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

NCT02320357 | Completed Phase 1

• 1 other identifier: CHUBX 2013/27
• Study Type: interventional
• Target: 18
• Locations: 1 country
• Sites: 3

Brief 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.

Conditions

Systemic Lupus Erythematous

Keywords

Platelet activation; CD40 ligand; CD154; Interferon alpha; clopidogrel

Outcome Measures

Primary Outcomes (1)

• Measurements of plasmatic sCD40L levels

  12 weeks afther the inclusion (D0)

Secondary Outcomes (7)

• Measurements of plasmatic sCD40L levels

  At 1 month before the inclusion (M-1) and at 24 hours, 7 days, 4, 8 and 16 weeks after the inclusion (D0)

• Measurements of IFN inducible genes by RT-PCR in circulating monocytes

  At the inclusion (D0) and 12 weeks after the inclusion (D0)

• Measurements of platelet activation markers by flow cytometry

  12 weeks afther the inclusion (D0)

• Measurements of platelet/circulating mononuclear cells aggregates by flow cytometry

  At 7 days and 12 weeks after the inclusion (D0)

• Measurements of T lymphocytes activation by flow cytometry

  At 7 days and 12 weeks after the inclusion (D0)

Study Arms (1)

Clopidogrel

EXPERIMENTAL

Drug: Treatment by clopidogrel

Interventions

Treatment by clopidogrel DRUG

Peripheral blood will be obtained during the study

Clopidogrel

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Diagnosis of SLE according to revised criteria of American College of Rheumatology
• Being affiliated to health insurance

You may not qualify if:

• Renal involvement that could required a kidney biopsy.
• Required surgery in the next 12 weeks.
• 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

Sponsors & Collaborators

• University Hospital, Bordeaux: lead
• Ministry for Health and Solidarity, France: collaborator

Study Sites (3)

Service de Médecine Interne et maladies Infectieuses - Hôpital Saint-André

Bordeaux, 33075, France

Location

Service de Médecine Interne

Limoges, 87000, France

Location

Service de Médecine Interne et Immunopathologie

Toulouse, 31 000, France

Location

MeSH Terms

Conditions

Hyper-IgM Immunodeficiency Syndrome

Condition Hierarchy (Ancestors)

Dysgammaglobulinemia; Blood Protein Disorders; Hematologic Diseases; Hemic and Lymphatic Diseases; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Primary Immunodeficiency Diseases; Immunologic Deficiency Syndromes; Immune System Diseases

Study Officials

• Pierre DUFFAU, MD

  University Hospital Bordeaux, France

  PRINCIPAL INVESTIGATOR

• Rodolphe THIEBAUT, Prof

  University Hospital Bordeaux, France

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 16, 2014
• First Posted: December 19, 2014
• Study Start: August 19, 2015
• Primary Completion: September 11, 2017
• Study Completion: September 11, 2017
• Last Updated: October 25, 2017

Record last verified: 2017-10

Locations

FR (3)