NCT02885818

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Oct 2014

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2014

Completed
1.9 years until next milestone

First Submitted

Initial submission to the registry

August 22, 2016

Completed
10 days until next milestone

First Posted

Study publicly available on registry

September 1, 2016

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 11, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 11, 2018

Completed
Last Updated

April 19, 2019

Status Verified

April 1, 2019

Enrollment Period

3.3 years

First QC Date

August 22, 2016

Last Update Submit

April 18, 2019

Conditions

Rheumatoid Arthritis

Outcome Measures

Primary Outcomes (1)

  • Peripheral blood B-cell phenotype changes

    Measure of the proportion of the main B-cell subsets (transitional, naïve, memory, plasmablasts) by FACS analysis before abatacept initiation and 3 months later.

    3 months

Secondary Outcomes (1)

  • In vitro B-cell function and regulatory properties

    3 months

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Patients with RA fulfilling ACR/EULAR criteria, in whom abatacept is started as part of their usual clinical care

You may qualify if:

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

You may not qualify if:

  • Treatment by rituximab in the previous year

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CHRU de Brest

Brest, 29609, France

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

Serum

MeSH Terms

Conditions

Arthritis, Rheumatoid

Condition Hierarchy (Ancestors)

ArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic DiseasesConnective Tissue DiseasesSkin and Connective Tissue DiseasesAutoimmune DiseasesImmune System Diseases

Study Officials

  • Jacques-Olivier Pers

    CHRU de Brest

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 22, 2016

First Posted

September 1, 2016

Study Start

October 1, 2014

Primary Completion

January 11, 2018

Study Completion

January 11, 2018

Last Updated

April 19, 2019

Record last verified: 2019-04

Data Sharing

IPD Sharing
Will not share

Locations

FR(1)