Post-marketing Observational Study in Subjects With Rheumatoid Arthritis

NCT ID: NCT00234884

Last Updated: 2011-09-30

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 3435 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2003-09-30
• Study Completion Date: 2010-07-31

Brief 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.

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.

Conditions

Rheumatoid Arthritis

Keywords

rheumatoid arthritis; adalimumab

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Adalimumab

RA patients in treatment with commercial adalimumab

adalimumab

Intervention Type: BIOLOGICAL

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

Interventions

adalimumab

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

Intervention Type: BIOLOGICAL

Other Intervention Names

HUMIRA®

Eligibility Criteria

Inclusion Criteria

• 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.

Exclusion Criteria

· Participants with contraindications according to the SmPC.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Abbott

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Laura Redden, MD, PhD

Role: STUDY_DIRECTOR

Abbott

Locations

Site Ref # / Investigator 5606

Camperdown, New South Wales, Australia

Site Ref # / Investigator 49504

New Lambton, New South Wales, Australia

Site Ref # / Investigator 49508

Brisbane, Queensland, Australia

Site Ref # / Investigator 49505

Woodville, South Australia, Australia

Site Ref # / Investigator 49503

West Heidelberg, Victoria, Australia

Site Ref # / Investigator 49502

Cairns, , Australia

Site Ref # / Investigator 49747

Bad Schallerbach, , Austria

Site Ref # / Investigator 49517

Graz, , Austria

Site Ref # / Investigator 49521

Graz, , Austria

Site Ref # / Investigator 49518

Innsbruck, , Austria

Site Ref # / Investigator 49746

Klagenfurt, , Austria

Site Ref # / Investigator 49748

Laab im Walde, , Austria

Site Ref # / Investigator 49516

Linz, , Austria

Site Ref # / Investigator 49523

Oberpullendorf, , Austria

Site Ref # / Investigator 49745

Sankt Pölten, , Austria

Site Ref # / Investigator 49519

Stockerau, , Austria

Site Ref # / Investigator 49520

Vienna, , Austria

Site Ref # / Investigator 4961

Vienna, , Austria

Site Ref # / Investigator 49794

Aalst, , Belgium

Site Ref # / Investigator 49817

Antwerp, , Belgium

Site Ref # / Investigator 49788

Assebroek, , Belgium

Site Ref # / Investigator 49764

Baudour, , Belgium

Site Ref # / Investigator 49808

Belsele, , Belgium

Site Ref # / Investigator 49806

Bonheiden, , Belgium

Site Ref # / Investigator 49809

Bonheiden, , Belgium

Site Ref # / Investigator 49798

Braine-l'Alleud, , Belgium

Site Ref # / Investigator 49773

Bruges, , Belgium

Site Ref # / Investigator 49774

Brussels, , Belgium

Site Ref # / Investigator 49763

Brussels, , Belgium

Site Ref # / Investigator 49791

Brussels, , Belgium

Site Ref # / Investigator 49762

Brussels, , Belgium

Site Ref # / Investigator 49811

Brussels, , Belgium

Site Ref # / Investigator 49807

Brussels, , Belgium

Site Ref # / Investigator 49772

Brussels, , Belgium

Site Ref # / Investigator 49780

Chimay, , Belgium

Site Ref # / Investigator 49795

Destelbergen, , Belgium

Site Ref # / Investigator 49768

Edegem, , Belgium

Site Ref # / Investigator 49776

Genk, , Belgium

Site Ref # / Investigator 49813

Genk, , Belgium

Site Ref # / Investigator 26424

Ghent, , Belgium

Site Ref # / Investigator 49766

Gosselies, , Belgium

Site Ref # / Investigator 49781

Hamme, , Belgium

Site Ref # / Investigator 49814

Hasselt, , Belgium

Site Ref # / Investigator 49810

Hasselt, , Belgium

