Examination of the efficacy of Peficitinib reduction in RA patients in sustained remission

JRCT ID: jRCTs051220027

Registered date:25/05/2022

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: Rheumatoid arthritis
• Date of first enrollment: 05/07/2022
• Target sample size: 60
• Study type: Interventional
• Intervention(s): RA patients who devided into into Peficitinib 150 mg and 100 mg groups, and their efficacy and safety will be examined among each group.

Outcome(s)

• Primary Outcome: The number of participants and the percentage of participants who sustain a disease activity score of (DAS28)-ESR<3.2 from the index date (the date of starting the study drug administration) to 24 weeks

Key inclusion & exclusion criteria

• Age minimum: >= 20age old
• Age maximum: Not applicable
• Gender: Both

Include criteria

1. Patients who provided written informed consent to participate in the study from the participant the myself after receiving a full explanation of the study drug and this study
2. 20 years and older (Adult, Older Adult) at the time of informed consent
3. RA patients who have been treated with peficitinib 150 mg for at least 12 weeks at the time of informed consent
4. Patients who achieved LDA or remission at the time of informed consent
5. Patients who did not receive any of the following drugs, or received any of the following drugs with stable dose (No dose reduction or increment) for at least 28 days prior to Visit 1:
Non-steroidal anti-inflammatory drugs (NSAIDs; excluding topical formulations), oral morphine or equivalent opioid analgesics (less than 30 mg/day), acetaminophen, oral corticosteroids (less than10 mg/day in prednisolone equivalent), methotrexate, salazosulfapyridine, leflunomide, gold, bucillamine,tacrolimus, iguratimod, cyclosporine, cyclophosphamide, azathioprine, minomycin, and other drugs indicated for the treatment of RA (lobenzarit, actarit, hydroxychloroquine and D-penicillamine)
6.Patients who, in the opinion of physician, did not need peficitinib dose reduction in terms of safety during peficitinib 150mg administration

Exclude criteria

1. Patients administered peficitinib for off-label use for the treatment of diseases other than RA
2. Patients with contraindications to peficitinib administration
3. Patient with a condition which, in the opinion of the investigator, makes the subject unsuitable for study participation
4. Patients who received any of the following drugs or treatment during the pretreatment period
:
Etanercept, adalimumab, infliximab, golimumab, certolizumab pegol, abatacept, tocilizumab,sarilumab, rituximab,ozoralizumab, upadacitinib, tofacitinib, baricitinib, filgotinib
Oral corticosteroids at doses exceeding 10 mg/day in the prednisolone equivalent
Oral morphine at doses exceeding 30 mg/day (or equivalent doses of other opioid analgesics)
Use of live and live attenuated vaccines; inactivated vaccines may be administered (influenza, pneum ococcal vaccines, herpes zoster vaccines and coronavirus disease 2019 vaccines, etc.)
Plasma exchange therapy
Surgery involving the target joint
Use of articular cartilage protective agents for the target joint (e.g., NSAID-conjugated hyaluronate, hyaluronic acid, steroids).
5.Patients who, in the opinion of physician, experi enced peficitinib dose reduction in terms of safety during peficitinib 150mg administration

Related Information

• Primary Sponsor: Hashimoto Motomu
• Source(s) of Monetary Support: Astellas Pharma Inc.