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

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ClinicalTrials.gov Identifier: NCT02320357
Recruitment Status : Completed
First Posted : December 19, 2014
Last Update Posted : October 25, 2017
Sponsor:
Collaborator:
Ministry for Health and Solidarity, France
Information provided by (Responsible Party):
University Hospital, Bordeaux

Study Description
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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.

Condition or disease Intervention/treatment Phase
Systemic Lupus Erythematous Drug: Treatment by clopidogrel Phase 1 Phase 2

Detailed Description:
Type I interferon (IFN) and CD40L have been identified as important in SLE pathogenesis (1). CD40L is now considered as a biomarker of lupus activity (4). Because platelets represent a major reservoir of CD40L, we previously studied the role of platelet derived CD40L in SLE pathogenesis (5). We showed that platelets from SLE patients were activated in vivo by circulating immune complexes composed of autoantibodies bound to self antigens through a Fc-gamma Receptor IIa (CD32)-dependent mechanism. Further, platelet activation correlated with severity of the disease and activated platelets formed aggregates with antigen-presenting cells including monocytes and plasmacytoid dendritic cells. In addition, activated platelets enhanced IFN-α secretion by immune complexes-stimulated plasmacytoid dendritic cells in vitro through a CD154-CD40 interaction. In lupus prone mice, depletion of platelets or administration of the clopidogrel improved all measures of disease activity and overall survival. In this pilot study the treatment of the research is clopidogrel given at the dose of 75mg once a day. For the features of the treatment, its contraindications, its disruption in case of side effects cf to annex 1. Clopidogrel associated with the usual treatment of patients will be given for 12 weeks, the follow up of patients will be 16 weeks, all side effects occurring during this period will be recorded.

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 18 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Pilot Study Related to the Effect of Clopidogrel on Plasmatic Soluble CD40 Ligand During Systemic Lupus Erythematous
Actual Study Start Date : August 19, 2015
Actual Primary Completion Date : September 11, 2017
Actual Study Completion Date : September 11, 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lupus

Arms and Interventions
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Arm Intervention/treatment
Experimental: Clopidogrel Drug: Treatment by clopidogrel
Peripheral blood will be obtained during the study


Outcome Measures
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Primary Outcome Measures :
  1. Measurements of plasmatic sCD40L levels [ Time Frame: 12 weeks afther the inclusion (D0) ]

Secondary Outcome Measures :
  1. Measurements of plasmatic sCD40L levels [ Time Frame: At 1 month before the inclusion (M-1) and at 24 hours, 7 days, 4, 8 and 16 weeks after the inclusion (D0) ]
  2. Measurements of IFN inducible genes by RT-PCR in circulating monocytes [ Time Frame: At the inclusion (D0) and 12 weeks after the inclusion (D0) ]
  3. Measurements of platelet activation markers by flow cytometry [ Time Frame: 12 weeks afther the inclusion (D0) ]
  4. Measurements of platelet/circulating mononuclear cells aggregates by flow cytometry [ Time Frame: At 7 days and 12 weeks after the inclusion (D0) ]
  5. Measurements of T lymphocytes activation by flow cytometry [ Time Frame: At 7 days and 12 weeks after the inclusion (D0) ]
  6. Rate of haemorrhagic side effects during the follow up [ Time Frame: At 24 hours, 7 days, 4, 8, 12 and 16 weeks after the inclusion (D0) ]
  7. Measurements of inflammation markers, antiantibodies levels, complement fractions [ Time Frame: At 24 hours, 7 days, 4, 8, 12 and 16 weeks after the inclusion (D0) ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02320357


Locations
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France
Service de Médecine Interne et maladies Infectieuses - Hôpital Saint-André
Bordeaux, France, 33075
Service de Médecine Interne
Limoges, France, 87000
Service de Médecine Interne et Immunopathologie
Toulouse, France, 31 000
Sponsors and Collaborators
University Hospital, Bordeaux
Ministry for Health and Solidarity, France
Investigators
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Principal Investigator: Pierre DUFFAU, MD University Hospital Bordeaux, France
Study Chair: Rodolphe THIEBAUT, Prof University Hospital Bordeaux, France
More Information
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Responsible Party: University Hospital, Bordeaux
ClinicalTrials.gov Identifier: NCT02320357     History of Changes
Other Study ID Numbers: CHUBX 2013/27
First Posted: December 19, 2014    Key Record Dates
Last Update Posted: October 25, 2017
Last Verified: October 2017
Keywords provided by University Hospital, Bordeaux:
Platelet activation
CD40 ligand
CD154
Interferon alpha
clopidogrel
Additional relevant MeSH terms:
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Lupus Erythematosus, Systemic
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases
Clopidogrel
Platelet Aggregation Inhibitors
Purinergic P2Y Receptor Antagonists
 Purinergic P2 Receptor Antagonists
Purinergic Antagonists
Purinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs