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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

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ClinicalTrials.gov Identifier: NCT01571206
Recruitment Status : Completed
First Posted : April 5, 2012
Last Update Posted : July 31, 2013
Sponsor:
Information provided by (Responsible Party):
Celltrion

Brief 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.

Condition or disease Intervention/treatment Phase
Ankylosing Spondylitis Biological: Infliximab Phase 1

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 174 participants
Intervention Model: Single Group Assignment
Masking: None (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
Study Start Date : March 2012
Actual Primary Completion Date : May 2013
Actual Study Completion Date : May 2013

Resource links provided by the National Library of Medicine

Drug Information available for: Infliximab
U.S. FDA Resources

Arm Intervention/treatment
Active Comparator: CT-P13
infliximab
Biological: Infliximab
CT-P13 (5mg/kg) administered as a 2-hour IV infusion per dose



Primary Outcome Measures :
  1. 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 ]


Information from the National Library of Medicine

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

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  • Patient who has been withdrawn from Study CT-P13 1.1 for any reason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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01571206


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

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Celltrion
ClinicalTrials.gov Identifier: NCT01571206     History of Changes
Other Study ID Numbers: CT-P13 1.3
2011-004572-11 ( EudraCT Number )
First Posted: April 5, 2012    Key Record Dates
Last Update Posted: July 31, 2013
Last Verified: July 2013

Keywords provided by Celltrion:
AS
Biosimilar

Additional relevant MeSH terms:
Spondylitis
Spondylitis, Ankylosing
Bone Diseases, Infectious
Infection
Bone Diseases
Musculoskeletal Diseases
Spinal Diseases
Spondylarthropathies
Spondylarthritis
Ankylosis
Joint Diseases
Arthritis
Infliximab
Dermatologic Agents
Gastrointestinal Agents
Antirheumatic Agents