Clinical trial NCT01642706: Regulatory B Cells in Inflammatory Rheumatisms and Biomarkers of Response to Biologic Treatments
Official title: Regulatory B Cells in Inflammatory Rheumatisms, Systemic Auto-immune Diseases in Adults and Biomarkers of Response to Biologic Treatments
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Rheumatoid Arthritis
Osteoarthritis
Systemic Lupus Erythematosus
Sjogren's Syndrome
Scleroderma
Spondylitis
Gout
Spinal Disease
Chondrocalcinosis
Keywords: Regulatory B cells
Rheumatoid arthritis
Biomarker
Lead sponsor: University Hospital, Montpellier
Sponsor class: OTHER
First posted: 2012-07-17
Enrollment: 240
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Assessment of Bregs levels
timeFrame: 30 months
Secondary outcomes:
measure: Change of Bregs levels after therapy
timeFrame: 30 months
Other outcomes:
Locations:
city: Montpellier
country: France
facility: Lapeyronie Hospital
Study officials:
affiliation: University Hospital, Montpellier
name: Jacques Morel, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: