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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

16 participants

Study Classification

INTERVENTIONAL

Study Start Date

2003-10-31

Study Completion Date

2005-04-30

Brief Summary

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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.

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Detailed Description

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Conditions

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Rheumatoid Arthritis

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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1

Group Type EXPERIMENTAL

Abatacept

Intervention Type DRUG

Parenteral, IV, 500 mg if \< 60 kg; 750 mg if \> 60 \& \< 100 kg; 1000 mg if \> 100 kg, Monthly, 4 months.

Interventions

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Abatacept

Parenteral, IV, 500 mg if \< 60 kg; 750 mg if \> 60 \& \< 100 kg; 1000 mg if \> 100 kg, Monthly, 4 months.

Intervention Type DRUG

Other Intervention Names

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Orencia

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No