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

August 11, 2025 updated by: Weiqian Chen, Zhejiang University

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

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

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed 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.

Study Type

Interventional

Enrollment (Estimated)

98

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • China
    • Zhejiang
      • Hangzhou, Zhejiang, China, 313000
        • Recruiting
        • Division of Rheumatology, the First Affiliated Hospital, Zhejiang University School of Medicine
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Treatment group
Prednisone (or equivalent dose of methylprednisolone) + Tofacitinib
Drug: Prednisone+Tofacitinib

Withdrawal of prednisone (or equivalent dose of methylprednisolone) within 4 weeks: 5mg tid for 2 weeks, 5mg bid for 1 week, 5mg qd for 1 week, then discontinue.

Take Tofacitinib 10mg/d for 3 months, then 7.5mg/d for 2 months, followed by 5mg qd for 2 months, then 5mg qod for 2 months, and finally 5mg every 3 days for 2 months, discontinue the Tofacitinib for 1 month. If there is a relapse during the dose reduction process, resume Tofacitinib at the original dosage.

Other Names:
  • Pred+Tof
Active Comparator: Positive control group
prednisone (or equivalent dose of methylprednisolone)
Drug: Prednisone
Prednisone 15mg (or equivalent dose of methylprednisolone) was set as the initial treatment of PMR. When improvement was achieved, the dose of Prednisone was reduced to 10mg daily within 4-10 weeks; When remission was achieved, then taper Prednisone gradually by 2.5mg every 6-8 weeks. Once relapse occurred, the dose increased to the pre-relapse dose. If reducing pred dosage is difficult, Methotrexate (MTX) 10mg qw can be added after 24 weeks.
Other Names:
  • Pred

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Proportion of patients with PMR-AS score <10 score at weeks 52
Time Frame: at 52 weeks
PMR-AS score: CRP (mg/dL)+Patient self-evaluation (0-10 visual scale)+ Physician global assessment (0-10 Visual Scale)+[morning stiffness (min) x0.1]+ EUL (0-3)
at 52 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
PMR-AS score at weeks 24
Time Frame: at 24 weeks
PMR-AS score: CRP (mg/dL)+Patient self-evaluation (0-10 visual scale)+ Physician global assessment (0-10 Visual Scale)+[morning stiffness (min) x0.1]+ ability to elevate the upper limbs(EUL 0-3)
at 24 weeks
PMR-AS score at weeks 52
Time Frame: at 52 weeks
PMR-AS score: CRP (mg/dL)+Patient self-evaluation (0-10 visual scale)+ Physician global assessment (0-10 Visual Scale)+[morning stiffness (min) x0.1]+EUL (0-3)
at 52 weeks
CRP at weeks 24
Time Frame: at 24 weeks
CRP (mg/dL)
at 24 weeks
CRP at weeks 52
Time Frame: at 52 weeks
CRP (mg/dL)
at 52 weeks
ESR at weeks 24
Time Frame: at 24 weeks
ESR (mm/h)
at 24 weeks
ESR at weeks 52
Time Frame: at 52 weeks
ESR (mm/h)
at 52 weeks
Proportion of patients who discontinue drugs at weeks 52
Time Frame: at 52 weeks
Proportion of patients who discontinue Tof in the treatment group, prednisone in the control group at weeks 52
at 52 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Zhejiang University

Investigators

  • Principal Investigator: Weiqian Chen, Division of Rheumatology, the First Affiliated Hospital, Zhejiang University School of Medicine

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 20, 2024

Primary Completion (Estimated)

September 30, 2025

Study Completion (Estimated)

January 30, 2026

Study Registration Dates

First Submitted

December 7, 2023

First Submitted That Met QC Criteria

December 7, 2023

First Posted (Actual)

December 15, 2023

Study Record Updates

Last Update Posted (Actual)

August 13, 2025

Last Update Submitted That Met QC Criteria

August 11, 2025

Last Verified

August 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IIT20230087C-X1

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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