Tofacitinib as a GC Sparing Agent for Polymyalgia Rheumatica

PHASE2CompletedINTERVENTIONAL
Enrollment

14

Participants

Timeline

Start Date

January 1, 2021

Primary Completion Date

March 16, 2022

Study Completion Date

May 1, 2022

Conditions
Polymyalgia RheumaticaEffect of DrugSafety Issues
Interventions
DRUG

Tofacitinib 5 MG

Oral tofacitinib at the dose of 5mg twice a day was given for 24 weeks. Prednisone (or equivalent oral GCs) of 15 mg daily at baseline willed be tapered to 2.5 mg or less within 20 weeks. Unless specifically considered by patients and physicians, the GC will be tapered followed the predefined taper regimen depending on the response to treatment judged by PMR-AS. The PMR-AS will be determined every two weeks; if\<10 the daily GC dosage was decreased by 2.5mg; if\>17, the GC daily dosage was increased to the previous dosage; if 10≤PMR-AS≤17, the GC daily dosage was maintained at the previous stable dose.

Trial Locations (1)

201112

Ren Ji Hospital, Shanghai

All Listed Sponsors
lead

RenJi Hospital

OTHER

NCT04799262 - Tofacitinib as a GC Sparing Agent for Polymyalgia Rheumatica | Biotech Hunter | Biotech Hunter