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

This study is currently recruiting participants. (see Contacts and Locations)
Verified April 2013 by University Hospital, Montpellier
Sponsor:
Information provided by (Responsible Party):
University Hospital, Montpellier
ClinicalTrials.gov Identifier:
NCT01642706
First received: July 11, 2012
Last updated: April 3, 2013
Last verified: April 2013
  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

Resource links provided by NLM:


Further study details as provided by University Hospital, Montpellier:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • 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
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.

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01642706

Contacts
Contact: Jacques Morel, MD, PhD 0033467338710 j-morel@chu-montpellier.fr
Contact: Claire Daien, MD 0033673042406 cdaien@gmail.com

Locations
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         
Sponsors and Collaborators
University Hospital, Montpellier
  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, Diffuse
Scleroderma, Systemic
Spondylitis
Bacterial Infections
Bone Diseases
Bone Diseases, Infectious
Connective Tissue Diseases
Dry Eye Syndromes
Eye Diseases
Gram-Positive Bacterial Infections
Infection
Joint Diseases
Lacrimal Apparatus Diseases
Mouth Diseases
Musculoskeletal Diseases
Salivary Gland Diseases
Skin Diseases
Spinal Diseases
Stomatognathic Diseases
Streptococcal Infections
Xerostomia

ClinicalTrials.gov processed this record on October 30, 2014