Study of the Optimal Protocol for Methotrexate and Adalimumab Combination Therapy in Early Rheumatoid Arthritis

Completed · Phase 4 · Has a placebo group

Conditions studied: Rheumatoid Arthritis

In brief

This study compared the safety and efficacy of combination therapy with adalimumab plus methotrexate (MTX) to that of MTX monotherapy (i.e., placebo plus MTX) in subjects with early rheumatoid arthritis (RA).

Key facts

Study ID

NCT00420927

Run by

Abbott

People needed

1032

Starts

2006-12-01

Expected to finish

2010-07-01

Last updated by the study team

2012-04-18

Who can join

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

You may qualify if…

• Subject must be 18 or older and in good health
• Subject must meet the definition of early rheumatoid arthritis (RA) defined by the 1987-revised American College of Rheumatology (ACR) classification criteria and had disease duration of less than 1 year from diagnosis
• Subject must have a Disease Activity Score (DAS28, based on C-reactive protein) greater than 3.2, at least 6 swollen joints out of the 66 assessed, and at least 8 tender joints out of the 68 assessed
• Subject must fulfill at least one of the following three criteria:
• Rheumatoid factor positive
• Greater than 1 joint erosion
• Anti-cyclic citrullinated peptide (CCP) antibody positive.

You may not qualify if…

• Subject has previously received systemic anti-tumor necrosis factor (TNF) therapy
• Subject has received any biologic or investigational therapy within 6 weeks prior to Baseline
• Subject has been previously treated with more than 2 disease-modifying antirheumatic drugs (DMARDs) or MTX, had been treated with intra-articular or parenteral administration of corticosteroids in preceding 4 weeks, or had undergone joint surgery within the preceding 2 months at joints to be assessed during the study.

Where it is running

• Site Reference ID/Investigator# 4547 — Birmingham, Alabama, United States
• Site Reference ID/Investigator# 6222 — Huntsville, Alabama, United States
• Site Reference ID/Investigator# 4537 — Mobile, Alabama, United States
• Site Reference ID/Investigator# 6758 — Tuscaloosa, Alabama, United States
• Site Reference ID/Investigator# 9323 — Hemet, California, United States
• Site Reference ID/Investigator# 4568 — La Jolla, California, United States
• Site Reference ID/Investigator# 4535 — Palm Desert, California, United States
• Site Reference ID/Investigator# 4571 — Santa Monica, California, United States
• Site Reference ID/Investigator# 9271 — Torrance, California, United States
• Site Reference ID/Investigator# 10746 — Victorville, California, United States
• Site Reference ID/Investigator# 4559 — Denver, Colorado, United States
• Site Reference ID/Investigator# 6229 — Aventura, Florida, United States
• Site Reference ID/Investigator# 10603 — Lake Mary, Florida, United States
• Site Reference ID/Investigator# 9325 — Orange Park, Florida, United States
• Site Reference ID/Investigator# 4550 — Palm Harbor, Florida, United States
• Site Reference ID/Investigator# 4570 — Sarasota, Florida, United States
• Site Reference ID/Investigator# 4601 — Tampa, Florida, United States
• Site Reference ID/Investigator# 4552 — Vero Beach, Florida, United States
• Site Reference ID/Investigator# 10745 — Meridian, Idaho, United States
• Site Reference ID/Investigator# 4548 — Chicago, Illinois, United States
• Site Reference ID/Investigator# 4557 — Springfield, Illinois, United States
• Site Reference ID/Investigator# 4605 — Wichita, Kansas, United States
• Site Reference ID/Investigator# 10741 — Wheaton, Maryland, United States
• Site Reference ID/Investigator# 6417 — Fall River, Massachusetts, United States
• Site Reference ID/Investigator# 4560 — Birmingham, Alabama, United States

Full record on ClinicalTrials.gov

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