Site Ref # / Investigator 49777

Kortrijk, , Belgium

Site Ref # / Investigator 49767

La Louvière, , Belgium

Site Ref # / Investigator 49801

La Louvière, , Belgium

Site Ref # / Investigator 49816

Leuven, , Belgium

Site Ref # / Investigator 49775

Lier, , Belgium

Site Ref # / Investigator 49789

Liège, , Belgium

Site Ref # / Investigator 49778

Lokeren, , Belgium

Site Ref # / Investigator 49771

Mechelen, , Belgium

Site Ref # / Investigator 49815

Mechelen, , Belgium

Site Ref # / Investigator 49796

Merksem, , Belgium

Site Ref # / Investigator 49785

Mons, , Belgium

Site Ref # / Investigator 49891

Montignies-sur-Sambre, , Belgium

Site Ref # / Investigator 49770

Namur, , Belgium

Site Ref # / Investigator 49783

Namur, , Belgium

Site Ref # / Investigator 49797

Nukerke, , Belgium

Site Ref # / Investigator 49787

Ostend, , Belgium

Site Ref # / Investigator 49802

Ottignies, , Belgium

Site Ref # / Investigator 49793

Sijsele, , Belgium

Site Ref # / Investigator 49805

Sint-Niklaas, , Belgium

Site Ref # / Investigator 49615

Aix-en-Provence, , France

Site Ref # / Investigator 49332

Aix-les-Bains, , France

Site Ref # / Investigator 49350

Angers, , France

Site Ref # / Investigator 49604

Aulnay-sous-Bois, , France

Site Ref # / Investigator 49340

Belfort, , France

Site Ref # / Investigator 49621

Berck, , France

Site Ref # / Investigator 49339

Besançon, , France

Site Ref # / Investigator 49351

Bobigny, , France

Site Ref # / Investigator 49365

Bordeaux, , France

Site Ref # / Investigator 49611

Boulogne-Billancourt, , France

Site Ref # / Investigator 49622

Bourg-en-Bresse, , France

Site Ref # / Investigator 49329

Brest, , France

Site Ref # / Investigator 49334

Caen, , France

Site Ref # / Investigator 49358

Cahors, , France

Site Ref # / Investigator 49607

Cannes, , France

Site Ref # / Investigator 49612

Carcassonne, , France

Site Ref # / Investigator 49628

Cherbourg, , France

Site Ref # / Investigator 49613

Clermont-Ferrand, , France

Site Ref # / Investigator 49624

Colombes, , France

Site Ref # / Investigator 49376

Compiègne, , France

Site Ref # / Investigator 49356

Corbeil-Essonnes, , France

Site Ref # / Investigator 49370

Créteil, , France

Site Ref # / Investigator 49605

Dijon, , France

Site Ref # / Investigator 49608

Gleizé, , France

Site Ref # / Investigator 49610

Gonesse, , France

Site Ref # / Investigator 49379

Grenoble, , France

Site Ref # / Investigator 49361

Grenoble, , France

Site Ref # / Investigator 49614

La Roche-sur-Yon, , France

Site Ref # / Investigator 49601

La Rochelle, , France

Site Ref # / Investigator 49373

Le Kremlin-Bicêtre, , France

Site Ref # / Investigator 49375

Le Mans, , France

Site Ref # / Investigator 49325

Libourne, , France

Site Ref # / Investigator 49620

Liévin, , France

Site Ref # / Investigator 49360

Lille, , France

Site Ref # / Investigator 49623

Limoges, , France

Site Ref # / Investigator 49333

Lomme, , France

Site Ref # / Investigator 49355

Lunel, , France

Site Ref # / Investigator 49337

Lyon, , France

Site Ref # / Investigator 49363

Lyon, , France

Site Ref # / Investigator 49364

Lyon, , France

Site Ref # / Investigator 49603

Mantes-la-Jolie, , France

Site Ref # / Investigator 49626

Marseille, , France

Site Ref # / Investigator 49342

Marseille, , France

Site Ref # / Investigator 49345

Marseille, , France

Site Ref # / Investigator 49362

Marseille, , France

Site Ref # / Investigator 49330

Montivilliers, , France

Site Ref # / Investigator 49323

Montpellier, , France

Site Ref # / Investigator 5590

Mulhouse, , France

Site Ref # / Investigator 49374

Nantes, , France

