Inhibition of Co-Stimulation in Rheumatoid Arthritis

• Status: Unknown status
• Trial end date: 2019-01-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to use abatacept as a clinical molecular probe to evaluate the effects of inhibiting costimulation on immune responses in patients with rheumatoid arthritis (RA).

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: NHS Greater Glasgow and Clyde
• Collaborator: University of Glasgow
• Treatments: Abatacept

Criteria

Inclusion Criteria:

• RA as defined by the 2010 European League Against Rheumatism/American College of Rheumatology (EULAR/ACR) classification criteria

• Eligible for abatacept therapy according to local/national guidelines

• Active RA defined by DAS28 score required by local guidelines for eligibility for abatacept

• Have previously failed (efficacy or tolerance) at least one disease-modifying antirheumatic drug (DMARD)

• Have no contraindications to treatment with abatacept

• Be able to tolerate methotrexate at dose of 10-25mg/week, either orally or subcutaneously

• Anti-cyclic citrullinated peptide (CCP) positive

• Human leukocyte antigen D related (HLA-DR) B1*0401 or 0404) positive

• Able and willing to give written informed consent and comply with the requirements of the study protocol

Exclusion Criteria:

• History of or current autoimmune rheumatic disease other than RA

• Concomitant use of any biologic agent, including tumor necrosis factor (TNF) inhibitors

• Previous abatacept treatment

• Patients requiring >10mg prednisolone daily or intramuscular (IM) corticosteroids

• Active infection

• Known HIV or hepatitis B/C infection

• Latent tuberculosis (TB) infection

• Malignancy (other than non-melanoma skin cell cancers) within 5 years

• Women who are pregnant, women of childbearing potential who are unwilling to use appropriate contraception or breast-feeding

• Inability to give informed consent