Rheumatoid Arthritis Clinical Trial
Official title:
A Multicenter, Randomized, Double-blind Phase 2 Study to Evaluate the Safety, Efficacy, Pharmacokinetics (PK) and Pharmacodynamics (PD) of Hemay007 in Patients With Moderate to Severe Rheumatoid Arthritis
This is a multicenter, randomized, double-blind phase2 study to evaluate the safety and investigate the efficacy, pharmacokinetics (PK) and pharmacodynamics (PD) of Hemay007 in Patients with moderate to severe Rheumatoid Arthritis who are on a stable dose of DMARDs.
This study adopts a multi-center, randomized, double-blind clinical study design. Patients with moderate to severe active rheumatoid arthritis who meet the inclusion criteria but do not meet the exclusion criteria will be randomly assigned into the 600 mg QD group, 800 mg QD group, 1200 mg QD group and placebo group at a ratio of 1:1:1:1, with about 35 subjects in each group. Patients in all the groups will be treated with Hemay007 or placebo for 12 weeks, and observed for 4 weeks after the treatment. This study is to evaluate the safety and investigate the efficacy, pharmacokinetics (PK) and pharmacodynamics (PD) of Hemay007 in Patients with moderate to severe Rheumatoid Arthritis who are on a stable dose of DMARDs. ;
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