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A Phase III Study of Abatacept in Patients With Rheumatoid Arthritis and an Inadequate Response to Methotrexate

NCT00409838 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 113

Last updated 2013-08-08

Study results available
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Summary

The purpose of the study is to demonstrate the clinical efficacy of abatacept (body-weight tiered dose approximating 10 mg/kg) compared with placebo on a background of methotrexate after 6 months (Day 169) of treatment in Korean patients with active rheumatoid arthritis and an inadequate clinical response to methotrexate

Conditions

Interventions

DRUG

Abatacept

Intravenous (IV) solution, - weight tiered (500 mg \<60 kg); (750 mg 60-100 kg); (1 gram \> 100 kg), Day 1, Day 15, Day 29; every 28 days thereafter, 6 months

DRUG

Methotrexate

Tablets, Oral, ≥ 15 mg, weekly, 6 months

DRUG

Placebo

IV solution, Intravenous, D5W, Day 1, Day 15, Day 29; every 28 days thereafter, 6 months

DRUG

Abatacept

Solution, intravenous, 10 mg/kg, every 28 days

DRUG

Methotrexate

Tablets, oral, 15 mg weekly to be adjusted according to patient condition

Sponsors & Collaborators

Principal Investigators

  • Bristol-Myers Squibb · Bristol-Myers Squibb

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2007-04-30
Primary Completion
2008-07-31
Completion
2011-12-31

Countries

  • South Korea

Study Locations

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Entities

Drugs
Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00409838 on ClinicalTrials.gov