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Efficacy and Safety of Adalimumab and Methotrexate (MTX) Versus MTX Monotherapy in Subjects With Early Rheumatoid Arthritis

NCT ID: NCT00195663

Last Updated: 2013-07-12

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

799 participants

Study Classification

INTERVENTIONAL

Study Start Date

2000-12-31

Study Completion Date

2012-04-30

Brief Summary

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The purpose of the study is to assess the safety and efficacy of adalimumab in combination with methotrexate in patients with recent onset rheumatoid arthritis (RA), and to assess the long-term safety and maintenance of efficacy after treatment with adalimumab for up to 10 years.

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Detailed Description

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This study had an initial 2-year double-blind treatment period followed by an 8-year open-label extension period, for a total of up to 10 years study duration. The study was designed to assess the potential of adalimumab + methotrexate to improve signs and symptoms of disease and to inhibit radiographic progression in patients with recent onset (disease duration less than 3 years) rheumatoid arthritis not previously treated with methotrexate. Adalimumab is a human anti-tumor necrosis factor (TNF) monoclonal antibody.

Conditions

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Early Rheumatoid Arthritis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Adalimumab

Participants received adalimumab 40 mg subcutaneous injection once every other week and placebo to methotrexate orally once a week during the 2-year double-blind treatment phase and then adalimumab 40 mg every other week for up to 8 years in the open-label extension.

Group Type EXPERIMENTAL

Adalimumab

Intervention Type BIOLOGICAL

Methotrexate placebo

Intervention Type DRUG

Adalimumab + methotrexate

Participants received adalimumab 40 mg subcutaneous injection once every other week and methotrexate orally once a week at a starting dose of 7.5 mg/week (could be escalated up to 20 mg/week) during the 2-year double-blind treatment phase. Participants received adalimumab 40 mg every other week for up to 8 years in the open-label extension phase.

Group Type EXPERIMENTAL

Adalimumab

Intervention Type BIOLOGICAL

Methotrexate

Intervention Type DRUG

Methotrexate

Participants received placebo to adalimumab subcutaneous injection once every other week and methotrexate orally once a week at a starting dose of 7.5 mg/week (could be escalated up to 20 mg/week) during the 2-year double-blind treatment phase. Participants received adalimumab 40 mg every other week for up to 8 years in the open-label extension phase.

Group Type EXPERIMENTAL

Methotrexate

Intervention Type DRUG

Adalimumab placebo

Intervention Type BIOLOGICAL

Interventions

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Adalimumab

Intervention Type BIOLOGICAL

Methotrexate

Intervention Type DRUG

Adalimumab placebo

Intervention Type BIOLOGICAL

Methotrexate placebo

Intervention Type DRUG

Other Intervention Names

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ABT-D2E7 Humira

Eligibility Criteria

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Inclusion Criteria

* Subject was age 18 or older and in good health (Investigator discretion) with a recent stable medical history.
* Diagnosis of rheumatoid arthritis (RA) as defined by the 1987-revised American College of Rheumatology (ACR) criteria, with a disease duration less than 3 years, at least 8 swollen joints out of the 66 joints assessed, at least 10 tender joints out of the 68 joints assessed, at least 1 joint erosion or rheumatoid factor (RF) positivity, erythrocyte sedimentation rate (ESR) \>= 28 mm/1h or C-reactive protein (CRP) \>= 1.5 mg/dl

Exclusion Criteria

* Chronic arthritis diagnosed before the age of 16
* Preceding treatment with MTX, cyclophosphamide, cyclosporin, azathioprine or more than 2 other disease-modifying anti-rheumatic drugs (DMARDs)
* Subject previously received anti-tumor necrosis factor (TNF) therapy
* Permanently wheelchair-bound or bedridden patients
* Subject considered by the investigator, for any reason, to be an unsuitable candidate for the study
* Female subject who is pregnant or breast-feeding or considering becoming pregnant
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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AbbVie (prior sponsor, Abbott)

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Dawn Carlson

Role: STUDY_DIRECTOR

AbbVie

Locations

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Site Reference ID/Investigator# 319

