Safety Study of Abatacept in Rheumatoid Arthritis Participants

NCT ID: NCT03696173

Last Updated: 2018-10-04

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

5800 participants

Study Classification

OBSERVATIONAL

Study Start Date

2015-12-17

Study Completion Date

2018-06-29

Brief Summary

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A observational study to assess whether biologic disease-modifying (BDM) treatment initiation with abatacept for rheumatoid arthritis is associated with an increased risk of serious infection and cancer

Detailed Description

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Conditions

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Rheumatoid Arthritis

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Study Groups

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Participants taking abatacept

Non-Interventional

Intervention Type OTHER

Non-Interventional

Participants taking abatacept with methotrexate

Non-Interventional

Intervention Type OTHER

Non-Interventional

Interventions

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Non-Interventional

Non-Interventional

Intervention Type OTHER

Non-Interventional

Non-Interventional

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Patient initiates BDM treatment with at least one claim for the treatment. Patients will be presumed to be new users of a treatment if there is no claim for the drug or any other BDM in the 180 days prior to the cohort entry date
* Patient has at least two diagnoses for RA in the patient's history prior to and including the entry date or within the 180 days after the entry date
* Patient is aged 18 years or older on the entry date
* Patient was enrolled in the database for at least 180 days before the entry date

Exclusion Criteria

* Patient is younger than 18 years on the entry date
* Patients who receive abatacept and another biologic simultaneously
* Patients who have an outcome diagnosis in the baseline period will be excluded from the cohort analyses for that outcome
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Bristol-Myers Squibb

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Bristol-Myers Squibb

Role: STUDY_DIRECTOR

Bristol-Myers Squibb

Locations

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Local Institution

Princeton, New Jersey, United States

Site Status

Countries

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United States

Related Links

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Other Identifiers

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IM101-605

Identifier Type: -

Identifier Source: org_study_id

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