Can a targeted drug help patients with polymyalgia rheumatica stop steroids faster?
NCT ID NCT06172361
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 Hide 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.
Get updates
Get notified about this study
Sign up to get updates when this study changes or when new studies for Polymyalgia rheumatica are added.
By submitting, you agree to our Terms of use
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
More trials for these conditions
Other studies related to the condition(s) this trial covers.
- New tool could predict who will suffer from steroid side effects
- New drug could ease painful muscle condition and cut steroid use
- New drug could help patients with painful muscle disease ditch steroids
- New study aims to unravel mysteries of common inflammatory condition in older adults
- New study links common arthritis treatments to diabetes risk
- Stress relief: could a simple hormone boost ease fatigue in PMR/GCA patients?