Efficacy and Safety of Adalimumab in Patients With Active Rheumatoid Arthritis Treated Concomitantly With Methotrexate.

Completed · Phase 3 · Has a placebo group

Conditions studied: Rheumatoid Arthritis

In brief

The purpose of the study was to assess the safety, immunogenicity, and clinical efficacy of adalimumab compared with placebo (during double-blind phase) and to to evaluate the long-term safety and maintenance of efficacy following repeated administration of adalimumab (during open-label extension phase) in patients with persistently active rheumatoid arthritis who were receiving concurrent methotrexate therapy.

Key facts

Study ID

NCT00195702

Run by

Abbott

People needed

619

Starts

2000-02-01

Expected to finish

2010-08-01

Last updated by the study team

2011-08-26

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Age 18 or older and in good health (Investigator discretion) with a recent stable medical history
• 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.

You may not qualify if…

• Subject considered by the investigator, for any reason, to be an unsuitable candidate for the study.
• 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.

Where it is running

• 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 424 — Huntsville, Alabama, United States

Full record on ClinicalTrials.gov

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