Post-marketing Observational Study in Subjects With Rheumatoid Arthritis

NCT00234884 | Completed Results

• 1 other identifier: M03-634
• Study Type: observational
• Target: 3,435
• Locations: 10 countries
• Sites: 299

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.

Conditions

Rheumatoid Arthritis

Keywords

rheumatoid arthritis; adalimumab

Outcome Measures

Primary Outcomes (5)

• 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.

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

• 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).

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

• 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).

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

• 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).

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

• 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).

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

Study Arms (1)

Adalimumab

RA patients in treatment with commercial adalimumab

Biological: adalimumab

Interventions

adalimumab BIOLOGICAL

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

Also known as: HUMIRA®

Adalimumab

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

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.

You may qualify if:

• 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.

You may not qualify if:

• · Participants with contraindications according to the SmPC.

Sponsors & Collaborators

• Abbott: lead

Study Sites (311)

Site Ref # / Investigator 5606

Camperdown, New South Wales, 2050, Australia

Location

Site Ref # / Investigator 49504

New Lambton, New South Wales, 2305, Australia

Location

Site Ref # / Investigator 49508

Brisbane, Queensland, 4102, Australia

Location

Site Ref # / Investigator 49505

Woodville, South Australia, 5011, Australia

Location

Site Ref # / Investigator 49503

West Heidelberg, Victoria, 3081, Australia

Location

Site Ref # / Investigator 49502

Cairns, 4870, Australia

Location

Site Ref # / Investigator 49747

Bad Schallerbach, 4701, Austria

Location

Site Ref # / Investigator 49517

Graz, 8036, Austria

Location

Site Ref # / Investigator 49521

Graz, A-8020, Austria

Location

Site Ref # / Investigator 49518

Innsbruck, A-6020, Austria

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Site Ref # / Investigator 49746

Klagenfurt, 9020, Austria

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Site Ref # / Investigator 49748

Laab im Walde, 2381, Austria

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Site Ref # / Investigator 49516

Linz, 4020, Austria

Location

Site Ref # / Investigator 49523

Oberpullendorf, 7350, Austria

Location

Site Ref # / Investigator 49745

Sankt Pölten, 3100, Austria

Location

Site Ref # / Investigator 49519

Stockerau, 2000, Austria

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Site Ref # / Investigator 49520

Vienna, 1090, Austria

Location

Site Ref # / Investigator 4961

Vienna, 1130, Austria

Location

Site Ref # / Investigator 49794

Aalst, 9300, Belgium

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Site Ref # / Investigator 49817

Antwerp, 2020, Belgium

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Site Ref # / Investigator 49788

Assebroek, 8310, Belgium

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Site Ref # / Investigator 49764

Baudour, 7331, Belgium

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Site Ref # / Investigator 49808

Belsele, 9111, Belgium

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Site Ref # / Investigator 49806

Bonheiden, 2820, Belgium

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Site Ref # / Investigator 49809

Bonheiden, 2820, Belgium

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Site Ref # / Investigator 49798

Braine-l'Alleud, 1421, Belgium

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Site Ref # / Investigator 49773

Bruges, 8000, Belgium

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Site Ref # / Investigator 49774

Brussels, 1000, Belgium

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Site Ref # / Investigator 49763

Brussels, 1020, Belgium

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Site Ref # / Investigator 49791

Brussels, 1050, Belgium

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Site Ref # / Investigator 49762

Brussels, 1070, Belgium

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Site Ref # / Investigator 49811

Brussels, 1090, Belgium

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Site Ref # / Investigator 49807

Brussels, 1180, Belgium

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Site Ref # / Investigator 49772

Brussels, 1200, Belgium

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Site Ref # / Investigator 49780

Chimay, 6460, Belgium

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Site Ref # / Investigator 49795

Destelbergen, 9070, Belgium

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Site Ref # / Investigator 49768

Edegem, 2650, Belgium

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Site Ref # / Investigator 49776

Genk, 3600, Belgium

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Site Ref # / Investigator 49813

Genk, 3600, Belgium

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Site Ref # / Investigator 26424

Ghent, 9000, Belgium

Location

Site Ref # / Investigator 49766

Gosselies, 6041, Belgium

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Site Ref # / Investigator 49781

Hamme, 9220, Belgium

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Site Ref # / Investigator 49814

