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Safety Study of Abatacept to Treat Rheumatoid Arthritis (A)

NCT ID: NCT01088321

Last Updated: 2016-12-08

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

81332 participants

Study Classification

OBSERVATIONAL

Study Start Date

2005-03-31

Study Completion Date

2016-11-30

Brief Summary

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The purpose of this study is to compare the incidence rates of infection 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 initiating abatacept

No interventions assigned to this group

Patients initiating other biologic disease-modifying drugs

No interventions assigned to this group

Pts initiate non-biologic disease-modify anti-rheumatic drugs

No interventions assigned to this group

Eligibility Criteria

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Inclusion Criteria

* Diagnosis of rheumatoid arthritis
* Claims indicating infusion, injection, or dispensing of abatacept, a DMARD, or a BDM
* Age 18 years or older at the time of drug initiation
* Enrollment in the health plan at least 6 continuous months leading up to the time of study drug initiation

Exclusion Criteria

* Below 18 years of age at the time of BDM or DMARD initiation
* Lacking six months of continuous enrollment prior to the initiation of one of the study drugs
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

Other Identifiers

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IM101-045A

Identifier Type: -

Identifier Source: org_study_id