AzTrials
AzTrials

Rheumatoid ArthritisReAliseNCT00234884

Post-marketing Observational Study in Subjects With Rheumatoid Arthritis

An observational study of Rheumatoid Arthritis, run by Abbott at 311 sites in 11 countries.

Completed

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

Official record
Search all trials

Trial summary

The purpose of this observational study was to observe and assess the long term use, safety, and effectiveness of adalimumab in a normal clinical setting. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Rheumatoid Arthritis
What is being tested?
adalimumab
How many people
3,435 participants
Where
311 sitesin 11 countries
Study dates
Sep 2003to Jul 2010
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: Participants were patients with rheumatoid arthritis (RA) who had received adalimumab for at least 3 months in NCT00448383 (Study M02-497) and had been prescribed commercial adalimumab following termination of that study. At the time of enrollment in NCT00448383 (Study M02-497), participants had failed one or more disease-modifying antirheumatic drugs (DMARDs) and had active, moderate to severe RA despite concurrent RA treatment.

Who may be able to join

  • Participants with ongoing adalimumab treatment who completed at least Month 3 (Visit 5) of NCT00448383 (Study M02-497) and who had subsequently been prescribed adalimumab according to the Summary of Product Characteristics (SmPC).
  • Participants must have been willing to consent to data being collected and provided to Abbott.

Who cannot join

  • Participants with contraindications according to the SmPC.

Trial locations and contacts

311 sites in 11 countries.

