Effectiveness and Safety of Tofacitinib in Korean Patients With Rheumatoid Arthritis

NCT ID: NCT03011281

Last Updated: 2020-06-25

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

UNKNOWN

Total Enrollment

378 participants

Study Classification

OBSERVATIONAL

Study Start Date

2016-09-30

Study Completion Date

2021-12-31

Brief Summary

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The objectives of this single center, prospective, non-interventional inception cohort is to understand patient characteristics, general treatment patterns, effectiveness, and safety of Tofacitinib for rheumatoid arthritis patients in the real-world setting.

1. To evaluate the baseline characteristics of Korean RA patients treated with Tofacitinib
2. To evaluate the effectiveness and safety of Tofacitinib in clinical practice in Korean RA patients.
3. To further evaluate safety, effectiveness and demographic characteristics of the patients treated with Tofacitinib matched with and compared to biologic DMARDs from the BIOPSY registry database.

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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RA patients who start Tofacitinib

Korean RA patients who start Tofacitinib with moderately to severely active RA who have had an inadequate response or intolerance to methotrexate or biologics.

Tofacitinib

Intervention Type DRUG

Interventions

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Tofacitinib

Intervention Type DRUG

Other Intervention Names

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Xeljanz

Eligibility Criteria

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Inclusion Criteria

A. Patients who provide a written informed consent form of participating in this study.

B. Patients who are more than 19 years old. C. Patients with moderately to severely active rheumatoid arthritis as defined per EULAR guidelines, who have had an inadequate response or are intolerant to methotrexate.

Exclusion Criteria

A. Patients who do not provide a written informed consent form of participating in this study
Minimum Eligible Age

19 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Hanyang University

OTHER

Sponsor Role lead

Responsible Party

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Yoon-Kyoung Sung

Associate professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Yoon-Kyoung Sung, MD, PhD, MPH

Role: PRINCIPAL_INVESTIGATOR

Hanyang University Hospital for Rheumatic Diseases

Locations

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Hanyang University

Seoul, , South Korea

Site Status RECRUITING

Countries

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South Korea

Central Contacts

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Yoon-Kyoung Sung, MD, PhD, MPH

Role: CONTACT

82-2-2290-9250

Facility Contacts

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Yoon-kyoung Sung, MD, PhD, MPH

Role: primary

82-2-2290-9250

Other Identifiers

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HUHRD-SPE-16-09

Identifier Type: -

Identifier Source: org_study_id

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