AzTrials
AzTrials

Rheumatoid ArthritisNCT01077258

Efficacy and Safety of Adalimumab in Patients With Rheumatoid Arthritis in Routine Clinical Practice

An observational study of Rheumatoid Arthritis, run by AbbVie (prior sponsor, Abbott) at 303 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 2 years. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Rheumatoid Arthritis
How many people
4,208 participants
Where
303 sitesGermany
Study dates
Apr 2004to Feb 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: Community sample: 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, Humira 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

303 sites in 1 country.

300 sites in 1 country

Germany300 sites

  • Site Reference ID/Investigator# 35036

    Aachen, 52062

  • Site Reference ID/Investigator# 35510

    Ahlen, 59227

  • Site Reference ID/Investigator# 35040

    Ahrensburg, 22926

  • Site Reference ID/Investigator# 35043

    Altenburg, 04600

  • Site Reference ID/Investigator# 35046

    Altenholz, 24161

  • Site Reference ID/Investigator# 35049

    Amberg, 92224

  • Site Reference ID/Investigator# 35057

    Arnstadt, 99310

  • Site Reference ID/Investigator# 35520

    Attendorn, 57439

  • Site Reference ID/Investigator# 33349

    Augsburg, 86150

  • Site Reference ID/Investigator# 33358

    Bad Abbach, 93077

  • Site Reference ID/Investigator# 33361

    Bad Abbach, 93077

  • Site Reference ID/Investigator# 35142

    Bad Aibling, 83043

  • Site Reference ID/Investigator# 35570

    Bad Brambach, 8648

  • Site Reference ID/Investigator# 35573

    Bad Bramstedt, 24576

  • Site Reference ID/Investigator# 33372

    Bad Endbach, 35080

  • Site Reference ID/Investigator# 33378

    Bad Iburg, 49186

  • Site Reference ID/Investigator# 33382

    Bad Iburg, 49186

  • Site Reference ID/Investigator# 33387

    Bad Kreuznach, 55543

  • Site Reference ID/Investigator# 35575

    Bad Kreuznach, 55543

  • Site Reference ID/Investigator# 33391

    Bad Liebenwerda, 04924

  • Site Reference ID/Investigator# 33396

    Bad Münder am Deister, 31848

  • Site Reference ID/Investigator# 102216

    Bad Nauheim, 61231

  • Site Reference ID/Investigator# 35578

    Bad Neuenahr, 53474

  • Site Reference ID/Investigator# 33404

    Bad Rappenau, 74906

  • Site Reference ID/Investigator# 51883

    Bad Salzungen, 36433

  • Site Reference ID/Investigator# 33412

    Bad Soden-Salmünster, 63628

  • Site Reference ID/Investigator# 33425

    Baden-Baden, 76530

  • Site Reference ID/Investigator# 33429

    Bamberg, 96047

  • Site Reference ID/Investigator# 33438

    Bautzen, 02625

  • Site Reference ID/Investigator# 33442

    Bayreuth, 95445

  • Site Reference ID/Investigator# 33446

    Bayreuth, 95445

  • Site Reference ID/Investigator# 33641

    Berlin, 10117

  • Site Reference ID/Investigator# 35089

    Berlin, 10117

  • Site Reference ID/Investigator# 33648

    Berlin, 10178

  • Site Reference ID/Investigator# 33693

    Berlin, 10247

  • Site Reference ID/Investigator# 33670

    Berlin, 10369

  • Site Reference ID/Investigator# 33658

    Berlin, 10435

  • Site Reference ID/Investigator# 33697

    Berlin, 10711

  • Site Reference ID/Investigator# 34246

    Berlin, 10719

  • Site Reference ID/Investigator# 33683

    Berlin, 10777

  • Site Reference ID/Investigator# 34269

    Berlin, 10961

  • Site Reference ID/Investigator# 35527

    Berlin, 12161

  • Site Reference ID/Investigator# 35597

    Berlin, 12161

  • Site Reference ID/Investigator# 33620

    Berlin, 12207

  • Site Reference ID/Investigator# 33690

    Berlin, 12435

  • Site Reference ID/Investigator# 33704

    Berlin, 12435

  • Site Reference ID/Investigator# 33687

    Berlin, 13055

  • Site Reference ID/Investigator# 33661

    Berlin, 13437

  • Site Reference ID/Investigator# 35550

    Berlin, 13595

  • Site Reference ID/Investigator# 33674

    Berlin, 14109

  • Site Reference ID/Investigator# 35551

    Berlin, 14163

  • Site Reference ID/Investigator# 34238

    Berlin, 14199

  • Site Reference ID/Investigator# 35556

    Bernau, 16321

  • Site Reference ID/Investigator# 34277

    Biberach, 88400

  • Site Reference ID/Investigator# 35562

    Binzen, 79589

  • Site Reference ID/Investigator# 34285

    Blankenburg/Hart, 38889

  • Site Reference ID/Investigator# 34288

    Blaubeuren Abbey, 89143

  • Site Reference ID/Investigator# 34291

    Bocholt, 46399

  • Site Reference ID/Investigator# 35566

    Bocholt, 46399

  • Site Reference ID/Investigator# 35641

    Bochum, 44789

  • Site Reference ID/Investigator# 35644

    Bogen, 94327

  • Site Reference ID/Investigator# 34302

    Bonn, 53111

  • Site Reference ID/Investigator# 35646

    Bonn, 53129

  • Site Reference ID/Investigator# 34296

    Bonn, 53177

  • Site Reference ID/Investigator# 35652

    Bottrop, 46242

  • Site Reference ID/Investigator# 34307

    Braunschweig, 38100

  • Site Reference ID/Investigator# 35603

    Breitenbrunn, 08359

  • Site Reference ID/Investigator# 35609

    Bremen, 28209

  • Site Reference ID/Investigator# 34266

    Buch, 13125

  • Site Reference ID/Investigator# 35611

    Celle, 29223

  • Site Reference ID/Investigator# 34699

    Chemnitz, 09126

  • Site Reference ID/Investigator# 35093

    Chemnitz, D-09130

  • Site Reference ID/Investigator# 35615

    Coesfeld, 48653

  • Site Reference ID/Investigator# 33989

    Cologne, 50823

  • Site Reference ID/Investigator# 35237

    Cologne, 51067

  • Site Reference ID/Investigator# 34708

    Cottbus, 03042

  • Site Reference ID/Investigator# 34711

    Cottbus, 03046

  • Site Reference ID/Investigator# 35621

    Darmstadt, 64295

  • Site Reference ID/Investigator# 34725

    Deggendorf, 94469

  • Site Reference ID/Investigator# 35631

    Dessau, 6842

  • Site Reference ID/Investigator# 34742

    Dortmund, 44147

  • Site Reference ID/Investigator# 35635

    Dortmund, 44147

  • Site Reference ID/Investigator# 35634

    Dortmund, 44263

  • Site Reference ID/Investigator# 35170

    Dresden, 01097

  • Site Reference ID/Investigator# 34754

    Dresden, 01109

  • Site Reference ID/Investigator# 34748

    Dresden, 01277

  • Site Reference ID/Investigator# 34751

    Dresden, 01277

  • Site Reference ID/Investigator# 34760

    Dresden, 01277

  • Site Reference ID/Investigator# 34778

    Duisburg, 47055

  • Site Reference ID/Investigator# 34773

    Düsseldorf, 40211

  • Site Reference ID/Investigator# 34768

    Düsseldorf, 40217

  • Site Reference ID/Investigator# 34784

    Eberswalde, 16225

  • Site Reference ID/Investigator# 35184

    Elmshorn, 25336

  • Site Reference ID/Investigator# 34809

    Erfurt, 99096

  • Site Reference ID/Investigator# 35096

