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

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.

Study Overview

• Status: Recruiting
• Conditions: Rheumatoid Arthritis (RA)
• Intervention / Treatment: Drug: 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).

• Study Type: Observational
• Enrollment (Estimated): 3000

Contacts and Locations

• Study Contact: Name: Astellas Pharma Inc.; Email: astellas.registration@astellas.com

Study Locations

• Japan
  • Aichi, Japan
    • Recruiting
    • Site JP00023
  • Akita, Japan
    • Recruiting
    • Site JP00005
  • Aomori, Japan
    • Recruiting
    • Site JP00002
  • Chiba, Japan
    • Recruiting
    • Site JP00012
  • Ehime, Japan
    • Recruiting
    • Site JP00038
  • Fukui, Japan
    • Recruiting
    • Site JP00018
  • Fukuoka, Japan
    • Recruiting
    • Site JP00040
  • Fukushima, Japan
    • Recruiting
    • Site JP00007
  • Gifu, Japan
    • Recruiting
    • Site JP00021
  • Gunma, Japan
    • Recruiting
    • Site JP00010
  • Hiroshima, Japan
    • Recruiting
    • Site JP00034
  • Hokkaido, Japan
    • Recruiting
    • Site JP00001
  • Hyogo, Japan
    • Recruiting
    • Site JP00028
  • Ibaraki, Japan
    • Recruiting
    • Site JP00008
  • Ishikawa, Japan
    • Recruiting
    • Site JP00017
  • Iwate, Japan
    • Recruiting
    • Site JP00003
  • Kagawa, Japan
    • Recruiting
    • Site JP00037
  • Kagoshima, Japan
    • Recruiting
    • Site JP00046
  • Kanagawa, Japan
    • Recruiting
    • Site JP00014
  • Kochi, Japan
    • Recruiting
    • Site JP00039
  • Kumamoto, Japan
    • Recruiting
    • Site JP00043
  • Kyoto, Japan
    • Recruiting
    • Site JP00026
  • Mie, Japan
    • Recruiting
    • Site JP00024
  • Miyagi, Japan
    • Recruiting
    • Site JP00004
  • Miyazaki, Japan
    • Recruiting
    • Site JP00045
  • Nagano, Japan
    • Recruiting
    • Site JP00020
  • Nagasaki, Japan
    • Recruiting
    • Site JP00042
  • Nara, Japan
    • Recruiting
    • Site JP00029
  • Niigata, Japan
    • Recruiting
    • Site JP00015
  • Oita, Japan
    • Recruiting
    • Site JP00044
  • Okayama, Japan
    • Recruiting
    • Site JP00033
  • Okinawa, Japan
    • Recruiting
    • Site JP00047
  • Osaka, Japan
    • Recruiting
    • Site JP00027
  • Saga, Japan
    • Recruiting
    • Site JP00041
  • Saitama, Japan
    • Recruiting
    • Site JP00011
  • Shiga, Japan
    • Recruiting
    • Site JP00025
  • Shimane, Japan
    • Recruiting
    • Site JP00032
  • Shizuoka, Japan
    • Recruiting
    • Site JP00022
  • Tochigi, Japan
    • Recruiting
    • Site JP00009
  • Tokushima, Japan
    • Recruiting
    • Site JP00036
  • Tokyo, Japan
    • Recruiting
    • Site JP00013
  • Tottori, Japan
    • Recruiting
    • Site JP00031
  • Toyama, Japan
    • Recruiting
    • Site JP00016
  • Wakayama, Japan
    • Recruiting
    • Site JP00030
  • Yamagata, Japan
    • Recruiting
    • Site JP00006
  • Yamaguchi, Japan
    • Recruiting
    • Site JP00035
  • Yamanashi, Japan
    • Recruiting
    • Site JP00019

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Patients with rheumatoid arthritis (RA) treated with peficitinib for the first time.

Description

Inclusion Criteria:

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

Exclusion Criteria:

• Not applicable.

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Peficitinib; Participants will receive peficitinib once daily after meal.	Drug: Peficitinib; Oral; Other Names: ASP015K; Smyraf

