Induction and Tapering Therapy With Tofacitinib and Glucocorticoid in Patients With Polymyalgia Rheumatica

Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age50-88
SponsorZhejiang University

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

98 Participants
are divided into 2 treatment groups

Locations

1
Division of Rheumatology, the First Affiliated Hospital, Zhejiang University School of Medicine313000, HangzhouZhejiang, China

Sponsors and collaborators

Zhejiang University

Lead sponsor