Efficacy and Safety of Induction and Tapering Therapy With Tofacitinib and Glucocorticoid in Patients With Polymyalgia Rheumatica (ITTG PMR): An Open-label 52-week Randomized Controlled Trial
Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 3
SUMMARY
This will be efficacy and safety of Induction and Tapering Therapy with Tofacitinib and Glucocorticoid in patients with Polymyalgia Rheumatica (ITTG PMR): An open-label 52-week randomized controlled trial
Eligibility
Participation Requirements
Sex: All
Minimum Age: 50
Maximum Age: 88
Healthy Volunteers: f
View:
• PMR patients who fulfilled the 1982 Chuang criteria or 2012ACR/EULAR criteria for PMR; They did not receive any glucocorticoids or biological agents during the 2 weeks period that preceded their inclusion in the study;
• Patients with high activity rheumatic polymyalgia: disease activity score PMR-AS (Table 3) \> 10,
• Adults age 50-88, Weight 45-85Kg,
• ESR\>20mm/h or CRP \>50mg/L (5mg/dl),
• Informed consent.
Locations
Other Locations
China
Division of Rheumatology, the First Affiliated Hospital, Zhejiang University School of Medicine
RECRUITING
Hangzhou
Contact Information
Primary
Yanlin He
yanlinriver@163.com
8617799855659
Time Frame
Start Date: 2024-01-20
Estimated Completion Date: 2026-01-30
Participants
Target number of participants: 98
Treatments
Experimental: Treatment group
Prednisone (or equivalent dose of methylprednisolone) + Tofacitinib
Active_comparator: Positive control group
prednisone (or equivalent dose of methylprednisolone)
Related Therapeutic Areas
Sponsors
Leads: Zhejiang University