GCs Sparing Regimen in PMR
Last updated on July 2021Recruitment
- Recruitment Status
- Not yet recruiting
- Estimated Enrollment
- Same as current
Summary
- Conditions
- Effect of Drug
- Polymyalgia Rheumatica
- Safety Issues
- Type
- Interventional
- Phase
- Phase 2
- Design
- Allocation: N/AIntervention Model: Single Group AssignmentMasking: None (Open Label)Masking Description: Assessor and data analyst blindness. To avoid bias, physicians who assess disease activity will be blinded. Participants are required not to discuss their treatment regimen with physicians at each visit. The success of the blind method will be judged by requiring the assessors to determine the therapy of participants after each visit. When the database is locked, the statistician will carry on the data analysis in the hidden of therapy.Primary Purpose: Treatment
Participation Requirements
- Age
- Between 50 years and 85 years
- Gender
- Both males and females
Description
A two-stage, phase 2 clinical trial was conducted to test whether tofacitinib would take into effect as a glucocorticoid sparing agent in patients with refractory polymyalgia rheumatica. Tofacitinib was given at the dose of 10mg daily through the 24 weeks. Patients were to receive prednisone in a do...
A two-stage, phase 2 clinical trial was conducted to test whether tofacitinib would take into effect as a glucocorticoid sparing agent in patients with refractory polymyalgia rheumatica. Tofacitinib was given at the dose of 10mg daily through the 24 weeks. Patients were to receive prednisone in a dosage of 15mg daily (or equivalent) at baseline and decreased to 10mg daily at week 2. The PMR-AS was determined every two weeks; if ?10, the prednisone dosage was decreased by 2.5 mg every two weeks; and if >17 the dosage was increased to previous dosage; if 10?PMR-AS ?17, the dosage was maintained at previous stable dose. The primary end point was the proportion of patients achieving sustained low disease activity (PMR-AS<7) with GC independence (prednisone<2.5mg daily or equivalent) at week 24.
Tracking Information
- NCT #
- NCT04799262
- Collaborators
- Not Provided
- Investigators
- Study Chair: Ting Li, MD RenJi Hospital
Get Well Soon