    Erfurt, 99096

  • Site Reference ID/Investigator# 35191

    Erfurt, 99096

  • Site Reference ID/Investigator# 34821

    Erlangen, 91056

  • Site Reference ID/Investigator# 35196

    Essen, 45326

  • Site Reference ID/Investigator# 35199

    Essen, 45356

  • Site Reference ID/Investigator# 35202

    Feldafing, 82340

  • Site Reference ID/Investigator# 35205

    Flensburg, 24937

  • Site Reference ID/Investigator# 34833

    Forchheim, 91301

  • Site Reference ID/Investigator# 35210

    Frankenberg, 09669

  • Site Reference ID/Investigator# 34849

    Frankfurt, 15230

  • Site Reference ID/Investigator# 34840

    Frankfurt, 60596

  • Site Reference ID/Investigator# 34843

    Frankfurt, 60596

  • Site Reference ID/Investigator# 35213

    Fraureuth, 08427

  • Site Reference ID/Investigator# 35219

    Freiberg, 09599

  • Site Reference ID/Investigator# 34854

    Freiburg im Breisgau, 79098

  • Site Reference ID/Investigator# 35221

    Freiburg im Breisgau, 79104

  • Site Reference ID/Investigator# 34861

    Freiburg im Breisgau, 79106

  • Site Reference ID/Investigator# 35101

    Freystadt, 92342

  • Site Reference ID/Investigator# 35224

    Friedrichroda, 99894

  • Site Reference ID/Investigator# 34879

    Gelsenkirchen, 45881

  • Site Reference ID/Investigator# 34883

    Gera, 07545

  • Site Reference ID/Investigator# 34887

    Giessen, 35392

  • Site Reference ID/Investigator# 35491

    Gosheim, 78559

  • Site Reference ID/Investigator# 34896

    Goslar, 38642

  • Site Reference ID/Investigator# 34901

    Greifswald, 17489

  • Site Reference ID/Investigator# 35496

    Greifswald, 17489

  • Site Reference ID/Investigator# 34904

    Greifswald, 17491

  • Site Reference ID/Investigator# 102217

    Groß Ammensleben, 39326

  • Site Reference ID/Investigator# 35498

    Guben, 3172

  • Site Reference ID/Investigator# 34912

    Güstrow, 18273

  • Site Reference ID/Investigator# 35503

    Hagen, 58089

  • Site Reference ID/Investigator# 34937

    Halle, 06108

  • Site Reference ID/Investigator# 34940

    Halle, 06108

  • Site Reference ID/Investigator# 34922

    Halle, 06112

  • Site Reference ID/Investigator# 34944

    Halle, 06120

  • Site Reference ID/Investigator# 34932

    Halle, 06128

  • Site Reference ID/Investigator# 35444

    Hamburg, 20144

  • Site Reference ID/Investigator# 35441

    Hamburg, 20148

  • Site Reference ID/Investigator# 34970

    Hamburg, 20251

  • Site Reference ID/Investigator# 34952

    Hamburg, 20355

  • Site Reference ID/Investigator# 34958

    Hamburg, 21075

  • Site Reference ID/Investigator# 35452

    Hamburg, 22081

  • Site Reference ID/Investigator# 35007

    Hamburg, 22089

  • Site Reference ID/Investigator# 35000

    Hamburg, 22119

  • Site Reference ID/Investigator# 34961

    Hamburg, 22147

  • Site Reference ID/Investigator# 35449

    Hamburg, 22179

  • Site Reference ID/Investigator# 34955

    Hamburg, 22415

  • Site Reference ID/Investigator# 34998

    Hamburg, 22459

  • Site Reference ID/Investigator# 34994

    Hamburg, 22523

  • Site Reference ID/Investigator# 34983

    Hamburg, 22609

  • Site Reference ID/Investigator# 34986

    Hamburg, 22609

  • Site Reference ID/Investigator# 35111

    Hamburg, 22609

  • Site Reference ID/Investigator# 34974

    Hamburg, 22767

  • Site Reference ID/Investigator# 35019

