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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.
Sponsor:
Information provided by (Responsible Party):
Celltrion
ClinicalTrials.gov Identifier:
NCT01571206
First received: March 23, 2012
Last updated: July 30, 2013
Last verified: July 2013
March 23, 2012
July 30, 2013
March 2012
May 2013   (Final data collection date for primary outcome measure)
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 ]
Same as current
Complete list of historical versions of study NCT01571206 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
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Not Provided
 
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
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
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.
Not Provided
Interventional
Phase 1
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Ankylosing Spondylitis
Biological: Infliximab
CT-P13 (5mg/kg) administered as a 2-hour IV infusion per dose
Active Comparator: CT-P13
infliximab
Intervention: Biological: Infliximab
Park W, Yoo DH, Miranda P, Brzosko M, Wiland P, Gutierrez-Ureña S, Mikazane H, Lee YA, Smiyan S, Lim MJ, Kadinov V, Abud-Mendoza C, Kim H, Lee SJ, Bae Y, Kim S, Braun J. Efficacy and safety of switching from reference infliximab to CT-P13 compared with maintenance of CT-P13 in ankylosing spondylitis: 102-week data from the PLANETAS extension study. Ann Rheum Dis. 2017 Feb;76(2):346-354. doi: 10.1136/annrheumdis-2015-208783. Epub 2016 Apr 26.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
174
May 2013
May 2013   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
18 Years to 75 Years   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Korea, Republic of
 
 
NCT01571206
CT-P13 1.3
2011-004572-11 ( EudraCT Number )
No
Not Provided
Not Provided
Not Provided
Celltrion
Celltrion
Not Provided
Study Director: Won Park, M.D., Ph.D. Inha University Hospital
Celltrion
July 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP