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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT03975361
Other study ID # APHP180341
Secondary ID 2019-A00103-54
Status Recruiting
Phase N/A
First received
Last updated
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
Health authority
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

Study Design


Related Conditions & MeSH terms


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
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