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项与 利妥昔单抗生物类似药(BioIntegrator LLC) 相关的临床试验Multicenter Double-blind Randomized Clinical Study of Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Biosimilar Drug Ritumax® Compared to Original Drug MabThera® in Patients With Rheumatoid Arthritis
This is a multicenter, double-blind, randomized clinical study of safety, tolerability, pharmacokinetics and pharmacodynamics of biosimilar drug Ritumax® compared to original drug MabThera® in patients with rheumatoid arthritis, receiving stable doses of Methotrexate.
At Week -2, after signing the Patient Information Sheet and Informed Consent Form, patients with rheumatoid arthritis receiving stable doses of Methotrexate (10-25 mg per week orally or parenterally) will pass screening procedures.
Patients meeting all the inclusion/exclusion criteria will be invited to the investigational site for Visit 2 (Week 0) to be randomized into one of two treatment arms:
Ritumax® 1000 mg х 2 intravenous infusions
MabThera® 1000 mg х 2 intravenous infusions After being assigned to the treatment arm patients will receive a course of study treatment, including two i/v infusions at 14-day interval: at Week 0 and Week 2.
After that, patients will be followed up for the next 22 weeks. Safety, pharmacokinetic and pharmacodynamic parameters will be monitored at this visits.
100 项与 利妥昔单抗生物类似药(BioIntegrator LLC) 相关的临床结果
100 项与 利妥昔单抗生物类似药(BioIntegrator LLC) 相关的转化医学
100 项与 利妥昔单抗生物类似药(BioIntegrator LLC) 相关的专利(医药)
100 项与 利妥昔单抗生物类似药(BioIntegrator LLC) 相关的药物交易