Pilot Study Related to the Effect of Clopidogrel on Plasmatic Soluble CD40 Ligand During Systemic Lupus Erythematous

• Status: Completed
• Trial end date: 2017-09-11
• Target enrollment: 0
• Participant gender: All

Summary

CD40 Ligand (CD40L) has been identified as a key feature in systemic lupus erythematosus (SLE) pathogenesis, a systemic autoimmune disease characterized by a multiorgan involvement. As platelets are a major source of soluble CD40L (sCD40L), we propose to study the effect of clopidogrel, a platelet inhibitor, on plasmatic sCD40L levels in SLE patients.

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University Hospital, Bordeaux
• Collaborator: Ministry for Health and Solidarity, France
• Treatments: Clopidogrel; Ticlopidine

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.