    Hanau, 63450

  • Site Reference ID/Investigator# 33712

    Hanover, 30159

  • Site Reference ID/Investigator# 35025

    Hanover, 30159

  • Site Reference ID/Investigator# 34023

    Hansestadt Salzwedel, 29410

  • Site Reference ID/Investigator# 33792

    Harrislee, 24955

  • Site Reference ID/Investigator# 35459

    Haselünne, 49740

  • Site Reference ID/Investigator# 102215

    Heidelberg, 69120

  • Site Reference ID/Investigator# 33798

    Heidelberg, 69120

  • Site Reference ID/Investigator# 35119

    Heidelberg, 69120

  • Site Reference ID/Investigator# 33801

    Heidelberg, 69121

  • Site Reference ID/Investigator# 33808

    Heidelberg, 69121

  • Site Reference ID/Investigator# 35464

    Heidenheim, 89520

  • Site Reference ID/Investigator# 33818

    Heilbad Heiligenstadt, 37308

  • Site Reference ID/Investigator# 33825

    Herrsching am Ammersee, 82211

  • Site Reference ID/Investigator# 33834

    Hof, 95028

  • Site Reference ID/Investigator# 33842

    Hofheim, 65719

  • Site Reference ID/Investigator# 33845

    Hohenfelde, 18209

  • Site Reference ID/Investigator# 33855

    Illertissen, 89257

  • Site Reference ID/Investigator# 33858

    Immenstadt im Allgäu, 87509

  • Site Reference ID/Investigator# 35479

    Ingolstadt, 85049

  • Site Reference ID/Investigator# 51882

    Jena, 07743

  • Site Reference ID/Investigator# 33942

    Jülich, 52428

  • Site Reference ID/Investigator# 33946

    Kahla, 07768

  • Site Reference ID/Investigator# 35125

    Kahla, 07768

  • Site Reference ID/Investigator# 33950

    Kaiserslautern, 67655

  • Site Reference ID/Investigator# 33956

    Karlsruhe, 76133

  • Site Reference ID/Investigator# 33961

    Karlsruhe, 76133

  • Site Reference ID/Investigator# 33964

    Kassel, 34131

  • Site Reference ID/Investigator# 34002

    Königs Wusterhausen, 15711

  • Site Reference ID/Investigator# 34008

    Kressbronn, 88079

  • Site Reference ID/Investigator# 34084

    Kronach, 96317

  • Site Reference ID/Investigator# 34005

    Lahr, 77933

  • Site Reference ID/Investigator# 35245

    Landau, 76829

  • Site Reference ID/Investigator# 34112

    Leipzig, 04109

  • Site Reference ID/Investigator# 34106

    Leipzig, 04129

  • Site Reference ID/Investigator# 34109

    Leipzig, 04207

  • Site Reference ID/Investigator# 34100

    Leipzig, 04299

  • Site Reference ID/Investigator# 35254

    Lippstadt, 59555

  • Site Reference ID/Investigator# 34136

    Lübeck, 23564

  • Site Reference ID/Investigator# 35306

    Ludwigsfelde, 14974

  • Site Reference ID/Investigator# 35262

    Ludwigshafen, 67069

  • Site Reference ID/Investigator# 34139

    Lüneburg, 21335

  • Site Reference ID/Investigator# 34147

    Magdeburg, 39104

  • Site Reference ID/Investigator# 34150

    Magdeburg, 39104

  • Site Reference ID/Investigator# 35276

    Mainz, 55116

  • Site Reference ID/Investigator# 34192

    Marktredwitz, 95615

  • Site Reference ID/Investigator# 34196

    Marl, 45768

  • Site Reference ID/Investigator# 34200

    Meissen, 01662

  • Site Reference ID/Investigator# 35285

    Menz, 39175

  • Site Reference ID/Investigator# 35287

    Minden, 32429

  • Site Reference ID/Investigator# 34208

    Mittelherwigsdorf, 02763

  • Site Reference ID/Investigator# 34221

    Moenkeberg, 24248

  • Site Reference ID/Investigator# 34218

