An Exploratory Study of Changes in Synovial Immune Responses Following BMS-188667 Therapy in Subjects With Active Rheumatoid Arthritis on Background DMARDs Who Have Failed Anti-TNF Therapy

Bristol-Myers Squibb (BMS)

Status and phase: Completed; Phase 1

Conditions: Rheumatoid Arthritis

Treatments: Drug: Abatacept

Study type: Interventional

Funder types: Industry

Identifiers

NCT00162201

IM101-015

Details and patient eligibility

About

Study to assess changes in synovial tissue before and after treatment with Abatacept in subjects with RA who remained on their background disease modifying anti-arthritis medications but who have failed previous therapy with anti-TNF (tumor necrosing factor)blocking agents.

Enrollment: 16 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• RA for at least 1 year
• Clear clinical signs of active RA in 1 knee joint
• Meet ARA (1987) criteria for diagnosis of RA and ACR (1991) criteria for RA functional classes I, II, or III
• Inadequate clinical response to a minimum of 3 months of therapy with anti-TNF-blocking agents
• Taking background DMARDs for a minimum of 3 months and at stable doses for at least 28 days

Exclusion criteria

• Serious bacterial infection in last 3 months
• History of TB
• History of cancer within 5 years
• Evidence of latent or active bacterial or viral infection
• Intra-articular corticosteroids within 3 months
• Exposure to live vaccines
• Exposure to CTLA4Ig or BMS-188667
• Treatment with immunoadsorption column(s), mycophenolate mofetil, leflunomide, anakinra, cyclosporine, etanercept, adalimumab, infliximab, azathioprine, oral or parenteral gold, D-penacillamine, calcineurin inhibitors, cyclophosphamide or other alkylating agents

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

---

16 participants in 1 patient group

1

Experimental group

Treatment:

Drug: Abatacept