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NCT05606107
To Compare the Efficacy and Safety of Low-dose Glucocorticoids and Tofacitinib in Alleviating Moderate to High Disease Activity Rheumatoid Arthritis for 24 Weeks
Conditions: Rheumatoid Arthritis
Sex: All
Ages: 18 Years – 70 Years
Phase: PHASE4
Enrollment: 230
Sponsor: Second Affiliated Hospital, School of Medicine, Zhejiang University
Location: China
Summary
Glucocorticoids are effective in the treatment of rheumatoid arthritis, but long-term use of glucocorticoids has many side effects.
Tofacitinib is a new small-molecule drug targeting JAK, which has been found to act quickly.
The aim of this clinical trial was to investigate the efficacy and safety of tofacitinib and low-dose glucocorticoids in inducing remission in patients with rheumatoid arthritis with moderate to high disease activity.
Eligibility Criteria
Inclusion Criteria:Age 18-70 years;met the 2010 ACR and EULAR diagnostic criteria for rheumatoid arthritis (RA), and was diagnosed as RA;After more than 3 months of initial treatment or conventional DMARDs treatment, the disease was still in medium-high disease activity, and DAS28-CRP>3.2;No birth plan during and within 3 months after the end of the study;Voluntarily sign the informed consent form.Exclusion Criteria:Patients who are using or have used glucocorticoids, tofacitib and biological agents in the past 3 months;At the time of screening, patients were in the acute phase of acute infection or chronic infection;Laboratory test results: Hb<100g/L; White blood cell count <4.0×10^9/L; Platelets <100×10^9/L; Liver function (transaminase, bilirubin)> 2 times the upper limit of normal value; Renal function (SCr) > the upper limit of normal;Active gastrointestinal disease: gastrointestinal bleeding or active gastrointestinal ulcer and acute gastric mucosal injury diagnosed by gastroenteroscopy in the past three months;A history of severe cardiovascular, cerebrovascular, kidney and other important organs, blood and endocrine system lesions, malignant tumors and thrombosis;suffering from serious, progressive and uncontrolled diseases of other important organs and systems;mental disease patients;Other conditions deemed unsuitable for trial participation by the investigator;Pregnancy tests of women of childbearing age were positive.
Source: ClinicalTrials.gov (NCT05606107). StuddyBuddy aggregates publicly available trial information.