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

Celltrion Healthcare

Status and phase

Completed

Phase 1

Conditions

Ankylosing Spondylitis

Treatments

Biological: Infliximab

Study type

Interventional

Funder types

Industry

Identifiers

NCT01571206

CT-P13 1.3

2011-004572-11 (EudraCT Number)

Details and patient eligibility

About

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.

Enrollment

174 patients

Sex

All

Ages

18 to 75 years old

Volunteers

No Healthy Volunteers

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Patient who has been withdrawn from Study CT-P13 1.1 for any reason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