311 sites in 11 countries

France81 sites

  • Site Ref # / Investigator 49615

    Aix-en-Provence, 13616

  • Site Ref # / Investigator 49332

    Aix-les-Bains, 73106

  • Site Ref # / Investigator 49350

    Angers, 49033

  • Site Ref # / Investigator 49604

    Aulnay-sous-Bois, 93602

  • Site Ref # / Investigator 49340

    Belfort, 90016

  • Site Ref # / Investigator 49621

    Berck, 62608

  • Site Ref # / Investigator 49339

    Besançon, 25030

  • Site Ref # / Investigator 49351

    Bobigny, 93009

  • Site Ref # / Investigator 49365

    Bordeaux, 33076

  • Site Ref # / Investigator 49611

    Boulogne-Billancourt, 92100

  • Site Ref # / Investigator 49622

    Bourg-en-Bresse, 01012

  • Site Ref # / Investigator 49329

    Brest, 29609

  • Site Ref # / Investigator 49334

    Caen, 14033

  • Site Ref # / Investigator 49358

    Cahors, 46005

  • Site Ref # / Investigator 49607

    Cannes, 06400

  • Site Ref # / Investigator 49612

    Carcassonne, 11012

  • Site Ref # / Investigator 49628

    Cherbourg, 50102

  • Site Ref # / Investigator 49613

    Clermont-Ferrand, 63003

  • Site Ref # / Investigator 49624

    Colombes, 92701

  • Site Ref # / Investigator 49376

    Compiègne, 60200

  • Site Ref # / Investigator 49356

    Corbeil-Essonnes, 91108

  • Site Ref # / Investigator 49370

    Créteil, 94010

  • Site Ref # / Investigator 49605

    Dijon, 21033

  • Site Ref # / Investigator 49608

    Gleizé, 69400

  • Site Ref # / Investigator 49610

    Gonesse, 95503

  • Site Ref # / Investigator 49379

    Grenoble, 38000

  • Site Ref # / Investigator 49361

    Grenoble, 38042

  • Site Ref # / Investigator 49614

    La Roche-sur-Yon, 85925

  • Site Ref # / Investigator 49601

    La Rochelle, 17019

  • Site Ref # / Investigator 49373

    Le Kremlin-Bicêtre, 94275

  • Site Ref # / Investigator 49375

    Le Mans, 72037

  • Site Ref # / Investigator 49325

    Libourne, 33505

  • Site Ref # / Investigator 49620

    Liévin, 62806

  • Site Ref # / Investigator 49360

    Lille, 59037

  • Site Ref # / Investigator 49623

    Limoges, 87042

  • Site Ref # / Investigator 49333

    Lomme, 59462

  • Site Ref # / Investigator 49355

    Lunel, 34400

  • Site Ref # / Investigator 49337

    Lyon, 69310

  • Site Ref # / Investigator 49363

    Lyon, 69365

  • Site Ref # / Investigator 49364

    Lyon, 69437

  • Site Ref # / Investigator 49603

    Mantes-la-Jolie, 78201

  • Site Ref # / Investigator 49626

    Marseille, 13274

  • Site Ref # / Investigator 49342

    Marseille, 13285

  • Site Ref # / Investigator 49345

    Marseille, 13385

  • Site Ref # / Investigator 49362

    Marseille, 13385

  • Site Ref # / Investigator 49330

    Montivilliers, 76290

  • Site Ref # / Investigator 49323

    Montpellier, 34295

  • Site Ref # / Investigator 5590

    Mulhouse, 68070

  • Site Ref # / Investigator 49374

    Nantes, 44035

  • Site Ref # / Investigator 49642

    Narbonne, 11108

  • Site Ref # / Investigator 49353

    Nice, 06200

  • Site Ref # / Investigator 49618

    Orange, 84106

  • Site Ref # / Investigator 49331

    Orléans, 45032

  • Site Ref # / Investigator 49326

    Paris, 75014

  • Site Ref # / Investigator 49600

    Paris, 75016

  • Site Ref # / Investigator 49625

    Paris, 75475

  • Site Ref # / Investigator 49359

    Paris, 75651

  • Site Ref # / Investigator 49352

    Paris, 75679

  • Site Ref # / Investigator 49343

    Pau, 64046

  • Site Ref # / Investigator 49344

    Pessac, 33604

  • Site Ref # / Investigator 49606

    Pierre-Bénite, 69495

  • Site Ref # / Investigator 49602

    Poissy, 78303

  • Site Ref # / Investigator 49349

    Poitiers, 86021

  • Site Ref # / Investigator 49627

    Provins, 77488

  • Site Ref # / Investigator 49382

    Reims, 51100

  • Site Ref # / Investigator 49328

    Rennes, 35056

  • Site Ref # / Investigator 49619

    Roubaix, 59056

  • Site Ref # / Investigator 49372

    Rouen, 76031

  • Site Ref # / Investigator 49609

    Saint-Aubin-lès-Elbeuf, 76410

  • Site Ref # / Investigator 49327

    Saint-Brieuc, 22023

  • Site Ref # / Investigator 49598

    Saint-Etienne, 42055

  • Site Ref # / Investigator 49336

    Saint-Maurice, 94415

  • Site Ref # / Investigator 49346

    Strasbourg, 67098

