Rheumatoid ArthritisCURE RANCT05203952
Purify Antigen-specific B Cells From Patients With Rheumatoid Arthritis
An observational study of Rheumatoid Arthritis, run by University Hospital, Montpellier at 1 site in France.
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… Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Rheumatoid Arthritis
- How many people
- 10 participants
- Where
- 1 siteFrance
- Study dates
- 1 Dec 2021to 1 Jan 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
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
Who may be able to join
- Antibodies anti-CCP + (ACPA +) > 250 IU/mL
Who cannot join
- Current or past Rituximab (Mabthera) treatment past (< 9 months)
- Abatacept treatment
Trial locations and contacts
1 site in 1 country.
France1 site, 1 recruiting
- Recruiting
UH Montpellier
Montpellier, 34295
Yves-Marie PERS, MCU-PH, 0467337231 ext. 33, ym-pers@chu-montpellier.fr
About this study
Official title: New Therapeutic Approach to Cure Rheumatoid Arthritis
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.
- Conditions
- Rheumatoid Arthritis
- Keywords
- B cells, Rheumatoid arthritis, ACPA
- Medical subject headings
- Arthritis, Rheumatoid
What is being measured
The primary outcome is the main question the study is designed to answer.
Establishment of B cell line
Establishment of B cell line From first COVID-19 symtpoms, or first positive SARS-COV2 PCR result, to recovery.
Measured: 1 day
Secondary outcomes (1)
Validation of new therapeutic molecules
Validation of new therapeutic molecules
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jan 2022
- Study start1 Dec 2021
- Primary completion30 Dec 2023 (estimated)
- Study completion1 Jan 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Rheumatoid ArthritisStudies of the same condition, open and under way.
- More trials run by University Hospital, MontpellierThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Montpellier
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Yves-Marie PERS, MCU-PH, Study director, University Hospitals of Montpellier
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05203952
- Sponsor's protocol ID
- RECHMPL21_0735
- Acronym
- CURE RA
- Status last verified
- Jan 2022
- First submitted
- 10 Jan 2022
- Last updated
- 1 Feb 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: NC
Study at a glance
From the registry record, last updated by the sponsor on 1 Feb 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- New Therapeutic Approach to Cure Rheumatoid Arthritis
- ClinicalTrials.gov ID
- NCT05203952
- Acronym / sponsor ID
- CURE RA / RECHMPL21_0735
- Conditions
- Rheumatoid Arthritis
- Keywords
- B cells, Rheumatoid arthritis, ACPA
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- University Hospital, MontpellierUniversity, hospital or other
- Study start
- 1 Dec 2021 (actual)
- Primary completion
- 30 Dec 2023 (estimated)
- Study completion
- 1 Jan 2024 (estimated)
- First posted
- 24 Jan 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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
Key inclusion criteria (1 listed)
- Antibodies anti-CCP + (ACPA +) > 250 IU/mL
Key exclusion criteria (2 listed)
- Current or past Rituximab (Mabthera) treatment past (< 9 months)
- Abatacept treatment
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Establishment of B cell line
Time frame: 1 day
Establishment of B cell line From first COVID-19 symtpoms, or first positive SARS-COV2 PCR result, to recovery.
1 secondary outcome
Validation of new therapeutic molecules
Time frame: 1 day
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Feb 2022.
- Individual participant dataSharing planned: Undecided. NC
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Yves-Marie PERS, MCU-PH study director
University Hospitals of Montpellier
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Rheumatoid Arthritis, run by University Hospital, Montpellier at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 1 Feb 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Yves-Marie PERS, MCU-PH (0467337231 ext. 33, ym-pers@chu-montpellier.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Establishment of B cell line (time frame: 1 day). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Feb 2022.