FindTrial
Sign In

A Phase IIIB Multi-Center, Randomized, Double-Blind Study to Evaluate Remission and Joint Damage Progression in Methotrexate Naive Early Erosive RA Subjects Treated With Abatacept Plus Methotrexate Compared With Methotrexate

A Phase IIIB Multi-Center, Randomized, Double-Blind Study to Evaluate Remission and Joint Damage Progression in Methotrexate Naive Early Erosive RA Subjects Treated With Abatacept Plus Methotrexate Compared With Methotrexate

Status
Recruiting
Phases
Phase 3
Study type
Interventional
Source
ANZCTR
Registry ID
ACTRN12605000784617
Acronym
IM101-023
Enrollment
500
Registered
2005-12-09
Start date
2006-01-01
Completion date
Unknown
Last updated
2020-01-13

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

Conditions

None listed

Interventions

Drug: Abatacept plus methotrexate for the first 12 months. Month 12 to 24, subjects previously treated with Abatacept plus methotrexate remain on this same treatment. Study Design: Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Efficacy Study

Sponsors

Bristol-Myers Squibb Australia
Lead SponsorCommercial sector/Industry

Study design

Allocation
Randomised controlled trial
Intervention model
Other
Primary purpose
Treatment
Masking
Blinded (masking used)

Eligibility

Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

Diagnosis of rheumatoid arthritis (RA) <2 years; never received treatment with methotrexate; erosions noted on x-ray. CRP >= 8.0 mg/L Rheumatoid factor or anti CCP positive.

Exclusion criteria

Women and men who are not willing to use birth control Diagnosed with other rheumatic disease History of cancer within 5 years Active tuberculosis Treatment with another investigation drug within 28 days Active bacterial or viral infection.

Outcome results

None listed

Source: ANZCTR · Data processed: Feb 4, 2026