An Extension Study to Demonstrate the Equivalence of Long-Term Efficacy and Safety of CT-P13 in Patients With Ankylosing Spondylitis Who Were Treated With Infliximab (Remicade or CT-P13) in Study CT-P13 1.1

Ankylosing Spondylitis Clinical Trial

Official title:

An Open-Label, Single-Arm, Extension Study to Demonstrate Long-Term Efficacy and Safety of CT-P13 in Patients With Ankylosing Spondylitis Who Were Treated With Infliximab (Remicade or CT-P13) in Study CT-P13 1.1

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01571206
• Other study ID #: CT-P13 1.3
• Secondary ID: 2011-004572-11
• Status: Completed
• Phase: Phase 1
• First received: March 23, 2012
• Last updated: July 30, 2013
• Start date: March 2012
• Est. completion date: May 2013

Study information

• Verified date: July 2013
• Source: Celltrion
• Contact: n/a
• Is FDA regulated: No
• Health authority: Korea: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

This open-label, single-arm, multicenter, multiple single-dose intravenous (IV) infusion, efficacy, and safety extension study of the Phase 1 Study CT-P13 1.1 is designed to assess the long-term efficacy and safety of multiple doses of CT-P13.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 174
• Est. completion date: May 2013
• Est. primary completion date: May 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

Inclusion Criteria:

• Patient who has completed the scheduled visits, including the End-of-Study Visit, in Study CT-P13 1.1

• Patient who has not had any major protocol violation in Study CT-P13 1.1

Exclusion Criteria:

• Patient who has been withdrawn from Study CT-P13 1.1 for any reason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 option of the investigator

• Patient who plans to participate in a study with an investigational drug during the period of this extension study

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Ankylosing Spondylitis
• Spondylitis
• Spondylitis, Ankylosing

Intervention

Biological:
• Infliximab
CT-P13 (5mg/kg) administered as a 2-hour IV infusion per dose

Locations

Country	Name	City	State
Korea, Republic of	Inha University Hospital	Incheon

Sponsors (1)

Lead Sponsor	Collaborator
Celltrion

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Long term efficacy evaluated by Assessment of Spondylo Arthritis International Society(ASAS) criteria and Long term safety evaluated by immunogenicity and clinical laboratory test		Up to Week 40	No