A Study of Adalimumab in Adult Japanese Subjects With Rheumatoid Arthritis

Phase 2

Completed

• Conditions: Rheumatoid Arthritis

• Registration Number: NCT00647491
• Lead Sponsor: Abbott

Brief Summary

The primary objective of this study is to evaluate the safety, efficacy and pharmacokinetics of three doses of adalimumab in adult Japanese subjects with RA

Detailed Description

Not available

Study Timeline

• Study Start: 2004-02
• Primary Completion: 2005-06
• Study Completion: 2005-08
• Status Verified: 2008-03
• Study First Submitted: 2008-03-27
• Study First Submitted QC: 2008-03-27
• Last Update Submitted: 2008-03-27
• Study First Posted: 2008-03-31
• Last Update Posted: 2008-03-31

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 352

Inclusion Criteria

• Meet ACR criteria for diagnosis of active RA and have at both screening and baseline visits >10 swollen joints, >12 tender joints.
• Subjects must have failed prior treatment with one or more DMARDs.
• A negative (serum) pregnancy test for all female subjects of child-bearing potential at screening and a negative (urine) pregnancy test prior to study drug administration.
• Body weight less than or equal to 100 kg

Exclusion Criteria

• A history of, or current, acute inflammatory joint disease of different origin from RA.
• Prior treatment with any TNF antagonist, including adalimumab.
• Any ongoing chronic or active infection or any major episode of infection requiring hospitalization or treatment with IV antibiotics.
• Unstable ischemic heart disease, active inflammatory bowel disease, active peptic ulcer disease, recent stroke or any poorly controlled medical condition.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
ACR20	Week 24

Secondary Outcome Measures

Name	Time	Method
ACR20	Week12
ACR50	Weeks 12 and 24
ACR70	Weeks 12 and 24