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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

This study has been completed.
Information provided by (Responsible Party):
Celltrion Identifier:
First received: March 23, 2012
Last updated: July 30, 2013
Last verified: July 2013
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.

Condition Intervention Phase
Ankylosing Spondylitis
Biological: Infliximab
Phase 1

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
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

Resource links provided by NLM:

Further study details as provided by Celltrion:

Primary Outcome Measures:
  • Long term efficacy evaluated by Assessment of Spondylo Arthritis International Society(ASAS) criteria and Long term safety evaluated by immunogenicity and clinical laboratory test [ Time Frame: Up to Week 40 ]

Enrollment: 174
Study Start Date: March 2012
Study Completion Date: May 2013
Primary Completion Date: May 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: CT-P13
Biological: Infliximab
CT-P13 (5mg/kg) administered as a 2-hour IV infusion per dose


Ages Eligible for Study:   18 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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  • Patient who has been withdrawn from Study CT-P13 1.1 for any reason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
  Contacts and Locations
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Please refer to this study by its identifier: NCT01571206

Korea, Republic of
Inha University Hospital
Incheon, Korea, Republic of
Sponsors and Collaborators
Study Director: Won Park, M.D., Ph.D. Inha University Hospital
  More Information

Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Celltrion Identifier: NCT01571206     History of Changes
Other Study ID Numbers: CT-P13 1.3
2011-004572-11 ( EudraCT Number )
Study First Received: March 23, 2012
Last Updated: July 30, 2013

Keywords provided by Celltrion:

Additional relevant MeSH terms:
Spondylitis, Ankylosing
Bone Diseases, Infectious
Bone Diseases
Musculoskeletal Diseases
Spinal Diseases
Joint Diseases
Dermatologic Agents
Gastrointestinal Agents
Antirheumatic Agents processed this record on May 25, 2017