Regulatory B Cells in Inflammatory Rheumatisms and Biomarkers of Response to Biologic Treatments
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Purpose
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.
| Condition | Intervention |
|---|---|
|
Rheumatoid Arthritis Healthy Subjects Osteoarthritis Auto-immune Disease Lupus Systemic Sclerosis Sjögren Syndrome Spondylitis Crystal Rheumatisms |
Other: Comparison of Bregs levels |
| Study Type: | Observational |
| Study Design: | Observational Model: Case Control Time Perspective: Prospective |
| Official Title: | Regulatory B Cells in Inflammatory Rheumatisms, Systemic Auto-immune Diseases in Adults and Biomarkers of Response to Biologic Treatments |
- Assessment of Bregs levels [ Time Frame: 30 months ] [ Designated as safety issue: No ]The levels of Bregs will be assessed in patients with RA and compared to subjects with mechanical pathologies.
- Change of Bregs levels after therapy [ Time Frame: 30 months ] [ Designated as safety issue: No ]The levels of Bregs will be assessed in patients who will start a therapy within the framework of their usual follow-up.
Biospecimen Retention: Samples Without DNA
Lymphocytes will be analyzed from :
- circulating blood
- serum
- articular serum
- synovial membrane
| Estimated Enrollment: | 200 |
| Study Start Date: | July 2012 |
| Estimated Study Completion Date: | January 2015 |
| Estimated Primary Completion Date: | January 2015 (Final data collection date for primary outcome measure) |
| Groups/Cohorts | Assigned Interventions |
|---|---|
|
RA patients
Patients affected by Rheumatoid arthritis.
|
Other: Comparison of Bregs levels
This is an observational study.The Bregs levels of patients with RA will be compared to subjects with mechanical pathologies.
|
|
Control
Subjects affected by mechanical pathologies.
|
Other: Comparison of Bregs levels
This is an observational study.The Bregs levels of patients with RA will be compared to subjects with mechanical pathologies.
|
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
| Sampling Method: | Non-Probability Sample |
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.
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
Contacts and Locations| Contact: Jacques Morel, MD, PhD | 0033467338710 | j-morel@chu-montpellier.fr |
| Contact: Claire Daien, MD | 0033673042406 | cdaien@gmail.com |
| France | |
| Lapeyronie Hospital | Recruiting |
| Montpellier, France, 34295 | |
| Contact: Jacques Morel, MD, PhD 0033467338710 j-morel@chu-montpellier.fr | |
| Contact: Claire Daien, MD 0033673042406 cdaien@gmail.com | |
| Principal Investigator: Jacques Morel, MD, PhD | |
More Information
No publications provided
| Responsible Party: | University Hospital, Montpellier |
| ClinicalTrials.gov Identifier: | NCT01642706 History of Changes |
| Other Study ID Numbers: | 8969 |
| Study First Received: | July 11, 2012 |
| Last Updated: | April 3, 2013 |
| Health Authority: | France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis) France: Committee for the Protection of Personnes |
Keywords provided by University Hospital, Montpellier:
|
Regulatory B cells Rheumatoid arthritis Biomarker |
Additional relevant MeSH terms:
|
Sjogren's Syndrome Arthritis Arthritis, Rheumatoid Autoimmune Diseases Immune System Diseases Osteoarthritis Rheumatic Diseases Rheumatic Fever Scleroderma, Systemic Scleroderma, Diffuse Sclerosis Spondylitis Joint Diseases Musculoskeletal Diseases Connective Tissue Diseases |
Streptococcal Infections Gram-Positive Bacterial Infections Bacterial Infections Skin Diseases Pathologic Processes Bone Diseases, Infectious Infection Bone Diseases Spinal Diseases Xerostomia Salivary Gland Diseases Mouth Diseases Stomatognathic Diseases Dry Eye Syndromes Lacrimal Apparatus Diseases |
ClinicalTrials.gov processed this record on May 22, 2013