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:
2025-12-24 @ 6:51 PM
Ignite Modification Date:
2025-12-24 @ 6:51 PM
NCT ID:
NCT02320357
Eligibility Criteria:
Inclusion Criteria:
* Diagnosis of SLE according to revised criteria of American College of Rheumatology
* Being affiliated to health insurance
* Having signed an informed consent (later than the day of inclusion and before any examination required by research)
Exclusion Criteria:
* \> 20mg/day of prednisone equivalent for \> 7 days 30 days before the pre-inclusion.
* Diseases flare 3 months before the inclusion. A disease flare is defined by an increase of SLEDAI score \>3 and or a change of the immunosuppressive treatment and or an increase of steroids dose.
* Is treated or has received 3 months before the pre-inclusion steroids pulses or intravenous immunoglobulins.
* Renal involvement that could required a kidney biopsy.
* Required surgery in the next 12 weeks.
* Has been treated by cyclophosphamide 3 months before the pre-inclusion.
* Has been treated by biotherapy 6 months before the pre-inclusion.
* Contraindication to clopidogrel (annex 1).
* History of cancer except healed basal cell carcinoma.
* History of severe hemorrhage
* Disease exposing to hemorrhage
* Associated antiphospholipid syndrome
* Pregnant or breastfeeding women
* No contraception for women of childbearing age
* Severe hypertension
* Ongoing statin, non-steroidal anti-inflammatory, antiplatelet and anticoagulant drugs.
* Being under guardianship
* Patient participating at an other biomedical research with an exclusion period at the screening visit.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT02320357
Study Brief:
Protocol Section:
NCT02320357