Hasselt, 3500, Belgium

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Site Ref # / Investigator 49810

Hasselt, B-3500, Belgium

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Site Ref # / Investigator 49777

Kortrijk, 8500, Belgium

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Site Ref # / Investigator 49767

La Louvière, 7100, Belgium

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Site Ref # / Investigator 49801

La Louvière, 7100, Belgium

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Site Ref # / Investigator 49816

Leuven, 3000, Belgium

Location

Site Ref # / Investigator 49775

Lier, 2500, Belgium

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Site Ref # / Investigator 49789

Liège, 4000, Belgium

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Site Ref # / Investigator 49778

Lokeren, 9160, Belgium

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Site Ref # / Investigator 49771

Mechelen, 2800, Belgium

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Site Ref # / Investigator 49815

Mechelen, 2800, Belgium

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Site Ref # / Investigator 49796

Merksem, 2170, Belgium

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Site Ref # / Investigator 49785

Mons, 7000, Belgium

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Site Ref # / Investigator 49891

Montignies-sur-Sambre, 6061, Belgium

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Site Ref # / Investigator 49770

Namur, 5000, Belgium

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Site Ref # / Investigator 49783

Namur, 5000, Belgium

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Site Ref # / Investigator 49797

Nukerke, 9681, Belgium

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Site Ref # / Investigator 49787

Ostend, 8400, Belgium

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Site Ref # / Investigator 49802

Ottignies, 1340, Belgium

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Site Ref # / Investigator 49793

Sijsele, 8340, Belgium

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Site Ref # / Investigator 49805

Sint-Niklaas, 9100, Belgium

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Site Ref # / Investigator 49615

Aix-en-Provence, 13616, France

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Site Ref # / Investigator 49332

Aix-les-Bains, 73106, France

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Site Ref # / Investigator 49350

Angers, 49033, France

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Site Ref # / Investigator 49604

Aulnay-sous-Bois, 93602, France

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Site Ref # / Investigator 49340

Belfort, 90016, France

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Site Ref # / Investigator 49621

Berck, 62608, France

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Site Ref # / Investigator 49339

Besançon, 25030, France

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Site Ref # / Investigator 49351

Bobigny, 93009, France

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Site Ref # / Investigator 49365

Bordeaux, 33076, France

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Site Ref # / Investigator 49611

Boulogne-Billancourt, 92100, France

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Site Ref # / Investigator 49622

Bourg-en-Bresse, 01012, France

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Site Ref # / Investigator 49329

Brest, 29609, France

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Site Ref # / Investigator 49334

Caen, 14033, France

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Site Ref # / Investigator 49358

Cahors, 46005, France

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Site Ref # / Investigator 49607

Cannes, 06400, France

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Site Ref # / Investigator 49612

Carcassonne, 11012, France

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Site Ref # / Investigator 49628

Cherbourg, 50102, France

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Site Ref # / Investigator 49613

Clermont-Ferrand, 63003, France

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Site Ref # / Investigator 49624

Colombes, 92701, France

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Site Ref # / Investigator 49376

Compiègne, 60200, France

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Site Ref # / Investigator 49356

Corbeil-Essonnes, 91108, France

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Site Ref # / Investigator 49370

Créteil, 94010, France

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Site Ref # / Investigator 49605

Dijon, 21033, France

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Site Ref # / Investigator 49608

Gleizé, 69400, France

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Site Ref # / Investigator 49610

Gonesse, 95503, France

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Site Ref # / Investigator 49379

Grenoble, 38000, France

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Site Ref # / Investigator 49361

Grenoble, 38042, France

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Site Ref # / Investigator 49614

La Roche-sur-Yon, 85925, France

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Site Ref # / Investigator 49601

La Rochelle, 17019, France

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Site Ref # / Investigator 49373

Le Kremlin-Bicêtre, 94275, France

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Site Ref # / Investigator 49375

Le Mans, 72037, France

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Site Ref # / Investigator 49325

Libourne, 33505, France

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Site Ref # / Investigator 49620

Liévin, 62806, France

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Site Ref # / Investigator 49360

Lille, 59037, France

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Site Ref # / Investigator 49623

Limoges, 87042, France

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Site Ref # / Investigator 49333

Lomme, 59462, France

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Site Ref # / Investigator 49355

Lunel, 34400, France

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Site Ref # / Investigator 49337

