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

Systemic Lupus Erythematosus (SLE) Clinical Trial

— 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)

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03975361
• Other study ID #: APHP180341
• Secondary ID: 2019-A00103-54
• Status: Recruiting
• Phase: N/A
• Start date: April 29, 2021
• Est. completion date: April 29, 2022

Study information

• Verified date: December 2020
• Source: Assistance Publique - Hôpitaux de Paris
• Contact: Mahevas Matthieu
• Phone: 01 49 81 20 76
• Email: matthieu.mahevas[@]aphp.fr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 10
• Est. completion date: April 29, 2022
• Est. primary completion date: April 29, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Immune Thrombocytopenia (ITP)
• Lupus Erythematosus, Systemic
• Purpura, Thrombocytopenic, Idiopathic
• Systemic Lupus Erythematosus (SLE)
• Thrombocytopenia

Intervention

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.

Locations

Country	Name	City	State
France	Henri Mondor Hospital	Créteil
France	Pitie Salpetriere Hospital	Paris

Sponsors (2)

Lead Sponsor	Collaborator
Assistance Publique - Hôpitaux de Paris	GlaxoSmithKline

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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).	1 year