NCT02037737

Brief Summary

The purpose of this study is to assess Abatacept Intravenous (IV) effectiveness in patients with inadequate response to one or more conventional Disease Modifying Against Rheumatism (DMARDs) including Methotrexate in France, through the estimation of Abatacept retention rate over 2 years and reasons of discontinuation

Trial Health

100
On Track

Trial Health Score

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

Enrollment
153

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Sep 2016

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

First Submitted

Initial submission to the registry

November 21, 2013

Completed
2 months until next milestone

First Posted

Study publicly available on registry

January 16, 2014

Completed
2.7 years until next milestone

Study Start

First participant enrolled

September 30, 2016

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 31, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 31, 2018

Completed
Last Updated

February 7, 2018

Status Verified

February 1, 2018

Enrollment Period

1.3 years

First QC Date

November 21, 2013

Last Update Submit

February 6, 2018

Conditions

Rheumatoid Arthritis

Outcome Measures

Primary Outcomes (1)

  • Abatacept IV effectiveness in patients with inadequate response to one or more conventional DMARDs including Methotrexate in France, through the estimation of Abatacept retention rate over 2 years and reasons of discontinuation

    Up to 2 years of followup

Secondary Outcomes (7)

  • Abatacept effectiveness in the treated population

    3, 6, and 12 months and every 3 months up to 2 years of followup

  • Impact of patient and disease characteristics on treatment outcomes

    Every 3 months up to 2 years of followup

  • Joint population of French patients with inadequate response to one or more conventional DMARDs including Methotrexate treated with Abatacept IV (demographics, medical history, disease characteristics, previous treatments)

    Every 3 months up to 2 years of followup

  • Conditions of Abatacept IV utilization in first line of biologic agents (indication, dosage, administration schedule, treatment duration, concomitant treatments)

    Every 3 months up to 2 years of followup

  • Therapeutic strategies over time including change in concomitants treatments

    Every 3 months up to 2 years of followup

  • +2 more secondary outcomes

Study Arms (1)

RA patients on Abatacept IV

Rheumatoid Arthritis (RA) patients with inadequate response to one or more conventional DMARDs including Methotrexate and treated with Abatacept IV according to routine clinical practice in France

Drug: Abatacept

Interventions

AbataceptDRUG
RA patients on Abatacept IV

Eligibility Criteria

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

RA patients with inadequate response to one or more conventional DMARDs including Methotrexate and treated with Abatacept IV according to routine clinical practice in France

You may qualify if:

  • \- All patients enrolled in ACTION with inadequate response to one or more conventional DMARDs including Methotrexate and treated with Abatacept IV will be included in ReACTION
  • Male or female subjects of more than 18 years old
  • Patients with a diagnosis of established moderate to severe active RA
  • Patients who at their physician's discretion are treated with Abatacept (initiated or already on treatment within 3 months) according to routine clinical practice
  • Patients for whom baseline characteristics are available
  • Patients consent for usage of their data in ACTION study
  • Patients who were not included in any interventional clinical trial in RA

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Arthritis, Rheumatoid

Interventions

Abatacept

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

ImmunoconjugatesAntibodiesImmunoglobulinsSerum GlobulinsBlood ProteinsProteinsAmino Acids, Peptides, and ProteinsGlobulins

Study Officials

  • Bristol-Myers Squibb

    Bristol-Myers Squibb

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
RETROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 21, 2013

First Posted

January 16, 2014

Study Start

September 30, 2016

Primary Completion

January 31, 2018

Study Completion

January 31, 2018

Last Updated

February 7, 2018

Record last verified: 2018-02