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Does Abatacept Induce Regulatory B Cells in Patients With Rheumatoid Arthritis (ABATACEPT_B)

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ClinicalTrials.gov Identifier: NCT02885818
Recruitment Status : Completed
First Posted : September 1, 2016
Last Update Posted : April 19, 2019
Sponsor:
Information provided by (Responsible Party):
University Hospital, Brest

Brief Summary:
Abatacept disrupts T-cell coactivation signals in rheumatoid arthritis (RA). Its potential effects on B cells are not well described. This study will assess the effects of abatacept therapy on the phenotype and function of peripheral blood B cells in patients with RA.

Condition or disease
Rheumatoid Arthritis

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Study Type : Observational
Actual Enrollment : 20 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Does Abatacept Induce Regulatory B Cells in Patients With Rheumatoid Arthritis
Actual Study Start Date : October 1, 2014
Actual Primary Completion Date : January 11, 2018
Actual Study Completion Date : January 11, 2018

Resource links provided by the National Library of Medicine

Drug Information available for: Abatacept




Primary Outcome Measures :
  1. Peripheral blood B-cell phenotype changes [ Time Frame: 3 months ]
    Measure of the proportion of the main B-cell subsets (transitional, naïve, memory, plasmablasts) by FACS analysis before abatacept initiation and 3 months later.


Secondary Outcome Measures :
  1. In vitro B-cell function and regulatory properties [ Time Frame: 3 months ]
    In vitro culture of B cells from the patients to assess B cell inhibition of T cell proliferation before abatacept initiation and 3 months later.


Biospecimen Retention:   Samples Without DNA
Serum


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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Patients with RA fulfilling ACR/EULAR criteria, in whom abatacept is started as part of their usual clinical care
Criteria

Inclusion Criteria:

  • RA as defined by ACR/EULAR criteria
  • Clinical indication to start abatacept therapy

Exclusion Criteria:

  • Treatment by rituximab in the previous year

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): NCT02885818


Locations
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France
CHRU de Brest
Brest, France, 29609
Sponsors and Collaborators
University Hospital, Brest
Investigators
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Study Director: Jacques-Olivier Pers CHRU de Brest

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Responsible Party: University Hospital, Brest
ClinicalTrials.gov Identifier: NCT02885818     History of Changes
Other Study ID Numbers: ABATACEPT AND B CELL
First Posted: September 1, 2016    Key Record Dates
Last Update Posted: April 19, 2019
Last Verified: April 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Additional relevant MeSH terms:
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Connective Tissue Diseases
Abatacept
Arthritis
Arthritis, Rheumatoid
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Autoimmune Diseases
Immune System Diseases
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Antirheumatic Agents