Japan Post-Marketing Surveillance for Peficitinib to Assess Safety and Effectiveness in the Patients With Rheumatoid Arthritis
- Registration Number
- NCT03971253
- Lead Sponsor
- Astellas Pharma Inc
- Brief 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).
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 3000
- All patients with rheumatoid arthritis (RA) treated with peficitinib for the first time.
- Not applicable.
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Peficitinib Peficitinib Participants will receive peficitinib once daily after meal.
- Primary Outcome Measures
Name Time Method C-reactive protein (CRP) Up to 52 weeks CRP will be recorded from blood samples collected.
Safety assessed by frequency of adverse events (AEs) Up to 52 weeks An AE is defined as any unwanted medical occurrence after drug administration and which does not necessarily have a causal relationship with the treatment.
Safety assessed by frequency of events leading to death Up to 156 weeks Any events leading to death will be reported as serious AEs.
Safety assessed by frequency of AEs of special interests Up to 156 weeks 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.
Safety assessed by frequency of serious adverse drug reactions (SADRs) Up to 156 weeks 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."
Disease activity score (DAS28) - C-reactive protein (CRP) Up to 52 weeks 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.Tender Joint Count (TJC) (28 joints) Up to 52 weeks The investigator/sub-investigator will examine the participant for tender joints, assessing the 28 joints and confirm the location of each tender joint.
Physician's Global Assessment of Arthritis (PGA) (VAS) Up to 52 weeks 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.
Safety assessed by frequency of adverse drug reactions (ADRs) Up to 52 weeks 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."
Safety assessed by frequency of malignancy Up to 156 weeks Frequency of malignancy found after drug administration.
Simplified Disease Activity Index (SDAI) score Up to 52 weeks 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.Safety assessed by frequency of serious infections Up to 156 weeks Serious infections include tuberculosis, pneumonia, pneumocystis pneumonia, ichorrhemia and opportunistic infection.
European League Against Rheumatism (EULAR) Response Criteria Up to 52 weeks 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."
Safety assessed by frequency of serious adverse events (SAEs) Up to 156 weeks 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.
DAS28- erythrocyte sedimentation rate (ESR) score Up to 52 weeks 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.Swollen Joint Count (SJC) (28 joints) Up to 52 weeks The investigator/sub-investigator will examine the participants for swollen joints, assessing the 28 joints and confirm the location of the swollen joints.
Clinical Disease Activity Index (CDAI) score Up to 52 weeks 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.
Erythrocyte sedimentation rate (ESR) Up to 52 weeks ESR will be recorded from blood samples collected.
Subject's Global Assessment of Arthritis (SGA) (visual analog scale (VAS)) Up to 52 weeks 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.
Percentage of participants achieving DAS28-CRP scores for remission Up to 52 weeks Percentage of participants with DAS28 scores less than 2.6.
Percentage of participants achieving DAS28-ESR scores for remission Up to 52 weeks Percentage of participants with DAS28 scores less than 2.6.
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (47)
Site JP00005
🇯🇵Akita, Japan
Site JP00038
🇯🇵Ehime, Japan
Site JP00002
🇯🇵Aomori, Japan
Site JP00023
🇯🇵Aichi, Japan
Site JP00012
🇯🇵Chiba, Japan
Site JP00007
🇯🇵Fukushima, Japan
Site JP00028
🇯🇵Hyogo, Japan
Site JP00034
🇯🇵Hiroshima, Japan
Site JP00008
🇯🇵Ibaraki, Japan
Site JP00014
🇯🇵Kanagawa, Japan
Site JP00039
🇯🇵Kochi, Japan
Site JP00043
🇯🇵Kumamoto, Japan
Site JP00026
🇯🇵Kyoto, Japan
Site JP00024
🇯🇵Mie, Japan
Site JP00045
🇯🇵Miyazaki, Japan
Site JP00004
🇯🇵Miyagi, Japan
Site JP00020
🇯🇵Nagano, Japan
Site JP00042
🇯🇵Nagasaki, Japan
Site JP00015
🇯🇵Niigata, Japan
Site JP00033
🇯🇵Okayama, Japan
Site JP00047
🇯🇵Okinawa, Japan
Site JP00027
🇯🇵Osaka, Japan
Site JP00041
🇯🇵Saga, Japan
Site JP00025
🇯🇵Shiga, Japan
Site JP00022
🇯🇵Shizuoka, Japan
Site JP00009
🇯🇵Tochigi, Japan
Site JP00036
🇯🇵Tokushima, Japan
Site JP00030
🇯🇵Wakayama, Japan
Site JP00006
🇯🇵Yamagata, Japan
Site JP00035
🇯🇵Yamaguchi, Japan
Site JP00019
🇯🇵Yamanashi, Japan
Site JP00017
🇯🇵Ishikawa, Japan
Site JP00046
🇯🇵Kagoshima, Japan
Site JP00029
🇯🇵Nara, Japan
Site JP00044
🇯🇵Oita, Japan
Site JP00040
🇯🇵Fukuoka, Japan
Site JP00031
🇯🇵Tottori, Japan
Site JP00018
🇯🇵Fukui, Japan
Site JP00021
🇯🇵Gifu, Japan
Site JP00010
🇯🇵Gunma, Japan
Site JP00037
🇯🇵Kagawa, Japan
Site JP00011
🇯🇵Saitama, Japan
Site JP00016
🇯🇵Toyama, Japan
Site JP00001
🇯🇵Hokkaido, Japan
Site JP00003
🇯🇵Iwate, Japan
Site JP00032
🇯🇵Shimane, Japan
Site JP00013
🇯🇵Tokyo, Japan