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

May 21, 2021 updated by: Assistance Publique - Hôpitaux de Paris

Tolerance Checkpoints Upon the B-cell Depletion Plus BAFF Blockade Strategy in Immune Thrombocytopenia (ITP) and Systemic Lupus Erythematosus (SLE) (Checkpoints ITP and SLE)

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).

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

10

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Créteil, France
        • Recruiting
        • Henri Mondor Hospital
        • Contact:
          • Matthieu MAHEVAS, PHD
      • Paris, France
        • Not yet recruiting
        • Pitié Salpêtrière hospital
        • Contact:
          • Zahir AMOURA

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: BASIC_SCIENCE
  • Allocation: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
OTHER: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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).
1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Assistance Publique - Hôpitaux de Paris

Collaborators

GlaxoSmithKline

Investigators

  • Principal Investigator: Mahevas Matthieu, Assistance Publique - Hôpitaux de Paris

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

April 29, 2021

Primary Completion (ANTICIPATED)

April 29, 2022

Study Completion (ANTICIPATED)

April 29, 2022

Study Registration Dates

First Submitted

May 24, 2019

First Submitted That Met QC Criteria

June 4, 2019

First Posted (ACTUAL)

June 5, 2019

Study Record Updates

Last Update Posted (ACTUAL)

May 25, 2021

Last Update Submitted That Met QC Criteria

May 21, 2021

Last Verified

December 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • APHP180341
  • 2019-A00103-54 (OTHER: IDRCB)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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