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

NCT01642706 | Unknown

• 1 other identifier: 8969
• Study Type: observational
• Target: 240
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Keywords

Regulatory B cells; Rheumatoid arthritis; Biomarker

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Change of Bregs levels after therapy

  30 months

Study Arms (2)

RA patients

Patients affected by Rheumatoid arthritis.

Control

Subjects affected by either : * mechanical pathology * systemic auto-immune pathology * other inflammatory rheumatism

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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) .

You may not qualify if:

• steroids over 15 mg/day
• rituximab infusion in less than 12 months

Sponsors & Collaborators

• University Hospital, Montpellier: lead

Study Sites (1)

Lapeyronie Hospital

Montpellier, 34295, France

RECRUITING

Biospecimen

Retention: SAMPLES WITHOUT DNA

Comparison of Bregs levels Lymphocytes will be analyzed from : * circulating blood * serum * articular serum * synovial membrane

MeSH Terms

Conditions

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

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases; Xerostomia; Salivary Gland Diseases; Mouth Diseases; Stomatognathic Diseases; Dry Eye Syndromes; Lacrimal Apparatus Diseases; Eye Diseases; Scleroderma, Systemic; Skin Diseases; Bone Diseases, Infectious; Infections; Bone Diseases; Crystal Arthropathies; Purine-Pyrimidine Metabolism, Inborn Errors; Metabolism, Inborn Errors; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Metabolic Diseases; Nutritional and Metabolic Diseases

Study Officials

• Jacques Morel, MD, PhD

  University Hospital, Montpellier

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jacques Morel, MD, PhD

CONTACT

0033467338710; j-morel@chu-montpellier.fr

Claire Daien, MD

CONTACT

0033673042406; cdaien@gmail.com

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 11, 2012
• First Posted: July 17, 2012
• Study Start: July 2, 2012
• Primary Completion: December 1, 2020
• Study Completion: December 1, 2020
• Last Updated: July 21, 2020

Record last verified: 2020-07

Locations

FR (1)