Lyon, 69310, France

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Site Ref # / Investigator 49363

Lyon, 69365, France

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Site Ref # / Investigator 49364

Lyon, 69437, France

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Site Ref # / Investigator 49603

Mantes-la-Jolie, 78201, France

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Site Ref # / Investigator 49626

Marseille, 13274, France

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Site Ref # / Investigator 49342

Marseille, 13285, France

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Site Ref # / Investigator 49345

Marseille, 13385, France

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Site Ref # / Investigator 49362

Marseille, 13385, France

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Site Ref # / Investigator 49330

Montivilliers, 76290, France

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Site Ref # / Investigator 49323

Montpellier, 34295, France

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Site Ref # / Investigator 5590

Mulhouse, 68070, France

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Site Ref # / Investigator 49374

Nantes, 44035, France

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Site Ref # / Investigator 49642

Narbonne, 11108, France

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Site Ref # / Investigator 49353

Nice, 06200, France

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Site Ref # / Investigator 49618

Orange, 84106, France

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Site Ref # / Investigator 49331

Orléans, 45032, France

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Site Ref # / Investigator 49326

Paris, 75014, France

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Site Ref # / Investigator 49600

Paris, 75016, France

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Site Ref # / Investigator 49625

Paris, 75475, France

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Site Ref # / Investigator 49359

Paris, 75651, France

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Site Ref # / Investigator 49352

Paris, 75679, France

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Site Ref # / Investigator 49343

Pau, 64046, France

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Site Ref # / Investigator 49344

Pessac, 33604, France

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Site Ref # / Investigator 49606

Pierre-Bénite, 69495, France

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Site Ref # / Investigator 49602

Poissy, 78303, France

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Site Ref # / Investigator 49349

Poitiers, 86021, France

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Site Ref # / Investigator 49627

Provins, 77488, France

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Site Ref # / Investigator 49382

Reims, 51100, France

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Site Ref # / Investigator 49328

Rennes, 35056, France

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Site Ref # / Investigator 49619

Roubaix, 59056, France

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Site Ref # / Investigator 49372

Rouen, 76031, France

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Site Ref # / Investigator 49609

Saint-Aubin-lès-Elbeuf, 76410, France

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Site Ref # / Investigator 49327

Saint-Brieuc, 22023, France

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Site Ref # / Investigator 49598

Saint-Etienne, 42055, France

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Site Ref # / Investigator 49336

Saint-Maurice, 94415, France

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Site Ref # / Investigator 49346

Strasbourg, 67098, France

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Site Ref # / Investigator 49366

Thionville, 57126, France

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Site Ref # / Investigator 49616

Toulon, 83800, France

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Site Ref # / Investigator 49322

Toulouse, 31059, France

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Site Ref # / Investigator 49348

Toulouse, 31059, France

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Site Ref # / Investigator 49324

Tours, 37044, France

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Site Ref # / Investigator 49617

Valence, 26953, France

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Site Ref # / Investigator 49371

Valenciennes, 59322, France

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Site Ref # / Investigator 49629

Vannes, 56017, France

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Site Ref # / Investigator 49573

Aachen, 52064, Germany

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Site Ref # / Investigator 49454

Berlin, 12163, Germany

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Site Ref # / Investigator 49705

Berlin, 12627, Germany

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Site Ref # / Investigator 49480

Berlin, 14163, Germany

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Site Ref # / Investigator 49433

Berlin, D-10117, Germany

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Site Ref # / Investigator 49577

Bremen, 28209, Germany

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Site Ref # / Investigator 49451

Chemnitz, D-09130, Germany

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Site Ref # / Investigator 49551

Cologne, 50823, Germany

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Site Ref # / Investigator 5602

Cottbus, 3048, Germany

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Site Ref # / Investigator 49441

Damp, 24351, Germany

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Site Ref # / Investigator 49446

Dresden, 01277, Germany

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Site Ref # / Investigator 49474

Dresden, 01307, Germany

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Site Ref # / Investigator 49483

Duisburg, 47055, Germany

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Site Ref # / Investigator 49455

Erfurt, 99096, Germany

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Site Ref # / Investigator 49579

Erlangen, 91054, Germany

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Site Ref # / Investigator 49475

Erlangen, 91056, Germany

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Site Ref # / Investigator 49481

Essen, 45239, Germany

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Site Ref # / Investigator 49469

