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

Phase 3

Completed

• Conditions: Rheumatoid Arthritis

• Registration Number: NCT00234845
• Lead Sponsor: Abbott

Brief 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

Detailed Description

Not available

Study Timeline

• Study Start: 2003-03
• Study First Submitted: 2005-09-13
• Study First Submitted QC: 2005-10-07
• Study First Posted: 2005-10-10
• Status Verified: 2007-08
• Last Update Submitted: 2007-08-28
• Last Update Posted: 2007-08-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 148

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Job loss measurement

Secondary Outcome Measures

Name	Time	Method
Job productivity measurements
DAS28
Patient reported outcomes
Safety parameters

Trial Locations

Locations (1)

Global Medical Information - Abbott; 🇺🇸 Abbott Park, Illinois, United States