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

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00162201

Enrollment

Registered

2005-09-13

Start date

2003-10-31

Completion date

2005-04-30

Last updated

2017-01-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Rheumatoid Arthritis

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.

Interventions

DRUGAbatacept

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

Study design

Allocation

NON_RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

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

Secondary

Measure	Time frame
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

Countries

United Kingdom

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026