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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: 25 January 2016
Main ID:  NCT02652273
Date of registration: 08/01/2016
Prospective Registration: Yes
Primary sponsor: NHS Greater Glasgow and Clyde
Public title: Inhibition of Co-Stimulation in Rheumatoid Arthritis ICoSRA
Scientific title: Inhibition of Co-Stimulation in Rheumatoid Arthritis
Date of first enrolment: January 2016
Target sample size: 25
Recruitment status: Not yet recruiting
URL:  https://clinicaltrials.gov/show/NCT02652273
Study type:  Interventional
Study design:  Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment  
Phase:  Phase 4
Countries of recruitment
United Kingdom
Contacts
Name:     Iain McInnes, Prof
Address: 
Telephone: +44 (0)141 330 8412
Email: iain.mcinnes@glasgow.ac.uk
Affiliation: 
Name:     Iain McInnes, Prof
Address: 
Telephone:
Email:
Affiliation:  University of Glasgow
Key inclusion & exclusion 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



Age minimum: 18 Years
Age maximum: N/A
Gender: Both
Health Condition(s) or Problem(s) studied
Arthritis, Rheumatoid
Intervention(s)
Drug: Abatacept
Primary Outcome(s)
Immunological response [Time Frame: Baseline and 12 weeks]
Secondary Outcome(s)
Biomarkers [Time Frame: 24 weeks]
Clinical response American College of Rheumatology (ACR) 20 [Time Frame: Baseline and 24 weeks]
Clinical response Disease Activity Score (DAS)28 [Time Frame: Baseline and 24 weeks]
DC (CD11c+) phenotype [Time Frame: 24 weeks]
Immunological response [Time Frame: Baseline, 4, 12 and 24 weeks]
T cell profile [Time Frame: Baseline, 12 and 24 weeks]
T cell response [Time Frame: 24 weeks]
Secondary ID(s)
2014-004419-35
GN13RH410
Source(s) of Monetary Support
Please refer to primary and secondary sponsors
Secondary Sponsor(s)
University of Glasgow
Ethics review
Results
Results available:
Date Posted:
Date Completed:
URL:
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