# 34279

    Bielefeld, 33611

  • Site Reference ID/Investigator# 54810

    Bielefeld, 33617

  • Site Reference ID/Investigator# 35559

    Bietigheim-Bissingen, 74321

  • Site Reference ID/Investigator# 35560

    Bietigheim-Bissingen, 74321

  • Site Reference ID/Investigator# 34283

    Blankenburg/Hart, 38889

  • Site Reference ID/Investigator# 34286

    Blaubeuren Abbey, 89143

  • Site Reference ID/Investigator# 34289

    Bocholt, 46399

  • Site Reference ID/Investigator# 53946

    Bocholt, 46399

  • Site Reference ID/Investigator# 35567

    Bochum, 44789

  • Site Reference ID/Investigator# 35642

    Bogen, 94327

  • Site Reference ID/Investigator# 34300

    Bonn, 53111

  • Site Reference ID/Investigator# 53969

    Bonn, 53129

  • Site Reference ID/Investigator# 35647

    Bonn, 53175

  • Site Reference ID/Investigator# 35648

    Bonn, 53175

  • Site Reference ID/Investigator# 34294

    Bonn, 53177

  • Site Reference ID/Investigator# 34305

    Braunschweig, 38100

  • Site Reference ID/Investigator# 34310

    Braunschweig, 38100

  • Site Reference ID/Investigator# 35601

    Breitenbrunn, 08359

  • Site Reference ID/Investigator# 35607

    Bremen, 28209

  • Site Reference ID/Investigator# 53975

    Bremen, 28329

  • Site Reference ID/Investigator# 34264

    Buch, 13125

  • Site Reference ID/Investigator# 53934

    Büchen, 21514

  • Site Reference ID/Investigator# 34696

    Celle, 29221

  • Site Reference ID/Investigator# 34700

    Chemnitz, 09126

  • Site Reference ID/Investigator# 35092

    Chemnitz, D-09130

  • Site Reference ID/Investigator# 33990

    Cologne, 50679

  • Site Reference ID/Investigator# 33987

    Cologne, 50823

  • Site Reference ID/Investigator# 33996

    Cologne, 50931

  • Site Reference ID/Investigator# 33993

    Cologne, 50969

  • Site Reference ID/Investigator# 35238

    Cologne, 51067

  • Site Reference ID/Investigator# 35617

    Cottbus, 3048

  • Site Reference ID/Investigator# 53987

    Cuxhaven, 27474

  • Site Reference ID/Investigator# 53889

    Cuxhaven, 27476

  • Site Reference ID/Investigator# 35622

    Darmstadt, 64295

  • Site Reference ID/Investigator# 53885

    Delmenhorst, 27749

  • Site Reference ID/Investigator# 34726

    Demmin, 17109

  • Site Reference ID/Investigator# 53932

    Denkendorf, 73770

  • Site Reference ID/Investigator# 35636

    Dortmund, 44147

  • Site Reference ID/Investigator# 35632

    Dortmund, 44263

  • Site Reference ID/Investigator# 35171

    Dresden, 01097

  • Site Reference ID/Investigator# 34762

    Dresden, 01109

  • Site Reference ID/Investigator# 53958

    Dresden, 01159

  • Site Reference ID/Investigator# 34749

    Dresden, 01277

  • Site Reference ID/Investigator# 34763

    Dresden, 01307

  • Site Reference ID/Investigator# 34776

    Duisburg, 47055

  • Site Reference ID/Investigator# 53897

    Duisburg, 47167

  • Site Reference ID/Investigator# 34771

    Düsseldorf, 40211

  • Site Reference ID/Investigator# 34774

    Düsseldorf, 40225

  • Site Reference ID/Investigator# 34779

    Ebensfeld, 96250

  • Site Reference ID/Investigator# 34782

    Eberswalde, 16225

  • Site Reference ID/Investigator# 54805

    Eisenberg, 07607

  • Site Reference ID/Investigator# 35180

    Elmshorn, 25335

  • Site Reference ID/Investigator# 34802

    Erftstadt, 50374

  • Site Reference ID/Investigator# 34807

    Erfurt, 99096

  • Site Reference ID/Investigator# 35097

    Erfurt, 99096

  • Site Reference ID/Investigator# 35189

    Erfurt, 99096

