Rheumatoid ArthritisNCT01642706
Regulatory B Cells in Inflammatory Rheumatisms and Biomarkers of Response to Biologic Treatments
An observational study of Rheumatoid Arthritis and Osteoarthritis, run by University Hospital, Montpellier at 1 site in France.
Trial summary
B cells are known to play an important role in auto-immune diseases by activating T cells, secreting inflammatory cytokines and autoreactive antibodies. However, a sub-type of B cells named regulatory B cells or Bregs has recently shown capacities to prevent or cure arthritis in mouse models. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Rheumatoid Arthritis, Osteoarthritis, Systemic Lupus Erythematosus
- How many people
- 240 participants
- Where
- 1 siteFrance
- Study dates
- 2 Jul 2012to Dec 2020
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Patients and controls will be recruited in the Immuno-rheumatology Service of the University Hospital of Montpellier. They will be recruited during consultations or hospitalizations, when a blood sample is planned within the framework of their usual follow-up.
Who may be able to join
- For RA patients and control patients:
- Age over 18 year old
- Blood sample taken as part of the usual management
- Steroid less than or equal to 15 mg/day and stable for at least a week
- For RA patients:
- Patient with RA meeting the ACR / EULAR 2010
- For control patients:
- Patients with systemic autoimmune disease (lupus, Sjogren's syndrome, scleroderma) or other inflammatory arthritis (spondylitis, crystals) or a mechanical pathology (limb osteoarthritis or spinal pathology) .
Who cannot join
- steroids over 15 mg/day
- rituximab infusion in less than 12 months
Trial locations and contacts
1 site in 1 country.
France1 site, 1 recruiting
- Recruiting
Lapeyronie Hospital
Montpellier, 34295
Jacques Morel, MD, PhD, 0033467338710, j-morel@chu-montpellier.fr
Claire Daien, MD, 0033673042406, cdaien@gmail.com
About this study
Official title: Regulatory B Cells in Inflammatory Rheumatisms, Systemic Auto-immune Diseases in Adults and Biomarkers of Response to Biologic Treatments
B cells are known to play an important role in auto-immune diseases by activating T cells, secreting inflammatory cytokines and autoreactive antibodies. However, a sub-type of B cells named regulatory B cells or Bregs has recently shown capacities to prevent or cure arthritis in mouse models. Bregs have also been identified in humans.
Read the detailed description
B cells are known to play an important role in auto-immune diseases by activating T cells, secreting inflammatory cytokines and autoreactive antibodies. However, a sub-type of B cells named regulatory B cells or Bregs has recently shown capacities to prevent or cure arthritis in mouse models. Bregs have also been identified in humans. Main objective: To study Bregs abnormalities in patients with rheumatoid arthritis (RA) at different stages of the disease compared to subjects with mechanical pathologies.Secondary objectives:- To evaluate the specificity of any abnormalities identified in RA by studying Bregs in patients with other autoimmune or other inflammatory joint diseases.- To evaluate the effect of biological and synthetic treatments on Bregs in patients with RA. - To assess whether the rate of Bregs before treatment is predictive of response to biological and synthetic treatments.
- Conditions
- Rheumatoid Arthritis, Osteoarthritis, Systemic Lupus Erythematosus, Sjogren's Syndrome, Scleroderma, Spondylitis
- Keywords
- Regulatory B cells, Rheumatoid arthritis, Biomarker
- Medical subject headings
- Arthritis, Rheumatoid, Osteoarthritis, Lupus Erythematosus, Systemic, Sjogren's Syndrome, Scleroderma, Diffuse, Spondylitis, Gout, Spinal Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| RA patients | Patients affected by Rheumatoid arthritis. | |
| Control | Subjects affected by either : * mechanical pathology * systemic auto-immune pathology * other inflammatory rheumatism |
What is being measured
The primary outcome is the main question the study is designed to answer.
Assessment of Bregs levels
The levels of Bregs will be assessed in patients with RA and compared to subjects with mechanical pathologies.
Measured: 30 months
Secondary outcomes (1)
Change of Bregs levels after therapy
The levels of Bregs will be assessed in patients who will start a therapy within the framework of their usual follow-up.