  • Site Ref # / Investigator 49366

    Thionville, 57126

  • Site Ref # / Investigator 49616

    Toulon, 83800

  • Site Ref # / Investigator 49322

    Toulouse, 31059

  • Site Ref # / Investigator 49348

    Toulouse, 31059

  • Site Ref # / Investigator 49324

    Tours, 37044

  • Site Ref # / Investigator 49617

    Valence, 26953

  • Site Ref # / Investigator 49371

    Valenciennes, 59322

  • Site Ref # / Investigator 49629

    Vannes, 56017

Other trials in France

Germany48 sites

  • Site Ref # / Investigator 49573

    Aachen, 52064

  • Site Ref # / Investigator 49454

    Berlin, 12163

  • Site Ref # / Investigator 49705

    Berlin, 12627

  • Site Ref # / Investigator 49480

    Berlin, 14163

  • Site Ref # / Investigator 49433

    Berlin, D-10117

  • Site Ref # / Investigator 49577

    Bremen, 28209

  • Site Ref # / Investigator 49451

    Chemnitz, D-09130

  • Site Ref # / Investigator 49551

    Cologne, 50823

  • Site Ref # / Investigator 5602

    Cottbus, 3048

  • Site Ref # / Investigator 49441

    Damp, 24351

  • Site Ref # / Investigator 49446

    Dresden, 01277

  • Site Ref # / Investigator 49474

    Dresden, 01307

  • Site Ref # / Investigator 49483

    Duisburg, 47055

  • Site Ref # / Investigator 49455

    Erfurt, 99096

  • Site Ref # / Investigator 49579

    Erlangen, 91054

  • Site Ref # / Investigator 49475

    Erlangen, 91056

  • Site Ref # / Investigator 49481

    Essen, 45239

  • Site Ref # / Investigator 49469

    Freiburg im Breisgau, 79098

  • Site Ref # / Investigator 49711

    Freiburg im Breisgau, 79106

  • Site Ref # / Investigator 49556

    Fürth, 90766

  • Site Ref # / Investigator 49482

    Gyhum, 27404

  • Site Ref # / Investigator 49422

    Halle, 06128

  • Site Ref # / Investigator 49468

    Hamburg, 20246

  • Site Ref # / Investigator 49552

    Hamburg, 22081

  • Site Ref # / Investigator 49466

    Hattingen, 45525

  • Site Ref # / Investigator 49544

    Herrsching am Ammersee, 82211

  • Site Ref # / Investigator 49548

    Hildesheim, 31134

  • Site Ref # / Investigator 49587

    Hofheim, 65719

  • Site Ref # / Investigator 49447

    Jena, 07747

  • Site Ref # / Investigator 49431

    Leipzig, 04207

  • Site Ref # / Investigator 49424

    Ludwigsburg, 71638

  • Site Ref # / Investigator 49557

    Ludwigshafen, 67065

  • Site Ref # / Investigator 49704

    Marl, 45770

  • Site Ref # / Investigator 49547

    Mönchengladbach, 41199

  • Site Ref # / Investigator 49450

    Munich, 80331

  • Site Ref # / Investigator 49563

    Munich, 81667

  • Site Ref # / Investigator 49440

    Münster, 48129

  • Site Ref # / Investigator 49442

    Passau, 94032

  • Site Ref # / Investigator 49549

    Ratingen, 40882

  • Site Ref # / Investigator 49708

    Rostock, 18059

  • Site Ref # / Investigator 49558

    Schlangenbad, 65388

  • Site Ref # / Investigator 49445

    Sendenhorst, 48324

  • Site Ref # / Investigator 49437

    Stuttgart, 70178

  • Site Ref # / Investigator 49560

    Tübingen, 72076

  • Site Ref # / Investigator 49460

    Villingen, 78054

  • Site Ref # / Investigator 49456

    Vogelsang-Gommern, 39245

  • Site Ref # / Investigator 49449

    Wuppertal, 42117

  • Site Ref # / Investigator 49545

    Würzburg, 97070

Other trials in Germany

Belgium45 sites

  • Site Ref # / Investigator 49794

    Aalst, 9300

  • Site Ref # / Investigator 49817

    Antwerp, 2020

  • Site Ref # / Investigator 49788

    Assebroek, 8310

  • Site Ref # / Investigator 49764

    Baudour, 7331

  • Site Ref # / Investigator 49808

    Belsele, 9111

  • Site Ref # / Investigator 49806

    Bonheiden, 2820

  • Site Ref # / Investigator 49809

    Bonheiden, 2820

  • Site Ref # / Investigator 49798

    Braine-l'Alleud, 1421

  • Site Ref # / Investigator 49773

    Bruges, 8000

  • Site Ref # / Investigator 49774

    Brussels, 1000

  • Site Ref # / Investigator 49763

    Brussels, 1020

  • Site Ref # / Investigator 49791

    Brussels, 1050

  • Site Ref # / Investigator 49762

    Brussels, 1070

  • Site Ref # / Investigator 49811

    Brussels, 1090

  • Site Ref # / Investigator 49807

    Brussels, 1180

  • Site Ref # / Investigator 49772

    Brussels, 1200

  • Site Ref # / Investigator 49780

