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

Last updated: July 25, 2024
Sponsor: Zhejiang University
Overall Status: Active - Recruiting

Phase

3

Condition

Connective Tissue Diseases

Collagen Vascular Diseases

Polymyalgia Rheumatica (Pmr)

Treatment

Prednisone+Tofacitinib

Prednisone

Clinical Study ID

NCT06172361
IIT20230087C-X1
  • Ages 50-88
  • All Genders

Study 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

Inclusion Criteria:

  1. PMR patients who fulfilled the 1982 Chuang criteria or 2012ACR/EULAR criteria forPMR; They did not receive any glucocorticoids or biological agents during the 2weeks 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

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 otherrheumatic diseases,

  3. Patients with severe osteoarthritis,

  4. Subjects with any severe acute, chronic or recurrent infection (e.g. pneumonia orpyelonephritis, 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 severerenal impairment (glomerular filtration rate <60); hyperlipidemia not improved bylipid-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 5years before screening without any evidence of recurrence),

  9. Patients with previous visual field disorder or single eye dysfunction, cataractpatients,

  10. Patients with decompensated cardiac insufficiency or severe hypertension or diabetesmellitus, i.e. systolic blood pressure higher than 160mmhg or diastolic bloodpressure higher than 100mmhg,

  11. For patients with abnormal blood routine, lymphocytes <500/mm3 or ANC <1000/mm3 orHGB < 90g/L,

  12. Patients with active bleeding and peptic ulcer,

  13. Have used biological agents or added azathioprine, leflunomide, FK 506 within 1month 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, orrifampicin within 4 weeks.

Study Design

Total Participants: 98
Treatment Group(s): 2
Primary Treatment: Prednisone+Tofacitinib
Phase: 3
Study Start date:
January 20, 2024
Estimated Completion Date:
January 30, 2026

Study 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.

Connect with a study center

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

    Hangzhou, Zhejiang 313000
    China

    Active - Recruiting

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