Rheumatoid Arthritis (RA)NCT03971253
Japan Post-Marketing Surveillance for Peficitinib to Assess Safety and Effectiveness in the Patients With Rheumatoid Arthritis
An observational study of Rheumatoid Arthritis (RA), run by Astellas Pharma Inc at 47 sites in Japan.
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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Rheumatoid Arthritis (RA)
- What is being tested?
- Peficitinib
- Type of treatment
- Pill or oral medicine
- How many people
- 3,000 participants
- Where
- 47 sitesJapan
- Study dates
- 2 Sep 2019to 29 May 2026
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Patients with rheumatoid arthritis (RA) treated with peficitinib for the first time.
Who may be able to join
- All patients with rheumatoid arthritis (RA) treated with peficitinib for the first time.
Who cannot join
- Not applicable.
Trial locations and contacts
47 sites in 1 country.
47 sites in 1 country
Japan47 sites
Site JP00023
Aichi
Site JP00005
Akita
Site JP00002
Aomori
Site JP00012
Chiba
Site JP00038
Ehime
Site JP00018
Fukui
Site JP00040
Fukuoka
Site JP00007
Fukushima
Site JP00021
Gifu
Site JP00010
Gunma
Site JP00034
Hiroshima
Site JP00001
Hokkaido
Site JP00028
Hyōgo
Site JP00008
Ibaraki
Site JP00017
Ishikawa
Site JP00037
Kagawa
Site JP00046
Kagoshima
Site JP00014
Kanagawa
Site JP00039
Kochi
Site JP00043
Kumamoto
Site JP00026
Kyoto
Site JP00024
Mie
Site JP00004
Miyagi
Site JP00045
Miyazaki
Site JP00020
Nagano
Site JP00042
Nagasaki
Site JP00029
Nara
Site JP00015
Niigata
Site JP00003
Numakunai
Site JP00044
Ōita
Site JP00033
Okayama
Site JP00047
Okinawa
Site JP00027
Osaka
Site JP00041
Saga
Site JP00011
Saitama
Site JP00025
Shiga
Site JP00032
Shimane
Site JP00022
Shizuoka
Site JP00009
Tochigi
Site JP00036
Tokushima
Site JP00013
Tokyo
Site JP00031
Tottori
Site JP00016
Toyama
Site JP00030
Wakayama
Site JP00006
Yamagata
Site JP00035
Yamaguchi
Site JP00019
Yamanashi
About this study
Official title: Japan Post-Marketing Surveillance - Specified Drug Use-results Survey for Peficitinib to Assess Safety and Effectiveness in the Patients With Rheumatoid Arthritis
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.
Read the 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).
- Conditions
- Rheumatoid Arthritis (RA)
- Being tested
- Peficitinib
- Keywords
- Post-Marketing Surveillance, ASP015K, Smyraf, Rheumatoid arthritis (RA), Peficitinib
- Medical subject headings
- Arthritis, Rheumatoid
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PeficitinibDrug
Also called ASP015K, Smyraf
Oral
| Study group | Role | What they receive |
|---|---|---|
| Peficitinib | Participants will receive peficitinib once daily after meal. Receives: Drug: Peficitinib |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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."
Measured: Up to 52 weeks
Safety assessed by frequency of serious infections
Serious infections include tuberculosis, pneumonia, pneumocystis pneumonia, ichorrhemia and opportunistic infection.
Measured: Up to 156 weeks
Safety assessed by frequency of malignancy
Frequency of malignancy found after drug administration.
Measured: Up to 156 weeks
Safety assessed by frequency of events leading to death
Any events leading to death will be reported as serious AEs.
Measured: 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.
Measured: 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.
Measured: 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."
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Up to 52 weeks
Erythrocyte sedimentation rate (ESR)
ESR will be recorded from blood samples collected.
Measured: Up to 52 weeks
C-reactive protein (CRP)
CRP will be recorded from blood samples collected.
Measured: 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.
Measured: 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.
Measured: 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."
