Purify Antigen-specific B Cells From Patients With Rheumatoid Arthritis
CURE RA
New Therapeutic Approach to Cure Rheumatoid Arthritis
1 other identifier
observational
10
1 country
1
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for all trials
Started Dec 2021
Typical duration for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
December 1, 2021
CompletedFirst Submitted
Initial submission to the registry
January 10, 2022
CompletedFirst Posted
Study publicly available on registry
January 24, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 30, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
January 1, 2024
CompletedFebruary 1, 2022
January 1, 2022
2.1 years
January 10, 2022
January 24, 2022
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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 Outcomes (1)
Validation of new therapeutic molecules
1 day
Eligibility Criteria
Patients are selected based on the presence of high serum ACPA levels (medical record analyses). Patients treated with Rituximab resulting in total B cell depletion are not selected for this study
You may qualify if:
- \- Antibodies anti-CCP + (ACPA +) \> 250 IU/mL
You may not qualify if:
- Current or past Rituximab (Mabthera) treatment past (\< 9 months)
- Abatacept treatment
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
UH Montpellier
Montpellier, 34295, France
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Yves-Marie PERS, MCU-PH
University Hospitals of Montpellier
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 10, 2022
First Posted
January 24, 2022
Study Start
December 1, 2021
Primary Completion
December 30, 2023
Study Completion
January 1, 2024
Last Updated
February 1, 2022
Record last verified: 2022-01