  • Site Reference ID/Investigator# 54811

    Erlangen, 91054

  • Site Reference ID/Investigator# 34815

    Erlangen, 91056

  • Site Reference ID/Investigator# 53925

    Essen, 45128

  • Site Reference ID/Investigator# 34823

    Essen, 45239

  • Site Reference ID/Investigator# 35194

    Essen, 45326

  • Site Reference ID/Investigator# 53931

    Essen, 45329

  • Site Reference ID/Investigator# 53945

    Essen, 45359

  • Site Reference ID/Investigator# 34829

    Esslingen am Neckar, 73732

  • Site Reference ID/Investigator# 35200

    Feldafing, 82340

  • Site Reference ID/Investigator# 35203

    Flensburg, 24937

  • Site Reference ID/Investigator# 34831

    Forchheim, 91301

  • Site Reference ID/Investigator# 34851

    Frankfurt, 60590

  • Site Reference ID/Investigator# 34838

    Frankfurt, 60596

  • Site Reference ID/Investigator# 35211

    Fraureuth, 08427

  • Site Reference ID/Investigator# 35217

    Freiberg, 09599

  • Site Reference ID/Investigator# 34852

    Freiburg im Breisgau, 79098

  • Site Reference ID/Investigator# 34855

    Freiburg im Breisgau, 79098

  • Site Reference ID/Investigator# 53926

    Freiburg im Breisgau, 79098

  • Site Reference ID/Investigator# 34859

    Freiburg im Breisgau, 79106

  • Site Reference ID/Investigator# 35099

    Freystadt, 92342

  • Site Reference ID/Investigator# 53960

    Friedberg, 61169

  • Site Reference ID/Investigator# 35222

    Friedrichroda, 99894

  • Site Reference ID/Investigator# 53976

    Geesthacht, 21502

  • Site Reference ID/Investigator# 53890

    Geilenkirchen, 52511

  • Site Reference ID/Investigator# 34877

    Gelsenkirchen, 45881

  • Site Reference ID/Investigator# 53909

    Giessen, 35392

  • Site Reference ID/Investigator# 53922

    Gladbeck, 45964

  • Site Reference ID/Investigator# 34894

    Goslar, 38642

  • Site Reference ID/Investigator# 35231

    Göttingen, 37073

  • Site Reference ID/Investigator# 65622

    Göttingen, 37075

  • Site Reference ID/Investigator# 34902

    Greifswald, 17491

  • Site Reference ID/Investigator# 34910

    Güstrow, 18273

  • Site Reference ID/Investigator# 35501

    Hagen, 58089

  • Site Reference ID/Investigator# 34924

    Halle, 06108

  • Site Reference ID/Investigator# 34935

    Halle, 06108

  • Site Reference ID/Investigator# 34938

    Halle, 06108

  • Site Reference ID/Investigator# 34920

    Halle, 06112

  • Site Reference ID/Investigator# 34942

    Halle, 06120

  • Site Reference ID/Investigator# 33819

    Halle, 06128

  • Site Reference ID/Investigator# 35442

    Hamburg, 20144

  • Site Reference ID/Investigator# 53984

    Hamburg, 20355

  • Site Reference ID/Investigator# 33367

    Hamburg, 21031

  • Site Reference ID/Investigator# 53900

    Hamburg, 21073

  • Site Reference ID/Investigator# 34956

    Hamburg, 21075

  • Site Reference ID/Investigator# 34962

    Hamburg, 22081

  • Site Reference ID/Investigator# 35450

    Hamburg, 22081

  • Site Reference ID/Investigator# 35112

    Hamburg, 22087

  • Site Reference ID/Investigator# 34946

    Hamburg, 22089

  • Site Reference ID/Investigator# 35001

    Hamburg, 22119

  • Site Reference ID/Investigator# 34959

    Hamburg, 22147

  • Site Reference ID/Investigator# 34977

    Hamburg, 22147

  • Site Reference ID/Investigator# 34965

    Hamburg, 22391

  • Site Reference ID/Investigator# 54806

    Hamburg, 22399

  • Site Reference ID/Investigator# 33578

    Hamburg, 22529

  • Site Reference ID/Investigator# 34967

    Hamburg, 22529

