Rheumatoid Arthritis Clinical Trial
Official title:
Regulatory B Cells in Inflammatory Rheumatisms, Systemic Auto-immune Diseases in Adults and Biomarkers of Response to Biologic Treatments
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 |
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.
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 |
Country | Name | City | State |
---|---|---|---|
France | Lapeyronie Hospital | Montpellier |
Lead Sponsor | Collaborator |
---|---|
University Hospital, Montpellier |
France,
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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