Safety Study of Abatacept to Treat Rheumatoid Arthritis (B)

NCT ID: NCT01088360

Last Updated: 2019-01-18

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

ACTIVE_NOT_RECRUITING

Total Enrollment

20000 participants

Study Classification

OBSERVATIONAL

Study Start Date

2005-03-31

Study Completion Date

2029-06-30

Brief Summary

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The purpose of this study is to compare the incidence rates of targeted infections, malignancies and mortality among patients with rheumatoid arthritis who are treated with abatacept and those who are treated with other anti-rheumatic medications.

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

PROSPECTIVE

Study Groups

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Patients with rheumatoid arthritis initiating abatacept

No interventions assigned to this group

Pts with RA initiating other biologic disease-modifying drugs

No interventions assigned to this group

Pts w/ RA non-biologic disease-modifying anti-rheumatic drugs

No interventions assigned to this group

Eligibility Criteria

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Inclusion Criteria

* Signed informed consent
* Diagnosis of rheumatoid arthritis
* \> 18 years at index treatment initiation or switch
* Starting treatment with abatacept or new disease-modifying anti-rheumatic drug (including switching or adding) or biologic disease modifying drug.
* Read/write English

Exclusion Criteria

* None
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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National Data Bank for Rheumatic Diseases (NDB)

OTHER

Sponsor Role collaborator

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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IM101-045B

Identifier Type: -

Identifier Source: org_study_id

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