A Prospective Interventional Study to Evaluate the Effect of Sarilumab on Bone Destruction in Rheumatoid Arthritis Patients - APPRECIATE

Kawahito Yutaka0 sites55 target enrollmentMarch 14, 2022

Overview

No summary available.

Registry

who.int

Start Date

March 14, 2022

End Date

TBD

Last Updated

2 years ago

Study Type

Interventional

Sex

All

Sponsor

Kawahito Yutaka

•(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 phalanges and carpal bones.
•(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.

•(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.