Freiburg im Breisgau, 79098, Germany

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Site Ref # / Investigator 49711

Freiburg im Breisgau, 79106, Germany

Location

Site Ref # / Investigator 49556

Fürth, 90766, Germany

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Site Ref # / Investigator 49482

Gyhum, 27404, Germany

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Site Ref # / Investigator 49422

Halle, 06128, Germany

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Site Ref # / Investigator 49468

Hamburg, 20246, Germany

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Site Ref # / Investigator 49552

Hamburg, 22081, Germany

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Site Ref # / Investigator 49466

Hattingen, 45525, Germany

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Site Ref # / Investigator 49544

Herrsching am Ammersee, 82211, Germany

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Site Ref # / Investigator 49548

Hildesheim, 31134, Germany

Location

Site Ref # / Investigator 49587

Hofheim, 65719, Germany

Location

Site Ref # / Investigator 49447

Jena, 07747, Germany

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Site Ref # / Investigator 49431

Leipzig, 04207, Germany

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Site Ref # / Investigator 49424

Ludwigsburg, 71638, Germany

Location

Site Ref # / Investigator 49557

Ludwigshafen, 67065, Germany

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Site Ref # / Investigator 49704

Marl, 45770, Germany

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Site Ref # / Investigator 49547

Mönchengladbach, 41199, Germany

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Site Ref # / Investigator 49450

Munich, 80331, Germany

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Site Ref # / Investigator 49563

Munich, 81667, Germany

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Site Ref # / Investigator 49440

Münster, 48129, Germany

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Site Ref # / Investigator 49442

Passau, 94032, Germany

Location

Site Ref # / Investigator 49549

Ratingen, 40882, Germany

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Site Ref # / Investigator 49708

Rostock, 18059, Germany

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Site Ref # / Investigator 49558

Schlangenbad, 65388, Germany

Location

Site Ref # / Investigator 49445

Sendenhorst, 48324, Germany

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Site Ref # / Investigator 49437

Stuttgart, 70178, Germany

Location

Site Ref # / Investigator 49560

Tübingen, 72076, Germany

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Site Ref # / Investigator 49460

Villingen, 78054, Germany

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Site Ref # / Investigator 49456

Vogelsang-Gommern, 39245, Germany

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Site Ref # / Investigator 49449

Wuppertal, 42117, Germany

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Site Ref # / Investigator 49545

Würzburg, 97070, Germany

Location

Site Ref # / Investigator 49580

Athens, 10682, Greece

Location

Site Ref # / Investigator 49568

Athens, 11521, Greece

Location

Site Ref # / Investigator 49584

Athens, 11521, Greece

Location

Site Ref # / Investigator 49554

Athens, 11526, Greece

Location

Site Ref # / Investigator 49565

Athens, 11527, Greece

Location

Site Ref # / Investigator 49583

Athens, 11527, Greece

Location

Site Ref # / Investigator 49585

Athens, 14500, Greece

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Site Ref # / Investigator 49564

Heraklion, 81352, Greece

Location

Site Ref # / Investigator 49567

Ioannina, 45500, Greece

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Site Ref # / Investigator 49581

Larissa, 41110, Greece

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Site Ref # / Investigator 26425

Pátrai, 26500, Greece

Location

Site Ref # / Investigator 49566

Thessaloniki, 54625, Greece

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Site Ref # / Investigator 49582

Thessaloniki, 54636, Greece

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Site Ref # / Investigator 49553

Thessaloniki, 54642, Greece

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Site Ref # / Investigator 49569

Thessaloniki, 57010, Greece

Location

Site Ref # / Investigator 49990

Acqui Terme (AL), 15011, Italy

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Site Ref # / Investigator 49591

Arenzano (GE), 16011, Italy

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Site Ref # / Investigator 49983

Bari, 70124, Italy

Location

Site Ref # / Investigator 49593

Bologna, 40138, Italy

Location

Site Ref # / Investigator 49980

Brescia, 25123, Italy

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Site Ref # / Investigator 49986

Cagliari, 09042, Italy

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Site Ref # / Investigator 50056

Ferrara, 44100, Italy

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Site Ref # / Investigator 49987

