NCT03971253

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

Japan Post-Marketing Surveillance - Specified Drug Use-results Survey for Peficitinib to Assess Safety and Effectiveness in the Patients With Rheumatoid Arthritis

• Status: Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 3,000 (estimated)
• Sponsor: Astellas Pharma Inc · Industry
• Sex: All
• Age: —
• Healthy volunteers: Not accepted

Summary

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

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

• Rheumatoid Arthritis (RA)

Interventions

Type	Name	Description
DRUG	Peficitinib	Oral

Timeline

• Start date: 2019-09-02
• Primary completion: 2026-05-31
• Completion: 2026-05-31
• First posted: 2019-06-03
• Last updated: 2026-04-06

Locations

47 sites across 1 country: Japan