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

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

Sponsors

Lead Sponsor: Assistance Publique - Hôpitaux de Paris

Collaborator: GlaxoSmithKline

Source Assistance Publique - Hôpitaux de Paris
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 before and after treatment (B-cell reconstitution time).

Overall Status Not yet recruiting
Start Date September 1, 2020
Completion Date June 1, 2023
Primary Completion Date June 1, 2023
Phase N/A
Study Type Interventional
Primary Outcome
Measure Time Frame
Number of polyreactive and autoreactive cells in immature and naïve B cells subsets in the peripheral blood From baseline (week 0) at week 52
Enrollment 12
Condition
Intervention

Intervention Type: Other

Intervention Name: Bliss-Believe

Description: 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.

Arm Group Label: Bliss-Believe

Eligibility

Criteria:

Inclusion Criteria: - Patients enrolled in the RITUX-PLUS (NCT03154385) - Patients enrolled in the BLISS BELIEVE studies (NCT03312907) Exclusion Criteria: - Patients enrolled in the RITUX-PLUS (NCT03154385) - Patients enrolled in the BLISS BELIEVE studies (NCT03312907)

Gender: All

Minimum Age: 18 Years

Maximum Age: N/A

Healthy Volunteers: No

Overall Official
Last Name Role Affiliation
Mahevas Matthieu Principal Investigator Assistance Publique - Hôpitaux de Paris
Overall Contact

Last Name: Mahevas Matthieu

Phone: 01 49 81 20 76

Email: [email protected]

Verification Date

March 2020

Responsible Party

Type: Sponsor

Keywords
Has Expanded Access No
Condition Browse
Number Of Arms 1
Arm Group

Label: Bliss-Believe

Type: Other

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

Acronym ITP and SLE
Study Design Info

Allocation: N/A

Intervention Model: Single Group Assignment

Primary Purpose: Basic Science

Masking: None (Open Label)

Source: ClinicalTrials.gov