Florence, 50100, Italy

Location

Site Ref # / Investigator 49597

Foggia, 71100, Italy

Location

Site Ref # / Investigator 49824

Genoa, 16132, Italy

Location

Site Ref # / Investigator 50051

Genoa, 16148, Italy

Location

Site Ref # / Investigator 49981

Jesi (Ancona), 60035, Italy

Location

Site Ref # / Investigator 49588

Messina, 98125, Italy

Location

Site Ref # / Investigator 49976

Milan, 20122, Italy

Location

Site Ref # / Investigator 50052

Milan, 20132, Italy

Location

Site Ref # / Investigator 49596

Milan, 20162, Italy

Location

Site Ref # / Investigator 49985

Modena, 41100, Italy

Location

Site Ref # / Investigator 49949

Naples, 80135, Italy

Location

Site Ref # / Investigator 49595

Novara, 28100, Italy

Location

Site Ref # / Investigator 49947

Padua, 35128, Italy

Location

Site Ref # / Investigator 49948

Palermo, 90127, Italy

Location

Site Ref # / Investigator 49978

Perugia, 06126, Italy

Location

Site Ref # / Investigator 49974

Pescara, 65126, Italy

Location

Site Ref # / Investigator 49592

Pisa, 56126, Italy

Location

Site Ref # / Investigator 49992

Potenza, 85100, Italy

Location

Site Ref # / Investigator 49822

Prato, 59100, Italy

Location

Site Ref # / Investigator 49946

Reggio Emilia, 42100, Italy

Location

Site Ref # / Investigator 49989

Rome, 00152, Italy

Location

Site Ref # / Investigator 49950

Rome, 00161, Italy

Location

Site Ref # / Investigator 50057

Rome, 00168, Italy

Location

Site Ref # / Investigator 49984

Rozzano, 20089, Italy

Location

Site Ref # / Investigator 49991

San Cesario Lecce, 73016, Italy

Location

Site Ref # / Investigator 49994

Torino, 10128, Italy

Location

Site Ref # / Investigator 49825

Udine, 33100, Italy

Location

Site Ref # / Investigator 26422

Valeggio Sul Mincio Verona, 37067, Italy

Location

Site Ref # / Investigator 49594

Varese, 21100, Italy

Location

Site Ref # / Investigator 50055

Verbania Pallanza, 28048, Italy

Location

Site Ref # / Investigator 49589

Verona, 37134, Italy

Location

Site Ref # / Investigator 50053

Vimercate, 20059, Italy

Location

Site Ref # / Investigator 49904

Alkmaar, 1815 JD, Netherlands

Location

Site Ref # / Investigator 49909

Almere Stad, 1315 RA, Netherlands

Location

Site Ref # / Investigator 49831

Amersfoort, 3818 ES, Netherlands

Location

Site Ref # / Investigator 49906

Bergen op Zoom, 4624 VT, Netherlands

Location

Site Ref # / Investigator 49907

Breda, 4818 CK, Netherlands

Location

Site Ref # / Investigator 49910

Den Helder, 1780 AT, Netherlands

Location

Site Ref # / Investigator 49835

Flushing, 4382 EE, Netherlands

Location

Site Ref # / Investigator 49902

Goes, 4462 RA, Netherlands

Location

Site Ref # / Investigator 49829

Leeuwarden, 8934 AD, Netherlands

Location

Site Ref # / Investigator 26426

Rotterdam, 3015 GD, Netherlands

Location

Site Ref # / Investigator 49830

Rotterdam, 3078 HT, Netherlands

Location

Site Ref # / Investigator 49908

Schiedam, 3118 JH, Netherlands

Location

Site Ref # / Investigator 49905

The Hague, 2545 CH, Netherlands

Location

Site Ref # / Investigator 49920

The Hague, 2597 AX, Netherlands

Location

Site Ref # / Investigator 49827

Utrecht, GA 3508, Netherlands

Location

Site Ref # / Investigator 49903

Venlo, 5912 BL, Netherlands

Location

Site Ref # / Investigator 49514

Coimbra, 3000-075, Portugal

Location

Site Ref # / Investigator 49515

Lisbon, 1050-034, Portugal

Location

Site Ref # / Investigator 49509

Lisbon, 1200, Portugal

Location

Site Ref # / Investigator 49510

Lisbon, 1349-019, Portugal

Location

Site Ref # / Investigator 49513

Lisbon, 1649-035, Portugal

Location

Site Ref # / Investigator 49512

Ponta Delgada-Acores, 9500-370, Portugal

Location