Cumberland, Maryland, United States

Site Status

Site Ref # / Investigator 95960

Hagerstown, Maryland, United States

Site Status

Site Reference ID/Investigator# 326

Wheaton, Maryland, United States

Site Status

Site Reference ID/Investigator# 322

Scottsdale, Arizona, United States

Site Status

Site Ref # / Investigator 95957

La Jolla, California, United States

Site Status

Site Reference ID/Investigator# 429

La Jolla, California, United States

Site Status

Site Reference ID/Investigator# 2491

Los Angeles, California, United States

Site Status

Site Reference ID/Investigator# 2500

Denver, Colorado, United States

Site Status

Site Reference ID/Investigator# 762

Aventura, Florida, United States

Site Status

Site Reference ID/Investigator# 328

Sarasota, Florida, United States

Site Status

Site Reference ID/Investigator# 327

Tampa, Florida, United States

Site Status

Site Reference ID/Investigator# 325

Zephyrhills, Florida, United States

Site Status

Site Reference ID/Investigator# 302

Rockford, Illinois, United States

Site Status

Site Reference ID/Investigator# 2533

Worcester, Massachusetts, United States

Site Status

Site Reference ID/Investigator# 336

Lincoln, Nebraska, United States

Site Status

Site Reference ID/Investigator# 318

Concord, New Hampshire, United States

Site Status

Site Reference ID/Investigator# 488

Durham, North Carolina, United States

Site Status

Site Reference ID/Investigator# 314

Dayton, Ohio, United States

Site Status

Site Reference ID/Investigator# 761

Oklahoma City, Oklahoma, United States

Site Status

Site Reference ID/Investigator# 757

Eugene, Oregon, United States

Site Status

Site Reference ID/Investigator# 361

Lake Oswego, Oregon, United States

Site Status

Site Reference ID/Investigator# 316

Bethlehem, Pennsylvania, United States

Site Status

Site Reference ID/Investigator# 4649

Duncansville, Pennsylvania, United States

Site Status

Site Ref # / Investigator 96122

Austin, Texas, United States

Site Status

Site Reference ID/Investigator# 306

Austin, Texas, United States

Site Status

Site Reference ID/Investigator# 313

Austin, Texas, United States

Site Status

Site Reference ID/Investigator# 2437

Dallas, Texas, United States

Site Status

Site Reference ID/Investigator# 2532

Houston, Texas, United States

Site Status

Site Reference ID/Investigator# 758

Houston, Texas, United States

Site Status

Site Reference ID/Investigator# 321

Spokane, Washington, United States

Site Status

Site Reference ID/Investigator# 305

Yakima, Washington, United States

Site Status

Site Reference ID/Investigator# 310

Brisbane, , Australia

Site Status

Site Reference ID/Investigator# 755

Camperdown, , Australia

Site Status

Site Reference ID/Investigator# 337

Clayton, , Australia

Site Status

Site Reference ID/Investigator# 331

Darlinghurst, Sydney, , Australia

Site Status

Site Reference ID/Investigator# 745

Kogarah, , Australia

Site Status

Site Reference ID/Investigator# 738

Maroochydore, , Australia

Site Status

Site Reference ID/Investigator# 335

New Lambton, , Australia

Site Status

Site Reference ID/Investigator# 737

Shenton Park, , Australia

Site Status

Site Reference ID/Investigator# 307

South Hobart, , Australia

Site Status

Site Reference ID/Investigator# 427

West Heidelberg, , Australia

Site Status

Site Reference ID/Investigator# 739

Woodville, , Australia

Site Status

Site Reference ID/Investigator# 344

Vienna, , Austria

Site Status

Site Reference ID/Investigator# 753

Brussels, , Belgium

Site Status

Site Reference ID/Investigator# 308

Brussels, , Belgium

Site Status

Site Reference ID/Investigator# 752

