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

• Status: Completed
• Trial end date: 1969-12-31
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Abbott
• Treatments: Adalimumab; Methotrexate

Criteria

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