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

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01642706
• Other study ID #: 8969
• Status: Recruiting
• 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
• 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

Related Conditions & MeSH terms

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

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