    Mönchengladbach, 41061

  • Site Reference ID/Investigator# 34213

    Mönchengladbach, 41199

  • Site Reference ID/Investigator# 34224

    Mühlhausen, 99974

  • Site Reference ID/Investigator# 35292

    Mülheim, 45468

  • Site Reference ID/Investigator# 34229

    Müllheim, 79379

  • Site Reference ID/Investigator# 34040

    Munich, 80639

  • Site Reference ID/Investigator# 35295

    Munich, 81377

  • Site Reference ID/Investigator# 34232

    Munich, 81547

  • Site Reference ID/Investigator# 34235

    Munich, 81547

  • Site Reference ID/Investigator# 35298

    Munich, 81667

  • Site Reference ID/Investigator# 34043

    Munich, 81925

  • Site Reference ID/Investigator# 34048

    Münster, 48149

  • Site Reference ID/Investigator# 34052

    Naunhof, 04683

  • Site Reference ID/Investigator# 34061

    Neubrandenburg, 17033

  • Site Reference ID/Investigator# 34064

    Neuburg am Inn, 86633

  • Site Reference ID/Investigator# 34071

    Neumünster, 24534

  • Site Reference ID/Investigator# 35313

    Neuss, 41460

  • Site Reference ID/Investigator# 34076

    Neustadt, 67434

  • Site Reference ID/Investigator# 35321

    Niederbrombach, 55767

  • Site Reference ID/Investigator# 34080

    Niefern-Öschelbronn, 75223

  • Site Reference ID/Investigator# 34158

    Nienburg, 31582

  • Site Reference ID/Investigator# 34173

    Oelsnitz, 09376

  • Site Reference ID/Investigator# 34176

    Offenburg, 77652

  • Site Reference ID/Investigator# 33492

    Oldenburg, 26121

  • Site Reference ID/Investigator# 34718

    Ostseebad Damp, 24351

  • Site Reference ID/Investigator# 35335

    Paderborn, 33098

  • Site Reference ID/Investigator# 33508

    Parchim, 19370

  • Site Reference ID/Investigator# 35340

    Passau, 94032

  • Site Reference ID/Investigator# 33517

    Pfullendorf, 88630

  • Site Reference ID/Investigator# 67482

    Pirna, 01796

  • Site Reference ID/Investigator# 33523

    Planegg, 82152

  • Site Reference ID/Investigator# 33528

    Plauen, 08523

  • Site Reference ID/Investigator# 33470

    Potsdam, 14467

  • Site Reference ID/Investigator# 33466

    Potsdam, 14469

  • Site Reference ID/Investigator# 33476

    Prüm, 54595

  • Site Reference ID/Investigator# 33479

    Püttlingen, 66346

  • Site Reference ID/Investigator# 33484

    Radebeul, 01445

  • Site Reference ID/Investigator# 35347

    Radebeul, 01445

  • Site Reference ID/Investigator# 35136

    Ratingen, 40882

  • Site Reference ID/Investigator# 33488

    Ratzeburg, 23909

  • Site Reference ID/Investigator# 33890

    Regensburg, 93049

  • Site Reference ID/Investigator# 33883

    Regensburg, 93051

  • Site Reference ID/Investigator# 33886

    Regensburg, 93051

  • Site Reference ID/Investigator# 33897

    Reken, 48734

  • Site Reference ID/Investigator# 33902

    Rendsburg, 24768

  • Site Reference ID/Investigator# 33907

    Rheine, 48431

  • Site Reference ID/Investigator# 35355

    Rickenbach, 79736

  • Site Reference ID/Investigator# 33911

    Riesa, 01589

  • Site Reference ID/Investigator# 33914

    Rinteln, 31737

  • Site Reference ID/Investigator# 33923

    Rostock, 18059

  • Site Reference ID/Investigator# 33927

    Rostock, 18059

  • Site Reference ID/Investigator# 33931

    Rothenburg, 02929

  • Site Reference ID/Investigator# 35362

    Rüdersdorf, 15562

  • Site Reference ID/Investigator# 34016