Brussels, , Belgium

Site Status

Site Reference ID/Investigator# 748

Diepenbeek, , Belgium

Site Status

Site Reference ID/Investigator# 6136

Ghent, , Belgium

Site Status

Site Ref # / Investigator 98256

Leuven, , Belgium

Site Status

Site Reference ID/Investigator# 333

Liège, , Belgium

Site Status

Site Ref # / Investigator 98199

North York, Ontario, Canada

Site Status

Site Reference ID/Investigator# 4646

Edmonton, , Canada

Site Status

Site Reference ID/Investigator# 303

Hamilton, , Canada

Site Status

Site Reference ID/Investigator# 330

Hamilton, , Canada

Site Status

Site Reference ID/Investigator# 4634

Montreal, , Canada

Site Status

Site Reference ID/Investigator# 311

Montreal, , Canada

Site Status

Site Reference ID/Investigator# 309

Newmarket, , Canada

Site Status

Site Reference ID/Investigator# 304

Pointe-Claire, , Canada

Site Status

Site Reference ID/Investigator# 4633

Richmond, , Canada

Site Status

Site Reference ID/Investigator# 763

St. John's, , Canada

Site Status

Site Reference ID/Investigator# 4635

Toronto, , Canada

Site Status

Site Reference ID/Investigator# 490

Toronto, , Canada

Site Status

Site Reference ID/Investigator# 760

Victoria, , Canada

Site Status

Site Reference ID/Investigator# 4632

Winnipeg, , Canada

Site Status

Site Reference ID/Investigator# 754

Hradec Králové, , Czechia

Site Status

Site Reference ID/Investigator# 332

Pilsen, , Czechia

Site Status

Site Reference ID/Investigator# 734

Prague, , Czechia

Site Status

Site Ref # / Investigator 95878

Gråsten, , Denmark

Site Status

Site Reference ID/Investigator# 6135

Heinola, , Finland

Site Status

Site Ref # / Investigator 6134

Helsinki, , Finland

Site Status

Site Reference ID/Investigator# 428

Bobigny, , France

Site Status

Site Reference ID/Investigator# 348

Montpellier, , France

Site Status

Site Reference ID/Investigator# 4650

Paris, , France

Site Status

Site Reference ID/Investigator# 3415

Pierre-Bénite, , France

Site Status

Site Reference ID/Investigator# 733

Rennes, , France

Site Status

Site Reference ID/Investigator# 346

Strasbourg, , France

Site Status

Site Reference ID/Investigator# 4631

Berlin, , Germany

Site Status

Site Reference ID/Investigator# 759

Berlin, , Germany

Site Status

Site Reference ID/Investigator# 3417

Buch, , Germany

Site Status

Site Reference ID/Investigator# 4630

Erlangen, , Germany

Site Status

Site Reference ID/Investigator# 347

Freiburg im Breisgau, , Germany

Site Status

Site Reference ID/Investigator# 742

Görlitz, , Germany

Site Status

Site Reference ID/Investigator# 746

Leipzig, , Germany

Site Status

Site Ref # / Investigator 98125

Munich, , Germany

Site Status

Site Reference ID/Investigator# 339

Munich, , Germany

Site Status

Site Reference ID/Investigator# 744

Ratingen, , Germany

Site Status

Site Reference ID/Investigator# 338

Vogelsang-Gommern, , Germany

Site Status

Site Reference ID/Investigator# 740

Cork, , Ireland

Site Status

Site Reference ID/Investigator# 751

Dublin, , Ireland

Site Status

Site Ref # / Investigator 95719

Genoa, , Italy

Site Status

Site Reference ID/Investigator# 323

Naples, , Italy

Site Status

Site Reference ID/Investigator# 345

Udine, , Italy

Site Status

Site Reference ID/Investigator# 756

Verona, , Italy

Site Status

Site Reference ID/Investigator# 343

Groningen, , Netherlands

Site Status

Site Reference ID/Investigator# 6133

Leiden, , Netherlands

Site Status

Site Reference ID/Investigator# 317

Maastricht, , Netherlands

Site Status

Site Reference ID/Investigator# 315

Nijmegen, , Netherlands

Site Status

Site Ref # / Investigator 95800

Oslo, , Norway

Site Status

