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

Primary Purpose

Immune Thrombocytopenia (ITP), Systemic Lupus Erythematosus (SLE)

Status
Unknown status
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Bliss-Believe
Sponsored by
Assistance Publique - Hôpitaux de Paris
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Immune Thrombocytopenia (ITP) focused on measuring Rituximab

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Henri Mondor HospitalRecruiting
  • Pitie Salpetriere Hospital

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

Bliss-Believe

Arm Description

Patients included in the BLISS-BELIEVE study (NCT03312907).

Outcomes

Primary Outcome Measures

Number of polyreactive and autoreactive cells in immature and naïve B cells subsets in the peripheral blood
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).

Secondary Outcome Measures

Full Information

First Posted
May 24, 2019
Last Updated
May 21, 2021
Sponsor
Assistance Publique - Hôpitaux de Paris
Collaborators
GlaxoSmithKline
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1. Study Identification

Unique Protocol Identification Number
NCT03975361
Brief Title
Autoreactivity Threshold Analysis in Lupus and Immune Thrombocytopenia (Checkpoints ITP and SLE)
Acronym
ITP&SLE
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)
Study Type
Interventional

2. Study Status

Record Verification Date
December 2020
Overall Recruitment Status
Unknown status
Study Start Date
April 29, 2021 (Actual)
Primary Completion Date
April 29, 2022 (Anticipated)
Study Completion Date
April 29, 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Assistance Publique - Hôpitaux de Paris
Collaborators
GlaxoSmithKline

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Immune Thrombocytopenia (ITP), Systemic Lupus Erythematosus (SLE)
Keywords
Rituximab

7. Study Design

Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
10 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Bliss-Believe
Arm Type
Other
Arm Description
Patients included in the BLISS-BELIEVE study (NCT03312907).
Intervention Type
Other
Intervention Name(s)
Bliss-Believe
Intervention Description
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.
Primary Outcome Measure Information:
Title
Number of polyreactive and autoreactive cells in immature and naïve B cells subsets in the peripheral blood
Description
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).
Time Frame
1 year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Mahevas Matthieu
Phone
01 49 81 20 76
Email
matthieu.mahevas@aphp.fr
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mahevas Matthieu
Organizational Affiliation
Assistance Publique - Hôpitaux de Paris
Official's Role
Principal Investigator
Facility Information:
Facility Name
Henri Mondor Hospital
City
Créteil
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Matthieu MAHEVAS, PHD
Facility Name
Pitie Salpetriere Hospital
City
Paris
Country
France
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Zahir AMOURA

12. IPD Sharing Statement

Learn more about this trial

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

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