Site Ref # / Investigator 26427

Ponte de Lima, 4990-041, Portugal

Location

Site Ref # / Investigator 49653

Alicante, 3010, Spain

Location

Site Ref # / Investigator 49662

Asturias, 33006, Spain

Location

Site Ref # / Investigator 49684

Barcelona, 08003, Spain

Location

Site Ref # / Investigator 49680

Barcelona, 08022, Spain

Location

Site Ref # / Investigator 49646

Barcelona, 08025, Spain

Location

Site Ref # / Investigator 49645

Barcelona, 08036, Spain

Location

Site Ref # / Investigator 49649

Barcelona, 08208, Spain

Location

Site Ref # / Investigator 49647

Barcelona, 08221, Spain

Location

Site Ref # / Investigator 49670

Barcelona, 08907, Spain

Location

Site Ref # / Investigator 49667

Cadiz, 11009, Spain

Location

Site Ref # / Investigator 49693

Cadiz, 11407, Spain

Location

Site Ref # / Investigator 5594

Castellon, 12004, Spain

Location

Site Ref # / Investigator 49663

Córdoba, 14004, Spain

Location

Site Ref # / Investigator 49652

Elche, 32032, Spain

Location

Site Ref # / Investigator 49651

Granada, 18012, Spain

Location

Site Ref # / Investigator 49681

Granada, 18014, Spain

Location

Site Ref # / Investigator 49695

Guadalajara, 19002, Spain

Location

Site Ref # / Investigator 49669

Jaén, 23007, Spain

Location

Site Ref # / Investigator 49689

Lleida, 25198, Spain

Location

Site Ref # / Investigator 49686

Madrid, 28007, Spain

Location

Site Ref # / Investigator 49697

Madrid, 28034, Spain

Location

Site Ref # / Investigator 49679

Madrid, 28040, Spain

Location

Site Ref # / Investigator 49650

Madrid, 28041, Spain

Location

Site Ref # / Investigator 49683

Madrid, 28046, Spain

Location

Site Ref # / Investigator 49687

Madrid, 28222, Spain

Location

Site Ref # / Investigator 49692

Madrid, 28905, Spain

Location

Site Ref # / Investigator 49664

Madrid, 28911, Spain

Location

Site Ref # / Investigator 49696

Madrid, 28922, Spain

Location

Site Ref # / Investigator 49665

Málaga, 29010, Spain

Location

Site Ref # / Investigator 49691

Málaga, 29010, Spain

Location

Site Ref # / Investigator 49685

Mostoles-Madrid, 28935, Spain

Location

Site Ref # / Investigator 49666

Sant Joan Despi (Barcelona), 08970, Spain

Location

Site Ref # / Investigator 49688

Seville, 41071, Spain

Location

Site Ref # / Investigator 49694

Toledo, 45004, Spain

Location

Site Ref # / Investigator 49654

Valencia, 46017, Spain

Location

Site Ref # / Investigator 49648

Vic (Barcelona), 08500, Spain

Location

Site Ref # / Investigator 49485

Brighton, BN2 5BE, United Kingdom

Location

Site Ref # / Investigator 49470

Greater Manchester, M6 8HD, United Kingdom

Location

Site Ref # / Investigator 49471

Harrogate, HG2 7SX, United Kingdom

Location

Site Ref # / Investigator 49476

Manchester, M41 5SL, United Kingdom

Location

Site Ref # / Investigator 49486

Oxford, OX3 7LD, United Kingdom

Location

Site Ref # / Investigator 49472

Wigan, WN6 9EP, United Kingdom

Location

Related Publications (1)

• 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.

  PMID: 24460746 DERIVED

MeSH Terms

Conditions

Arthritis, Rheumatoid

Interventions

Adalimumab

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Results Point of Contact

• Title: Global Medical Services
• Organization: Abbott

1-800-633-9110

Study Officials

• Laura Redden, MD, PhD

  Abbott

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 16, 2005
• First Posted: October 10, 2005
• Study Start: September 1, 2003
• Primary Completion: July 1, 2010
• Study Completion: July 1, 2010
• Last Updated: September 30, 2011
• Results First Posted: September 30, 2011

Record last verified: 2011-08

Locations

FR (81); NL (16); DE (48); IT (39); AU (6); ES (36); GB (6); BE (45); GR (15); PT (7)