Measured: 30 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jul 2012 (estimated)
- Study start2 Jul 2012
- Primary completionDec 2020 (estimated)
- Study completionDec 2020 (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
- Case-control
- Time perspective
- Prospective
- Enrolment
- 240 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Montpellier
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jacques Morel, MD, PhD, Principal investigator, University Hospital, Montpellier
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01642706
- Sponsor's protocol ID
- 8969
- Status last verified
- Jul 2020
- First submitted
- 11 Jul 2012
- Last updated
- 21 Jul 2020
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Regulatory B Cells in Inflammatory Rheumatisms, Systemic Auto-immune Diseases in Adults and Biomarkers of Response to Biologic Treatments
- ClinicalTrials.gov ID
- NCT01642706
- Acronym / sponsor ID
- 8969
- Conditions
- Rheumatoid Arthritis, Osteoarthritis, Systemic Lupus Erythematosus, Sjogren's Syndrome, Scleroderma, Spondylitis
- Keywords
- Regulatory B cells, Rheumatoid arthritis, Biomarker
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 240 participants (estimated)
- Lead sponsor
- University Hospital, MontpellierUniversity, hospital or other
- Study start
- 2 Jul 2012 (actual)
- Primary completion
- Dec 2020 (estimated)
- Study completion
- Dec 2020 (estimated)
- First posted
- 17 Jul 2012 (estimated)
- 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.
B cells are known to play an important role in auto-immune diseases by activating T cells, secreting inflammatory cytokines and autoreactive antibodies. However, a sub-type of B cells named regulatory B cells or Bregs has recently shown capacities to prevent or cure arthritis in mouse models. Bregs have also been identified in humans.
Detailed description
B cells are known to play an important role in auto-immune diseases by activating T cells, secreting inflammatory cytokines and autoreactive antibodies. However, a sub-type of B cells named regulatory B cells or Bregs has recently shown capacities to prevent or cure arthritis in mouse models. Bregs have also been identified in humans. Main objective: To study Bregs abnormalities in patients with rheumatoid arthritis (RA) at different stages of the disease compared to subjects with mechanical pathologies.Secondary objectives:- To evaluate the specificity of any abnormalities identified in RA by studying Bregs in patients with other autoimmune or other inflammatory joint diseases.- To evaluate the effect of biological and synthetic treatments on Bregs in patients with RA. - To assess whether the rate of Bregs before treatment is predictive of response to biological and synthetic treatments.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| RA patients | – | –Patients affected by Rheumatoid arthritis. |
| Control | – | –Subjects affected by either : * mechanical pathology * systemic auto-immune pathology * other inflammatory rheumatism |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Patients and controls will be recruited in the Immuno-rheumatology Service of the University Hospital of Montpellier. They will be recruited during consultations or hospitalizations, when a blood sample is planned within the framework of their usual follow-up.
Key inclusion criteria (8 listed)
- Age over 18 year old
- Blood sample taken as part of the usual management
- Steroid less than or equal to 15 mg/day and stable for at least a week
- Patient with RA meeting the ACR / EULAR 2010
- Patients with systemic autoimmune disease (lupus, Sjogren's syndrome, scleroderma) or other inflammatory arthritis (spondylitis, crystals) or a mechanical pathology (limb osteoarthritis or spinal pathology) .
Key exclusion criteria (2 listed)
- steroids over 15 mg/day
- rituximab infusion in less than 12 months
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
Assessment of Bregs levels
Time frame: 30 months
The levels of Bregs will be assessed in patients with RA and compared to subjects with mechanical pathologies.
1 secondary outcome
Change of Bregs levels after therapy
Time frame: 30 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Jul 2020.
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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.
Jacques Morel, MD, PhD principal investigator
University Hospital, 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 and Osteoarthritis, 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 8 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 21 Jul 2020. 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 Jacques Morel, MD, PhD (0033467338710, j-morel@chu-montpellier.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Assessment of Bregs levels (time frame: 30 months). 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 21 Jul 2020.