Autoreactivity Threshold Analysis in Lupus and Immune Thrombocytopenia (Checkpoints ITP and SLE) (ITP&SLE)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT03975361|
Recruitment Status : Recruiting
First Posted : June 5, 2019
Last Update Posted : May 25, 2021
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 Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||10 participants|
|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|
Patients included in the BLISS-BELIEVE study (NCT03312907).
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.
- 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).
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
|Contact: Mahevas Matthieu||01 49 81 20 firstname.lastname@example.org|
|Henri Mondor Hospital||Recruiting|
|Contact: Matthieu MAHEVAS, PHD|
|Pitie Salpetriere Hospital||Not yet recruiting|
|Contact: Zahir AMOURA|
|Principal Investigator:||Mahevas Matthieu||Assistance Publique - Hôpitaux de Paris|