Site Ref # / Investigator 95875

Oslo, , Norway

Site Status

Site Reference ID/Investigator# 3426

Piešťany, , Slovakia

Site Status

Site Ref # / Investigator 96121

Alicante, , Spain

Site Status

Site Reference ID/Investigator# 735

Alicante, , Spain

Site Status

Site Reference ID/Investigator# 1525

Barcelona, , Spain

Site Status

Site Reference ID/Investigator# 1528

Barcelona, , Spain

Site Status

Site Reference ID/Investigator# 750

Guadalajara, , Spain

Site Status

Site Reference ID/Investigator# 1526

Madrid, , Spain

Site Status

Site Reference ID/Investigator# 741

Madrid, , Spain

Site Status

Site Reference ID/Investigator# 390

Santiago de Compostela, , Spain

Site Status

Site Reference ID/Investigator# 749

Seville, , Spain

Site Status

Site Reference ID/Investigator# 728

Stockholm, , Sweden

Site Status

Site Reference ID/Investigator# 2565

Stockholm, , Sweden

Site Status

Site Reference ID/Investigator# 4638

Stockholm, , Sweden

Site Status

Site Ref # / Investigator 96126

Umeå, , Sweden

Site Status

Site Reference ID/Investigator# 747

Uppsala, , Sweden

Site Status

Site Ref # / Investigator 96120

Västerås, , Sweden

Site Status

Site Reference ID/Investigator# 736

Västerås, , Sweden

Site Status

Site Reference ID/Investigator# 334

Lausanne, , Switzerland

Site Status

Site Ref # / Investigator 96116

Bangor, , United Kingdom

Site Status

Site Ref # / Investigator 95877

Cambridge, , United Kingdom

Site Status

Site Ref # / Investigator 98258

Hereford, , United Kingdom

Site Status

Site Ref # / Investigator 95795

Leeds, , United Kingdom

Site Status

Site Ref # / Investigator 95958

London, , United Kingdom

Site Status

Site Ref # / Investigator 98255

Newcastle upon Tyne, , United Kingdom

Site Status

Countries

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United States Australia Austria Belgium Canada Czechia Denmark Finland France Germany Ireland Italy Netherlands Norway Slovakia Spain Sweden Switzerland United Kingdom

References

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Smolen J, Fleischmann R, Aletaha D, Li Y, Zhou Y, Sainsbury I, Galindo IL. Disease activity improvements with optimal discriminatory ability between treatment arms: applicability in early and established rheumatoid arthritis clinical trials. Arthritis Res Ther. 2019 Nov 10;21(1):231. doi: 10.1186/s13075-019-2005-9.

Reference Type DERIVED
PMID: 31707982 (View on PubMed)

Smolen JS, van Vollenhoven RF, Florentinus S, Chen S, Suboticki JL, Kavanaugh A. Predictors of disease activity and structural progression after treatment with adalimumab plus methotrexate or continued methotrexate monotherapy in patients with early rheumatoid arthritis and suboptimal response to methotrexate. Ann Rheum Dis. 2018 Nov;77(11):1566-1572. doi: 10.1136/annrheumdis-2018-213502. Epub 2018 Aug 3.

Reference Type DERIVED
PMID: 30076156 (View on PubMed)

Keystone EC, Breedveld FC, Kupper H, Li Y, Florentinus S, Sainsbury I. Long-term use of adalimumab as monotherapy after attainment of low disease activity with adalimumab plus methotrexate in patients with rheumatoid arthritis. RMD Open. 2018 Jun 13;4(1):e000637. doi: 10.1136/rmdopen-2017-000637. eCollection 2018.

Reference Type DERIVED
PMID: 29955381 (View on PubMed)

Keystone EC, Breedveld FC, van der Heijde D, van Vollenhoven RF, Emery P, Smolen JS, Sainsbury I, Florentinus S, Kupper H, Chen K, Kavanaugh A. Achieving comprehensive disease control in patients with early and established rheumatoid arthritis treated with adalimumab plus methotrexate versus methotrexate alone. RMD Open. 2017 Sep 26;3(2):e000445. doi: 10.1136/rmdopen-2017-000445. eCollection 2017.

