Analysis of efficacy of peficitinib in RA

JRCT ID: jRCTs071220070

Registered date:22/11/2022

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: Rheumatoid arthritis
• Date of first enrollment: 25/11/2022
• Target sample size: 19
• Study type: Interventional
• Intervention(s): Administer peficitinb 150mg once a day druing 12 months.

Outcome(s)

• Primary Outcome: The changes of volume of bone erosion detected by HR-pQCT.
• Secondary Outcome: The changes of parametors about bone structures detected by HR-pQCT.

Key inclusion & exclusion criteria

• Age minimum: >= 18age old
• Age maximum: Not applicable
• Gender: Both

Include criteria

1 The patients who fulfill 2010 ACR/EULAR criteria of rheumatoid arthritis.
2 The patient aged >18 years when signing his/her informed consent.
3 The patients who are showing arthritis although the patients have history of DMARDs treatment.
4 The patients signed infromed consent fof this study.
5 In case of having tubeculosis history, the patiets under went chest X-ray and a tuberculin reaction or IGRA within one year after consent, and these test need to show negative result about tubeculosis.

Exclude criteria

1 Pregnant patients
2 The patients who is treated with TNF inhibitors, IL-6R inhibitors, abatacept and JAK inhibitors
3 The patients who is treated with prednisone >10mg
4 The patients who are taking intraarticular corticosteroid injection into evaluation joints within six months
5 The patients receiving denosumab
6 The patients with serious infections such as sepsis
7 The patients with active tuberculosis
8 The patients with serious liver dysfunction
9 The patients with lymphocyte count <500 cells/mm3, absolute neutrophil count<500cells/mm3 or hemoglobin <8 g/dl within three months after consent or most recent blood test before taking peficitinib
10 In the opinion of the investigator, the patients who is not suitable for this study for other reasons

Related Information

• Primary Sponsor: Iwamoto Naoki
• Source(s) of Monetary Support: Astellas Pharma Inc.