Back to resultsAn 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
Primary Purpose
Ankylosing Spondylitis
Status
Completed
Phase
Phase 1
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Infliximab
Sponsored by
About this trial
This is an interventional treatment trial for Ankylosing Spondylitis focused on measuring AS, Biosimilar
Eligibility 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- Patient who has been withdrawn from Study CT-P13 1.1 for any reason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
Sites / Locations
- Inha University Hospital
Arms of the Study
Arm 1
Arm Type
Active Comparator
Arm Label
CT-P13
Arm Description
infliximab
Outcomes
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
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01571206
Brief Title
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
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 Type
Interventional
2. Study Status
Record Verification Date
July 2013
Overall Recruitment Status
Completed
Study Start Date
March 2012 (undefined)
Primary Completion Date
May 2013 (Actual)
Study Completion Date
May 2013 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Celltrion
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Ankylosing Spondylitis
Keywords
AS, Biosimilar
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
174 (Actual)
8. Arms, Groups, and Interventions
Arm Title
CT-P13
Arm Type
Active Comparator
Arm Description
infliximab
Intervention Type
Biological
Intervention Name(s)
Infliximab
Intervention Description
CT-P13 (5mg/kg) administered as a 2-hour IV infusion per dose
Primary Outcome Measure Information:
Title
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
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Won Park, M.D., Ph.D.
Organizational Affiliation
Inha University Hospital
Official's Role
Study Director
Facility Information:
Facility Name
Inha University Hospital
City
Incheon
Country
Korea, Republic of
12. IPD Sharing Statement
Citations:
PubMed Identifier
27117698
Citation
Park W, Yoo DH, Miranda P, Brzosko M, Wiland P, Gutierrez-Urena 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.
Results Reference
derived
Learn more about this trial
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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