    Chimay, 6460

  • Site Ref # / Investigator 49795

    Destelbergen, 9070

  • Site Ref # / Investigator 49768

    Edegem, 2650

  • Site Ref # / Investigator 49776

    Genk, 3600

  • Site Ref # / Investigator 49813

    Genk, 3600

  • Site Ref # / Investigator 26424

    Ghent, 9000

  • Site Ref # / Investigator 49766

    Gosselies, 6041

  • Site Ref # / Investigator 49781

    Hamme, 9220

  • Site Ref # / Investigator 49814

    Hasselt, 3500

  • Site Ref # / Investigator 49810

    Hasselt, B-3500

  • Site Ref # / Investigator 49777

    Kortrijk, 8500

  • Site Ref # / Investigator 49767

    La Louvière, 7100

  • Site Ref # / Investigator 49801

    La Louvière, 7100

  • Site Ref # / Investigator 49816

    Leuven, 3000

  • Site Ref # / Investigator 49789

    Liège, 4000

  • Site Ref # / Investigator 49775

    Lier, 2500

  • Site Ref # / Investigator 49778

    Lokeren, 9160

  • Site Ref # / Investigator 49771

    Mechelen, 2800

  • Site Ref # / Investigator 49815

    Mechelen, 2800

  • Site Ref # / Investigator 49796

    Merksem, 2170

  • Site Ref # / Investigator 49785

    Mons, 7000

  • Site Ref # / Investigator 49891

    Montignies-sur-Sambre, 6061

  • Site Ref # / Investigator 49770

    Namur, 5000

  • Site Ref # / Investigator 49783

    Namur, 5000

  • Site Ref # / Investigator 49797

    Nukerke, 9681

  • Site Ref # / Investigator 49787

    Ostend, 8400

  • Site Ref # / Investigator 49802

    Ottignies, 1340

  • Site Ref # / Investigator 49793

    Sijsele, 8340

  • Site Ref # / Investigator 49805

    Sint-Niklaas, 9100

Other trials in Belgium

Italy39 sites

  • Site Ref # / Investigator 49990

    Acqui Terme (AL), 15011

  • Site Ref # / Investigator 49591

    Arenzano (GE), 16011

  • Site Ref # / Investigator 49983

    Bari, 70124

  • Site Ref # / Investigator 49593

    Bologna, 40138

  • Site Ref # / Investigator 49980

    Brescia, 25123

  • Site Ref # / Investigator 49986

    Cagliari, 09042

  • Site Ref # / Investigator 50056

    Ferrara, 44100

  • Site Ref # / Investigator 49987

    Florence, 50100

  • Site Ref # / Investigator 49597

    Foggia, 71100

  • Site Ref # / Investigator 49824

    Genoa, 16132

  • Site Ref # / Investigator 50051

    Genoa, 16148

  • Site Ref # / Investigator 49981

    Jesi (Ancona), 60035

  • Site Ref # / Investigator 49588

    Messina, 98125

  • Site Ref # / Investigator 49976

    Milan, 20122

  • Site Ref # / Investigator 50052

    Milan, 20132

  • Site Ref # / Investigator 49596

    Milan, 20162

  • Site Ref # / Investigator 49985

    Modena, 41100

  • Site Ref # / Investigator 49949

    Naples, 80135

  • Site Ref # / Investigator 49595

    Novara, 28100

  • Site Ref # / Investigator 49947

    Padova, 35128

  • Site Ref # / Investigator 49948

    Palermo, 90127

  • Site Ref # / Investigator 49978

    Perugia, 06126

  • Site Ref # / Investigator 49974

    Pescara, 65126

  • Site Ref # / Investigator 49592

    Pisa, 56126

  • Site Ref # / Investigator 49992

    Potenza, 85100

  • Site Ref # / Investigator 49822

    Prato, 59100

  • Site Ref # / Investigator 49946

    Reggio Emilia, 42100

  • Site Ref # / Investigator 49989

    Rome, 00152

  • Site Ref # / Investigator 49950

    Rome, 00161

  • Site Ref # / Investigator 50057

    Rome, 00168

  • Site Ref # / Investigator 49984

    Rozzano, 20089

  • Site Ref # / Investigator 49991

    San Cesario Lecce, 73016

  • Site Ref # / Investigator 49994

    Torino, 10128

  • Site Ref # / Investigator 49825

    Udine, 33100

  • Site Ref # / Investigator 26422

    Valeggio Sul Mincio Verona, 37067

  • Site Ref # / Investigator 49594

    Varese, 21100

  • Site Ref # / Investigator 50055

    Verbania Pallanza, 28048

  • Site Ref # / Investigator 49589

    Verona, 37134

  • Site Ref # / Investigator 50053

    Vimercate, 20059

Other trials in Italy

Spain36 sites

  • Site Ref # / Investigator 49653

    Alicante, 3010

  • Site Ref # / Investigator 49662

    Asturias, 33006

  • Site Ref # / Investigator 49684

    Barcelona, 08003

  • Site Ref # / Investigator 49680

    Barcelona, 08022

  • Site Ref # / Investigator 49646

    Barcelona, 08025

  • Site Ref # / Investigator 49645

    Barcelona, 08036

  • Site Ref # / Investigator 49649

