An Extension Study to Demonstrate Long-Term Efficacy and Safety of CT-P13 When Co-administered With Methotrexate in Patient With Rheumatoid Arthritis Who Were Treated With Infliximab (Remicade or CT-P13) in Study CT-P13 3.1

CT-P13 (Infliximab) is a monoclonal antibody currently being developed by CELLTRION, Inc. This open-label, single-arm, multicenter, multiple single dose intravenous (IV) infusion, efficacy, and safety extension study of the Phase 3 Study CT-P13 3.1 is designed to assess the long-term efficacy and safety of multiple doses of CT-P13.

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Key information

Conditions

Rheumatoid Arthritis Arthritis Arthritis, Rheumatoid Autoimmune Diseases Connective Tissue Diseases Immune System Diseases Joint Diseases Musculoskeletal Diseases Rheumatic Diseases Skin and Connective Tissue Diseases

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Hanyang University Medical Center

Seoul, South Korea

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Patient who has completed the scheduled visits, including the End-of-Study Visit, in Study CT-P13 3.1
Patient who has not had any major protocol violation in Study CT-P13 3.1
Patient is permitted to enter the extension study if, in the option of their general practitioner or the investigator, the patient will continue to gain benefit from treatment in the extension study. Local guidelines for patient treatment will be followed

Exclusion criteria

Patient who has been withdrawn from Study CT-P13 3.1 for any reason
Patient who, at the time of providing informed consent, has any ongoing medical issues such as serious adverse events (SAEs) or intolerance issues that mean continuation in this extension study could be detrimental to their health, in the opinion of the investigator
Patient who plans to participate in a study with an investigational drug during the period of this extension study

Treatment and study plan

Infliximab

Biological

CT-P13(3mg/kg) administered as a 2-hour IV infusion per dose co-administered with methotrexate between 12.5 to 25 mg/week, oral or parenteral dose (dose and route must be maintained from Study CT-P13 3.1 and be maintained from the beginning to the end of the extension study) and folic acid(≥5mg/week, oral dose)

Primary outcomes

Long term efficacy evaluated by American College of Rheumatology(ACR) criteria and Long term safety evaluated by immunogenicity and clinical laboratory test

Time frame: Up to week 40

Sponsors and collaborators

Lead sponsor

Celltrion

Industry

Registry information

Official study title

An Open-Label, Single-Arm, Extension Study to Demonstrate Long-Term Efficacy and Safety of CT-P13 When Co-Administered With Methotrexate in Patient With Rheumatoid Arthritis Who Were Treated With Infliximab(Remicade or CP-P13) in Study CT-P13 3.1

Important dates

Study start: 2012
Primary completion: 2013
Study completion: 2013
First posted: Apr 5, 2012
Registry last updated: Aug 1, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed