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

Rheumatoid Arthritis (RA) Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03971253
• Other study ID #: 015K-MA-3311
• Status: Recruiting
• Start date: September 2, 2019
• Est. completion date: December 31, 2025

Study information

• Verified date: June 2024
• Source: Astellas Pharma Inc
• Contact: Astellas Pharma Inc.
• Email: astellas.registration[@]astellas.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 3000
• Est. completion date: December 31, 2025
• Est. primary completion date: December 31, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

Inclusion Criteria:

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

Exclusion Criteria:

• Not applicable.

Related Conditions & MeSH terms

• Arthritis
• Arthritis, Rheumatoid
• Rheumatoid Arthritis (RA)

Intervention

Drug:
• Peficitinib
Oral

Locations

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

Sponsors (1)

Lead Sponsor	Collaborator
Astellas Pharma Inc

Country where clinical trial is conducted

Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	Safety assessed by frequency of serious infections	Serious infections include tuberculosis, pneumonia, pneumocystis pneumonia, ichorrhemia and opportunistic infection.	Up to 156 weeks
Primary	Safety assessed by frequency of malignancy	Frequency of malignancy found after drug administration.	Up to 156 weeks
Primary	Safety assessed by frequency of events leading to death	Any events leading to death will be reported as serious AEs.	Up to 156 weeks
Primary	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
Primary	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
Primary	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
Primary	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 = 0.56v(TJC) + 0.28v(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
Primary	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 = 0.56v(TJC) + 0.28v(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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	Erythrocyte sedimentation rate (ESR)	ESR will be recorded from blood samples collected.	Up to 52 weeks
Primary	C-reactive protein (CRP)	CRP will be recorded from blood samples collected.	Up to 52 weeks
Primary	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
Primary	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
Primary	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
Primary	Percentage of participants achieving DAS28-CRP scores for remission	Percentage of participants with DAS28 scores less than 2.6.	Up to 52 weeks
Primary	Percentage of participants achieving DAS28-ESR scores for remission	Percentage of participants with DAS28 scores less than 2.6.	Up to 52 weeks