Efficacy and Safety of Adalimumab in Patients With Active Rheumatoid Arthritis Treated Concomitantly With Methotrexate.
NCT ID: NCT00195702
Last Updated: 2011-08-26
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
619 participants
INTERVENTIONAL
2000-02-29
2010-08-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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DB adalimumab 20 mg ew
Subjects received 20 mg adalimumab subcutaneously (SC) once weekly (ew) and concomitant methotrexate (MTX) during the double-blind (DB) phase.
Adalimumab
Self-administered, subcutaneous injection of 20 mg adalimumab (1.6 mL/injection) once weekly (ew) for up to 52 weeks.
DB adalimumab 40 mg eow
Subjects received 40 mg adalimumab subcutaneously (SC) every other week (eow) and concomitant methotrexate (MTX) during the double-blind (DB) phase. Subjects received placebo injections SC and concomitant MTX on the alternate weeks during the DB phase.
Adalimumab
Self-administered, subcutaneous injection of 40 mg adalimumab (1.6 mL/injection) every other week (eow) for up to 52 weeks.
DB placebo ew
Subjects received placebo subcutaneously (SC) once weekly (ew) and concomitant methotrexate (MTX) during the double-blind (DB) phase.
Placebo
Self-administered, subcutaneous injection of placebo (1.6 mL/injection) once weekly (ew) for up to 52 weeks.
DB adalimumab 20 mg ew/OL adalimumab 40 mg eow
Subjects received adalimumab 20 mg subcutaneously (SC) once weekly (ew) during the double-blind (DB) phase, then adalimumab 40 mg SC every other week (eow) during the open-label (OL) extension phase, along with concomitant methotrexate (MTX).
Adalimumab
Self-administration, subcutaneous (SC) injection of adalimumab 20 mg (1.6 mL/injection) once weekly (ew) for 52 weeks, followed by self-administration, SC injection of adalimumab 40 mg (0.8 mL/injection) every other week (eow) for up to Week 520.
DB adalimumab 40 mg eow/OL adalimumab 40 mg eow
Subjects received adalimumab 40 mg subcutaneously (SC) every other week (eow) with placebo on alternate weeks during the double-blind (DB) phase, then adalimumab 40 mg SC eow during the open-label (OL) extension phase, along with concomitant methotrexate (MTX).
Adalimumab
Self-administration, subcutaneous (SC) injection of adalimumab 40 mg (1.6 mL/injection) every other week (eow) (with a placebo 1.6 mL/injection on alternate weeks) for 52 weeks, followed by self-administration, SC injection of adalimumab 40 mg (0.8 mL injection) eow for up to Week 520.
DB placebo ew/OL adalimumab 40 mg eow
Subjects received placebo subcutaneously (SC) once weekly (ew) during the double-blind phase, then adalimumab 40 mg SC every other week (eow) during the open-label (OL) extension phase, along with concomitant methotrexate (MTX).
Adalimumab
Self-administration, subcutaneous (SC) injection of placebo solution (1.6 mL/injection) once weekly (ew) for 52 weeks, followed by self-administration, SC injection of adalimumab 40 mg (0.8 mL/injection) every other week (eow) for up to Week 520.
Interventions
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Adalimumab
Self-administered, subcutaneous injection of 20 mg adalimumab (1.6 mL/injection) once weekly (ew) for up to 52 weeks.
Adalimumab
Self-administered, subcutaneous injection of 40 mg adalimumab (1.6 mL/injection) every other week (eow) for up to 52 weeks.
Placebo
Self-administered, subcutaneous injection of placebo (1.6 mL/injection) once weekly (ew) for up to 52 weeks.
Adalimumab
Self-administration, subcutaneous (SC) injection of adalimumab 20 mg (1.6 mL/injection) once weekly (ew) for 52 weeks, followed by self-administration, SC injection of adalimumab 40 mg (0.8 mL/injection) every other week (eow) for up to Week 520.
Adalimumab
Self-administration, subcutaneous (SC) injection of adalimumab 40 mg (1.6 mL/injection) every other week (eow) (with a placebo 1.6 mL/injection on alternate weeks) for 52 weeks, followed by self-administration, SC injection of adalimumab 40 mg (0.8 mL injection) eow for up to Week 520.