    Saarbrücken, 66111

  • Site Reference ID/Investigator# 35383

    Saint Martin, 67487

  • Site Reference ID/Investigator# 34027

    Sande, 26452

  • Site Reference ID/Investigator# 33534

    Schneeberg, 08289

  • Site Reference ID/Investigator# 33539

    Schramberg, 78713

  • Site Reference ID/Investigator# 33542

    Schutterwald, 77746

  • Site Reference ID/Investigator# 35371

    Schwandorf in Bayern, 92421

  • Site Reference ID/Investigator# 33549

    Schwerin, 19053

  • Site Reference ID/Investigator# 35376

    Schwerin, 19053

  • Site Reference ID/Investigator# 33555

    Schwerte, 58239

  • Site Reference ID/Investigator# 33559

    Seesen, 38723

  • Site Reference ID/Investigator# 33563

    Senden, 48308

  • Site Reference ID/Investigator# 35380

    Singen, 78224

  • Site Reference ID/Investigator# 33567

    Sinsheim, 74889

  • Site Reference ID/Investigator# 33572

    Soltau, 29614

  • Site Reference ID/Investigator# 33577

    Spremberg, 03130

  • Site Reference ID/Investigator# 33588

    Stadthagen, 31655

  • Site Reference ID/Investigator# 33592

    Steinhagen, 33803

  • Site Reference ID/Investigator# 33604

    Stuttgart, 70178

  • Site Reference ID/Investigator# 33607

    Stuttgart, 70178

  • Site Reference ID/Investigator# 33611

    Stuttgart, 70199

  • Site Reference ID/Investigator# 33598

    Stuttgart, 70372

  • Site Reference ID/Investigator# 35389

    Suhl, 98529

  • Site Reference ID/Investigator# 35391

    Tegernau, 79692

  • Site Reference ID/Investigator# 33625

    Torgelow, 17358

  • Site Reference ID/Investigator# 33637

    Ueberlingen-Nussdorf, 88662

  • Site Reference ID/Investigator# 35395

    Uffenheim, 97215

  • Site Reference ID/Investigator# 33721

    Ulm, 89073

  • Site Reference ID/Investigator# 33724

    Ulm, 89073

  • Site Reference ID/Investigator# 33734

    Viersen, 41747

  • Site Reference ID/Investigator# 33737

    Villingen-Schwenningen, 78054

  • Site Reference ID/Investigator# 35397

    Vöhringen, 72189

  • Site Reference ID/Investigator# 33742

    Waltrop, 45731

  • Site Reference ID/Investigator# 34252

    Wannsee, 14109

  • Site Reference ID/Investigator# 33749

    Weener, 26826

  • Site Reference ID/Investigator# 33751

    Weißenfels, 06667

  • Site Reference ID/Investigator# 33852

    Welzow, 03119

  • Site Reference ID/Investigator# 35404

    Wiefelstede, 26215

  • Site Reference ID/Investigator# 33761

    Wiesbaden, 65189

  • Site Reference ID/Investigator# 35408

    Wiesbaden, 65189

  • Site Reference ID/Investigator# 33765

    Wiesbaden, 65191

  • Site Reference ID/Investigator# 35413

    Wiesbaden, 65191

  • Site Reference ID/Investigator# 33772

    Wilhelmshaven, 26382

  • Site Reference ID/Investigator# 33780

    Wittlich, 54516

  • Site Reference ID/Investigator# 35420

    Wuppertal, 42105

  • Site Reference ID/Investigator# 33718

    Würzburg, 97070

  • Site Reference ID/Investigator# 33864

    Zerbst, 39261

  • Site Reference ID/Investigator# 33867

    Zeven, 27404

Other trials in Germany

About this study

Official title: Effectiveness and Safety of Adalimumab in Patients With Rheumatoid Arthritis in Routine Clinical Practice

Observation of safety, tolerability and effectiveness of adalimumab (Humira) therapy in a large patient collective under everyday clinical conditions over 2 years.

