Autoreactivity Threshold Analysis in Lupus and Immune Thrombocytopenia (Checkpoints ITP and SLE) (ITP and SLE)
|ClinicalTrials.gov Identifier: NCT03975361|
Recruitment Status : Not yet recruiting
First Posted : June 5, 2019
Last Update Posted : July 17, 2019
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 before and 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 :||12 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)|
|Estimated Study Start Date :||September 1, 2019|
|Estimated Primary Completion Date :||September 1, 2021|
|Estimated Study Completion Date :||September 1, 2021|
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. Samples will be obtained the day of inclusion, at the week 36, 40 and week 52.To improve the number of timepoints, patients already included in Bliss Believe can be included in this study if W36, W40, W52 can be obtained. It will be 7ml X 3 (21 ml) of blood every time.
The samples of patients included in RITUX-PLUS STUDY are already collected according to the protocol at baseline, W36, W52.
- Number of polyreactive and autoreactive cells in immature and naïve B cells subsets in the peripheral blood [ Time Frame: From baseline (week 0) at week 52 ]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 before and after treatment (reconstitution time).
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03975361
|Contact: Mahevas Matthieu||01 49 81 20 firstname.lastname@example.org|
|Principal Investigator:||Mahevas Matthieu||Assistance Publique - Hôpitaux de Paris|