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Trial record 69 of 1725 for:    Recruiting, Not yet recruiting, Available Studies | Autoimmunity

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

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ClinicalTrials.gov Identifier: NCT01642706
Recruitment Status : Recruiting
First Posted : July 17, 2012
Last Update Posted : October 14, 2019
Sponsor:
Information provided by (Responsible Party):
University Hospital, Montpellier

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.

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

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.

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Study Type : Observational
Estimated Enrollment : 240 participants
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
Actual Study Start Date : July 2, 2012
Estimated Primary Completion Date : October 2020
Estimated Study Completion Date : October 2020


Group/Cohort
RA patients
Patients affected by Rheumatoid arthritis.
Control

Subjects affected by either :

  • mechanical pathology
  • systemic auto-immune pathology
  • other inflammatory rheumatism



Primary Outcome Measures :
  1. Assessment of Bregs levels [ Time Frame: 30 months ]
    The levels of Bregs will be assessed in patients with RA and compared to subjects with mechanical pathologies.


Secondary Outcome Measures :
  1. Change of Bregs levels after therapy [ Time Frame: 30 months ]
    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

Comparison of Bregs levels

Lymphocytes will be analyzed from :

  • circulating blood
  • serum
  • articular serum
  • synovial membrane


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01642706


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

Locations
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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
Investigators
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Principal Investigator: Jacques Morel, MD, PhD University Hospital, Montpellier

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Responsible Party: University Hospital, Montpellier
ClinicalTrials.gov Identifier: NCT01642706     History of Changes
Other Study ID Numbers: 8969
First Posted: July 17, 2012    Key Record Dates
Last Update Posted: October 14, 2019
Last Verified: October 2019
Keywords provided by University Hospital, Montpellier:
Regulatory B cells
Rheumatoid arthritis
Biomarker
Additional relevant MeSH terms:
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Autoimmune Diseases
Spondylitis
Rheumatic Fever
Arthritis
Arthritis, Rheumatoid
Sjogren's Syndrome
Spinal Diseases
Rheumatic Diseases
Chondrocalcinosis
Lupus Erythematosus, Systemic
Joint Diseases
Musculoskeletal Diseases
Connective Tissue Diseases
Immune System Diseases
Bone Diseases, Infectious
Infection
Bone Diseases
Xerostomia
Salivary Gland Diseases
Mouth Diseases
Stomatognathic Diseases
Dry Eye Syndromes
Lacrimal Apparatus Diseases
Eye Diseases
Streptococcal Infections
Gram-Positive Bacterial Infections
Bacterial Infections
Crystal Arthropathies