Site Ref # / Investigator 49642

Narbonne, , France

Site Ref # / Investigator 49353

Nice, , France

Site Ref # / Investigator 49618

Orange, , France

Site Ref # / Investigator 49331

Orléans, , France

Site Ref # / Investigator 49326

Paris, , France

Site Ref # / Investigator 49600

Paris, , France

Site Ref # / Investigator 49625

Paris, , France

Site Ref # / Investigator 49359

Paris, , France

Site Ref # / Investigator 49352

Paris, , France

Site Ref # / Investigator 49343

Pau, , France

Site Ref # / Investigator 49344

Pessac, , France

Site Ref # / Investigator 49606

Pierre-Bénite, , France

Site Ref # / Investigator 49602

Poissy, , France

Site Ref # / Investigator 49349

Poitiers, , France

Site Ref # / Investigator 49627

Provins, , France

Site Ref # / Investigator 49382

Reims, , France

Site Ref # / Investigator 49328

Rennes, , France

Site Ref # / Investigator 49619

Roubaix, , France

Site Ref # / Investigator 49372

Rouen, , France

Site Ref # / Investigator 49609

Saint-Aubin-lès-Elbeuf, , France

Site Ref # / Investigator 49327

Saint-Brieuc, , France

Site Ref # / Investigator 49598

Saint-Etienne, , France

Site Ref # / Investigator 49336

Saint-Maurice, , France

Site Ref # / Investigator 49346

Strasbourg, , France

Site Ref # / Investigator 49366

Thionville, , France

Site Ref # / Investigator 49616

Toulon, , France

Site Ref # / Investigator 49322

Toulouse, , France

Site Ref # / Investigator 49348

Toulouse, , France

Site Ref # / Investigator 49324

Tours, , France

Site Ref # / Investigator 49617

Valence, , France

Site Ref # / Investigator 49371

Valenciennes, , France

Site Ref # / Investigator 49629

Vannes, , France

Site Ref # / Investigator 49573

Aachen, , Germany

Site Ref # / Investigator 49454

Berlin, , Germany

Site Ref # / Investigator 49705

Berlin, , Germany

Site Ref # / Investigator 49480

Berlin, , Germany

Site Ref # / Investigator 49433

Berlin, , Germany

Site Ref # / Investigator 49577

Bremen, , Germany

Site Ref # / Investigator 49451

Chemnitz, , Germany

Site Ref # / Investigator 49551

Cologne, , Germany

Site Ref # / Investigator 5602

Cottbus, , Germany

Site Ref # / Investigator 49441

Damp, , Germany

Site Ref # / Investigator 49446

Dresden, , Germany

Site Ref # / Investigator 49474

Dresden, , Germany

Site Ref # / Investigator 49483

Duisburg, , Germany

Site Ref # / Investigator 49455

Erfurt, , Germany

Site Ref # / Investigator 49579

Erlangen, , Germany

Site Ref # / Investigator 49475

Erlangen, , Germany

Site Ref # / Investigator 49481

Essen, , Germany

Site Ref # / Investigator 49469

Freiburg im Breisgau, , Germany

Site Ref # / Investigator 49711

Freiburg im Breisgau, , Germany

Site Ref # / Investigator 49556

Fürth, , Germany

Site Ref # / Investigator 49482

Gyhum, , Germany

Site Ref # / Investigator 49422

Halle, , Germany

Site Ref # / Investigator 49468

Hamburg, , Germany

Site Ref # / Investigator 49552

Hamburg, , Germany

Site Ref # / Investigator 49466

Hattingen, , Germany

Site Ref # / Investigator 49544

Herrsching am Ammersee, , Germany

Site Ref # / Investigator 49548

Hildesheim, , Germany

Site Ref # / Investigator 49587

Hofheim, , Germany

Site Ref # / Investigator 49447

Jena, , Germany

Site Ref # / Investigator 49431

Leipzig, , Germany

Site Ref # / Investigator 49424

Ludwigsburg, , Germany

Site Ref # / Investigator 49557

Ludwigshafen, , Germany

Site Ref # / Investigator 49704

Marl, , Germany

Site Ref # / Investigator 49547

Mönchengladbach, , Germany

Site Ref # / Investigator 49450

Munich, , Germany

Site Ref # / Investigator 49563

Munich, , Germany

Site Ref # / Investigator 49440