    Barcelona, 08208

  • Site Ref # / Investigator 49647

    Barcelona, 08221

  • Site Ref # / Investigator 49670

    Barcelona, 08907

  • Site Ref # / Investigator 49667

    Cadiz, 11009

  • Site Ref # / Investigator 49693

    Cadiz, 11407

  • Site Ref # / Investigator 5594

    Castellon, 12004

  • Site Ref # / Investigator 49663

    Córdoba, 14004

  • Site Ref # / Investigator 49652

    Elche, 32032

  • Site Ref # / Investigator 49651

    Granada, 18012

  • Site Ref # / Investigator 49681

    Granada, 18014

  • Site Ref # / Investigator 49695

    Guadalajara, 19002

  • Site Ref # / Investigator 49669

    Jaén, 23007

  • Site Ref # / Investigator 49689

    Lleida, 25198

  • Site Ref # / Investigator 49686

    Madrid, 28007

  • Site Ref # / Investigator 49697

    Madrid, 28034

  • Site Ref # / Investigator 49679

    Madrid, 28040

  • Site Ref # / Investigator 49650

    Madrid, 28041

  • Site Ref # / Investigator 49683

    Madrid, 28046

  • Site Ref # / Investigator 49687

    Madrid, 28222

  • Site Ref # / Investigator 49692

    Madrid, 28905

  • Site Ref # / Investigator 49664

    Madrid, 28911

  • Site Ref # / Investigator 49696

    Madrid, 28922

  • Site Ref # / Investigator 49665

    Málaga, 29010

  • Site Ref # / Investigator 49691

    Málaga, 29010

  • Site Ref # / Investigator 49685

    Mostoles-Madrid, 28935

  • Site Ref # / Investigator 49666

    Sant Joan Despi (Barcelona), 08970

  • Site Ref # / Investigator 49688

    Seville, 41071

  • Site Ref # / Investigator 49694

    Toledo, 45004

  • Site Ref # / Investigator 49654

    Valencia, 46017

  • Site Ref # / Investigator 49648

    Vic (Barcelona), 08500

Other trials in Spain

Netherlands16 sites

  • Site Ref # / Investigator 49904

    Alkmaar, 1815 JD

  • Site Ref # / Investigator 49909

    Almere Stad, 1315 RA

  • Site Ref # / Investigator 49831

    Amersfoort, 3818 ES

  • Site Ref # / Investigator 49906

    Bergen op Zoom, 4624 VT

  • Site Ref # / Investigator 49907

    Breda, 4818 CK

  • Site Ref # / Investigator 49910

    Den Helder, 1780 AT

  • Site Ref # / Investigator 49835

    Flushing, 4382 EE

  • Site Ref # / Investigator 49902

    Goes, 4462 RA

  • Site Ref # / Investigator 49829

    Leeuwarden, 8934 AD

  • Site Ref # / Investigator 26426

    Rotterdam, 3015 GD

  • Site Ref # / Investigator 49830

    Rotterdam, 3078 HT

  • Site Ref # / Investigator 49908

    Schiedam, 3118 JH

  • Site Ref # / Investigator 49905

    The Hague, 2545 CH

  • Site Ref # / Investigator 49920

    The Hague, 2597 AX

  • Site Ref # / Investigator 49827

    Utrecht, GA 3508

  • Site Ref # / Investigator 49903

    Venlo, 5912 BL

Other trials in Netherlands

Greece15 sites

  • Site Ref # / Investigator 49580

    Athens, 10682

  • Site Ref # / Investigator 49568

    Athens, 11521

  • Site Ref # / Investigator 49584

    Athens, 11521

  • Site Ref # / Investigator 49554

    Athens, 11526

  • Site Ref # / Investigator 49565

    Athens, 11527

  • Site Ref # / Investigator 49583

    Athens, 11527

  • Site Ref # / Investigator 49585

    Athens, 14500

  • Site Ref # / Investigator 49564

    Heraklion, 81352

  • Site Ref # / Investigator 49567

    Ioannina, 45500

  • Site Ref # / Investigator 49581

    Larissa, 41110

  • Site Ref # / Investigator 26425

    Pátrai, 26500

  • Site Ref # / Investigator 49566

    Thessaloniki, 54625

  • Site Ref # / Investigator 49582

    Thessaloniki, 54636

  • Site Ref # / Investigator 49553

    Thessaloniki, 54642

  • Site Ref # / Investigator 49569

    Thessaloniki, 57010

Other trials in Greece

Austria12 sites

  • Site Ref # / Investigator 49747

    Bad Schallerbach, 4701

  • Site Ref # / Investigator 49517

    Graz, 8036

  • Site Ref # / Investigator 49521

    Graz, A-8020

  • Site Ref # / Investigator 49518

    Innsbruck, A-6020

  • Site Ref # / Investigator 49746

    Klagenfurt, 9020

  • Site Ref # / Investigator 49748

    Laab im Walde, 2381

  • Site Ref # / Investigator 49516

    Linz, 4020

  • Site Ref # / Investigator 49523

    Oberpullendorf, 7350

  • Site Ref # / Investigator 49745

    Sankt Pölten, 3100

  • Site Ref # / Investigator 49519

    Stockerau, 2000

  • Site Ref # / Investigator 49520

    Vienna, 1090

