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JRCT ID: jRCTs031210665

Registered date:14/03/2022

Basic Information

• Recruitment status: Not Recruiting
• Health condition(s) or Problem(s) studied: Rheumatoid arthritis
• Date of first enrollment: 15/05/2022
• Target sample size: 55
• Study type: Interventional

Intervention(s)

Administration of sarilumab for research purposes
Invasion byHr PQCT imaging

Outcome(s)

• Primary Outcome: Change in the volume (EV) of bone erosions of the phalanges and carpal bones from baseline to Week 52

Secondary Outcome

(1)Changes in the following endpoints from baseline to each assessment time point (Week 12.week 24 and Week 52) for the finger joint and wrist joint.
EV and joint space (JSW/JSV)
Disease activity parameters
Functional activity parameters
Patient Reported Outcome (PRO).
(2)The relationship between changes in EV of the finger joint and wrist joint from baseline to Week 52 and changes in disease activity, changes in functional activity and changes in PROs.
(3)The relationship between the change in JSW JSV and the change in disease activity, change in functional activity, and change in PRO from baseline
to Week 52.
(4)Change from baseline in markers of bone and cartilage metabolism at each assessment time point (Week 12, Week 24 and Week 52).

Key inclusion & exclusion criteria

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

Include criteria

(1)Adult patients at the time of obtaining consent
(2)Patients who have been diagnosed with RA based on the American College of Rheumatology (ACR) criteria for RA diagnosis (revised in 1987) or the 2010 ACR/European College of Rheumatology (EULAR) criteria for RA classification.
(3)Patients who are scheduled to be newly started on sarilumab for RA.
(4)Patients with at least one bone erosion on radiographs of the finger joint and wrist joint.
(5) Patients for whom sarilumab is to be started at a dose of 200 mg every two weeks.
(6)Patients who can sign the consent document in person.

Exclude criteria

(1) Patients for whom sarilumab is contraindicated according to the Japanese package insert.
(2) Patients who are currently participating in clinical trials other than this study.
(3) Patients who are scheduled to receive bDMARD or tsDMARD in combination with sarilumab.
(4) Patients whose corticosteroid dosage is more than 6 mg/day of prednisolone equivalent for the last 4 weeks.
(5) Patients with a history of treatment with sarilumab (including participation in clinical trials)
(6) Patients who have been treated with denosumab within 1 year
(7)Patients who have received romosozumab, teriparatide, teriparatide BS, or abaloparatide (if marketed)
(8)Patients who are pregnant, lactating, or who may become pregnant, or who are planning to become pregnant within one year.
(9)Patients who are judged to be uncooperative or who may not be able to comply with the procedures, etc. for conducting the study for some reason by the patient.

Related Information

• Primary Sponsor: Kawahito Yutaka
• Secondary Sponsor: ASAHI KASEI PHARMA