Reference Type DERIVED
PMID: 29018564 (View on PubMed)

Moller B, Everts-Graber J, Florentinus S, Li Y, Kupper H, Finckh A. Low Hemoglobin and Radiographic Damage Progression in Early Rheumatoid Arthritis: Secondary Analysis From a Phase III Trial. Arthritis Care Res (Hoboken). 2018 Jun;70(6):861-868. doi: 10.1002/acr.23427. Epub 2018 Apr 25.

Reference Type DERIVED
PMID: 28950430 (View on PubMed)

Burmester GR, Landewe R, Genovese MC, Friedman AW, Pfeifer ND, Varothai NA, Lacerda AP. Adalimumab long-term safety: infections, vaccination response and pregnancy outcomes in patients with rheumatoid arthritis. Ann Rheum Dis. 2017 Feb;76(2):414-417. doi: 10.1136/annrheumdis-2016-209322. Epub 2016 Jun 23.

Reference Type DERIVED
PMID: 27338778 (View on PubMed)

Landewe R, Smolen JS, Florentinus S, Chen S, Guerette B, van der Heijde D. Existing joint erosions increase the risk of joint space narrowing independently of clinical synovitis in patients with early rheumatoid arthritis. Arthritis Res Ther. 2015 May 21;17(1):133. doi: 10.1186/s13075-015-0626-1.

Reference Type DERIVED
PMID: 25994819 (View on PubMed)

Landewe R, Ostergaard M, Keystone EC, Florentinus S, Liu S, van der Heijde D. Analysis of integrated radiographic data from two long-term, open-label extension studies of adalimumab for the treatment of rheumatoid arthritis. Arthritis Care Res (Hoboken). 2015 Feb;67(2):180-6. doi: 10.1002/acr.22426.

Reference Type DERIVED
PMID: 25073879 (View on PubMed)

Keystone EC, Haraoui B, Guerette B, Mozaffarian N, Liu S, Kavanaugh A. Clinical, functional, and radiographic implications of time to treatment response in patients with early rheumatoid arthritis: a posthoc analysis of the PREMIER study. J Rheumatol. 2014 Feb;41(2):235-43. doi: 10.3899/jrheum.121468. Epub 2013 Dec 1.

Reference Type DERIVED
PMID: 24293583 (View on PubMed)

Keystone EC, Breedveld FC, van der Heijde D, Landewe R, Florentinus S, Arulmani U, Liu S, Kupper H, Kavanaugh A. Longterm effect of delaying combination therapy with tumor necrosis factor inhibitor in patients with aggressive early rheumatoid arthritis: 10-year efficacy and safety of adalimumab from the randomized controlled PREMIER trial with open-label extension. J Rheumatol. 2014 Jan;41(1):5-14. doi: 10.3899/jrheum.130543. Epub 2013 Nov 15.

Reference Type DERIVED
PMID: 24241487 (View on PubMed)

Smolen JS, van der Heijde DM, Keystone EC, van Vollenhoven RF, Goldring MB, Guerette B, Cifaldi MA, Chen N, Liu S, Landewe RB. Association of joint space narrowing with impairment of physical function and work ability in patients with early rheumatoid arthritis: protection beyond disease control by adalimumab plus methotrexate. Ann Rheum Dis. 2013 Jul;72(7):1156-62. doi: 10.1136/annrheumdis-2012-201620. Epub 2012 Aug 22.

Reference Type DERIVED
PMID: 22915617 (View on PubMed)

Strand V, Rentz AM, Cifaldi MA, Chen N, Roy S, Revicki D. Health-related quality of life outcomes of adalimumab for patients with early rheumatoid arthritis: results from a randomized multicenter study. J Rheumatol. 2012 Jan;39(1):63-72. doi: 10.3899/jrheum.101161. Epub 2011 Nov 1.

Reference Type DERIVED
PMID: 22045836 (View on PubMed)

Related Links

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http://rxabbvie.com

Related Info

Other Identifiers

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DE013

Identifier Type: -

Identifier Source: org_study_id

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