Measured: Up to 52 weeks
Percentage of participants achieving DAS28-CRP scores for remission
Percentage of participants with DAS28 scores less than 2.6.
Measured: Up to 52 weeks
Percentage of participants achieving DAS28-ESR scores for remission
Percentage of participants with DAS28 scores less than 2.6.
Measured: Up to 52 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jun 2019
- Study start2 Sep 2019
- Primary completion29 May 2026
- Study completion29 May 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Rheumatoid Arthritis (RA)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 3,000 participants (actual)
Sponsor and investigators
- Lead sponsor
- Astellas Pharma Inc
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Central Contact, Study director, Astellas Pharma Inc
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03971253
- Sponsor's protocol ID
- 015K-MA-3311
- Status last verified
- Jun 2026
- First submitted
- 30 May 2019
- Last updated
- 10 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Access to anonymized individual participant level data will not be provided for this trial. Further details on Astellas' data sharing policy can be found at https://www.clinicaltrials.astellas.com/transparency/.
Study at a glance
From the registry record, last updated by the sponsor on 10 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Japan Post-Marketing Surveillance - Specified Drug Use-results Survey for Peficitinib to Assess Safety and Effectiveness in the Patients With Rheumatoid Arthritis
- ClinicalTrials.gov ID
- NCT03971253
- Acronym / sponsor ID
- 015K-MA-3311
- Conditions
- Rheumatoid Arthritis (RA)
- Keywords
- Post-Marketing Surveillance, ASP015K, Smyraf, Rheumatoid arthritis (RA), Peficitinib
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 3,000 participants (actual)
- Lead sponsor
- Astellas Pharma IncIndustry (pharma, biotech, devices)
- Study start
- 2 Sep 2019 (actual)
- Primary completion
- 29 May 2026 (actual)
- Study completion
- 29 May 2026 (actual)
- First posted
- 3 Jun 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Peficitinib | – | Drug: PeficitinibParticipants will receive peficitinib once daily after meal. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients with rheumatoid arthritis (RA) treated with peficitinib for the first time.
Key inclusion criteria (1 listed)
- All patients with rheumatoid arthritis (RA) treated with peficitinib for the first time.
Key exclusion criteria (1 listed)
- Not applicable.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PeficitinibAlso: ASP015K, SmyrafOral | Drug | Peficitinib |
Primary outcome
Safety assessed by frequency of adverse events (AEs)
Time frame: 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)
Time frame: 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
Time frame: Up to 156 weeks
Serious infections include tuberculosis, pneumonia, pneumocystis pneumonia, ichorrhemia and opportunistic infection.
Safety assessed by frequency of malignancy
Time frame: Up to 156 weeks
Frequency of malignancy found after drug administration.
Safety assessed by frequency of events leading to death
Time frame: Up to 156 weeks
Any events leading to death will be reported as serious AEs.
Safety assessed by frequency of AEs of special interests
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: Up to 52 weeks
ESR will be recorded from blood samples collected.
C-reactive protein (CRP)
Time frame: Up to 52 weeks
CRP will be recorded from blood samples collected.
Subject's Global Assessment of Arthritis (SGA) (visual analog scale (VAS))
Time frame: 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)
Time frame: 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
Time frame: 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
Time frame: Up to 52 weeks
Percentage of participants with DAS28 scores less than 2.6.
Percentage of participants achieving DAS28-ESR scores for remission
Time frame: Up to 52 weeks
Percentage of participants with DAS28 scores less than 2.6.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jun 2026.
- Individual participant dataSharing planned: No. Access to anonymized individual participant level data will not be provided for this trial. Further details on Astellas' data sharing policy can be found at https://www.clinicaltrials.astellas.com/transparency/.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Central Contact study director
Astellas Pharma Inc
47 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Rheumatoid Arthritis (RA), run by Astellas Pharma Inc at 47 sites in Japan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 47 sites in Japan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Safety assessed by frequency of adverse events (AEs) (time frame: Up to 52 weeks). The study lists 21 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Jun 2026.