Read the detailed description

Patients with rheumatoid arthritis who started treatment with adalimumab in a normal clinical setting according to the product label were documented. The follow-up observation period was for 2 years and focused on safety information and maintenance of efficacy during a 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, Long-term observation, Routine Clinical Setting, 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 NCT01077258
Study groupRoleWhat they receive
Rheumatoid arthritisParticipants with rheumatoid arthritis prescribed adalimumab in routine clinical practice were observed from the first dose for up to 24 months.

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 Disease Activity Score 28 is a validated index of rheumatoid arthritis disease activity. Twenty-eight tender joint counts, 28 swollen joint counts, the erythrocyte sedimentation rate (ESR), and the patient's assessment of global disease activity (on a visual analog scale [VAS] from 0 to 10 cm) are included in the DAS28 score. If the ESR value is missing, the C-reactive protein (CRP) value can be substituted. Scores on the DAS28 range from 0 to 10; higher scores indicate more disease activity. 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, 9, 12, 18, and 24

  2. Percentage of Participants in DAS28 Remission

    Clinical remission is defined as a disease activity score (DAS) 28 score of < 2.6. 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 the patient's assessment of global disease activity (assessed on a visual analog scale [VAS] from 0 to 10 cm) are included in the DAS28. If the ESR value is missing, the C-reactive protein (CRP) value can be substituted. Scores on the DAS28 range from 0 to 10; higher scores indicate more disease activity.

    Measured: Months 3, 6, 9, 12, 18, and 24

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 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 the patient's assessment of global disease activity (assessed on a visual analog scale [VAS] from 0 to 10 cm) are included in the DAS28. If the ESR value is missing, the C-reactive protein (CRP) value can be substituted. Scores on the DAS28 range from 0 to 10; higher scores indicate more disease activity.

    Measured: Baseline and Months 3, 6, 9, 12, 18, and 24

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

    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 the patient's assessment of global disease activity (assessed on a visual analog scale [VAS] from 0 to 10 cm) are included in the DAS28. If the ESR value is missing, the C-reactive protein (CRP) value can be substituted. Scores on the DAS28 range from 0 to 10; higher scores indicate more 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.

    Measured: Baseline and Months 3, 6, 9, 12, 18, and 24

  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, 9, 12, 18, and 24

  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, 9, 12, 18, and 24

  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, 9, 12, 18, and 24

  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, 9, 12, 18, and 24

  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, 9, 12, 18, and 24

  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) from 0 (best) to 10 (worst) cm; lower scores indicate better patient status.

    Measured: Baseline and Months 3, 6, 9, 12, 18 and 24

  9. Participants Assessment of Fatigue Over Time

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

    Measured: Baseline and Month 3, 6, 9, 12, 18, and 24

  10. Participants Assessment of Pain Over Time

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

    Measured: Baseline and Months 3, 6, 9, 12, 18, and 24

  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 3, 6, 9, 18, and 24

  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. The Baseline measurement includes data for the prior 12 months.

    Measured: Baseline and Months 6, 12, 18, and 24

  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: Month 6, 12, 18, and 24

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

    Measured: Baseline and Months 3, 6, 9, 12, 18, and 24

Timeline

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

  1. First posted1 Mar 2010 (estimated)
  2. Study startApr 2004
  3. Primary completionFeb 2013
  4. Study completionFeb 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
4,208 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01077258
Sponsor's protocol ID
P10-448
Status last verified
Apr 2014
First submitted
25 Feb 2010
Last updated
25 Apr 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 303 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 2 inclusion and 3 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 25 Apr 2014. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 303 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 8 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, 9, 12, 18, and 24). 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 NCT01077258, 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 25 Apr 2014.

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