Treatment for Polymyalgia Rheumatica using Tofacitinib and Glucocorticoids

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 study is testing if a new combination of tofacitinib and glucocorticoids can help people with polymyalgia rheumatica feel better while reducing their need for steroids.

Quick facts

• Phase: PHASE3
• Study type: Interventional
• Enrollment: 98 (estimated)
• Ages: 50 Years to 88 Years
• Sex: All
• Sponsor: Zhejiang University (other)
• Drugs / interventions: tofacitinib, prednisone
• Locations: 1 site (Hangzhou, Zhejiang)
• Trial ID: NCT06172361 on ClinicalTrials.gov

What this trial studies

This clinical trial evaluates the efficacy and safety of a combination therapy using tofacitinib and glucocorticoids in patients with polymyalgia rheumatica (PMR). It is an open-label, 52-week randomized controlled trial aimed at inducing rapid improvement in PMR symptoms while allowing for a tapering of steroid use. The study targets patients aged 50-88 who meet specific diagnostic criteria and have high disease activity. The goal is to provide a new treatment option that minimizes the side effects associated with long-term glucocorticoid use.

Who should consider this trial

Good fit: Ideal candidates are adults aged 50-88 with high activity polymyalgia rheumatica who have not received glucocorticoids or biological agents in the two weeks prior to the study.

Not a fit: Patients with other rheumatic diseases or severe infections, as well as those allergic to the study medications, may not benefit from this trial.

Why it matters

Potential benefit: If successful, this treatment could offer a more effective and safer management option for patients with polymyalgia rheumatica.

How similar studies have performed: Previous studies have shown promising results with tofacitinib for treating polymyalgia rheumatica, indicating potential for success in this approach.

Eligibility criteria

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.

Where this trial is running

Hangzhou, Zhejiang

• Division of Rheumatology, the First Affiliated Hospital, Zhejiang University School of Medicine — Hangzhou, Zhejiang, China (RECRUITING)

Study contacts

• Principal investigator: Weiqian Chen — Division of Rheumatology, the First Affiliated Hospital, Zhejiang University School of Medicine
• Study coordinator: Yanlin He

Conditions: Polymyalgia Rheumatica, Tofacitinib, Glucocorticoid