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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Celltrion
ClinicalTrials.gov Identifier:
NCT01571206
First received: March 23, 2012
Last updated: July 30, 2013
Last verified: July 2013
  Purpose

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.


Condition Intervention Phase
Ankylosing Spondylitis
Biological: Infliximab
Phase 1

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

Resource links provided by NLM:


Further study details as provided by Celltrion:

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 [ Time Frame: Up to Week 40 ] [ Designated as safety issue: No ]

Enrollment: 174
Study Start Date: March 2012
Study Completion Date: May 2013
Primary Completion Date: May 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: CT-P13
infliximab
Biological: Infliximab
CT-P13 (5mg/kg) administered as a 2-hour IV infusion per dose

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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  • Patient who has been withdrawn from Study CT-P13 1.1 for any reason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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01571206

Locations
Korea, Republic of
Inha University Hospital
Incheon, Korea, Republic of
Sponsors and Collaborators
Celltrion
Investigators
Study Director: Won Park, M.D., Ph.D. Inha University Hospital
  More Information

No publications provided

Responsible Party: Celltrion
ClinicalTrials.gov Identifier: NCT01571206     History of Changes
Other Study ID Numbers: CT-P13 1.3, 2011-004572-11
Study First Received: March 23, 2012
Last Updated: July 30, 2013
Health Authority: Korea: Food and Drug Administration

Keywords provided by Celltrion:
AS
Biosimilar

Additional relevant MeSH terms:
Spondylitis
Spondylitis, Ankylosing
Bone Diseases, Infectious
Infection
Bone Diseases
Musculoskeletal Diseases
Spinal Diseases
Spondylarthropathies
Spondylarthritis
Ankylosis
Joint Diseases
Arthritis
Infliximab
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Anti-Inflammatory Agents
Therapeutic Uses
Antirheumatic Agents
Dermatologic Agents
Gastrointestinal Agents
Central Nervous System Agents

ClinicalTrials.gov processed this record on September 18, 2014