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JAPANESE
国立保健医療科学院
JRCT ID: jRCTs071220070

Registered date:22/11/2022

Analysis of efficacy of peficitinib in RA

Basic Information

Recruitment status Recruiting
Health condition(s) or Problem(s) studiedRheumatoid arthritis
Date of first enrollment22/11/2022
Target sample size19
Countries of recruitment
Study typeInterventional
Intervention(s)Administer peficitinb 150mg once a day druing 12 months.

Outcome(s)

Primary OutcomeThe changes of volume of bone erosion detected by HR-pQCT.
Secondary OutcomeThe changes of parametors about bone structures detected by HR-pQCT.

Key inclusion & exclusion criteria

Age minimum>= 18age old
Age maximumNot applicable
GenderBoth
Include criteria1 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 criteria1 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

Contact

Public contact
Name Naoki Iwamoto
Address 1-7-1 Sakamoto, Nagasaki-shi, Nagasaki-ken Nagasaki Japan 852-8501
Telephone +81-95-819-7200
E-mail naoki-iwa@nagasaki-u.ac.jp
Affiliation Nagasaki University Hospital
Scientific contact
Name Naoki Iwamoto
Address 1-7-1 Sakamoto, Nagasaki-shi, Nagasaki-ken Nagasaki Japan 852-8501
Telephone +81-95-819-7200
E-mail naoki-iwa@nagasaki-u.ac.jp
Affiliation Nagasaki University Hospital