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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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19 February 2015 |
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Main ID: |
NCT01571206 |
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Date of registration:
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23/03/2012 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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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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Scientific title:
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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 |
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Date of first enrolment:
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March 2012 |
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Target sample size:
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174 |
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Recruitment status: |
Completed |
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URL:
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http://clinicaltrials.gov/show/NCT01571206 |
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Study type:
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Interventional |
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Study design:
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Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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Phase:
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Phase 1
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Countries of recruitment
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Korea, Republic of
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Contacts
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Name:
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Won Park, M.D., Ph.D. |
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Address:
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Telephone:
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Email:
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Affiliation:
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Inha University Hospital |
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Key inclusion & exclusion criteria
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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
Age minimum:
18 Years
Age maximum:
75 Years
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Ankylosing Spondylitis
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Intervention(s)
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Biological: Infliximab
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Primary Outcome(s)
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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]
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Secondary ID(s)
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2011-004572-11
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CT-P13 1.3
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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