Induction and Tapering Therapy With Tofacitinib and Glucocorticoid in Patients With Polymyalgia Rheumatica (ITTGPMR)

Zhejiang University

Status and phase: Enrolling; Phase 3

Conditions: Polymyalgia Rheumatica

Treatments: Drug: Prednisone; Drug: Prednisone+Tofacitinib

Study type: Interventional

Funder types: Other

Identifiers

NCT06172361

IIT20230087C-X1

Details and patient eligibility

About

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

Full 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 conditions. Currently, glucocorticoids are the primary treatment for PMR, but they can lead to various side effects, and recurrence is common during steroid tapering. Our previous 24-week study confirmed the effective treatment of PMR patients with tofacitinib. Given the relatively slow efficacy of tofacitinib, early adjunctive therapy with NSAIDs is needed. To address this, we are planning an open-label 52-week randomized controlled trial. This study aims to assess the use of tofacitinib in combination with glucocorticoids to induce rapid improvement, followed by rapid tapering of steroids and slow tapering of tofacitinib. The objective is to observe the efficacy and safety of this regimen for PMR, providing a new treatment option for clinical use.

Enrollment: 98 estimated patients

Sex: All

Ages: 50 to 88 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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98 participants in 2 patient groups

Treatment group

Experimental group

Description:

Prednisone (or equivalent dose of methylprednisolone) + Tofacitinib

Treatment:

Drug: Prednisone+Tofacitinib

Positive control group

Active Comparator group

Description:

prednisone (or equivalent dose of methylprednisolone)

Treatment:

Drug: Prednisone