Japan Post-Marketing Surveillance for Peficitinib to Assess Safety and Effectiveness in the Patients With Rheumatoid Arthritis

NCT ID: NCT03971253

Last Updated: 2025-12-04

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

RECRUITING

Total Enrollment

3000 participants

Study Classification

OBSERVATIONAL

Study Start Date

2019-09-02

Study Completion Date

2026-05-31

Brief Summary

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The objective of this study is to investigate the safety and effectiveness in routine clinical practice and actual clinical setting for all patients with rheumatoid arthritis (RA) treated with peficitinib.

Detailed Description

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This is a mandatory Post-Marketing Surveillance (PMS) requested by Pharmaceuticals and Medical Devices Agency (PMDA) as a part of the Japan-Risk Management Plan (J-RMP).

Conditions

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Rheumatoid Arthritis (RA)

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Peficitinib

Participants will receive peficitinib once daily after meal.

Peficitinib

Intervention Type DRUG

Oral

Interventions

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Peficitinib

Oral

Intervention Type DRUG

Other Intervention Names

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ASP015K Smyraf

Eligibility Criteria

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Inclusion Criteria

* All patients with rheumatoid arthritis (RA) treated with peficitinib for the first time.

Exclusion Criteria

* Not applicable.
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Astellas Pharma Inc

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Central Contact

Role: STUDY_DIRECTOR

Astellas Pharma Inc

Locations

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Site JP00019

Yamanashi, , Japan

Site Status RECRUITING

Site JP00024

Mie, , Japan

Site Status RECRUITING

Site JP00004

Miyagi, , Japan

Site Status RECRUITING

Site JP00045

Miyazaki, , Japan

Site Status RECRUITING

Site JP00020

Nagano, , Japan

Site Status RECRUITING

Site JP00042

Nagasaki, , Japan

Site Status RECRUITING

Site JP00029

Nara, , Japan

Site Status RECRUITING

Site JP00015

Niigata, , Japan

Site Status RECRUITING

Site JP00003

Numakunai, , Japan

Site Status RECRUITING

Site JP00033

Okayama, , Japan

Site Status RECRUITING

Site JP00047

Okinawa, , Japan

Site Status RECRUITING

Site JP00027

Osaka, , Japan

Site Status RECRUITING

Site JP00044

Ōita, , Japan

Site Status RECRUITING

Site JP00041

Saga, , Japan

Site Status RECRUITING

Site JP00011

Saitama, , Japan

Site Status RECRUITING

Site JP00025

Shiga, , Japan

Site Status RECRUITING

Site JP00032

Shimane, , Japan

Site Status RECRUITING

Site JP00022

Shizuoka, , Japan

Site Status RECRUITING

Site JP00009

Tochigi, , Japan

Site Status RECRUITING

Site JP00036

Tokushima, , Japan

Site Status RECRUITING

Site JP00013

Tokyo, , Japan

Site Status RECRUITING

Site JP00031

Tottori, , Japan

Site Status RECRUITING

Site JP00016

Toyama, , Japan

Site Status RECRUITING

Site JP00030

Wakayama, , Japan

Site Status RECRUITING

Site JP00006

Yamagata, , Japan

Site Status RECRUITING

Site JP00035

Yamaguchi, , Japan

Site Status RECRUITING

Site JP00014

Kanagawa, , Japan

Site Status RECRUITING

Site JP00039

Kochi, , Japan

Site Status RECRUITING

Site JP00043

Kumamoto, , Japan

Site Status RECRUITING

Site JP00026

Kyoto, , Japan

Site Status RECRUITING

Site JP00023

Aichi, , Japan

Site Status RECRUITING

Site JP00005

Akita, , Japan

Site Status RECRUITING

Site JP00002

Aomori, , Japan

Site Status RECRUITING

Site JP00012

Chiba, , Japan

Site Status RECRUITING

Site JP00038

Ehime, , Japan

Site Status RECRUITING

Site JP00018

Fukui, , Japan

Site Status RECRUITING

Site JP00040

Fukuoka, , Japan

Site Status RECRUITING

Site JP00007

Fukushima, , Japan

Site Status RECRUITING

Site JP00021

Gifu, , Japan

Site Status RECRUITING

Site JP00010

Gunma, , Japan

Site Status RECRUITING

Site JP00034

Hiroshima, , Japan

Site Status RECRUITING

Site JP00001

Hokkaido, , Japan

Site Status RECRUITING

Site JP00028

Hyōgo, , Japan

Site Status RECRUITING

Site JP00008

Ibaraki, , Japan

Site Status RECRUITING

Site JP00017

Ishikawa, , Japan

Site Status RECRUITING

Site JP00037

Kagawa, , Japan

Site Status RECRUITING

Site JP00046

Kagoshima, , Japan

Site Status RECRUITING

Countries

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Japan

Central Contacts

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Astellas Pharma Inc.

Role: CONTACT

Other Identifiers

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015K-MA-3311

Identifier Type: -

Identifier Source: org_study_id

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