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DRL_RI (Rituximab Biosimilar) vs Rituxan/MabThera in Rheumatoid Arthritis
NCT02296775Phase 2
Key facts
- Status
- Completed
- Start
- Nov 2014
- Primary completion
- Nov 2016
- Countries
- 2
- Sponsor
- Dr. Reddy's Laboratories
- Modality
- Monoclonal Antibodies
- Drugs
- rituximab
- Conditions
- rheumatoid arthritis (RA)
01
Overview
Phase 2, randomised, double-blind trial of rituximab in rheumatoid arthritis (RA) (3 arms), sponsored by Dr. Reddy's Laboratories. Primary endpoints: Area Under the Concentration-Time Curve From Time 0 to 336 Hours Post First Dose, Area Under the Concentration-Time Curve From Time 0 to Infinity Over the Entire Course of Therapy at 16 weeks and 1 more. Started Nov 2014; status: completed.
02
Design
3 arms- Study design
- RandomizedDouble-blind
DRL_RI
DRL_RI 1000 mg IV + MTX
Rituxan
Rituxan 1000 mg IV + MTX
MabThera
MabThera 1000 mg IV + MTX
03
Who it enrols
Adult patients with moderate to severe active rheumatoid arthritis for at least 6 months, on stable methotrexate dose, with no prior biologic therapy.
04
Endpoints
Primary
Area Under the Concentration-Time Curve From Time 0 to 336 Hours Post First Dose
Area Under the Concentration-Time Curve From Time 0 to Infinity Over the Entire Course of Therapy
Area Under Concentration-time Curve From Time 0 to the Time of the Last Quantifiable Concentration
Secondary
Maximum Plasma Concentration
Time to Maximum Plasma Concentration
Volume of Distribution
Systemic Clearance
Terminal Half-life
Disease Activity Score-28 with C-Reactive Protein
Percentage of Patients With Peripheral B-cell Counts Depletion
American College of Rheumatology 20% Response
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