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

Rheumatoid Arthritis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00234845
• Other study ID #: M02-527
• Status: Completed
• Phase: Phase 3
• First received: September 13, 2005
• Last updated: August 28, 2007
• Start date: March 2003

Study information

• Verified date: August 2007
• Source: Abbott
• Contact: n/a
• Is FDA regulated: No
• Health authority: United Kingdom: Medicines and Healthcare Products Regulatory Agency
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 148
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Arthritis
• Arthritis, Rheumatoid
• Rheumatoid Arthritis

Intervention

Drug:
• adalimumab

• methotrexate

Locations

Country	Name	City	State
United States	Global Medical Information - Abbott	Abbott Park	Illinois

Sponsors (1)

Lead Sponsor	Collaborator
Abbott

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Job loss measurement
Secondary	Job productivity measurements
Secondary	Patient reported outcomes
Secondary	DAS28
Secondary	Safety parameters