Comparative Pharmacokinetic Trial of RGB-03 and MabThera
- Registration Number
- NCT02371096
- Lead Sponsor
- Gedeon Richter Plc.
- Brief Summary
Pharmacokinetic properties, efficacy, safety and tolerability of RGB-03 and MabThera will be compared in patients suffering from Rheumatoid Arthritis.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- Not specified
Inclusion Criteria
- Active Rheumatoid Arthritis
- Inadequate response or intolerance to other DMARDs and anti-TNFs
- Treatment with Methotrexate
Read More
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.
Read More
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description RGB-03 RGB-03 - MabThera (rituximab) MabThera (rituximab) -
- Primary Outcome Measures
Name Time Method Area under the serum concentration versus time curve (AUC) 0-24 weeks
- Secondary Outcome Measures
Name Time Method