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Safety assessed by frequency of adverse events (AEs)	An AE is defined as any unwanted medical occurrence after drug administration and which does not necessarily have a causal relationship with the treatment.	Up to 52 weeks
Safety assessed by frequency of adverse drug reactions (ADRs)	AEs whose relationship to the study drugs could not be ruled out is considered adverse drug reaction. AEs that fall under either "Probable" or "Possible" or "Unassessable" should be defined as "AEs whose relationship to the study drugs could not be ruled out."	Up to 52 weeks
Safety assessed by frequency of serious infections	Serious infections include tuberculosis, pneumonia, pneumocystis pneumonia, ichorrhemia and opportunistic infection.	Up to 156 weeks
Safety assessed by frequency of malignancy	Frequency of malignancy found after drug administration.	Up to 156 weeks
Safety assessed by frequency of events leading to death	Any events leading to death will be reported as serious AEs.	Up to 156 weeks
Safety assessed by frequency of serious adverse events (SAEs)	An AE is considered "serious" if, in the view of either the investigator, it results in any of the following outcomes: death, life-threatening, persistent or significant disability/incapacity or substantial disruption, congenital anomaly or birth defect, hospitalization or prolongation of hospitalization, or medically important events.	Up to 156 weeks
Safety assessed by frequency of serious adverse drug reactions (SADRs)	SAEs whose relationship to the study drugs could not be ruled out is considered serious ADR. SAEs that fall under either "Probable" or "Possible" or "Unassessable" should be defined as "SAEs whose relationship to the study drugs could not be ruled out."	Up to 156 weeks
Disease activity score (DAS28) - C-reactive protein (CRP)	DAS28-CRP will be calculated using data from Tender Joint Count (TJC) (28 joints), Swollen Joint Count (SJC) (28 joints), C-reactive protein (CRP) and Subject's Global Assessment of Arthritis (SGA) with the formula; DAS28-CRP = 0.56√(TJC) + 0.28√(SJC) + 0.36 ln (CRP (mg/dL) x 10 + 1) + 0.014 x SGA (mm) + 0.96. DAS28-CRP exceeding 5.1 is considered high disease activity; exceeding 3.2 and not greater than 5.1, moderate disease activity; exceeding 2.6 and not greater than 3.2, low disease activity.	Up to 52 weeks
DAS28- erythrocyte sedimentation rate (ESR) score	DAS28-ESR will be calculated using data from TJC (28 joints), SJC (28 joints), ESR and SGA with the formula; DAS28- ESR = 0.56√(TJC) + 0.28√(SJC) + 0.70 ln ESR (mm/h) + 0.014 x SGA (mm). DAS28-ESR exceeding 5.1 is considered high disease activity; exceeding 3.2 and not greater than 5.1, moderate disease activity; exceeding 2.6 and not greater than 3.2, low disease activity.	Up to 52 weeks
Simplified Disease Activity Index (SDAI) score	SDAI score will be calculated with formula SDAI = TJC + SJC + SGA + Physician's Global Assessment of Arthritis (PGA) + CRP. SDAI score exceeding 26 is considered high disease activity; exceeding 11 and not greater than 26, moderate disease activity; exceeding 3.3 and not greater than 11, low disease activity.	Up to 52 weeks
Clinical Disease Activity Index (CDAI) score	CDAI score will be calculated with formula CDAI = TJC + SJC + SGA + PGA. CDAI score exceeding 22 is considered high disease activity; exceeding 10 and not greater than 22, moderate disease activity; exceeding 2.8 and not greater than 10, low disease activity.	Up to 52 weeks
Tender Joint Count (TJC) (28 joints)	The investigator/sub-investigator will examine the participant for tender joints, assessing the 28 joints and confirm the location of each tender joint.	Up to 52 weeks
Swollen Joint Count (SJC) (28 joints)	The investigator/sub-investigator will examine the participants for swollen joints, assessing the 28 joints and confirm the location of the swollen joints.	Up to 52 weeks
Erythrocyte sedimentation rate (ESR)	ESR will be recorded from blood samples collected.	Up to 52 weeks
C-reactive protein (CRP)	CRP will be recorded from blood samples collected.	Up to 52 weeks
Subject's Global Assessment of Arthritis (SGA) (visual analog scale (VAS))	The participant assesses his/her own disease activity on a VAS of 0 - 100 mm, corresponding from 'no disease activity' to 'very severe disease activity', on the questionnaire form.	Up to 52 weeks
Physician's Global Assessment of Arthritis (PGA) (VAS)	The investigator assesses participant's disease activity on a VAS of 0 - 100 mm, corresponding from 'no disease activity' to 'very severe disease activity', on the questionnaire form.	Up to 52 weeks
European League Against Rheumatism (EULAR) Response Criteria	Based on DAS28 scores and changes in DAS28 scores before and after treatment with the study drug, EULAR Response Criteria categorize response to treatment as "No response", "Moderate response," or "Good response."	Up to 52 weeks
Percentage of participants achieving DAS28-CRP scores for remission	Percentage of participants with DAS28 scores less than 2.6.	Up to 52 weeks
Percentage of participants achieving DAS28-ESR scores for remission	Percentage of participants with DAS28 scores less than 2.6.	Up to 52 weeks
Safety assessed by frequency of AEs of special interests	AEs of special interests include neutrophil decrease, lymphocyte decrease, hemoglobin decrease, Herpes zoster, gastrointestinal perforation, interstitial pneumonia, reactivation of Hepatitis B virus, hepatic function disorder, venous thromboembolism, cardiovascular events, rhabdomyolysis and myopathy.	Up to 156 weeks

Collaborators and Investigators

• Sponsor: Astellas Pharma Inc
• Investigators: Study Director: Central Contact, Astellas Pharma Inc

Study record dates

Study Major Dates

• Study Start (Actual): September 2, 2019
• Primary Completion (Estimated): December 31, 2025
• Study Completion (Estimated): December 31, 2025

Study Registration Dates

• First Submitted: May 30, 2019
• First Submitted That Met QC Criteria: May 30, 2019
• First Posted (Actual): June 3, 2019

Study Record Updates

• Last Update Posted (Actual): April 17, 2024
• Last Update Submitted That Met QC Criteria: April 16, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Keywords: ASP015K; Post-Marketing Surveillance; Rheumatoid arthritis (RA); Smyraf; Peficitinib
• Additional Relevant MeSH Terms: Immune System Diseases; Autoimmune Diseases; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Connective Tissue Diseases; Arthritis; Arthritis, Rheumatoid; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Immunosuppressive Agents; Immunologic Factors; Peficitinib
• Other Study ID Numbers: 015K-MA-3311

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Access to anonymized individual participant level data will not be provided for this trial as it meets one or more of the exceptions described on www.clinicalstudydatarequest.com under "Sponsor Specific Details for Astellas."

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No