Münster, , Germany

Site Ref # / Investigator 49442

Passau, , Germany

Site Ref # / Investigator 49549

Ratingen, , Germany

Site Ref # / Investigator 49708

Rostock, , Germany

Site Ref # / Investigator 49558

Schlangenbad, , Germany

Site Ref # / Investigator 49445

Sendenhorst, , Germany

Site Ref # / Investigator 49437

Stuttgart, , Germany

Site Ref # / Investigator 49560

Tübingen, , Germany

Site Ref # / Investigator 49460

Villingen, , Germany

Site Ref # / Investigator 49456

Vogelsang-Gommern, , Germany

Site Ref # / Investigator 49449

Wuppertal, , Germany

Site Ref # / Investigator 49545

Würzburg, , Germany

Site Ref # / Investigator 49580

Athens, , Greece

Site Ref # / Investigator 49568

Athens, , Greece

Site Ref # / Investigator 49584

Athens, , Greece

Site Ref # / Investigator 49554

Athens, , Greece

Site Ref # / Investigator 49565

Athens, , Greece

Site Ref # / Investigator 49583

Athens, , Greece

Site Ref # / Investigator 49585

Athens, , Greece

Site Ref # / Investigator 49564

Heraklion, , Greece

Site Ref # / Investigator 49567

Ioannina, , Greece

Site Ref # / Investigator 49581

Larissa, , Greece

Site Ref # / Investigator 26425

Pátrai, , Greece

Site Ref # / Investigator 49566

Thessaloniki, , Greece

Site Ref # / Investigator 49582

Thessaloniki, , Greece

Site Ref # / Investigator 49553

Thessaloniki, , Greece

Site Ref # / Investigator 49569

Thessaloniki, , Greece

Site Ref # / Investigator 49990

Acqui Terme (AL), , Italy

Site Ref # / Investigator 49591

Arenzano (GE), , Italy

Site Ref # / Investigator 49983

Bari, , Italy

Site Ref # / Investigator 49593

Bologna, , Italy

Site Ref # / Investigator 49980

Brescia, , Italy

Site Ref # / Investigator 49986

Cagliari, , Italy

Site Ref # / Investigator 50056

Ferrara, , Italy

Site Ref # / Investigator 49987

Florence, , Italy

Site Ref # / Investigator 49597

Foggia, , Italy

Site Ref # / Investigator 49824

Genoa, , Italy

Site Ref # / Investigator 50051

Genoa, , Italy

Site Ref # / Investigator 49981

Jesi (Ancona), , Italy

Site Ref # / Investigator 49588

Messina, , Italy

Site Ref # / Investigator 49976

Milan, , Italy

Site Ref # / Investigator 50052

Milan, , Italy

Site Ref # / Investigator 49596

Milan, , Italy

Site Ref # / Investigator 49985

Modena, , Italy

Site Ref # / Investigator 49949

Naples, , Italy

Site Ref # / Investigator 49595

Novara, , Italy

Site Ref # / Investigator 49947

Padua, , Italy

Site Ref # / Investigator 49948

Palermo, , Italy

Site Ref # / Investigator 49978

Perugia, , Italy

Site Ref # / Investigator 49974

Pescara, , Italy

Site Ref # / Investigator 49592

Pisa, , Italy

Site Ref # / Investigator 49992

Potenza, , Italy

Site Ref # / Investigator 49822

Prato, , Italy

Site Ref # / Investigator 49946

Reggio Emilia, , Italy

Site Ref # / Investigator 49989

Rome, , Italy

Site Ref # / Investigator 49950

Rome, , Italy

Site Ref # / Investigator 50057

Rome, , Italy

Site Ref # / Investigator 49984

Rozzano, , Italy

Site Ref # / Investigator 49991

San Cesario Lecce, , Italy

Site Ref # / Investigator 49994

Torino, , Italy

Site Ref # / Investigator 49825

Udine, , Italy

Site Ref # / Investigator 26422

Valeggio Sul Mincio Verona, , Italy

Site Ref # / Investigator 49594

Varese, , Italy

Site Ref # / Investigator 50055

Verbania Pallanza, , Italy

Site Ref # / Investigator 49589

Verona, , Italy

Site Ref # / Investigator 50053

Vimercate, , Italy

Site Ref # / Investigator 49904

Alkmaar, , Netherlands

Site Ref # / Investigator 49909

Almere Stad, , Netherlands

Site Ref # / Investigator 49831

Amersfoort, , Netherlands

Site Ref # / Investigator 49906

Bergen op Zoom, , Netherlands

