Can a targeted drug help patients with polymyalgia rheumatica stop steroids faster?

NCT ID NCT06172361

What the study statuses mean

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Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Sep 08, 2026 · Last updated Sep 09, 2026 · Updated 1 time

Summary

This trial tests whether adding tofacitinib to a standard steroid treatment can better control polymyalgia rheumatica, a condition causing pain and stiffness in the shoulders and hips. Adults aged 50 to 88 with active disease will receive either tofacitinib plus a tapering course of prednisone or prednisone alone. Researchers will track disease activity over 52 weeks to see if the combination leads to lower symptom scores and allows patients to safely stop steroids.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Tofacitinib combined with prednisone (a corticosteroid)
What this could lead to
If it works, this combination could offer a way to control polymyalgia rheumatica symptoms and let patients stop treatment sooner, reducing steroid side effects.
What could go wrong
The trial is still testing the approach, and results may not confirm it works. Tofacitinib and steroids carry risks like infection, and some patients may relapse when medication is tapered.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

104 people

The number who actually took part.

Started

Jan 2024

Finished

May 2026

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

50 to 88 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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.

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Contacts and locations

Locations

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

    Hangzhou, Zhejiang, 313000, China

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