  • Site Ref # / Investigator 4961

    Vienna, 1130

Other trials in Austria

Portugal7 sites

  • Site Ref # / Investigator 49514

    Coimbra, 3000-075

  • Site Ref # / Investigator 49515

    Lisbon, 1050-034

  • Site Ref # / Investigator 49509

    Lisbon, 1200

  • Site Ref # / Investigator 49510

    Lisbon, 1349-019

  • Site Ref # / Investigator 49513

    Lisbon, 1649-035

  • Site Ref # / Investigator 49512

    Ponta Delgada-Acores, 9500-370

  • Site Ref # / Investigator 26427

    Ponte de Lima, 4990-041

Other trials in Portugal

Australia6 sites

  • Site Ref # / Investigator 49508

    Brisbane, Queensland, 4102

  • Site Ref # / Investigator 49502

    Cairns, 4870

  • Site Ref # / Investigator 5606

    Camperdown, New South Wales, 2050

  • Site Ref # / Investigator 49504

    New Lambton, New South Wales, 2305

  • Site Ref # / Investigator 49503

    West Heidelberg, Victoria, 3081

  • Site Ref # / Investigator 49505

    Woodville, South Australia, 5011

Other trials in Australia

United Kingdom6 sites

  • Site Ref # / Investigator 49485

    Brighton, BN2 5BE

  • Site Ref # / Investigator 49470

    Greater Manchester, M6 8HD

  • Site Ref # / Investigator 49471

    Harrogate, HG2 7SX

  • Site Ref # / Investigator 49476

    Manchester, M41 5SL

  • Site Ref # / Investigator 49486

    Oxford, OX3 7LD

  • Site Ref # / Investigator 49472

    Wigan, WN6 9EP

Other trials in United Kingdom

About this study

Official title: A Five-year, Post-marketing Observational Study to Follow-up Patients With Rheumatoid Arthritis Formerly Treated in Study M02-497 (ReAct) and Subsequently Prescribed Humira

The purpose of this observational study was to observe and assess the long term use, safety, and effectiveness of adalimumab in a normal clinical setting.

Read the detailed description

This was a multicenter, uncontrolled, 5-year observational study of adalimumab in the treatment of patients with rheumatoid arthritis (RA) who had received adalimumab for at least 3 months in NCT00448383 (Study M02-497), an interventional study that ended when adalimumab became commercially available for the treatment of RA. Participants had to have been receiving ongoing adalimumab treatment at the time NCT00448383 (Study M02-497) ended and been prescribed commercial adalimumab, and could have received commercial adalimumab for up to 1 year afterward prior to enrollment in NCT00234884 (Study M03-634).

Physician investigators were encouraged to treat participants as they would any other patient with RA in their routine clinical practice, and were free to determine the appropriate therapy for each patient. Concomitant treatment with disease-modifying antirheumatic drugs (DMARDs), including methotrexate, could be continued while receiving adalimumab. If treatment with adalimumab was permanently discontinued for any reason, participants were discontinued from the study and the reason was recorded. Investigators were asked to record adverse events up to 3 months after last administration of adalimumab.

Being tested
adalimumab
Keywords
rheumatoid arthritis, adalimumab
Medical subject headings
Arthritis, Rheumatoid

What participants receive

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

  • adalimumabBiological

    Also called HUMIRA®

    commercial adalimumab as prescribed by the rheumatologist in a normal clinical setting and in accordance with the Summary of Product Characteristics (SmPC)

Study groups in NCT00234884
Study groupRoleWhat they receive
AdalimumabRA patients in treatment with commercial adalimumab
Receives: Biological: adalimumab

What is being measured

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

  1. Disease Activity Score in 28 Joints (DAS28) Based on Erythrocyte Sedimentation Rate (ESR)

    DAS28 is a composite measure of disease activity in patients with rheumatoid arthritis. It is calculated on the basis of tender and swollen joint counts (each assessed in 28 joints), the patient's ESR, and the patient's subjective assessment of disease activity (assessed using a 100-mm visual analog scale). A DAS28 less than 3.2 indicates low disease activity and a DAS28 greater than 5.1 indicates high disease activity; there is no absolute range of scores due to inter-patient variability in ESR.

