ClinicalTrials.Veeva

Menu

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

Bristol-Myers Squibb (BMS) logo

Bristol-Myers Squibb (BMS)

Status and phase

Completed
Phase 3

Conditions

Rheumatoid Arthritis

Treatments

Drug: Abatacept
Drug: Methotrexate
Drug: Placebo

Study type

Interventional

Funder types

Industry

Identifiers

NCT00409838
IM101-124

Details and patient eligibility

About

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

Enrollment

113 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion criteria

Key Inclusion Criteria:

  • Rheumatoid arthritis (RA) for longer than 1 year from the time of the initial diagnosis of RA
  • Patients must have been taking methotrexate for at least 3 months with at least a weekly dose of 15 mg, and a stable dose for 28 days prior to treatment (Day 1)
  • Methotrexate weekly dose as low as 10 mg is permitted for patients who cannot tolerate higher doses

Key Exclusion Criteria:

  • Evidence (as assessed by the Investigator) of active or latent bacterial or viral infections at the time of potential enrollment

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Double Blind

113 participants in 3 patient groups, including a placebo group

Abatacept and Methotrexate
Experimental group
Treatment:
Drug: Abatacept
Drug: Methotrexate
Drug: Methotrexate
Drug: Abatacept
Placebo and Methotrexate
Placebo Comparator group
Description:
(standard of care)
Treatment:
Drug: Placebo
Drug: Methotrexate
Drug: Methotrexate
Abatacept - Open Label
Experimental group
Description:
Open-label extension phase
Treatment:
Drug: Abatacept
Drug: Methotrexate
Drug: Methotrexate
Drug: Abatacept

Trial contacts and locations

7

Loading...

Data sourced from clinicaltrials.gov

Clinical trials

Find clinical trialsTrials by location
© Copyright 2025 Veeva Systems