NCT02149121

PK Similarity Prospective Phase 3 Study in Patients With Rheumatoid Arthritis

A Randomized, Controlled, Double-Blind, Parallel-Group, Phase 3 Study to Compare the Pharmacokinetics, Efficacy and Safety Between CT-P10, Rituxan and MabThera in Patients With Rheumatoid Arthritis

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 384 (actual)
• Sponsor: Celltrion · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

This is a Phase 3 Study to Compare the Pharmacokinetics, Efficacy and Safety between CT-P10, Rituxan and MabThera in Patients with Rheumatoid Arthritis.

Conditions

• Rheumatoid Arthritis

Interventions

Type	Name	Description
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

Timeline

• Start date: 2014-08-01
• Primary completion: 2016-01-01
• Completion: 2017-01-01
• First posted: 2014-05-29
• Last updated: 2021-12-16
• Results posted: 2021-12-16

Regulatory

• FDA-regulated drug study