We're building a better ClinicalTrials.gov. Check it out and tell us what you think!
Try the New Site
We're building a modernized ClinicalTrials.gov! Visit Beta.ClinicalTrials.gov to try the new functionality.
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

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.
 
ClinicalTrials.gov Identifier: NCT01220518
Recruitment Status : Completed
First Posted : October 14, 2010
Last Update Posted : March 12, 2013
Sponsor:
Information provided by (Responsible Party):
Celltrion

Study Description
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Brief Summary:
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 or disease Intervention/treatment Phase
Ankylosing Spondylitis Drug: Infliximab Phase 1

Study Design
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 257 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: Randomized, Double-blind, Parallel-group, Phase 1 Study
Study Start Date : October 2010
Actual Primary Completion Date : November 2011
Actual Study Completion Date : June 2012

Resource links provided by the National Library of Medicine

Drug Information available for: Infliximab

Arms and Interventions
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Arm Intervention/treatment
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.


Outcome Measures
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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

Secondary Outcome Measures :
  1. 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 ]
  2. 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 ]
  3. Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) at Weeks 14, 30 and 54 compared with Baseline [ Time Frame: at week 14, 30 and 54 ]
  4. Bath Ankylosing Spondylitis Functional Index (BASFI) at Weeks 14, 30 and 54 compared with Baseline [ Time Frame: at week 14, 30 and 54 ]
  5. Bath Ankylosing Spondylitis Metrology Index (BASMI) at Weeks 14, 30 and 54 compared with Baseline [ Time Frame: at weeks 14, 30 and 54 ]
  6. Chest expansion at Weeks 14, 30 and 54 compared with Baseline [ Time Frame: at weeks 14, 30 and 54 ]
  7. Quality of life questionnaire (SF-36) [ Time Frame: at week 14, 30 and 54 ]

Eligibility Criteria
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

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, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
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
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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
Layout table for location information
Korea, Republic of
Inha University Hostpital
Incheon, Korea, Republic of
Sponsors and Collaborators
Celltrion
Investigators
Layout table for investigator information
Principal Investigator: Won Park, M.D., Ph.D. Inha University Hospital
More Information
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Layout table for additonal information
Responsible Party: Celltrion
ClinicalTrials.gov Identifier: NCT01220518    
Other Study ID Numbers: CT-P13 1.1
First Posted: October 14, 2010    Key Record Dates
Last Update Posted: March 12, 2013
Last Verified: March 2013
Additional relevant MeSH terms:
Layout table for MeSH terms
Spondylitis
Spondylitis, Ankylosing
Bone Diseases, Infectious
Infections
Bone Diseases
Musculoskeletal Diseases
Spinal Diseases
Spondylarthritis
Arthritis
Joint Diseases
 Axial Spondyloarthritis
Spondylarthropathies
Ankylosis
Infliximab
Tumor Necrosis Factor Inhibitors
Anti-Inflammatory Agents
Dermatologic Agents
Gastrointestinal Agents
Antirheumatic Agents