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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05203952
Other study ID # RECHMPL21_0735
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date December 1, 2021
Est. completion date January 1, 2024

Study information

Verified date January 2022
Source University Hospital, Montpellier
Contact Yves-Marie PERS, MCU-PH
Phone 0467337231
Email ym-pers@chu-montpellier.fr
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

Rheumatoid arthritis (RA) is an autoimmune disease characterized by the presence of autoantibodies directed against citrullinated proteins, called ACPAs. These antibodies are very specific to RA, and the severity of the disease is closely correlated with the level of these ACPAs, even though they appear much earlier than the clinical signs. Current treatments by biotherapies are effective but only treat the inflammatory symptoms of the disease or, on the contrary, induce a global immunosuppression with a depletion of all B lymphocytes. Contrary to the current approaches, the CURE RA project proposes a double innovative character: - The project aims at specifically destroying B lymphocytes expressing / or secreting ACPAs for a more specific approach to RA, without inducing immunosuppression. - The new therapeutic molecule is entirely original and has no equivalent at present, it uses the target antigens of autoantibodies, the citrullinated peptides, as tools to destroy the pathogenic B cells that express/produce these autoantibodies.


Recruitment information / eligibility

Status Recruiting
Enrollment 10
Est. completion date January 1, 2024
Est. primary completion date December 30, 2023
Accepts healthy volunteers No
Gender All
Age group 18 Years to 65 Years
Eligibility Inclusion criteria: - Antibodies anti-CCP + (ACPA +) > 250 IU/mL Exclusion criteria: - Current or past Rituximab (Mabthera) treatment past (< 9 months) - Abatacept treatment

Study Design


Related Conditions & MeSH terms


Locations

Country Name City State
France UH Montpellier Montpellier

Sponsors (1)

Lead Sponsor Collaborator
University Hospital, Montpellier

Country where clinical trial is conducted

France, 

Outcome

Type Measure Description Time frame Safety issue
Primary Establishment of B cell line Establishment of B cell line From first COVID-19 symtpoms, or first positive SARS-COV2 PCR result, to recovery. 1 day
Secondary Validation of new therapeutic molecules Validation of new therapeutic molecules 1 day
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