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Autoreactivity Threshold Analysis in Lupus and Immune Thrombocytopenia (Checkpoints ITP and SLE) (ITP&SLE)

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ClinicalTrials.gov Identifier: NCT03975361
Recruitment Status : Unknown
Verified December 2020 by Assistance Publique - Hôpitaux de Paris.
Recruitment status was:  Recruiting
First Posted : June 5, 2019
Last Update Posted : May 25, 2021
Sponsor:
Collaborator:
GlaxoSmithKline
Information provided by (Responsible Party):
Assistance Publique - Hôpitaux de Paris

Study Description
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Brief Summary:

The aim of this proposal is to test if anti-BAFF antibody can restore a normal threshold of tolerance in patients in two auto-immune diseases along the RITUX-PLUS study in immune thrombocytopenia, and along the Believe study in SLE. This work would help to conclude whether or not the 'double hit' therapy may help to reset the immune system toward a more tolerogenic profile.

The aim is to compare the polyreactivity and autoreactivity, of immature (central tolerance) and naïve B cells (peripheral tolerance) in the peripheral blood along the RITUX-PLUS STUDY and the BLISS BELIEVE study after treatment (B-cell reconstitution time).


Condition or disease Intervention/treatment Phase
Immune Thrombocytopenia (ITP) Systemic Lupus Erythematosus (SLE) Other: Bliss-Believe Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 10 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: Tolerance Checkpoints Upon the B-cell Depletion Plus BAFF Blockade Strategy in Immune Thrombocytopenia (ITP) and Systemic Lupus Erythematosus (SLE) (Checkpoints ITP and SLE)
Actual Study Start Date : April 29, 2021
Estimated Primary Completion Date : April 29, 2022
Estimated Study Completion Date : April 29, 2022

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Bliss-Believe
Patients included in the BLISS-BELIEVE study (NCT03312907).
 Other: Bliss-Believe
The samples from the blood samples carried out within the framework of Bliss Believe will be collected for a biological collection. Only one sample of patients included in BLISS BELIEVE STUDY will be obtained during a standard of care visit. It will be 21ml of blood.


Outcome Measures
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Primary Outcome Measures :
  1. Number of polyreactive and autoreactive cells in immature and naïve B cells subsets in the peripheral blood [ Time Frame: 1 year ]
    Number of polyreactive and autoreactive cells in immature (central tolerance) and naïve B cells (peripheral tolerance) subsets in the peripheral blood along the RITUX-PLUS and the BLISS BELIEVE studies after treatment (reconstitution time).


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

There are no specific inclusion and exclusion criteria for this study.

The inclusion and exclusion criteria are those of patients enrolled in the RITUX-PLUS (NCT03154385) and BLISS BELIEVE studies (NCT03312907) including the following inclusion criteria:

  • individuals are affiliated to social security
  • individuals not be placed under judicial protection, guardianship or curatoship
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): NCT03975361


Contacts
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Contact: Mahevas Matthieu 01 49 81 20 76 matthieu.mahevas@aphp.fr

Locations
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France
Henri Mondor Hospital Recruiting
Créteil, France
Contact: Matthieu MAHEVAS, PHD         
Pitie Salpetriere Hospital Not yet recruiting
Paris, France
Contact: Zahir AMOURA         
Sponsors and Collaborators
Assistance Publique - Hôpitaux de Paris
GlaxoSmithKline
Investigators
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Principal Investigator: Mahevas Matthieu Assistance Publique - Hôpitaux de Paris
More Information
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Responsible Party: Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier: NCT03975361    
Other Study ID Numbers: APHP180341
2019-A00103-54 ( Other Identifier: IDRCB )
First Posted: June 5, 2019    Key Record Dates
Last Update Posted: May 25, 2021
Last Verified: December 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Assistance Publique - Hôpitaux de Paris:
Rituximab
Additional relevant MeSH terms:
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Thrombocytopenia
Purpura, Thrombocytopenic, Idiopathic
Lupus Erythematosus, Systemic
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases
Blood Platelet Disorders
Hematologic Diseases
 Purpura, Thrombocytopenic
Purpura
Blood Coagulation Disorders
Thrombotic Microangiopathies
Hemorrhagic Disorders
Hemorrhage
Pathologic Processes
Skin Manifestations