Phase
Condition
Connective Tissue Diseases
Collagen Vascular Diseases
Polymyalgia Rheumatica (Pmr)
Treatment
Prednisone+Tofacitinib
Prednisone
Clinical Study ID
Ages 50-88 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
PMR patients who fulfilled the 1982 Chuang criteria or 2012ACR/EULAR criteria forPMR; They did not receive any glucocorticoids or biological agents during the 2weeks period that preceded their inclusion in the study;
Patients with high activity rheumatic polymyalgia: disease activity score PMR-AS (Table 3) > 10,
Adults age 50-88, Weight 45-85Kg,
ESR>20mm/h or CRP >50mg/L (5mg/dl),
Informed consent.
Exclusion
Exclusion Criteria:
Patients with known allergies to tofacitinib, prednisone or methylprednisolone,
Patients with identified giant cell arteritis, systemic lupus erythematosus,rheumatoid arthritis, calcium pyrophosphate deposition (CPPD) arthropathy, and otherrheumatic diseases,
Patients with severe osteoarthritis,
Subjects with any severe acute, chronic or recurrent infection (e.g. pneumonia orpyelonephritis, recurrent pneumonia, chronic bronchiectasis, tuberculosis, etc.),
Hepatitis B virus carriers or individuals with chronic active hepatitis B or C,other chronic liver diseases, HIV infection,
Patients with abnormal liver function (ALT/AST 2 times higher); Moderate to severerenal impairment (glomerular filtration rate <60); hyperlipidemia not improved bylipid-lowering drugs,
Pregnant or lactating women,
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 5years before screening without any evidence of recurrence),
Patients with previous visual field disorder or single eye dysfunction, cataractpatients,
Patients with decompensated cardiac insufficiency or severe hypertension or diabetesmellitus, i.e. systolic blood pressure higher than 160mmhg or diastolic bloodpressure higher than 100mmhg,
For patients with abnormal blood routine, lymphocytes <500/mm3 or ANC <1000/mm3 orHGB < 90g/L,
Patients with active bleeding and peptic ulcer,
Have used biological agents or added azathioprine, leflunomide, FK 506 within 1month before enrollment,
Those who have participated in other drug clinical trials within 4 weeks,
Patients using CYP3A4 inhibitors or inducers such as ketoconazole, fluconazole, orrifampicin within 4 weeks.
Study Design
Study Description
Connect with a study center
Division of Rheumatology, the First Affiliated Hospital, Zhejiang University School of Medicine
Hangzhou, Zhejiang 313000
ChinaActive - Recruiting
Not the study for you?
Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.