Survey on Long-Term Use of ORENCIA® Intravenous Infusion 250mg

NCT ID: NCT02600468

Last Updated: 2017-01-16

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

671 participants

Study Classification

OBSERVATIONAL

Study Start Date

2013-09-30

Study Completion Date

2015-12-31

Brief Summary

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The purpose of this study to collect information on the safety, especially serious infections and malignancies, and efficacy of the long-term use of ORENCIA Intravenous Infusion 250mg in patients with rheumatoid arthritis.

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 who use ORENCIA

Patients who use ORENCIA for the approved indications and who at the start of treatment

Orencia

Intervention Type DRUG

Interventions

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Orencia

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Patients who are beginning to receive the treatment with ORENCIA Intravenous Infusion 250mg under the approved indications, dosage, and administration
* Have available HAQ data
* Have available DAS28-ESR or DAS28- CRP data
* Have no past or present history of malignancies
* Are expected to be followed up for 3 years
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Ono Pharmaceutical Co. Ltd

INDUSTRY

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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IM101-516

Identifier Type: -

Identifier Source: org_study_id

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