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

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.

Trial locations and contacts

47 sites in 1 country.

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

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

What is being measured

The primary outcome is the main question the study is designed to answer.

1. 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

2. 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

3. Safety assessed by frequency of serious infections

   Serious infections include tuberculosis, pneumonia, pneumocystis pneumonia, ichorrhemia and opportunistic infection.

   Measured: Up to 156 weeks

4. Safety assessed by frequency of malignancy

   Frequency of malignancy found after drug administration.

   Measured: Up to 156 weeks

5. 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

6. 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

7. 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

8. 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

9. 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

10. 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

11. 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

12. 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

13. 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

14. 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

15. Erythrocyte sedimentation rate (ESR)

    ESR will be recorded from blood samples collected.

    Measured: Up to 52 weeks

16. C-reactive protein (CRP)

    CRP will be recorded from blood samples collected.

    Measured: Up to 52 weeks

17. 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

18. 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

19. 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

20. Percentage of participants achieving DAS28-CRP scores for remission

    Percentage of participants with DAS28 scores less than 2.6.

    Measured: Up to 52 weeks

21. 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.

1. First posted3 Jun 2019
2. Study start2 Sep 2019
3. Primary completion29 May 2026
4. 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.