  • Site Reference ID/Investigator# 34989

    Hamburg, 22529

  • Site Reference ID/Investigator# 34981

    Hamburg, 22609

  • Site Reference ID/Investigator# 34984

    Hamburg, 22609

  • Site Reference ID/Investigator# 34996

    Hamburg, 22609

  • Site Reference ID/Investigator# 53953

    Hamm, 59065

  • Site Reference ID/Investigator# 35017

    Hanau, 63450

  • Site Reference ID/Investigator# 33713

    Hanover, 30159

  • Site Reference ID/Investigator# 35032

    Hanover, 30159

  • Site Reference ID/Investigator# 35021

    Hanover, 30161

  • Site Reference ID/Investigator# 33788

    Hanover, 30625

  • Site Reference ID/Investigator# 34021

    Hansestadt Salzwedel, 29410

  • Site Reference ID/Investigator# 33790

    Harrislee, 24955

  • Site Reference ID/Investigator# 65629

    Haselünne, 49740

  • Site Reference ID/Investigator# 33795

    Hattingen, 45525

  • Site Reference ID/Investigator# 33796

    Heidelberg, 69120

  • Site Reference ID/Investigator# 33806

    Heidelberg, 69121

  • Site Reference ID/Investigator# 33811

    Heidelberg, D-69115

  • Site Reference ID/Investigator# 33816

    Heilbad Heiligenstadt, 37308

  • Site Reference ID/Investigator# 53911

    Herne, 44623

  • Site Reference ID/Investigator# 53910

    Herne, 44625

  • Site Reference ID/Investigator# 65623

    Herne, 44652

  • Site Reference ID/Investigator# 33823

    Herrsching am Ammersee, 82211

  • Site Reference ID/Investigator# 33831

    Hildesheim, 31124

  • Site Reference ID/Investigator# 33836

    Hof, 95028

  • Site Reference ID/Investigator# 33840

    Hofheim, 65719

  • Site Reference ID/Investigator# 33843

    Hohenfelde, 18209

  • Site Reference ID/Investigator# 54807

    Homburg, 66424

  • Site Reference ID/Investigator# 53985

    Illingen, 66557

  • Site Reference ID/Investigator# 33933

    Ingolstadt, 85049

  • Site Reference ID/Investigator# 53938

    Jena, 07743

  • Site Reference ID/Investigator# 5323

    Jena, 07745

  • Site Reference ID/Investigator# 33940

    Jülich, 52428

  • Site Reference ID/Investigator# 33944

    Kahla, 07768

  • Site Reference ID/Investigator# 35124

    Kahla, 07768

  • Site Reference ID/Investigator# 33948

    Kaiserslautern, 67655

  • Site Reference ID/Investigator# 53935

    Kaltenkirchen, 24568

  • Site Reference ID/Investigator# 33397

    Karlsruhe, 76133

  • Site Reference ID/Investigator# 33954

    Karlsruhe, 76133

  • Site Reference ID/Investigator# 35482

    Karlstadt am Main, 97753

  • Site Reference ID/Investigator# 33962

    Kassel, 34131

  • Site Reference ID/Investigator# 35239

    Kolkwitz, 3099

  • Site Reference ID/Investigator# 34000

    Königs Wusterhausen, 15711

  • Site Reference ID/Investigator# 34006

    Kressbronn, 88079

  • Site Reference ID/Investigator# 34009

    Kronach, 96317

  • Site Reference ID/Investigator# 34086

    Kyritz, 16866

  • Site Reference ID/Investigator# 34003

    Lahr, 77933

  • Site Reference ID/Investigator# 53937

    Leipzig, 04103

  • Site Reference ID/Investigator# 65628

    Leipzig, 04109

  • Site Reference ID/Investigator# 34107

    Leipzig, 04207

  • Site Reference ID/Investigator# 34098

    Leipzig, 04299

  • Site Reference ID/Investigator# 34119

    Leverkusen, 51373

  • Site Reference ID/Investigator# 34121

    Lichtenstein, 09350

  • Site Reference ID/Investigator# 35252

    Lippstadt, 59555

  • Site Reference ID/Investigator# 53882

    Löhne, 49393

  • Site Reference ID/Investigator# 34133

    Lübeck, 23552

