NCT05203952

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

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
10

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Dec 2021

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2021

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

January 10, 2022

Completed
14 days until next milestone

First Posted

Study publicly available on registry

January 24, 2022

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 30, 2023

Completed
2 days until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2024

Completed
Last Updated

February 1, 2022

Status Verified

January 1, 2022

Enrollment Period

2.1 years

First QC Date

January 10, 2022

Last Update Submit

January 24, 2022

Conditions

Keywords

B cellsRheumatoid arthritisACPA

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

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

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

RECRUITING

MeSH Terms

Conditions

Arthritis, Rheumatoid

Condition Hierarchy (Ancestors)

ArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic DiseasesConnective Tissue DiseasesSkin and Connective Tissue DiseasesAutoimmune DiseasesImmune System Diseases

Study Officials

  • Yves-Marie PERS, MCU-PH

    University Hospitals of Montpellier

    STUDY DIRECTOR

Central Study Contacts

Yves-Marie PERS, MCU-PH

CONTACT

Christian Jorgensen, PU PH

CONTACT

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

Locations