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Completed

NCT Number: NCT02037737

Impact and Use of Abatacept IV for Rheumatoid Arthritis in Real Life Setting

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

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Key information

Conditions

Rheumatoid Arthritis Arthritis Arthritis, Rheumatoid Autoimmune Diseases Connective Tissue Diseases Immune System Diseases Joint Diseases Musculoskeletal Diseases Rheumatic Diseases Skin and Connective Tissue Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

About this study

Observational Model:

Other: ReACTION is a study using secondary data originally collected in ACTION study. In ACTION, data were collected prospectively from October 2010 up to 2015 at each clinical visit. In France, data collection started in June 2011

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Abatacept

Drug

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

    Time frame: Up to 2 years of followup

Secondary outcomes

  1. Abatacept effectiveness in the treated population

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

    Based on simplified disease activity score - 28 joints (DAS28), clinical disease activity index (CDAI), health assessment questionnaire (HAQ), and occurrence of serious adverse events

  2. Impact of patient and disease characteristics on treatment outcomes

    Time frame: Every 3 months up to 2 years of followup

  3. 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

  4. 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

  5. Therapeutic strategies over time including change in concomitants treatments

    Time frame: Every 3 months up to 2 years of followup

  6. 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

  7. 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

Sponsors and collaborators

Lead sponsor

Bristol-Myers Squibb

Industry

Registry information

Official study 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

Acronym: ReACTION

Important dates

Study start
2016
Primary completion
2018
Study completion
2018
First posted
Jan 16, 2014
Registry last updated
Feb 7, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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