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 @ 4:48 AM
Ignite Modification Date:
2025-12-25 @ 4:48 AM
NCT ID:
NCT01971918
Eligibility Criteria:
Inclusion Criteria:
* Spondyloarthritis positive for the ASAS criteria, treated with a first biologic : infliximab ( 5mg/kg intravenously every 8 weeks) or adalimumab (40mg subcutaneously every 2 weeks)
* Active spondyloarthritis definite by ASDAS-CRP \> 2.1 at two successive evaluations while patient was previously responder (ASDAS\<2.1 at least once in the 6th months after beginning of treatment)
* Positivity to anti-drug antibodies (ADAb)
* Consent of the patient
* No contra-indication to another anti-tnf biologic
* affiliation to health insurance
* woman of childbearing age must use an appropriate mean of contraception
Exclusion Criteria:
* Pregnant or breastfeeding woman
* contra-indication to anti-tnf biologic
* patient with known hypersensitivity to any of the excipients
* Severe and uncontrolled opportunistic infection , includins septicemia, tuberculosis, abcess and opportunistic infection
* Evolutive infection, including chronic or localised infection
* Patient with moderate to severe heart failure (NYHA class III/IV)
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
80 Years
Study:
NCT01971918
Study Brief:
Protocol Section:
NCT01971918