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.
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
3,000
Oral
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.
Time frame: 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."
Time frame: Up to 52 weeks
Safety assessed by frequency of serious infections
Serious infections include tuberculosis, pneumonia, pneumocystis pneumonia, ichorrhemia and opportunistic infection.
Time frame: Up to 156 weeks
Safety assessed by frequency of malignancy
Frequency of malignancy found after drug administration.
Time frame: Up to 156 weeks
Safety assessed by frequency of events leading to death
Any events leading to death will be reported as serious AEs.
Time frame: 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.
Time frame: 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.
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Site JP00023
Aichi, Japan
RECRUITINGSite JP00005
Akita, Japan
RECRUITINGSite JP00002
Aomori, Japan
RECRUITINGSite JP00012
Chiba, Japan
RECRUITINGSite JP00038
Ehime, Japan
RECRUITINGSite JP00018
Fukui, Japan
RECRUITINGSite JP00040
Fukuoka, Japan
RECRUITINGSite JP00007
Fukushima, Japan
RECRUITINGSite JP00021
Gifu, Japan
RECRUITINGSite JP00010
Gunma, Japan
RECRUITING...and 37 more locations
Time frame: 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."
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: Up to 52 weeks
Erythrocyte sedimentation rate (ESR)
ESR will be recorded from blood samples collected.
Time frame: Up to 52 weeks
C-reactive protein (CRP)
CRP will be recorded from blood samples collected.
Time frame: 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.
Time frame: 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.
Time frame: 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."
Time frame: Up to 52 weeks
Percentage of participants achieving DAS28-CRP scores for remission
Percentage of participants with DAS28 scores less than 2.6.
Time frame: Up to 52 weeks
Percentage of participants achieving DAS28-ESR scores for remission
Percentage of participants with DAS28 scores less than 2.6.
Time frame: Up to 52 weeks