Regulatory B Cells in Inflammatory Rheumatisms and Biomarkers of Response to Biologic Treatments

• Conditions: Spondylitis; Sjogren's Syndrome; Gout; Rheumatoid Arthritis; Systemic Lupus Erythematosus; Chondrocalcinosis; Osteoarthritis; Scleroderma; Spinal Disease

• Registration Number: NCT01642706
• Lead Sponsor: University Hospital, Montpellier

Brief 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.

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 Timeline

• Study Start: 2012-07-02
• Study First Submitted: 2012-07-11
• Study First Submitted QC: 2012-07-13
• Study First Posted: 2012-07-17
• Status Verified: 2020-07
• Last Update Submitted: 2020-07-20
• Last Update Posted: 2020-07-21
• Primary Completion: 2020-12
• Study Completion: 2020-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 240

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

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Assessment of Bregs levels	30 months	The levels of Bregs will be assessed in patients with RA and compared to subjects with mechanical pathologies.

Secondary Outcome Measures

Name	Time	Method
Change of Bregs levels after therapy	30 months	The levels of Bregs will be assessed in patients who will start a therapy within the framework of their usual follow-up.

Trial Locations

Locations (1)

Lapeyronie Hospital; 🇫🇷 Montpellier, France