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

Assistance Publique - Hôpitaux de Paris

Status: Unknown

Conditions: Immune Thrombocytopenia (ITP); Systemic Lupus Erythematosus (SLE)

Treatments: Other: Bliss-Believe

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT03975361

APHP180341

2019-A00103-54 (Other Identifier)

Details and patient eligibility

About

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).

Enrollment: 10 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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

Trial design

Primary purpose: Basic Science

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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10 participants in 1 patient group

Bliss-Believe

Other group

Description:

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

Treatment:

Other: Bliss-Believe