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

Rheumatoid Arthritis Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00162201
• Other study ID #: IM101-015
• Status: Completed
• Phase: Phase 1
• First received: September 9, 2005
• Last updated: January 11, 2017
• Start date: October 2003
• Est. completion date: April 2005

Study information

• Verified date: April 2011
• Source: Bristol-Myers Squibb
• Contact: n/a
• Is FDA regulated: No
• Health authority: United Kingdom: Medicines and Healthcare Products Regulatory Agency
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 16
• Est. completion date: April 2005
• Est. primary completion date: April 2005
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Allocation: Non-Randomized, Endpoint Classification: Pharmacodynamics Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Arthritis
• Arthritis, Rheumatoid
• Rheumatoid Arthritis

Intervention

Drug:
• Abatacept
Parenteral, IV, 500 mg if < 60 kg; 750 mg if > 60 & < 100 kg; 1000 mg if > 100 kg, Monthly, 4 months.

Locations

Country	Name	City	State
United Kingdom	Local Institution	Leeds	Essex

Sponsors (1)

Lead Sponsor	Collaborator
Bristol-Myers Squibb

Country where clinical trial is conducted

United Kingdom, 

References & Publications (1)

Buch MH, Boyle DL, Rosengren S, Saleem B, Reece RJ, Rhodes LA, Radjenovic A, English A, Tang H, Vratsanos G, O'Connor P, Firestein GS, Emery P. Mode of action of abatacept in rheumatoid arthritis patients having failed tumour necrosis factor blockade: a histological, gene expression and dynamic magnetic resonance imaging pilot study. Ann Rheum Dis. 2009 Jul;68(7):1220-7. doi: 10.1136/ard.2008.091876. Erratum in: Ann Rheum Dis. 2011 Aug;70(8):1519. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Comparison of each subject's synovial tissue markers		at baseline and after 4 months of treatment with abatacept
Secondary	assess baseline & post treatment synovitis by dynamic gadolinium enhanced MRI; determine concentrations of abatacept in synovial fluid & serum		after 4 months of treatment
Secondary	assess safety & tolerability of abatacept		administered for 4 months

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