Join us at Health Research Day — June 6th at Canton Waterfront Park, Baltimore!   Learn More →
← Back to all trials
Completed NCT06172361

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

Conditions: Polymyalgia Rheumatica

Sex: All
Ages: 50 Years – 88 Years
Healthy volunteers: No
Phase: PHASE3
Enrollment: 104
Sponsor: Zhejiang University

Location: Division of Rheumatology, the First Affiliated Hospital, Zhejiang University School of Medicine Hangzhou Zhejiang

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 Criteria

Inclusion Criteria: 1. 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; 2. Patients with high activity rheumatic polymyalgia: disease activity score PMR-AS (Table 3) \> 10, 3. Adults age 50-88, Weight 45-85Kg, 4. ESR\>20mm/h or CRP \>50mg/L (5mg/dl), 5. Informed consent. Exclusion Criteria: 1. Patients with known allergies to tofacitinib, prednisone or methylprednisolone, 2. Patients with identified giant cell arteritis, systemic lupus erythematosus, rheumatoid arthritis, calcium pyrophosphate deposition (CPPD) arthropathy, and other rheumatic diseases, 3. Patients with severe osteoarthritis, 4. Subjects with any severe acute, chronic or recurrent infection (e.g. pneumonia or pyelonephritis, recurrent pneumonia, chronic bronchiectasis, tuberculosis, etc.), 5. Hepatitis B virus carriers or individuals with chronic active hepatitis B or C, other chronic liver diseases, HIV infection, 6. Patients with abnormal liver function (ALT/AST 2 times higher); Moderate to severe renal impairment (glomerular filtration rate \

Interested in this study? View the official listing for contact and enrollment details.

View on ClinicalTrials.gov

Source: ClinicalTrials.gov (NCT06172361). StuddyBuddy aggregates publicly available trial information.