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

NCT03147248 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 407

Last updated 2020-04-08

Study results available
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Summary

This is a Phase I/III Study to Evaluate Efficacy, Pharmacokinetics and Safety between CT-P13 SC and CT-P13 IV in Patients with Active Rheumatoid Arthritis (RA).

Conditions

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

Sponsors & Collaborators

Principal Investigators

  • MoonSun Choi · Celltrion

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-09-12
Primary Completion
2018-05-21
Completion
2019-04-15

Countries

  • South Korea

Study Locations

More Related Trials

Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03147248 on ClinicalTrials.gov