Comparative Pharmacokinetic Trial of RGB-03 and MabThera

• Status: Unknown status
• Trial end date: 1969-12-31
• Target enrollment: 0
• Participant gender: All

Summary

Pharmacokinetic properties, efficacy, safety and tolerability of RGB-03 and MabThera will be compared in patients suffering from Rheumatoid Arthritis.

• Phase: Phase 1

Details

• Lead Sponsor: Gedeon Richter Plc.
• Treatments: Rituximab

Criteria

Inclusion Criteria:

• Active Rheumatoid Arthritis

• Inadequate response or intolerance to other DMARDs and anti-TNFs

• Treatment with Methotrexate

Exclusion Criteria:

• Previous treatment with rituximab

• Patients with systemic manifestations of rheumatoid arthritis

• Patients seropositive for HIV, HCV, HBV

• Female patients nursing

Other protocol-defined inclusion/exclusion criteria may apply.