Clinical Pharmacology Study of MRA in Patient With Rheumatoid Arthritis (RA) With Renal Impairment

Not Applicable

Completed

• Conditions: Rheumatoid Arthritis

• Registration Number: NCT00144573
• Lead Sponsor: Chugai Pharmaceutical

Brief Summary

This is an open-label, clinical pharmacology study to evaluate the safety and PK of MRA in patients with RA with Renal Impairment.

Detailed Description

Not available

Study Timeline

• Study Start: 2005-01
• Study First Submitted: 2005-09-02
• Study First Submitted QC: 2005-09-02
• Study First Posted: 2005-09-05
• Primary Completion: 2005-10
• Study Completion: 2005-10
• Status Verified: 2008-12
• Last Update Submitted: 2008-12-11
• Last Update Posted: 2008-12-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 14

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
20% improvement based on the ACR criteria compared with the baseline value.	throughout study

Secondary Outcome Measures

Name	Time	Method
Time courses taken from baseline values for DAS28, for ACR20%, 50%, and 70% improvement, and for each ACR core set variable.	Week 0, Week 4