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

Abbott

Status and phase

Completed

Phase 3

Conditions

Rheumatoid Arthritis

Treatments

Drug: methotrexate

Drug: adalimumab

Study type

Interventional

Funder types

Industry

Identifiers

NCT00234845

M02-527

Details and patient eligibility

About

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

Enrollment

148 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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