polymyalgia rheumatica
Conditions
Interventions
Experimental group:Tofacitinib 5mg bid combined with glucocorticoid, treat for 24 weeks
Control group:The placebo combined with glucocorticoid, treat for 24 weeks
Sponsors
Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology
Eligibility
Sex/Gender
All
Age
50 Years to 80 Years
Inclusion criteria
Inclusion criteria: 1.Prior to specific procedures related to the study, subjects should be able to read and provide written signatures and dated informed consent and be able to participate in the study in accordance with GCP and applicable regulations; 2.Understand, be able and willing to fully comply with research procedures and restrictions; 3.Male or female patients aged 50 (inclusive) to 80 (inclusive) years; 4.Women participating in the study should be infertile or are willing to use at least one of the following medically acceptable contraceptive methods; 5.Patients who meet the 1982 or 2012 ACR /EULAR diagnostic criteria for rheumatic polymyalgia; newly diagnosed patients, or patients with glucocorticoid no more than 1 month, and these patients should stop above drugs for more than 7 days; 6.Patients with high activity: disease activity score PMR-AS >= 10; 7.Patients with ESR >= 40mm /h or CRP >= 100mg /L (10mg/dl).
Exclusion criteria
Exclusion criteria: 1.Subjects with other rheumatic diseases, such as giant cell arteritis, systemic lupus erythematosus, and so on; 2.During the 1 month prior to enrollment, the following drugs were used or the dosage was adjusted: (1)Tacrolimus; (2)Cyclosporin; (3)Leflunomide; (4)Thalidomide; (5)Azathioprine; (6)Cyclophosphamide; (7)Methotrexate; (8)Tumor necrosis factor inhibitor (TNFi) or tumor necrosis factor receptor antibody fusion protein; (9)Rituximab; (10)Other Janus kinase inhibitors. 3.Known allergy to the study drug; 4.Subjects with currently infected, chronic or recurrent infectious disease, or tuberculosis evidence (PPD positive or QuantiFERON TB - Gold positive), or screening known infected with HIV, hepatitis B or hepatitis C; 5.According to the researchers, subjects suffering from any clinically unstable heart, respiratory, neurological, immune, blood, or kidney disease, or any other conditions that may harm the interests of the subjects, or impair communication with researchers, should be prohibited from participating in the trial; 6.The subjects have obvious liver and kidney diseases and laboratory abnormalities, which were defined as: (1)Glutamic oxaloacetic transaminase, glutamic pyruvic transaminase and lactate dehydrogenase >= 3 x upper limit of normal value [ULN]; (2)Creatinine or total bilirubin >= 1.5 x ULN; (3)Hemoglobin 170mmHg or diastolic blood pressure > 100 mmHg (which can be re-measured after a 5-minute rest); 9.Female subjects who are pregnant, planning to become pregnant or breastfeeding; 10.Subjects who are known to be addicted to alcohol or other drugs; 11.Subjects have participated in any other clinical trials in the past 3 months, or during the five metabolic half-lives of other clinical trial drugs; 12.The researchers believe that the subjects have any situation that endangers the evaluation of efficacy or the safety of the subjects, or poor compliance with the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Effectiveness; | — |
Secondary
| Measure | Time frame |
|---|---|
| Security;Changes in disease status scores;Hormone dosage;ESR;Inflammation levels; | — |
Countries
China
Contacts
Public ContactDong Lingli
Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology
Outcome results
None listed