Korean Post-marketing Surveillance for Orencia®

NCT ID: NCT01583244

Last Updated: 2016-05-12

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

701 participants

Study Classification

OBSERVATIONAL

Study Start Date

2010-03-31

Study Completion Date

2016-02-29

Brief Summary

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The purpose of this post-marketing surveillance is to investigate and confirm the type and incidence of newly identified adverse events and any other factors affecting safety and efficacy of Orencia® so that the regulatory authority can manage the marketing approval properly.

Detailed Description

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Time Perspective: Prospective / Retrospective(On-treatment)

Conditions

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Rheumatoid Arthritis

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Study Groups

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Patients with active rheumatoid arthritis

Patients aged 6 years and over who have moderate-to-severe active rheumatoid arthritis

No Intervention (subjects were previously treated with Orencia®)

Intervention Type DRUG

No Intervention

Interventions

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No Intervention (subjects were previously treated with Orencia®)

No Intervention

Intervention Type DRUG

Other Intervention Names

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Abatacept

Eligibility Criteria

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Inclusion Criteria

* Patients must be diagnosed with: Adult Rheumatoid arthritis (RA): adult patients with moderate-to-severe active RA

Or

* Juvenile idiopathic RA: juvenile patients aged 6 years and older with moderate-to-severe active RA

Exclusion Criteria

* Children aged \<6 years
* Pregnant or lactating women
* Patients who are participating in another study
* Patients known to be hypersensitive to the active component of the surveillance drug or any other component of the surveillance drug
* Patients who had a positive tuberculosis screening test but were not treated with standard therapy before participating in the study
* Patients who have a positive hepatitis virus test
* Patients who were given a live vaccine concurrently with the surveillance drug or are expected to be given a live vaccine again within 3 months after discontinuation of the surveillance drug
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

Seoul, , South Korea

Site Status

Countries

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South Korea

References

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Lee JS, Ahmad H, Shim SC, Bae SC, Song YW, Lee EY. High Proportion of Subjective Component to the Disease Activity Score is Associated with Favorable Response to Abatacept in Rheumatoid Arthritis. Patient. 2019 Jun;12(3):319-326. doi: 10.1007/s40271-018-0347-z.

Reference Type DERIVED
PMID: 30484084 (View on PubMed)

Related Links

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Other Identifiers

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IM101-300

Identifier Type: -

Identifier Source: org_study_id

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