Status:
RECRUITING
Induction and Tapering Therapy With Tofacitinib and Glucocorticoid in Patients With Polymyalgia Rheumatica
Lead Sponsor:
Zhejiang University
Conditions:
Polymyalgia Rheumatica
Eligibility:
All Genders
50-88 years
Phase:
PHASE3
Brief 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 t...
Detailed Description
Rheumatic polymyalgia (PMR) is more commonly observed in individuals over the age of 50, who may have a higher prevalence of osteoporosis, diabetes, cardiovascular diseases, and other chronic conditio...
Eligibility Criteria
Inclusion
- 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),
- Informed consent.
Exclusion
- 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.),
- Hepatitis B virus carriers or individuals with chronic active hepatitis B or C, other chronic liver diseases, HIV infection,
- 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,
- Pregnant or lactating women,
- 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),
- Patients with previous visual field disorder or single eye dysfunction, cataract patients,
- 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,
- For patients with abnormal blood routine, lymphocytes \<500/mm3 or ANC \<1000/mm3 or HGB \< 90g/L,
- Patients with active bleeding and peptic ulcer,
- Have used biological agents or added azathioprine, leflunomide, FK 506 within 1 month before enrollment,
- Those who have participated in other drug clinical trials within 4 weeks,
- Patients using CYP3A4 inhibitors or inducers such as ketoconazole, fluconazole, or rifampicin within 4 weeks.
Key Trial Info
Start Date :
January 20 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
January 30 2026
Estimated Enrollment :
98 Patients enrolled
Trial Details
Trial ID
NCT06172361
Start Date
January 20 2024
End Date
January 30 2026
Last Update
August 13 2025
Active Locations (1)
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1
Division of Rheumatology, the First Affiliated Hospital, Zhejiang University School of Medicine
Hangzhou, Zhejiang, China, 313000