A Phase I/III Study to Evaluate Efficacy, PK and Safety Between CT-P13 SC and CT-P13 IV in Patients With Active RA

PHASE3CompletedINTERVENTIONAL
Enrollment

407

Participants

Timeline

Start Date

September 12, 2016

Primary Completion Date

May 21, 2018

Study Completion Date

April 15, 2019

Conditions
Rheumatoid Arthritis
Interventions
BIOLOGICAL

CT-P13

CT-P13 (3 mg/kg) by IV infusion administered as a 2 hour IV infusion per dose every 8 weeks

BIOLOGICAL

CT-P13

CT-P13 (90 mg) by single SC injection every other week

BIOLOGICAL

CT-P13

CT-P13 (120 mg) by single SC injection every other week

BIOLOGICAL

CT-P13

CT-P13 (180 mg) by double SC 90 mg injections every other week

BIOLOGICAL

CT-P13

CT-P13 (120 mg) by single SC injection every other week with placebo IV at Weeks 6, 14 and 22.

BIOLOGICAL

CT-P13

CT-P13 (3 mg/kg) by IV infusion administered as a 2 hour IV infusion per dose every 8 weeks with placebo SC at Week 6 and every other week thereafter up to Week 28

Trial Locations (1)

Unknown

Hanyang University Medical Center, Seoul

Sponsors

Lead Sponsor

All Listed Sponsors
lead

Celltrion

INDUSTRY

NCT03147248 - A Phase I/III Study to Evaluate Efficacy, PK and Safety Between CT-P13 SC and CT-P13 IV in Patients With Active RA | Biotech Hunter | Biotech Hunter