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

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

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01571219

Enrollment

302

Registered

2012-04-05

Start date

2012-03-31

Completion date

2013-07-31

Last updated

2017-08-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Rheumatoid Arthritis

Keywords

RA, Biosimilar

Brief summary

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.

Interventions

BIOLOGICALInfliximab

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)

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 75 Years

Healthy volunteers

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* Patient who has been withdrawn from Study CT-P13 3.1 for any reason * Patient who, at the time of providing informed consent, has any ongoing medical issues such as serious adverse events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

Design outcomes

Primary

Measure	Time frame
Long term efficacy evaluated by American College of Rheumatology(ACR) criteria and Long term safety evaluated by immunogenicity and clinical laboratory test	Up to week 40

Countries

South Korea

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 13, 2026