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

• Status: Not yet recruiting
• Trial end date: 2026-01-30
• Target enrollment: 0
• Participant gender: All

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

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Zhejiang University
• Treatments: Prednisone; Tofacitinib

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 <60); hyperlipidemia not improved by lipid-lowering drugs,

7. Pregnant or lactating women,

8. Patients with a history of malignancy who do not meet the following condition (patients with malignant tumors who have been successfully treated for more than 5 years before screening without any evidence of recurrence),

9. Patients with previous visual field disorder or single eye dysfunction, cataract patients,

10. Patients with decompensated cardiac insufficiency or severe hypertension or diabetes mellitus, i.e. systolic blood pressure higher than 160mmhg or diastolic blood pressure higher than 100mmhg,

11. For patients with abnormal blood routine, lymphocytes <500/mm3 or ANC <1000/mm3 or HGB < 90g/L,

12. Patients with active bleeding and peptic ulcer,

13. Have used biological agents or added azathioprine, leflunomide, FK 506 within 1 month before enrollment,

14. Those who have participated in other drug clinical trials within 4 weeks,

15. Patients using CYP3A4 inhibitors or inducers such as ketoconazole, fluconazole, or rifampicin within 4 weeks.