  • Site Reference ID/Investigator# 53943

    Lüdenscheid, 58311

  • Site Reference ID/Investigator# 53886

    Ludwigsburg, 71638

  • Site Reference ID/Investigator# 35257

    Ludwigsfelde, 14974

  • Site Reference ID/Investigator# 53906

    Ludwigslust, 19288

  • Site Reference ID/Investigator# 33407

    Lüneburg, 21335

  • Site Reference ID/Investigator# 53888

    Lüneburg, 21335

  • Site Reference ID/Investigator# 34148

    Magdeburg, 39104

  • Site Reference ID/Investigator# 53981

    Magdeburg, 39110

  • Site Reference ID/Investigator# 53913

    Magdeburg, 39120

  • Site Reference ID/Investigator# 53928

    Mainz, 55116

  • Site Reference ID/Investigator# 65631

    Mainz, 55116

  • Site Reference ID/Investigator# 34184

    Mannheim, 68165

  • Site Reference ID/Investigator# 34194

    Marl, 45768

  • Site Reference ID/Investigator# 35283

    Menz, 39175

  • Site Reference ID/Investigator# 53896

    Merxheim, 55627

  • Site Reference ID/Investigator# 33418

    Minden, 32429

  • Site Reference ID/Investigator# 34206

    Mittelherwigsdorf, 02763

  • Site Reference ID/Investigator# 34219

    Moenkeberg, 24248

  • Site Reference ID/Investigator# 34216

    Mönchengladbach, 41061

  • Site Reference ID/Investigator# 53915

    Mönchengladbach, 41061

  • Site Reference ID/Investigator# 34211

    Mönchengladbach, 41199

  • Site Reference ID/Investigator# 34214

    Mönchengladbach, 41199

  • Site Reference ID/Investigator# 34222

    Mühlhausen, 99974

  • Site Reference ID/Investigator# 53904

    Munich, 80331

  • Site Reference ID/Investigator# 53956

    Munich, 80336

  • Site Reference ID/Investigator# 34037

    Munich, 80639

  • Site Reference ID/Investigator# 53962

    Munich, 80798

  • Site Reference ID/Investigator# 53912

    Munich, 81547

  • Site Reference ID/Investigator# 35296

    Munich, 81667

  • Site Reference ID/Investigator# 53924

    Munich, 81667

  • Site Reference ID/Investigator# 34041

    Munich, 81925

  • Site Reference ID/Investigator# 34035

    Munich, D-81541

  • Site Reference ID/Investigator# 34044

    Münster, 48143

  • Site Reference ID/Investigator# 53970

    Münster, 48143

  • Site Reference ID/Investigator# 34046

    Münster, 48149

  • Site Reference ID/Investigator# 34050

    Naunhof, 04683

  • Site Reference ID/Investigator# 34059

    Neubrandenburg, 17033

  • Site Reference ID/Investigator# 34062

    Neuburg am Inn, 86633

  • Site Reference ID/Investigator# 34980

    Neunkirchen, 66538

  • Site Reference ID/Investigator# 35311

    Neuss, 41460

  • Site Reference ID/Investigator# 34072

    Neustadt, 67434

  • Site Reference ID/Investigator# 65630

    Neuwied, 56564

  • Site Reference ID/Investigator# 82694

    Niederbrombach, 55767

  • Site Reference ID/Investigator# 34078

    Niefern-Öschelbronn, 75223

  • Site Reference ID/Investigator# 34081

    Nienburg, 31582

  • Site Reference ID/Investigator# 34082

    Nienburg, 31582

  • Site Reference ID/Investigator# 53923

    Nuremberg, 90402

  • Site Reference ID/Investigator# 34168

    Obergünzburg, 87634

  • Site Reference ID/Investigator# 34174

    Offenburg, 77652

  • Site Reference ID/Investigator# 33490

    Oldenburg, 26121

  • Site Reference ID/Investigator# 53950

    Olsberg, 59939

  • Site Reference ID/Investigator# 33499

    Osnabrück, D-49074

  • Site Reference ID/Investigator# 54803

    Osnabrück, D-49074

  • Site Reference ID/Investigator# 34715

    Ostseebad Damp, 24351

  • Site Reference ID/Investigator# 35333

