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Program evaLuating the Autoimmune Disease iNvEstigational Drug cT-p13 in AS Patients(PLANETAS)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01220518
First Posted: October 14, 2010
Last Update Posted: March 12, 2013
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Celltrion
  Purpose
This study is the trial to demonstrate how our product is similar to remicade by comparing the results of blood samples in active Ankylosing Spondylitis patients.

Condition Intervention Phase
Ankylosing Spondylitis Drug: Infliximab Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: Randomized, Double-blind, Parallel-group, Phase 1 Study

Resource links provided by NLM:


Further study details as provided by Celltrion:

Primary Outcome Measures:
  • PK equivalence to remicade [ Time Frame: PK sampling at week 22 ]

Secondary Outcome Measures:
  • Proportion of patients achieving clinical response according to the Assessment of SpondyloArthritis International Society (ASAS) 20% criteria [ Time Frame: at week 14, 30 and 54 ]
  • Proportion of patients achieving clinical response according to the Assessment of SpondyloArthritis International Society (ASAS) 40 criteria [ Time Frame: at week 14, 30 and 54 ]
  • Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) at Weeks 14, 30 and 54 compared with Baseline [ Time Frame: at week 14, 30 and 54 ]
  • Bath Ankylosing Spondylitis Functional Index (BASFI) at Weeks 14, 30 and 54 compared with Baseline [ Time Frame: at week 14, 30 and 54 ]
  • Bath Ankylosing Spondylitis Metrology Index (BASMI) at Weeks 14, 30 and 54 compared with Baseline [ Time Frame: at weeks 14, 30 and 54 ]
  • Chest expansion at Weeks 14, 30 and 54 compared with Baseline [ Time Frame: at weeks 14, 30 and 54 ]
  • Quality of life questionnaire (SF-36) [ Time Frame: at week 14, 30 and 54 ]

Enrollment: 257
Study Start Date: October 2010
Study Completion Date: June 2012
Primary Completion Date: November 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: CT-P13
infliximab
Drug: Infliximab
Infliximab 5mg/kg is going to be administered for both arm as a 2-hour infusion per dose.
Active Comparator: Remicade
infliximab
Drug: Infliximab
Infliximab 5mg/kg is going to be administered for both arm as a 2-hour infusion per dose.

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • diagnosed with active ankylosing spondylitis
  • BASDAI score ≥ 4 and visual analogue scale(VAS) score of spinal pain ≥ 4

Exclusion Criteria:

  • have total ankylosing of spine
  • have allergies to infliximab
  • serious infection
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01220518


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

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Celltrion
ClinicalTrials.gov Identifier: NCT01220518     History of Changes
Other Study ID Numbers: CT-P13 1.1
First Submitted: October 4, 2010
First Posted: October 14, 2010
Last Update Posted: March 12, 2013
Last Verified: March 2013

Additional relevant MeSH terms:
Spondylitis
Spondylitis, Ankylosing
Bone Diseases, Infectious
Infection
Bone Diseases
Musculoskeletal Diseases
Spinal Diseases
Spondylarthropathies
Spondylarthritis
Ankylosis
Joint Diseases
Arthritis
Infliximab
Dermatologic Agents
Gastrointestinal Agents
Antirheumatic Agents