About this trial
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 criteria
Qualifiers
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),
Disqualifiers
Patients with known allergies to tofacitinib, prednisone or methylprednisolone,
Patients with identified giant cell arteritis, systemic lupus erythematosus, rheumatoid arthritis, calcium pyrophosphate deposition (CPPD) arthropathy, and other rheumatic diseases,
Patients with severe osteoarthritis,
Subjects with any severe acute, chronic or recurrent infection (e.g. pneumonia or pyelonephritis, recurrent pneumonia, chronic bronchiectasis, tuberculosis, etc.),
Trial design
Treatments tested in this trial
- Prednisone+Tofacitinib
- Prednisone
Treatment groups
Locations
1Sponsors and collaborators
Zhejiang University
Lead sponsor