    Paderborn, 33098

  • Site Reference ID/Investigator# 33503

    Papenburg, 26871

  • Site Reference ID/Investigator# 33506

    Parchim, 19370

  • Site Reference ID/Investigator# 33509

    Parsberg, 92331

  • Site Reference ID/Investigator# 35338

    Passau, 94032

  • Site Reference ID/Investigator# 33511

    Petershagen, 32469

  • Site Reference ID/Investigator# 33519

    Pinneberg, 25421

  • Site Reference ID/Investigator# 33520

    Pirna, 01796

  • Site Reference ID/Investigator# 33521

    Planegg, 82152

  • Site Reference ID/Investigator# 33526

    Plauen, 08523

  • Site Reference ID/Investigator# 33468

    Potsdam, 14467

  • Site Reference ID/Investigator# 33464

    Potsdam, 14469

  • Site Reference ID/Investigator# 53940

    Pulheim, 50259

  • Site Reference ID/Investigator# 33482

    Radebeul, 01445

  • Site Reference ID/Investigator# 53964

    Raststatt, 76437

  • Site Reference ID/Investigator# 33485

    Ratingen, 40882

  • Site Reference ID/Investigator# 35134

    Ratingen, 40882

  • Site Reference ID/Investigator# 54812

    Ratingen, 40882

  • Site Reference ID/Investigator# 33888

    Regensburg, 93049

  • Site Reference ID/Investigator# 33891

    Regensburg, 93049

Other trials in Germany

About this study

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

Read the detailed description

Patients with Rheumatoid Arthritis and started treatment with adalimumab in a normal clinical setting according to the label were documented. The follow-up observation period was for 5 years and focused on safety information and maintenance of efficacy during the normal clinical setting. Follow-up with participants was via regular office visits at intervals as determined by routine clinical practice or as recommended by national guidelines.

Keywords
Safety, Rheumatoid Arthritis, Effectiveness
Medical subject headings
Arthritis, Rheumatoid

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT01078090
Study groupRoleWhat they receive
Rheumatoid arthritisParticipants with rheumatoid arthritis prescribed adalimumab in routine clinical practice were observed from the first dose for up to 5 years.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

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

  2. 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.

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

Secondary outcomes (14)

  1. Percentage of Participants With a Significant Therapeutic Response

    Significant therapeutic response was determined by DAS28 critical difference (Dcrit). A Dcrit response is a statistically determined value that exceeds the threshold of random fluctuation and signifies a positive individual response during treatment. A DAS28-Dcrit individual therapeutic response is defined as a decrease (improvement) in DAS28 from Baseline of ≥ 1.8.

    The Disease Activity Score (DAS28) is a validated index of rheumatoid arthritis disease activity calculated from the 28 tender joint count, 28 swollen joint count, the erythrocyte sedimentation rate (ESR), and the patient's assessment of global disease activity (measured on a visual analog scale [VAS] from 0 to 10 cm). Scores on the DAS28 range from 0 to 10; higher scores indicate more disease activity.

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

  2. Percentage of Participants With Low, Moderate and High Disease Activity

    Low disease activity is defined as a DAS28 score ≤ 3.2; Moderate disease activity as a DAS28 >3.2 to ≤5.1; High disease activity as a DAS28 >5.1.

