Rheumatic polymyalgia
Conditions
Interventions
Experimental group: tofacitinib 5mg bid, course of treatment for 24 weeks
Control group:Prednisone (or equivalent dose of methylprednisolone) 15mg/d for 2 weeks
12.5mg/d for 2 weeks
10mg/d for 6 weeks
7.5mg/d for 6 weeks
5mg/d for 8 weeks for 24 weeks. If the disease recurs, the hormone dose is restored to the original dose.
Sponsors
The First Affiliated Hospital of Medical College of Zhejiang University
Eligibility
Sex/Gender
All
Age
50 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Patients who meet the 1982 or 2012 ACR / EULAR diagnostic criteria for rheumatic polymyalgia; newly diagnosed patients (without using hormone and immunosuppressant), or patients with recurrence (stopping hormone and immunosuppressant for more than 1 month); 2. Patients with high activity rheumatic polymyalgia: disease activity score PMR-AS > 10; 3. Patients aged 50-75 years, weighing 45-80kg; 4. Patients with ESR > 40mm / h or CRP > 100mg / L (10mg / dl); 5. Patients who sign informed consent.
Exclusion criteria
Exclusion criteria: 1. Patients with known allergies to tolfatib, prednisone and methylprednisolone; 2. Patients with giant cell arteritis, systemic lupus erythematosus, rheumatoid arthritis 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. Patients with abnormal liver function (ALT or ast 2 times higher than the upper limit of normal value); 6. Pregnant or lactating women; 7. Patients with a history of malignancy who do not meet the following conditions (basal cell carcinoma with appropriate treatment; patients with other malignant tumors who have been successfully treated for more than 5 years before screening without any evidence of recurrence); 8. Patients with previous visual field disorder or single eye dysfunction, cataract patients; 9. 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; 10. For patients with abnormal blood routine, WBC < 2 x 10^9 / L, HGB < 60g / L, or PLT < 50 x 10^9 / L, it is up to the doctor to determine whether the drug can be used; 11. Patients with active bleeding and peptic ulcer; 12. Patients with other autoimmune diseases; 13. Patients who used biological agents 6 months before enrollment; 14. Patients who have received azathioprine, leflunomide, methotrexate, cyclosporin (or any other calcineurin inhibitor) within one month before enrollment, or patients who have adjusted the dosage of the above drugs within one month; 15. Patients who participated in clinical trials of other drugs within 4 weeks.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The percent of patients who have a PMR-AS < 10 at 12 and 24 weeks; | — |
Secondary
| Measure | Time frame |
|---|---|
| PMR-AS Score;CRP;ESR;pain VAS score;fatigue VAS score;patients global assessment;Doctor global assessment;Morning stiffness(min);Degree of shoulder joint lifting (0, 1, 2, 3);Squats and stands (0, 1, 2, 3); | — |
Countries
China
Contacts
Public ContactLin Jin
The First Affiliated Hospital of Medical College of Zhejiang University
Outcome results
None listed