Rheumatoid Arthritis (RA)
Conditions
Keywords
Post-Marketing Surveillance, ASP015K, Smyraf, Rheumatoid arthritis (RA), Peficitinib
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).
Interventions
DRUGPeficitinib
Oral
Sponsors
Astellas Pharma Inc
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
Inclusion criteria
* All patients with rheumatoid arthritis (RA) treated with peficitinib for the first time.
Exclusion criteria
* Not applicable.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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 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 serious infections | Up to 156 weeks | Serious infections include tuberculosis, pneumonia, pneumocystis pneumonia, ichorrhemia and opportunistic infection. |
| Safety assessed by frequency of malignancy | Up to 156 weeks | Frequency of malignancy found after drug administration. |
| 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 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. |
| 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. |
| 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. |
| 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. |
| 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. |
| 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. |
| 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. |
| Erythrocyte sedimentation rate (ESR) | Up to 52 weeks | ESR will be recorded from blood samples collected. |
| C-reactive protein (CRP) | Up to 52 weeks | CRP 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. |
| 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. |
| 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." |
| 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. |
Countries
Japan
Contacts
STUDY_DIRECTORCentral Contact
Astellas Pharma Inc
Outcome results
None listed