Adalimumab in Combination With Methotrexate vs Methotrexate Alone in Early Rheumatoid Arthritis

A Multi-Centre Randomized, Double-Blind Study Comparing Adalimumab (D2E7) Plus Methotrexate With Placebo Plus Methotrexate on Work Disability in Subjects With Early Rheumatoid Arthritis

The purpose of the study is to evaluate the effectiveness of adalimumab in combination with methotrexate compared to methotrexate alone on work disability in subjects with early rheumatoid arthritis

Inclusion Criteria:

• Subject is age 18 or older and in good health (Investigator discretion) with a recent stable medical history
• Subject has a diagnosis of rheumatoid arthritis as defined by the 1987-revised ACR criteria
• Subject must be in paid employment
• Subject has self-reported work impairment since onset of symptoms

Exclusion Criteria:

• A subject has chronic arthritis diagnosed before age 16 years.
• Subject has been on preceding treatment with methotrexate Subject unable to withdraw from current DMARDs
• Subject has preceding treatment with any biological TNF antagonist
• 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