    The Disease Activity Score (DAS28) is a validated index of rheumatoid arthritis disease activity calculated from the 28 tender joint count, 28 swollen joint count, the erythrocyte sedimentation rate (ESR), and the patient's assessment of global disease activity (measured on a visual analog scale [VAS] from 0 to 10 cm). Scores on the DAS28 range from 0 to 10; higher scores indicate more disease activity.

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

  3. Erythrocyte Sedimentation Rate (ESR) Over Time

    Erythrocyte sedimentation rate (ESR) indirectly measures how much inflammation is in the body. A higher ESR is indicative of increased inflammation.

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

  4. C-Reactive Protein (CRP) Levels Over Time

    C-reactive protein (CRP) was measured from blood samples as a marker for inflammation. Higher levels are indicative of more inflammation. Normal concentration in healthy human serum is usually lower than 10 mg/L, slightly increasing with age.

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

  5. Tender Joint Count (TJC) Over Time

    Twenty-eight joints were assessed and classified as tender/not tender by pressure and joint manipulation on physical examination.

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

  6. Swollen Joint Count (SJC) Over Time

    Twenty-eight joints were assessed and classified as swollen/not swollen by pressure and joint manipulation on physical examination.

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

  7. Hannover Functional Questionnaire (FFbH) Over Time

    A self-administered patient questionnaire used to assess patient function based on 18 questions. The numerically coded responses to the questions are added to provide a total patient score. The FFbH was calculated from this patient score by the following formula: FFbH = (patient score x 100) ÷ 2 (number of valid responses). The resulting FFbH score reflects the degree of remaining functional capacity where 0% indicates maximal impairment and 100% indicates maximal functional capacity.

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

  8. Patients Global Assessment of Disease Activity Over Time

    Participants indicated their global assessment of disease activity over the last 7 days on a visual analog scale (VAS) ranging from 0 (best) to 10 (worst) cm; lower scores indicate better patient status.

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

  9. Participants Assessment of Pain Over Time

    Participants indicated their level of pain over the last 7 days on a visual analog scale (VAS) ranging from 0 (best) to 10 (worst) cm; lower scores indicate better patient status.

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

  10. Participants Assessment of Fatigue Over Time

    Participants indicated their level of fatigue over the last 7 days on a visual analog scale (VAS) ranging from 0 (best) to 10 (worst) cm; lower scores indicate better patient status.

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

  11. Percentage of Participants With Impairment in Daily Activities

    Participants were asked to report how many days of impairment in daily activities they had experienced in the last 4 weeks.

    Measured: Baseline and Months 6, 18, 24, and 30

  12. Number of Days Missed From Work Due to Rheumatoid Arthritis

    Participants reported the number of days they had missed from work in the prior 6 months due to rheumatoid arthritis. The Baseline measurement includes data for the prior 12 months.

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

  13. Percentage of Participants With In-patient Hospitalization

    The percentage of participants with in-patient hospitalization in the prior 6 months. Baseline data includes in-patient hospitalizations that occurred within the prior 12 months.

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

  14. Percentage of Participants on Concomitant Rheumatoid Arthritis and Pain Relief/Anti-inflammatory Medication

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted2 Mar 2010 (estimated)
  2. Study startApr 2003
  3. Primary completionMar 2013
  4. Study completionMar 2013

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Case only
Time perspective
Prospective
Enrolment
5,745 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01078090
Sponsor's protocol ID
HUM 03-1
Status last verified
Apr 2014
First submitted
26 Feb 2010
Last updated
8 May 2014
Data monitoring committee
No

Publications

  • 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.

    PubMed 31311386

  • 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.

    PubMed 26990995

Questions about this trial

What is this clinical trial studying?

An observational study of Rheumatoid Arthritis, run by AbbVie (prior sponsor, Abbott) at 370 sites in Germany.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 8 May 2014. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 370 sites in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 23 Apr 2014). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change From Baseline in Disease Activity Score (DAS) 28 (time frame: Baseline and Months 3, 6, 12, 18, 24, 30, 36, 48, and 60). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01078090, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 May 2014.

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Clinical Trial NCT01078090 | AzTrials