Monitoring the safety and effectiveness of peficitinib in rheumatoid arthritis patients in Japan
Japan Post-Marketing Surveillance - Specified Drug Use-results Survey for Peficitinib to Assess Safety and Effectiveness in the Patients With Rheumatoid Arthritis
This study is testing how safe and effective the medication peficitinib is for people with rheumatoid arthritis in Japan who are using it for the first time.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 3000 (estimated) |
| Sex | All |
| Sponsor | Astellas Pharma Inc Industry-sponsored |
| Drugs / interventions | peficitinib |
| Locations | 47 sites (Aichi and 46 other locations) |
| Trial ID | NCT03971253 on ClinicalTrials.gov |
What this trial studies
This observational study aims to assess the safety and effectiveness of peficitinib in patients with rheumatoid arthritis (RA) in a real-world clinical setting. It is a mandatory post-marketing surveillance requested by the Pharmaceuticals and Medical Devices Agency (PMDA) as part of Japan's Risk Management Plan. The study will include all patients who are treated with peficitinib for the first time, allowing for a comprehensive evaluation of its use in routine practice.
Who should consider this trial
Good fit: Ideal candidates for this study are patients with rheumatoid arthritis who are starting treatment with peficitinib.
Not a fit: Patients who are not being treated with peficitinib will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide valuable insights into the real-world effectiveness and safety profile of peficitinib for RA patients.
How similar studies have performed: Other post-marketing surveillance studies have shown success in evaluating the safety and effectiveness of treatments in real-world settings, making this approach well-established.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * All patients with rheumatoid arthritis (RA) treated with peficitinib for the first time. Exclusion Criteria: * Not applicable.
Where this trial is running
Aichi and 46 other locations
- Site JP00023 — Aichi, Japan (Recruiting)
- Site JP00005 — Akita, Japan (Recruiting)
- Site JP00002 — Aomori, Japan (Recruiting)
- Site JP00012 — Chiba, Japan (Recruiting)
- Site JP00038 — Ehime, Japan (Recruiting)
- Site JP00018 — Fukui, Japan (Recruiting)
- Site JP00040 — Fukuoka, Japan (Recruiting)
- Site JP00007 — Fukushima, Japan (Recruiting)
- Site JP00021 — Gifu, Japan (Recruiting)
- Site JP00010 — Gunma, Japan (Recruiting)
- Site JP00034 — Hiroshima, Japan (Recruiting)
- Site JP00001 — Hokkaido, Japan (Recruiting)
- Site JP00028 — Hyōgo, Japan (Recruiting)
- Site JP00008 — Ibaraki, Japan (Recruiting)
- Site JP00017 — Ishikawa, Japan (Recruiting)
- Site JP00037 — Kagawa, Japan (Recruiting)
- Site JP00046 — Kagoshima, Japan (Recruiting)
- Site JP00014 — Kanagawa, Japan (Recruiting)
- Site JP00039 — Kochi, Japan (Recruiting)
- Site JP00043 — Kumamoto, Japan (Recruiting)
- Site JP00026 — Kyoto, Japan (Recruiting)
- Site JP00024 — Mie, Japan (Recruiting)
- Site JP00004 — Miyagi, Japan (Recruiting)
- Site JP00045 — Miyazaki, Japan (Recruiting)
- Site JP00020 — Nagano, Japan (Recruiting)
- Site JP00042 — Nagasaki, Japan (Recruiting)
- Site JP00029 — Nara, Japan (Recruiting)
- Site JP00015 — Niigata, Japan (Recruiting)
- Site JP00003 — Numakunai, Japan (Recruiting)
- Site JP00033 — Okayama, Japan (Recruiting)
- Site JP00047 — Okinawa, Japan (Recruiting)
- Site JP00027 — Osaka, Japan (Recruiting)
- Site JP00044 — Ōita, Japan (Recruiting)
- Site JP00041 — Saga, Japan (Recruiting)
- Site JP00011 — Saitama, Japan (Recruiting)
- Site JP00025 — Shiga, Japan (Recruiting)
- Site JP00032 — Shimane, Japan (Recruiting)
- Site JP00022 — Shizuoka, Japan (Recruiting)
- Site JP00009 — Tochigi, Japan (Recruiting)
- Site JP00036 — Tokushima, Japan (Recruiting)
- Site JP00013 — Tokyo, Japan (Recruiting)
- Site JP00031 — Tottori, Japan (Recruiting)
- Site JP00016 — Toyama, Japan (Recruiting)
- Site JP00030 — Wakayama, Japan (Recruiting)
- Site JP00006 — Yamagata, Japan (Recruiting)
- Site JP00035 — Yamaguchi, Japan (Recruiting)
- Site JP00019 — Yamanashi, Japan (Recruiting)
Study contacts
- Study coordinator: Astellas Pharma Inc.
- Email: astellas.registration@astellas.com
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.