Purify Antigen-specific B Cells From Patients With Rheumatoid Arthritis

Rheumatoid Arthritis Clinical Trial

— CURE RA  

Official title:

New Therapeutic Approach to Cure Rheumatoid Arthritis

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05203952
• Other study ID #: RECHMPL21_0735
• Status: Recruiting
• 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
• 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

Related Conditions & MeSH terms

• Arthritis
• Arthritis, Rheumatoid
• Rheumatoid Arthritis

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