Comparative Pharmacokinetic Trial of RGB-03 and MabThera
- Sponsor
- Gedeon Richter Plc.
- Study ID
- NCT02371096
- Phase
- PHASE1
- Status
- Unknown
Conditions
Eligibility Criteria
- Sex
- ALL
- Age
- 18 Years - 75 Years
- Healthy Volunteers
- Not accepted
Interventions
- MabThera (rituximab) — DRUG
- RGB-03 — DRUG
Study Details
Pharmacokinetic properties, efficacy, safety and tolerability of RGB-03 and MabThera will be compared in patients suffering from Rheumatoid Arthritis.
Key Dates
- Status verified
- Feb 2015
- Primary completion
- Jun 30, 2016
Arms
- Experimental: RGB-03
- Active Comparator: MabThera (rituximab)
Primary Outcome Measure
Area under the serum concentration versus time curve (AUC) [ Time Frame: 0-24 weeks ]
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