    Measured: Baseline, Months 12, 24, 36, 48, and 60, and Last Observed Value

  2. American College of Rheumatology 20% (ACR20) Response Rate

    ACR20 response is a 20% or better improvement from Baseline in tender joint count, swollen joint count, and at least 3 of the following 5 parameters: patient's assessment of pain, patient's global assessment of disease activity, physician's global assessment of disease activity, Health Assessment Questionnaire Disability Index (HAQ-DI), and C-reactive protein. Response was calculated based on values at Baseline of NCT00448383 (Study M02-497).

    Measured: Baseline, Months 12, 24, 36, 48, and 60, and Last Observed Value

  3. American College of Rheumatology 50% (ACR50) Response Rate

    ACR50 response is a 50% or better improvement from Baseline in tender joint count, swollen joint count, and at least 3 of the following 5 parameters: patient's assessment of pain, patient's global assessment of disease activity, physician's global assessment of disease activity, Health Assessment Questionnaire Disability Index (HAQ-DI), and C-reactive protein. Response was calculated based on values at Baseline of NCT00448383 (Study M02-497).

    Measured: Baseline, Months 12, 24, 36, 48, and 60, and Last Observed Value

  4. American College of Rheumatology 70% (ACR70) Response Rate

    ACR70 response is a 70% or better improvement from Baseline in tender joint count, swollen joint count, and at least 3 of the following 5 parameters: patient's assessment of pain, patient's global assessment of disease activity, physician's global assessment of disease activity, Health Assessment Questionnaire Disability Index (HAQ-DI), and C-reactive protein. Response was calculated based on values at Baseline of NCT00448383 (Study M02-497).

    Measured: Baseline, Months 12, 24, 36, 48, and 60, and Last Observed Value

  5. Change From Baseline in the Health Assessment Questionnaire Disability Index (HAQ-DI)

    HAQ-DI is a composite measure of physical function calculated on the basis of 20 questions in 8 domains (dressing, arising, eating, walking, hygiene, reach, grip, and common activities), each evaluated on a 4-point scale ranging from 0 (without any difficulty) to 3 (unable to do). HAQ-DI score is the sum of worst scores in each domain divided by the number of domains answered, and ranges from 0 (no difficulty) to 3 (unable to do). A mean change of -0.22 is considered the minimum clinically important change. Mean change in HAQ-DI was calculated from Baseline of NCT00448383 (Study M02-497).

    Measured: Baseline, Months 12, 24, 36, 48, and 60, and Last Observed Value

Timeline

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

  1. First posted10 Oct 2005 (estimated)
  2. Study startSep 2003
  3. Primary completionJul 2010
  4. Study completionJul 2010

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
Cohort
Time perspective
Prospective
Enrolment
3,435 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00234884
Sponsor's protocol ID
M03-634
Acronym
ReAlise
Status last verified
Aug 2011
First submitted
16 Sep 2005
Last updated
30 Sep 2011
Data monitoring committee
No

Publications

  • Burmester GR, Matucci-Cerinic M, Mariette X, Navarro-Blasco F, Kary S, Unnebrink K, Kupper H. Safety and effectiveness of adalimumab in patients with rheumatoid arthritis over 5 years of therapy in a phase 3b and subsequent postmarketing observational study. Arthritis Res Ther. 2014 Jan 27;16(1):R24. doi: 10.1186/ar4452.

    PubMed 24460746

Questions about this trial

What is this clinical trial studying?

An observational study of Rheumatoid Arthritis, run by Abbott at 311 sites in 11 countries.

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 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 30 Sep 2011. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 311 sites in France, Germany, Belgium, Italy, Spain and 6 more countries. 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 30 Sep 2011). 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?

Disease Activity Score in 28 Joints (DAS28) Based on Erythrocyte Sedimentation Rate (ESR) (time frame: Baseline, Months 12, 24, 36, 48, and 60, and Last Observed Value). The study lists 5 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 NCT00234884, which also lists 1 linked publication.

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 30 Sep 2011.

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