NCT02149121 - PK Similarity Prospective Phase 3 Study in Patients With Rheumatoid Arthritis | Biotech Hunter

Enrollment

384

Participants

Timeline

Start Date

August 31, 2014

Primary Completion Date

January 31, 2016

Study Completion Date

January 31, 2017

Conditions

Rheumatoid Arthritis

Interventions

BIOLOGICAL

CT-P10

1000mg by intravenous infusion. 2 infusions with a 2-week interval between the first and second infusion

DRUG

Rituxan

US-licensed reference product, 1000mg by intravenous infusion. 2 infusions with a 2-week interval between the first and second infusion

DRUG

MabThera

EU-approved reference product, 1000mg by intravenous infusion. 2 infusions with a 2-week interval between the first and second infusion