Phase 3 Polymyalgia Rheumatica Trial, Recruiting NCT06172361 Sponsor: Zhejiang University Condition: Polymyalgia Rheumatica
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Phase 3 Polymyalgia Rheumatica Trial, Recruiting

NCT06172361
Recruiting Phase 3

Who may be able to join

AI generated eligibility summary. Written by an AI model from the official source data and checked on a sample basis. It can contain mistakes, so confirm anything important against the original source. How we use AI

Who might be able to join this trial:

  • You have been diagnosed with Polymyalgia Rheumatica (PMR) based on recognized medical criteria
  • You have not taken steroids or biological medications in the 2 weeks before joining the study
  • Your PMR is currently highly active, based on a standard disease activity score above 10
  • You are between 50 and 88 years old and weigh between 45 and 85 kg (roughly 99–187 lbs)
  • Your blood tests show signs of inflammation (elevated ESR or CRP levels above certain thresholds)
  • You are willing and able to give your informed consent to participate

Who may not be able to join:

  • You have a known allergy to tofacitinib, prednisone, or methylprednisolone
  • You have been diagnosed with giant cell arteritis, lupus, rheumatoid arthritis, or another rheumatic disease
  • You have severe osteoarthritis
  • You have any serious ongoing, recent, or recurring infection, such as pneumonia or tuberculosis
  • You carry hepatitis B, have chronic active hepatitis B or C, another chronic liver disease, or HIV
  • You have significantly abnormal liver function, moderate to severe kidney problems, or high cholesterol that does not respond to medication
  • You are pregnant or breastfeeding
  • You have a history of cancer, unless it was successfully treated more than 5 years ago with no signs of return
  • You have a history of vision field problems, loss of sight in one eye, or cataracts
  • You have serious heart failure, or poorly controlled high blood pressure (above 160/100 mmHg) or diabetes
  • Your blood cell counts are significantly abnormal (low white blood cells, low red blood cells, or low lymphocyte levels)
  • You have active bleeding or a peptic ulcer
  • You have used certain immune-suppressing medications (biological agents, azathioprine, leflunomide, or FK506) within the past month
  • You have participated in another clinical drug trial within the past 4 weeks
  • You have taken certain medications that affect how drugs are processed by the body (such as ketoconazole, fluconazole, or rifampicin) within the past 4 weeks

Important: Always verify eligibility with the trial site directly before applying.

Based on publicly available eligibility criteria from ClinicalTrials.gov. Verify directly with the trial site before acting. This is not medical advice.

This is a simplified plain English summary of the eligibility criteria. Full criteria are set by the trial investigators and may include additional requirements not shown here. Never self-exclude from a trial based on this summary. Contact the trial site directly to confirm your eligibility.
Last synced 28 July 2026
Phase 3: approximately ~65% of drugs entering this phase reach regulatory approval, based on published industry-wide historical data. This is not specific to this trial.
Phase success rates shown are historical industry-wide averages based on published data. They are not a prediction for this specific trial or your individual situation.

Contact this trial

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

Phone: 8617799855659

Contact details sourced from ClinicalTrials.gov. Verify directly with the trial site before attending.

GP referral letter

Print a one-page summary to share with your doctor.

Trial details

Status
Recruiting
Phase
Phase 3
Sponsor
Zhejiang University
Registry
ClinicalTrials.gov
Start date
20 January 2024
Est. completion
30 September 2025

Where this trial is recruiting

🇨🇳 China

Primary endpoints

Proportion of patients with PMR-AS score <10 score at weeks 52

Can't join this trial?

Expanded access pathways

If this trial is not available to you, other access pathways may exist. In Australia, the TGA Special Access Scheme allows access to unapproved therapeutic goods for individual patients.

TGA Special Access Scheme information

Find other recruiting trials on ClinicalTrials.gov

Data last synced from ClinicalTrials.gov: 28 July 2026. Trial status can change. Always verify current status directly with the trial site before making any decision.

Trial recruitment status can change without notice between our nightly data updates. Always contact the trial site directly to confirm current recruitment status before making any decisions or travel arrangements.

View original record on ClinicalTrials.gov