Site Ref # / Investigator 49907

Breda, , Netherlands

Site Ref # / Investigator 49910

Den Helder, , Netherlands

Site Ref # / Investigator 49835

Flushing, , Netherlands

Site Ref # / Investigator 49902

Goes, , Netherlands

Site Ref # / Investigator 49829

Leeuwarden, , Netherlands

Site Ref # / Investigator 26426

Rotterdam, , Netherlands

Site Ref # / Investigator 49830

Rotterdam, , Netherlands

Site Ref # / Investigator 49908

Schiedam, , Netherlands

Site Ref # / Investigator 49905

The Hague, , Netherlands

Site Ref # / Investigator 49920

The Hague, , Netherlands

Site Ref # / Investigator 49827

Utrecht, , Netherlands

Site Ref # / Investigator 49903

Venlo, , Netherlands

Site Ref # / Investigator 49514

Coimbra, , Portugal

Site Ref # / Investigator 49515

Lisbon, , Portugal

Site Ref # / Investigator 49509

Lisbon, , Portugal

Site Ref # / Investigator 49510

Lisbon, , Portugal

Site Ref # / Investigator 49513

Lisbon, , Portugal

Site Ref # / Investigator 49512

Ponta Delgada-Acores, , Portugal

Site Ref # / Investigator 26427

Ponte de Lima, , Portugal

Site Ref # / Investigator 49653

Alicante, , Spain

Site Ref # / Investigator 49662

Asturias, , Spain

Site Ref # / Investigator 49684

Barcelona, , Spain

Site Ref # / Investigator 49680

Barcelona, , Spain

Site Ref # / Investigator 49646

Barcelona, , Spain

Site Ref # / Investigator 49645

Barcelona, , Spain

Site Ref # / Investigator 49649

Barcelona, , Spain

Site Ref # / Investigator 49647

Barcelona, , Spain

Site Ref # / Investigator 49670

Barcelona, , Spain

Site Ref # / Investigator 49667

Cadiz, , Spain

Site Ref # / Investigator 49693

Cadiz, , Spain

Site Ref # / Investigator 5594

Castellon, , Spain

Site Ref # / Investigator 49663

Córdoba, , Spain

Site Ref # / Investigator 49652

Elche, , Spain

Site Ref # / Investigator 49651

Granada, , Spain

Site Ref # / Investigator 49681

Granada, , Spain

Site Ref # / Investigator 49695

Guadalajara, , Spain

Site Ref # / Investigator 49669

Jaén, , Spain

Site Ref # / Investigator 49689

Lleida, , Spain

Site Ref # / Investigator 49686

Madrid, , Spain

Site Ref # / Investigator 49697

Madrid, , Spain

Site Ref # / Investigator 49679

Madrid, , Spain

Site Ref # / Investigator 49650

Madrid, , Spain

Site Ref # / Investigator 49683

Madrid, , Spain

Site Ref # / Investigator 49687

Madrid, , Spain

Site Ref # / Investigator 49692

Madrid, , Spain

Site Ref # / Investigator 49664

Madrid, , Spain

Site Ref # / Investigator 49696

Madrid, , Spain

Site Ref # / Investigator 49665

Málaga, , Spain

Site Ref # / Investigator 49691

Málaga, , Spain

Site Ref # / Investigator 49685

Mostoles-Madrid, , Spain

Site Ref # / Investigator 49666

Sant Joan Despi (Barcelona), , Spain

Site Ref # / Investigator 49688

Seville, , Spain

Site Ref # / Investigator 49694

Toledo, , Spain

Site Ref # / Investigator 49654

Valencia, , Spain

Site Ref # / Investigator 49648

Vic (Barcelona), , Spain

Site Ref # / Investigator 49485

Brighton, , United Kingdom

Site Ref # / Investigator 49470

Greater Manchester, , United Kingdom

Site Ref # / Investigator 49471

Harrogate, , United Kingdom

Site Ref # / Investigator 49476

Manchester, , United Kingdom

Site Ref # / Investigator 49486

Oxford, , United Kingdom

Site Ref # / Investigator 49472

Wigan, , United Kingdom

Countries

Australia; Austria; Belgium; France; Germany; Greece; Italy; Netherlands; Portugal; Spain; United Kingdom

References

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.

Reference Type: DERIVED

PMID: 24460746 (View on PubMed)

Other Identifiers

M03-634

Identifier Type: -

Identifier Source: org_study_id