NCT01534884

Demonstrate the Equivalence of CT-P10 to MabThera With Respect to the Pharmacokinetic Profile in Patients With Rheumatoid Arthritis

Phase 1, Randomized, Controlled, Multicenter, 2-Arm, Parallel-Group, Double-Blind Study to Demonstrate the Equivalence of CT-P10 to MabThera With Respect to the Pharmacokinetic Profile in Patients With Rheumatoid Arthritis

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 154 (actual)
• Sponsor: Celltrion · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

This randomized,controlled, multicenter, 2-arm, parallel-group, double-blind, prospective, Phase 1 study is designed to demonstrate comparable pharmacokinetics in terms of AUC0-last and Cmax (after second infusion) between CT-P10 and MabThera in patients with active RA concomitantly treated with MTX during the Core Study Period.

Conditions

• Rheumatoid Arthritis

Interventions

Type	Name	Description
BIOLOGICAL	rituximab	1000 mg by intravenous (IV) infusion. Each patient may receive 2 courses of treatment.

Timeline

• Start date: 2012-02-01
• Primary completion: 2013-08-01
• Completion: 2014-02-01
• First posted: 2012-02-17
• Last updated: 2015-05-22

Locations

1 site across 1 country: South Korea