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RECRUITING

NCT06172361

PHASE3

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

Sponsor: Zhejiang University

View on ClinicalTrials.gov

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

Official title: 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

Key Details

Gender

All

Age Range

50 Years - 88 Years

Study Type

INTERVENTIONAL

Enrollment

Start Date

2024-01-20

Completion Date

2026-01-30

Last Updated

2025-08-13

Healthy Volunteers

Conditions

Polymyalgia Rheumatica

Interventions

DRUG

Prednisone+Tofacitinib

Withdrawal of prednisone (or equivalent dose of methylprednisolone) within 4 weeks: 5mg tid for 2 weeks, 5mg bid for 1 week, 5mg qd for 1 week, then discontinue. Take Tofacitinib 10mg/d for 3 months, then 7.5mg/d for 2 months, followed by 5mg qd for 2 months, then 5mg qod for 2 months, and finally 5mg every 3 days for 2 months, discontinue the Tofacitinib for 1 month. If there is a relapse during the dose reduction process, resume Tofacitinib at the original dosage.

DRUG

Prednisone

Prednisone 15mg (or equivalent dose of methylprednisolone) was set as the initial treatment of PMR. When improvement was achieved, the dose of Prednisone was reduced to 10mg daily within 4-10 weeks; When remission was achieved, then taper Prednisone gradually by 2.5mg every 6-8 weeks. Once relapse occurred, the dose increased to the pre-relapse dose. If reducing pred dosage is difficult, Methotrexate (MTX) 10mg qw can be added after 24 weeks.

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.

Locations (1)

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

Hangzhou, Zhejiang, China