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

NCT ID: NCT01642706

Last Updated: 2020-07-21

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

240 participants

Study Classification

OBSERVATIONAL

Study Start Date

2012-07-02

Study Completion Date

2020-12-31

Brief Summary

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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.

Detailed Description

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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.

Conditions

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

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

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RA patients

Patients affected by Rheumatoid arthritis.

No interventions assigned to this group

Control

Subjects affected by either :

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

No interventions assigned to this group

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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University Hospital, Montpellier

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Jacques Morel, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

University Hospital, Montpellier

Locations

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Lapeyronie Hospital

Montpellier, , France

Site Status RECRUITING

Countries

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France

Central Contacts

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Jacques Morel, MD, PhD

Role: CONTACT

0033467338710

Claire Daien, MD

Role: CONTACT

0033673042406

Facility Contacts

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Jacques Morel, MD, PhD

Role: primary

0033467338710

Claire Daien, MD

Role: backup

0033673042406

Other Identifiers

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8969

Identifier Type: -

Identifier Source: org_study_id

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