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
Phase 1
Completed
- Conditions
- Ankylosing Spondylitis
- Interventions
- Biological: Infliximab
- Registration Number
- NCT01571206
- Lead Sponsor
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 174
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- Patient who has been withdrawn from Study CT-P13 1.1 for any reason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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description CT-P13 Infliximab infliximab
- Primary Outcome Measures
Name Time Method Long term efficacy evaluated by Assessment of Spondylo Arthritis International Society(ASAS) criteria and Long term safety evaluated by immunogenicity and clinical laboratory test Up to Week 40
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Inha University Hospital
🇰🇷Incheon, Korea, Republic of