A Study of Abatacept in Japanese Patients With Active Rheumatoid Arthritis While Receiving Methotrexate

Phase 2

Completed

• Conditions: Rheumatoid Arthritis
• Interventions: Drug: Abatacept; Drug: Placebo

• Registration Number: NCT00345748
• Lead Sponsor: Bristol-Myers Squibb

Brief Summary

The purpose of this study is to demonstrate that Abatacept combined with Methotrexate will demonstrate a dose response efficacy in Japanese subjects with active Rheumatoid Arthritis similar to the dose response efficacy previously observed in the International clinical trials.

Detailed Description

Not available

Study Timeline

• Study Start: 2006-06
• Study First Submitted: 2006-06-23
• Study First Submitted QC: 2006-06-27
• Study First Posted: 2006-06-28
• Primary Completion: 2007-11
• Study Completion: 2007-11
• Status Verified: 2011-04
• Disposition First Submitted: 2011-04-11
• Disposition First Submitted QC: 2011-04-11
• Last Update Submitted: 2011-04-11
• Disposition First Posted: 2011-04-25
• Last Update Posted: 2011-04-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 194

Inclusion Criteria

• patients with active Rheumatoid Arthritis while on methotrexate having 12 tender and 10 swollen joints at randomization

Exclusion Criteria

• no current infection or other evolutive or uncontrolled disease

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Abatacept 2 mg/kg	Abatacept	-
Abatacept 10 mg/kg	Abatacept	-
Placebo	Placebo	-

Primary Outcome Measures

Name	Time	Method
Efficacy will be evaluated using the American College of Rheumatology response rate or ACR 20. This means the respective proportion of patients reaching an improvement of at least 20% of the ACR composite index from baseline.	at 6 months

Secondary Outcome Measures

Name	Time	Method
ACR 50 and ACR 70 will be assessed as respectively 50 and 70% improvement of the ACR composite index, quality of life by using SF36 questionnaire, Population Pharmacokinetics, Biomarkers, Immunogenicity	at 6 months
Safety (Severity of adverse events, causal relationship to the study drug, outcome, action taken with respect to the investigational product, treatment required)	at 6 months

Trial Locations

Locations (1)

Local Institution; 🇯🇵 Tochigi, Japan