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

Completed

• Conditions: Rheumatoid Arthritis
• Interventions: Drug: Abatacept

• Registration Number: NCT00162201
• Lead Sponsor: Bristol-Myers Squibb

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2003-10
• Primary Completion: 2005-04
• Study Completion: 2005-04
• Study First Submitted: 2005-09-09
• Study First Submitted QC: 2005-09-09
• Study First Posted: 2005-09-13
• Status Verified: 2011-04
• Last Update Submitted: 2017-01-11
• Last Update Posted: 2017-01-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 16

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
1	Abatacept	-

Primary Outcome Measures

Name	Time	Method
Comparison of each subject's synovial tissue markers	at baseline and after 4 months of treatment with abatacept

Secondary Outcome Measures

Name	Time	Method
assess baseline & post treatment synovitis by dynamic gadolinium enhanced MRI; determine concentrations of abatacept in synovial fluid & serum	after 4 months of treatment
assess safety & tolerability of abatacept	administered for 4 months

Trial Locations

Locations (1)

Local Institution; 🇬🇧 Leeds, Essex, United Kingdom