Actively Recruiting

Phase 3
Age: 50Years - 88Years
All Genders
NCT06172361

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

Led by Zhejiang University · Updated on 2025-08-13

98

Participants Needed

1

Research Sites

105 weeks

Total Duration

On this page

AI-Summary

What this Trial Is 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

CONDITIONS

Official Title

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

Who Can Participate

Age: 50Years - 88Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Diagnosed with Polymyalgia Rheumatica using 1982 Chuang or 2012 ACR/EULAR criteria
  • No use of glucocorticoids or biological agents in the 2 weeks before study entry
  • High disease activity with PMR-AS score greater than 10
  • Age between 50 and 88 years
  • Weight between 45 and 85 kilograms
  • Elevated ESR greater than 20 mm/h or CRP greater than 50 mg/L (5 mg/dl)
  • Provided informed consent
Not Eligible

You will not qualify if you...

  • Allergy to tofacitinib, prednisone, or methylprednisolone
  • Diagnosed with giant cell arteritis, systemic lupus erythematosus, rheumatoid arthritis, calcium pyrophosphate deposition arthropathy, or other rheumatic diseases
  • Severe osteoarthritis
  • Severe acute, chronic, or recurrent infections such as pneumonia, pyelonephritis, recurrent pneumonia, chronic bronchiectasis, or tuberculosis
  • Hepatitis B or C infection, chronic liver diseases, or HIV infection
  • Abnormal liver function (ALT/AST twice the normal limit)
  • Moderate to severe kidney impairment (glomerular filtration rate less than 60)
  • Uncontrolled hyperlipidemia
  • Pregnancy or breastfeeding
  • History of cancer unless treated successfully over 5 years ago without recurrence
  • Previous visual field disorders, single eye dysfunction, or cataracts
  • Severe heart failure, uncontrolled high blood pressure (systolic >160 mmHg or diastolic >100 mmHg), or diabetes
  • Abnormal blood counts (low lymphocytes, neutrophils, or hemoglobin)
  • Active bleeding or peptic ulcers
  • Use of biological agents or certain immunosuppressants within 1 month before enrollment
  • Participation in another drug trial within 4 weeks
  • Use of CYP3A4 inhibitors or inducers such as ketoconazole, fluconazole, or rifampicin within 4 weeks

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

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

Hangzhou, Zhejiang, China, 313000

Actively Recruiting

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Research Team

Y

Yanlin He

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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