Adalimumab
Self-administration, subcutaneous (SC) injection of placebo solution (1.6 mL/injection) once weekly (ew) for 52 weeks, followed by self-administration, SC injection of adalimumab 40 mg (0.8 mL/injection) every other week (eow) for up to Week 520.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Met American College of Rheumatology (ACR) criteria for diagnosis of active rheumatoid arthritis (RA) and had at both screening and baseline visits \>=6 swollen joints and \>=9 tender joints, despite a minimum of 3-months treatment with methotrexate (MTX). (Distal interphalangeal joints \[DIPs\] were not to be included in joint count for inclusion. The screening and baseline visits could be 3 to 28 days apart for patients not previously receiving disease-modifying anti-rheumatic drugs \[DMARDs\] other than MTX or 4 to 6 weeks for patients requiring a DMARD washout period.)
* Insufficient efficacy with MTX 12.5 to 25 mg per week (10 mg per week if MTX intolerant).
* If patient on a second-line treatment (DMARD) other than MTX, he/she had to discontinue it for at least 28 days before the baseline visit (the washout period).
* Treatment with oral folic acid 1-3 mg/day or, if appropriate, up to 10 mg leucovorin per week.
* Both rheumatoid factor positivity and a C-reactive protein value \>=1 mg/dL, or at least one joint erosion on X-ray.
Exclusion Criteria
* Female subject who was pregnant or breast-feeding or considering becoming pregnant.
* Preceding treatment with any tumor necrosis factor (TNF) antagonist, including adalimumab.
* Prior exposure to alkylating agents, such as chlorambucil or cyclophosphamide.
* Intra-articular, intramuscular, or intravenous administration of corticosteroids within 4 weeks prior to the screening visit.
* Subject was wheelchair bound or bedridden.
18 Years
ALL
No
Sponsors
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Abbott
INDUSTRY
Responsible Party
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Principal Investigators
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Laura Redden, MD, PhD
Role: STUDY_DIRECTOR
Abbott
Locations
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Site Ref # / Investigator 424
Huntsville, Alabama, United States
Site Ref # / Investigator 2510
Mobile, Alabama, United States
Site Ref # / Investigator 60729
Phoenix, Arizona, United States
Site Ref # / Investigator 725
Scottsdale, Arizona, United States
Site Ref # / Investigator 60736
Anaheim, California, United States
Site Ref # / Investigator 360
Escondido, California, United States
Site Ref # / Investigator 714
La Jolla, California, United States
Site Ref # / Investigator 469
La Jolla, California, United States
Site Ref # / Investigator 419
Palm Desert, California, United States
Site Ref # / Investigator 492
San Jose, California, United States
Site Ref # / Investigator 60734
San Louis Obispo, California, United States
Site Ref # / Investigator 60739
Van Nuys, California, United States
Site Ref # / Investigator 712
Danbury, Connecticut, United States
Site Ref # / Investigator 710
Aventura, Florida, United States
Site Ref # / Investigator 498
Dunedin, Florida, United States
Site Ref # / Investigator 499
Orlando, Florida, United States
Site Ref # / Investigator 729
Tampa, Florida, United States
Site Ref # / Investigator 463
Zephyrhills, Florida, United States
Site Ref # / Investigator 2436
Boise, Idaho, United States
Site Ref # / Investigator 485
Idaho Falls, Idaho, United States
Site Ref # / Investigator 60732
Chicago, Illinois, United States
Site Ref # / Investigator 726
Springfield, Illinois, United States
Site Ref # / Investigator 2506
Indianapolis, Indiana, United States
Site Ref # / Investigator 732
South Bend, Indiana, United States
Site Ref # / Investigator 60730
Shawnee Mission, Kansas, United States
Site Ref # / Investigator 467
Wichita, Kansas, United States
Site Ref # / Investigator 494
Wichita, Kansas, United States
Site Ref # / Investigator 491
Lexington, Kentucky, United States
Site Ref # / Investigator 2508
Portland, Maine, United States
Site Ref # / Investigator 392
Baltimore, Maryland, United States
Site Ref # / Investigator 354
Cumberland, Maryland, United States
Site Ref # / Investigator 730
Wheaton, Maryland, United States
Site Ref # / Investigator 465
Burlington, Massachusetts, United States
Site Ref # / Investigator 2512
Worcester, Massachusetts, United States
Site Ref # / Investigator 471
Grand Rapids, Michigan, United States
Site Ref # / Investigator 473
Kalamazoo, Michigan, United States
Site Ref # / Investigator 731
Kansas City, Missouri, United States
