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

Completed · Phase 3

Conditions studied: Rheumatoid Arthritis

In brief

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

Key facts

Study ID

NCT00234845

Run by

Abbott

People needed

148

Starts

2003-03-01

Last updated by the study team

2007-08-29

Who can join

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

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Global Medical Information - Abbott — Abbott Park, Illinois, United States

Full record on ClinicalTrials.gov

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