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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


Phase 1
18 Years
N/A
Not Enrolling
Both
Rheumatoid Arthritis

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Trial Information

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


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

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Endpoint Classification: Pharmacodynamics Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Comparison of each subject's synovial tissue markers

Outcome Time Frame:

at baseline and after 4 months of treatment with abatacept

Principal Investigator

Bristol Myers Squibb

Investigator Role:

Study Director

Investigator Affiliation:

Bristol-Myers Squibb

Authority:

United Kingdom: Medicines and Healthcare Products Regulatory Agency

Study ID:

IM101-015

NCT ID:

NCT00162201

Start Date:

December 2003

Completion Date:

April 2005

Related Keywords:

  • Rheumatoid Arthritis
  • Arthritis
  • Arthritis, Rheumatoid

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