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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01571206
Other study ID # CT-P13 1.3
Secondary ID 2011-004572-11
Status Completed
Phase Phase 1
First received March 23, 2012
Last updated July 30, 2013
Start date March 2012
Est. completion date May 2013

Study information

Verified date July 2013
Source Celltrion
Contact n/a
Is FDA regulated No
Health authority Korea: Food and Drug Administration
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 174
Est. completion date May 2013
Est. primary completion date May 2013
Accepts healthy volunteers No
Gender Both
Age group 18 Years to 75 Years
Eligibility 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- Patient who has been withdrawn from Study CT-P13 1.1 for any reason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

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment


Intervention

Biological:
Infliximab
CT-P13 (5mg/kg) administered as a 2-hour IV infusion per dose

Locations

Country Name City State
Korea, Republic of Inha University Hospital Incheon

Sponsors (1)

Lead Sponsor Collaborator
Celltrion

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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 No
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