Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 1:24 AM
Ignite Modification Date:
2025-12-25 @ 1:24 AM
NCT ID:
NCT02547493
Eligibility Criteria:
Inclusion Criteria:
* RA according to American College of Rheumatology (ACR)/European League Against rheumatism (EULAR) 2010 criteria
* Disease Activity Score (DAS) 28 ≥ 3.2
* Initiation of a treatment by sub-cutaneous abatacept in combination with methotrexate (MTX), whatever treatment they were receiving before (apart from rituximab (RTX) in the last year)
* Patient has signed study consent form
Exclusion Criteria:
* age \< 18 or \> 85 year
* dementia
* patients subjects to legal protection measures
* Corticosteroids ≥ 10mg/d the day of inclusion
* Patient who had a pneumococcal vaccination in the previous 3 years
* Last pneumococcal vaccination \< 3 year
* rituximab in the last year
* History of anaphylactic response to a vaccination
* Contraindications to abatacept or methotrexate
* Pregnancy or pregnancy wish
* Breast feeding
* Patient who currently abuse drugs or alcohol
* Subject who have received any live vaccines within 3 months of the anticipated first dose of study medication.
* Subject who have receive any vaccine within 1 month of the anticipated first dose of the study medication and for all the duration of the study
* Patient with contraindication to intramuscular injections
* Subject with respiratory insufficiency
* Subject at risk for Tuberculosis.
* Blood transfusion within the 3 months previous to the study and for all the duration of the study.
* Concomitant biologic disease-modifying antirheumatic drug (DMARD)
* Within 4 weeks of receiving treatment with any investigational drug.
* Patient positive for hepatitis B surface antigen
* Patient who are positive for hepatitis C antibody if the presence of hepatitis C virus was also shown with polymerase chain reaction or recombinant immunoblot assay.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
85 Years
Study:
NCT02547493
Study Brief:
Protocol Section:
NCT02547493