Study of Adalimumab Administered as Subcutaneous Injections in Adult Chinese Rheumatoid Arthritis Subjects Treated With Methotrexate

Phase 3

Completed

• Conditions: Rheumatoid Arthritis
• Interventions: Biological: adalimumab; Biological: placebo

• Registration Number: NCT00647920
• Lead Sponsor: Abbott

Brief Summary

A Randomized, Double-Blind, Placebo-Controlled, Study of the Adalimumab Administered as Subcutaneous Injections in Adult Chinese Rheumatoid Arthritis Subjects Treated with Methotrexate

Detailed Description

Not available

Study Timeline

• Study Start: 2003-07
• Primary Completion: 2005-04
• Status Verified: 2008-03
• Study First Submitted: 2008-03-28
• Study First Submitted QC: 2008-03-28
• Last Update Submitted: 2008-03-28
• Study First Posted: 2008-04-01
• Last Update Posted: 2008-04-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 47

Inclusion Criteria

• Meet ACR criteria for diagnosis of active RA and have at both screening and baseline visits 6 swollen joints and 9 tender joints.

Exclusion Criteria

• A history of, or current, acute inflammatory joint disease of different origin than RA (e.g., mixed connective tissue disease, seronegative spondyloarthropathy, psoriatic arthritis, Reiter's syndrome, systemic lupus erythematosus or any arthritide with onset prior to age 16 years).

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
40 mg	adalimumab	-
Placebo	placebo	-

Primary Outcome Measures

Name	Time	Method
ACR20	Week 12

Secondary Outcome Measures

Name	Time	Method
ACR50	Week 12
ACR70	Week 12