Post-marketing Study Assessing the Long-Term Safety of Abatacept

NCT ID: NCT02169544

Last Updated: 2017-04-25

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

100000 participants

Study Classification

OBSERVATIONAL

Study Start Date

2014-01-31

Study Completion Date

2017-02-28

Brief Summary

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The purpose of this study is to evaluate the risk of infections and malignancies among Rheumatoid Arthritis (RA) patients treated with Abatacept compared to other RA treatments.

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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RA patients who are prescribed Abatacept

Abatacept

Abatacept

Intervention Type DRUG

Patients who are prescribed other RA treatments

No interventions assigned to this group

Interventions

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Abatacept

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Patient has at least two claims for RA (714.xx) in the 180 days prior to and including the index date (baseline period)
* Patient is aged 18 years or older on the index date
* Patient was enrolled in the database for at least 180 days before the index date
* Patient is newly prescribed Abatacept or another RA treatment and has at least two claims for the treatment
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

Related Links

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Other Identifiers

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IM101-488

Identifier Type: -

Identifier Source: org_study_id

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