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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register.
Register: ClinicalTrials.gov
Last refreshed on: 16 December 2017
Main ID:  NCT00162201
Date of registration: 09/09/2005
Prospective Registration: No
Primary sponsor: Bristol-Myers Squibb
Public 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
Scientific 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
Date of first enrolment: October 2003
Target sample size: 16
Recruitment status: Completed
URL:  https://clinicaltrials.gov/show/NCT00162201
Study type:  Interventional
Study design:  Allocation: Non-Randomized. Intervention model: Single Group Assignment. Primary purpose: Treatment. Masking: None (Open Label).  
Phase:  Phase 1
Countries of recruitment
United Kingdom
Contacts
Name:     Bristol Myers Squibb
Address: 
Telephone:
Email:
Affiliation:  Bristol-Myers Squibb
Key inclusion & exclusion criteria

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



Age minimum: 18 Years
Age maximum: N/A
Gender: All
Health Condition(s) or Problem(s) studied
Rheumatoid Arthritis
Intervention(s)
Drug: Abatacept
Primary Outcome(s)
Comparison of each subject's synovial tissue markers [Time Frame: at baseline and after 4 months of treatment with abatacept]
Secondary Outcome(s)
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]
Secondary ID(s)
IM101-015
Source(s) of Monetary Support
Please refer to primary and secondary sponsors
Secondary Sponsor(s)
Ethics review
Results
Results available:
Date Posted:
Date Completed:
URL:
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