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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT01642706
Other study ID # 8969
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date July 2, 2012
Est. completion date December 2020

Study information

Verified date July 2020
Source University Hospital, Montpellier
Contact Jacques Morel, MD, PhD
Phone 0033467338710
Email j-morel@chu-montpellier.fr
Is FDA regulated No
Health authority
Study type Observational

Clinical 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. Bregs have also been identified in humans.


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.


Recruitment information / eligibility

Status Recruiting
Enrollment 240
Est. completion date December 2020
Est. primary completion date December 2020
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria:

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) .

Exclusion Criteria:

- steroids over 15 mg/day

- rituximab infusion in less than 12 months

Study Design


Locations

Country Name City State
France Lapeyronie Hospital 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 Assessment of Bregs levels The levels of Bregs will be assessed in patients with RA and compared to subjects with mechanical pathologies. 30 months
Secondary 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. 30 months
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