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

Astellas

Status: Enrolling

Conditions: Rheumatoid Arthritis (RA)

Treatments: Drug: Peficitinib

Study type: Observational

Funder types: Industry

Identifiers

NCT03971253

015K-MA-3311

Details and patient eligibility

About

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.

Full 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).

Enrollment: 3,000 estimated patients

Sex: All

Volunteers: No Healthy Volunteers

Inclusion criteria

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

Exclusion criteria

• Not applicable.

Trial design

3,000 participants in 1 patient group

Peficitinib

Description:

Participants will receive peficitinib once daily after meal.

Treatment:

Drug: Peficitinib