NCT06172361 Induction and Tapering Therapy With Tofacitinib and Glucocorticoid in Patients With Polymyalgia Rheumatica
| NCT ID | NCT06172361 |
| Status | Recruiting |
| Phase | Phase 3 |
| Sponsor | Zhejiang University |
| Condition | Polymyalgia Rheumatica |
| Study Type | INTERVENTIONAL |
| Enrollment | 98 participants |
| Start Date | 2024-01-20 |
| Primary Completion | 2025-09-30 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 3 trials are large pivotal studies comparing the treatment to current standard of care or placebo. Your participation directly contributes to the evidence needed for regulatory approval.
This trial targets 98 participants in total. It began in 2024-01-20 with a primary completion date of 2025-09-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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 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 \<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.
Contact & Investigator
Weiqian Chen
PRINCIPAL INVESTIGATOR
Division of Rheumatology, the First Affiliated Hospital, Zhejiang University School of Medicine
Frequently Asked Questions
Who can join the NCT06172361 clinical trial?
This trial is open to participants of all sexes, aged 50 Years or older, up to 88 Years, studying Polymyalgia Rheumatica. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06172361 trial and what does that mean for participants?
Phase 3 trials are large-scale studies comparing the new treatment to existing standards of care or a placebo. They provide the evidence needed for regulatory approval. This trial targets 98 participants.
Is NCT06172361 currently recruiting?
Yes, NCT06172361 is actively recruiting participants. Contact the research team at yanlinriver@163.com for enrollment information.
Where is the NCT06172361 trial being conducted?
This trial is being conducted at Hangzhou, China.
Who is sponsoring the NCT06172361 clinical trial?
NCT06172361 is sponsored by Zhejiang University. The principal investigator is Weiqian Chen at Division of Rheumatology, the First Affiliated Hospital, Zhejiang University School of Medicine. The trial plans to enroll 98 participants.