Site Ref # / Investigator 502
St Louis, Missouri, United States
Site Ref # / Investigator 482
St Louis, Missouri, United States
Site Ref # / Investigator 371
St Louis, Missouri, United States
Site Ref # / Investigator 487
Omaha, Nebraska, United States
Site Ref # / Investigator 353
Concord, New Hampshire, United States
Site Ref # / Investigator 364
Dover, New Hampshire, United States
Site Ref # / Investigator 60726
Mercerville, New Jersey, United States
Site Ref # / Investigator 358
Voorhees Township, New Jersey, United States
Site Ref # / Investigator 483
Rochester, New York, United States
Site Ref # / Investigator 512
Durham, North Carolina, United States
Site Ref # / Investigator 340
Greensboro, North Carolina, United States
Site Ref # / Investigator 461
Raleigh, North Carolina, United States
Site Ref # / Investigator 500
Raleigh, North Carolina, United States
Site Ref # / Investigator 60731
Raleigh, North Carolina, United States
Site Ref # / Investigator 60737
Salisbury, North Carolina, United States
Site Ref # / Investigator 456
Mayfield Village, Ohio, United States
Site Ref # / Investigator 470
Oklahoma City, Oklahoma, United States
Site Ref # / Investigator 60723
Oklahoma City, Oklahoma, United States
Site Ref # / Investigator 422
Eugene, Oregon, United States
Site Ref # / Investigator 60735
Colmar, Pennsylvania, United States
Site Ref # / Investigator 2507
Duncansville, Pennsylvania, United States
Site Ref # / Investigator 717
East Norriton, Pennsylvania, United States
Site Ref # / Investigator 352
Mechanicsburg, Pennsylvania, United States
Site Ref # / Investigator 480
Wexford, Pennsylvania, United States
Site Ref # / Investigator 2511
Wyomissing, Pennsylvania, United States
Site Ref # / Investigator 60724
Wyomissing, Pennsylvania, United States
Site Ref # / Investigator 718
Charleston, South Carolina, United States
Site Ref # / Investigator 460
Memphis, Tennessee, United States
Site Ref # / Investigator 462
Nashville, Tennessee, United States
Site Ref # / Investigator 716
Austin, Texas, United States
Site Ref # / Investigator 60728
Galveston, Texas, United States
Site Ref # / Investigator 2509
Houston, Texas, United States
Site Ref # / Investigator 510
Houston, Texas, United States
Site Ref # / Investigator 60725
Falls Church, Virginia, United States
Site Ref # / Investigator 711
Richmond, Virginia, United States
Site Ref # / Investigator 509
Seattle, Washington, United States
Site Ref # / Investigator 356
Spokane, Washington, United States
Site Ref # / Investigator 464
Tacoma, Washington, United States
Site Ref # / Investigator 60738
Kenosha, Wisconsin, United States
Site Ref # / Investigator 475
Calgary, Alberta, Canada
Site Ref # / Investigator 495
Penticton, British Columbia, Canada
Site Ref # / Investigator 2496
Richmond, British Columbia, Canada
Site Ref # / Investigator 2495
Winnipeg, Manitoba, Canada
Site Ref # / Investigator 496
Halifax, Nova Scotia, Canada
Site Ref # / Investigator 444
Newmarket, Ontario, Canada
Site Ref # / Investigator 2497
Toronto, Ontario, Canada
Site Ref # / Investigator 478
Toronto, Ontario, Canada
Site Ref # / Investigator 421
Toronto, Ontario, Canada
Site Ref # / Investigator 363
Montreal, Quebec, Canada
Site Ref # / Investigator 60702
Saskatoon, Saskatchewan, Canada
Countries
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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.
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.
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.
Emery P, Kavanaugh A, Bao Y, Ganguli A, Mulani P. Comprehensive disease control (CDC): what does achieving CDC mean for patients with rheumatoid arthritis? Ann Rheum Dis. 2015 Dec;74(12):2165-74. doi: 10.1136/annrheumdis-2014-205302. Epub 2014 Aug 19.
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.
Keystone EC, van der Heijde D, Kavanaugh A, Kupper H, Liu S, Guerette B, Mozaffarian N. Clinical, functional, and radiographic benefits of longterm adalimumab plus methotrexate: final 10-year data in longstanding rheumatoid arthritis. J Rheumatol. 2013 Sep;40(9):1487-97. doi: 10.3899/jrheum.120964. Epub 2013 Jul 1.
Keystone EC, Kavanaugh A, Weinblatt ME, Patra K, Pangan AL. Clinical consequences of delayed addition of adalimumab to methotrexate therapy over 5 years in patients with rheumatoid arthritis. J Rheumatol. 2011 May;38(5):855-62. doi: 10.3899/jrheum.100752. Epub 2011 Feb 1.
Other Identifiers
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DE019
Identifier Type: -
Identifier Source: org_study_id
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