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

Launched by ZHEJIANG UNIVERSITY · Dec 7, 2023

Keywords

ClinConnect Summary

This clinical trial is investigating the effectiveness and safety of a treatment involving tofacitinib, a medication, combined with glucocorticoids (a type of steroid) for patients with Polymyalgia Rheumatica (PMR), a condition that causes pain and stiffness in the muscles. The study will run for 52 weeks and is currently looking for participants aged 50 to 88 who are experiencing high levels of disease activity and have not used certain medications in the last two weeks. Eligible participants should also meet specific disease criteria and have certain blood test results indicating inflammation.

If you join this trial, you will receive the study treatment and be monitored closely by healthcare professionals throughout the year. Your progress will be regularly assessed, and you'll have the chance to contribute valuable information that could help improve treatments for PMR. However, there are specific criteria that might exclude some individuals, such as those with certain other health conditions or ongoing infections, so it's important to discuss your health history with the research team.

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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 \<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.