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

Plain-language summary

This study is a pilot evaluating the effect of the drug Clopidogrel on levels of soluble CD40 ligand (linked to inflammation) in patients with systemic lupus erythematosus (an immune disease affecting many organs). It included patients diagnosed with lupus per ACR criteria. It was a Phase 1/Phase 2 study and has been completed.

The summary above is a plain-language rendering of the official record. The original English title is shown for reference.

Trial details

Phase

PHASE1/PHASE2

Status

Completed

Sponsor

University Hospital, Bordeaux

Intervention

Treatment by clopidogrel

Start date

8/19/2015

Estimated completion

9/11/2017

Countries

France

Related genes

Locations

• Bordeaux, France
• Limoges, France
• Toulouse, France

Eligibility criteria

Criteria are reproduced from the ClinicalTrials.gov record in the original English. Only the trial team can determine eligibility.

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.