Rheumatoid Arthritis Clinical Trial
Official title:
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.
n/a
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