Rheumatoid Arthritis
Conditions
Interventions
Experimental group:Tofacitinib 5mg twice per day
Control group:Methotrexate 10-15mg/week+folic acid 5mg/week, Diprospan 1ml muscular injection at enrollment.
Sponsors
Peking University First Hospital
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1. Fulfilled the 2010 European League Against Rheumatism (EULAR)/American College of?Rheumatology (ACR) classification criteria for RA; 2. Aged >=18 years; 3. Have never received mono or combined conventional synthetic disease-modifying anti-rheumatic drugs (csDMARDs) or biological DMARDs or target therapy for RA; 4. With SDAI > 3.3.
Exclusion criteria
Exclusion criteria: 1. Complicating of other connective tissue diseases, except for Sjogrens Syndrome; 2. Uncontroled chronic disease, including asthma,diabetes,COPD,moderate to severe interstitial lung disease; 3. Received NSAIDs in the past 1 week; 4. Mental disorders; 5. Pregnant or plan to be pregnant in 2 years, or nursing mothers.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| clinical target achievement rate of the two groups at week 12 (SDAI <= 3.3); | — |
Secondary
| Measure | Time frame |
|---|---|
| clinical target achievement rate of the two groups at week 24 (SDAI<=3.3);Improvement rate of total ultrasound PD and GS scores in two groups of patients at 24 weeks;The compliance rate of ACR20/ACR50/ACR70 in two groups of patients at 12 weeks;The compliance rate of ACR20/ACR50/ACR70 in two groups of patients at 24 weeks;Changes in HAQ-DI scores of two groups of patients at 24 weeks;The incidence of adverse events and reactions;Pharmacoeconomic evaluation; | — |
Countries
China
Contacts
Public ContactZhang Zhuoli
Peking University First Hospital
Outcome results
None listed