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

Completed · Phase 3 · Has a placebo group

Conditions studied: Early Rheumatoid Arthritis

In brief

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.

Key facts

Study ID

NCT00195663

Run by

AbbVie (prior sponsor, Abbott)

People needed

799

Starts

2000-12-01

Expected to finish

2012-04-01

Last updated by the study team

2013-07-12

Who can join

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

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Site Ref # / Investigator 95957 — La Jolla, California, United States
• Site Reference ID/Investigator# 429 — La Jolla, California, United States
• Site Reference ID/Investigator# 2491 — Los Angeles, California, United States
• Site Reference ID/Investigator# 2500 — Denver, Colorado, United States
• Site Reference ID/Investigator# 762 — Aventura, Florida, United States
• Site Reference ID/Investigator# 328 — Sarasota, Florida, United States
• Site Reference ID/Investigator# 327 — Tampa, Florida, United States
• Site Reference ID/Investigator# 325 — Zephyrhills, Florida, United States
• Site Reference ID/Investigator# 302 — Rockford, Illinois, United States
• Site Reference ID/Investigator# 319 — Cumberland, Maryland, United States
• Site Ref # / Investigator 95960 — Hagerstown, Maryland, United States
• Site Reference ID/Investigator# 326 — Wheaton, Maryland, United States
• Site Reference ID/Investigator# 2533 — Worcester, Massachusetts, United States
• Site Reference ID/Investigator# 336 — Lincoln, Nebraska, United States
• Site Reference ID/Investigator# 318 — Concord, New Hampshire, United States
• Site Reference ID/Investigator# 488 — Durham, North Carolina, United States
• Site Reference ID/Investigator# 314 — Dayton, Ohio, United States
• Site Reference ID/Investigator# 761 — Oklahoma City, Oklahoma, United States
• Site Reference ID/Investigator# 757 — Eugene, Oregon, United States
• Site Reference ID/Investigator# 361 — Lake Oswego, Oregon, United States
• Site Reference ID/Investigator# 316 — Bethlehem, Pennsylvania, United States
• Site Reference ID/Investigator# 4649 — Duncansville, Pennsylvania, United States
• Site Ref # / Investigator 96122 — Austin, Texas, United States
• Site Reference ID/Investigator# 306 — Austin, Texas, United States
• Site Reference ID/Investigator# 322 — Scottsdale, Arizona, United States

Full record on ClinicalTrials.gov

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