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
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ClinicalTrials.gov Identifier: NCT00162201 |
Recruitment Status :
Completed
First Posted : September 13, 2005
Last Update Posted : January 12, 2017
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Rheumatoid Arthritis | Drug: Abatacept | Phase 1 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 16 participants |
Allocation: | Non-Randomized |
Intervention Model: | Single Group Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | 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 Start Date : | October 2003 |
Actual Primary Completion Date : | April 2005 |
Actual Study Completion Date : | April 2005 |

Arm | Intervention/treatment |
---|---|
Experimental: 1 |
Drug: Abatacept
Parenteral, IV, 500 mg if < 60 kg; 750 mg if > 60 & < 100 kg; 1000 mg if > 100 kg, Monthly, 4 months.
Other Name: Orencia |
- Comparison of each subject's synovial tissue markers [ Time Frame: at baseline and after 4 months of treatment with abatacept ]
- assess baseline & post treatment synovitis by dynamic gadolinium enhanced MRI; determine concentrations of abatacept in synovial fluid & serum [ Time Frame: after 4 months of treatment ]
- assess safety & tolerability of abatacept [ Time Frame: administered for 4 months ]

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Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00162201
United Kingdom | |
Local Institution | |
Leeds, Essex, United Kingdom |
Study Director: | Bristol Myers Squibb | Bristol-Myers Squibb |
Publications:
ClinicalTrials.gov Identifier: | NCT00162201 |
Other Study ID Numbers: |
IM101-015 |
First Posted: | September 13, 2005 Key Record Dates |
Last Update Posted: | January 12, 2017 |
Last Verified: | April 2011 |
Arthritis Arthritis, Rheumatoid Joint Diseases Musculoskeletal Diseases Rheumatic Diseases Connective Tissue Diseases Autoimmune Diseases Immune System Diseases |
Abatacept Immune Checkpoint Inhibitors Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Immunosuppressive Agents Immunologic Factors Physiological Effects of Drugs Antirheumatic Agents |