A Phase 3 Study Comparing TLL-018 to Tofacitinib in RA Subjects With Inadequate Response or Intolerance to bDMARDs

Exclusion Criteria

• •With other rheumatic diseases;
• •With other systemic inflammatory diseases;
• •With progressive or uncontrolled symptoms of renal, hepatic, hematologic, gastrointestinal, endocrine, pulmonary, cardiovascular, neurologic, psychiatric, or cerebral disease;
• •Previous history of severe hematologic diseases;
• •Previous history of malignancy within five years, with exception of cured basal cell carcinoma or cutaneous squamous cell carcinoma or cervical carcinoma in situ.
• •With active infection before randomization;
• •Herpes zoster occurred within 1 year prior to randomization; disseminated or recurrent herpes zoster prior to randomization; disseminated herpes simplex before randomization;
• •Previous history of active tuberculosis (TB) and no evidence of clinical cure or imaging evidence of active TB; or T-spot or PPD positive at screening but have received TB preventive therapy less than one month;
• •HBsAg positive (or HBsAg negative but anti-HBc positive and HBV-DNA quantitative test positive), HCV antibody and HCV-RNA positive, or HIV antibody positive;
• •Previous history of thrombocytopenia, coagulopathy, or platelet dysfunction;
• •Previous history of cardiovascular and cerebrovascular accidents;
• •Previous history of thromboembolism or risk factors;
• •Previous history of gastrointestinal perforation;
• •Temporary usage of NSAIDs within 48 hours prior to the baseline visit;
• •Have received anti-rheumatic herb within 4 weeks before randomization;
• •Have received interferon therapy within 4 weeks before randomization;
• •Have donated blood more than 400 ml or received blood transfusion within 3 months prior to the study;
• •Have received any live vaccine within 2 months before randomization or plan to receive a live vaccine during the study;
• •Have experienced major surgery within 4 weeks before randomization, or expected to receive major surgical treatment after enrollment;
• •Laboratory test results are abnormal and may interfere the study judged by investigators;
• •Use of potent opioids within 4 weeks before the baseline visit;
• •Allergy to ingredients or excipients of tofacitinib or TLL-018;
• •Unable to accomplish evaluation in study;
• •Receiving any study drug within 4 weeks or less than 5 elimination of half-life period) before randomization (whichever is longer);