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

A Phase II, Multi-center, Randomized, Double-Blind, Placebo Controlled, Dose Response Study to Evaluate the Safety and Efficacy of Two Different Doses of Abatacept (BMS-188667) Administered Intravenously to Japanese Subjects With Active Rheumatoid Arthritis While Receiving Methotrexate

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00345748

Enrollment

194

Registered

2006-06-28

Start date

2006-06-30

Completion date

2007-11-30

Last updated

2011-04-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Rheumatoid Arthritis

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.

Interventions

DRUGAbatacept

Injection, IV Infusion, Day 1, 15, 29 and every 28 days for 24 weeks

DRUGPlacebo

Injectio, IV Infusion, Day 1, 15, 29 and every 28 days for 24 weeks

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender

ALL

Age

20 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
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

Measure	Time frame
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

Countries

Japan

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 20, 2026