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

Study Overview
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Brief Summary
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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
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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).

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

Conditions
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Rheumatoid Arthritis (RA)

Intervention / Treatment
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* Drug: Peficitinib


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: All patients with rheumatoid arthritis (RA) treated with peficitinib for the first time. Exclusion Criteria: Not applicable.
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Peficitinib<br>Participants will receive peficitinib once daily after meal. | Drug: Peficitinib<br>* Oral<br>* Other names: Smyraf;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 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 | 
| 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 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Post-Marketing Surveillance, ASP015K, Smyraf, Rheumatoid arthritis (RA), Peficitinib