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Trial record 5 of 69 for:    response | "Connective Tissue Disease" | "Abatacept"

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

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ClinicalTrials.gov Identifier: NCT02037737
Recruitment Status : Completed
First Posted : January 16, 2014
Last Update Posted : February 7, 2018
Sponsor:
Information provided by (Responsible Party):
Bristol-Myers Squibb

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

Condition or disease Intervention/treatment
Rheumatoid Arthritis Drug: Abatacept

Detailed Description:

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


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Study Type : Observational
Actual Enrollment : 153 participants
Observational Model: Other
Time Perspective: Retrospective
Official 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
Actual Study Start Date : September 30, 2016
Actual Primary Completion Date : January 31, 2018
Actual Study Completion Date : January 31, 2018

Resource links provided by the National Library of Medicine

Drug Information available for: Abatacept

Group/Cohort Intervention/treatment
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



Primary Outcome Measures :
  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 Outcome Measures :
  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 ]


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-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
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

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): NCT02037737


Sponsors and Collaborators
Bristol-Myers Squibb
Investigators
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Study Director: Bristol-Myers Squibb Bristol-Myers Squibb

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Responsible Party: Bristol-Myers Squibb
ClinicalTrials.gov Identifier: NCT02037737     History of Changes
Other Study ID Numbers: IM101-409
First Posted: January 16, 2014    Key Record Dates
Last Update Posted: February 7, 2018
Last Verified: February 2018
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
Methotrexate
Abortifacient Agents, Nonsteroidal
Abortifacient Agents
Reproductive Control Agents
Physiological Effects of Drugs
Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Dermatologic Agents
Enzyme Inhibitors
Folic Acid Antagonists
Immunosuppressive Agents
Immunologic Factors
Antirheumatic Agents
Nucleic Acid Synthesis Inhibitors