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

Regulatory B Cells in Inflammatory Rheumatisms, Systemic Auto-immune Diseases in Adults and Biomarkers of Response to Biologic Treatments

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT01642706
Enrollment
240
Registered
2012-07-17
Start date
2012-07-02
Completion date
2020-12-31
Last updated
2020-07-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chondrocalcinosis, Gout, Osteoarthritis, Rheumatoid Arthritis, Scleroderma, Sjogren's Syndrome, Spinal Disease, Spondylitis, Systemic Lupus Erythematosus

Keywords

Regulatory B cells, Rheumatoid arthritis, Biomarker

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.

Interventions

None listed

Sponsors

University Hospital, Montpellier
Lead SponsorOTHER

Study design

Observational model
CASE_CONTROL
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Assessment of Bregs levels30 monthsThe levels of Bregs will be assessed in patients with RA and compared to subjects with mechanical pathologies.

Secondary

MeasureTime frameDescription
Change of Bregs levels after therapy30 monthsThe levels of Bregs will be assessed in patients who will start a therapy within the framework of their usual follow-up.

Countries

France

Contacts

Primary ContactJacques Morel, MD, PhD
j-morel@chu-montpellier.fr0033467338710
Backup ContactClaire Daien, MD
cdaien@gmail.com0033673042406

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026