181
Participants
Start Date
September 29, 2016
Primary Completion Date
February 4, 2019
Study Completion Date
October 2, 2019
CT-P13
CT-P13 (5 mg/kg) by IV infusion administered as a 2-hour IV infusion per dose every 8 weeks (Part 1)
CT-P13
CT-P13 (120 mg) by single SC injection every 2 weeks (Part 1)
CT-P13
CT-P13 (180 mg) by double SC 90 mg injections every 2 weeks (Part 1)
CT-P13
CT-P13 (240 mg) by double SC 120 mg injections every 2 weeks (Part 1)
CT-P13
CT-P13 (120 mg) by single SC injection every 2 weeks in patients with body weight less than 80 kg, and CT-P13 (240 mg) by double SC 120 mg injections in patients with body weight at or above 80 kg based on body weight at Week 6 (Part 2)
CT-P13
CT-P13 (5 mg/kg) by IV infusion administered as a 2-hour IV infusion per dose every 8 weeks up to Week 22. From Week 30, CT-P13 (120 mg) by single SC injection every 2 weeks in patients with body weight less than 80 kg, and CT-P13 (240 mg) by double SC 120 mg injections in patients with body weight at or above 80 kg based on body weight at Week 30 (Part 2)
Yeungnam University Hospital, Daegu
Lead Sponsor
Celltrion
INDUSTRY