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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register.
Register: ClinicalTrials.gov
Last refreshed on: 12 December 2020
Main ID:  NCT02037737
Date of registration: 21/11/2013
Prospective Registration: Yes
Primary sponsor: Bristol-Myers Squibb
Public title: Impact and Use of Abatacept IV for Rheumatoid Arthritis in Real Life Setting ReACTION
Scientific title: Impact and Use of Abatacept IV for Rheumatoid Arthritis in Real Life Setting in Patients With Inadequate Response to One or Several Conventional DMARDs Including Methotrexate in France. A Database Analysis Based on the ACTION Study
Date of first enrolment: September 30, 2016
Target sample size: 153
Recruitment status: Completed
URL:  https://clinicaltrials.gov/show/NCT02037737
Study type:  Observational
Study design:   
Phase: 
Countries of recruitment
Contacts
Name:     Bristol-Myers Squibb
Address: 
Telephone:
Email:
Affiliation:  Bristol-Myers Squibb
Key inclusion & exclusion criteria

Inclusion Criteria:

- 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

ACTION inclusion criteria for France were:

- 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



Age minimum: 18 Years
Age maximum: N/A
Gender: All
Health Condition(s) or Problem(s) studied
Rheumatoid Arthritis
Intervention(s)
Drug: Abatacept
Primary Outcome(s)
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 [Time Frame: Up to 2 years of followup]
Secondary Outcome(s)
Abatacept effectiveness in patients with inadequate response to one or more conventional DMARDs including Methotrexate of the patients treated with Abatacept IV according to Summary Product Characteristics (SmPC) [Time Frame: Every 3 months up to 2 years of followup]
Abatacept effectiveness in the treated population [Time Frame: 3, 6, and 12 months and 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) [Time Frame: Every 3 months up to 2 years of followup]
Impact of patient and disease characteristics on treatment outcomes [Time Frame: 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) [Time Frame: Every 3 months up to 2 years of followup]
The healthcare resource use as assessed by number of visits to any rheumatologists, hospitalizations [Time Frame: Every 3 months up to 2 years of followup]
Therapeutic strategies over time including change in concomitants treatments [Time Frame: Every 3 months up to 2 years of followup]
Secondary ID(s)
IM101-409
Source(s) of Monetary Support
Please refer to primary and secondary sponsors
Secondary Sponsor(s)
Ethics review
Results
Results available:
Date Posted:
Date Completed:
URL:
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