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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Celltrion
ClinicalTrials.gov Identifier:
NCT01220518
First received: October 4, 2010
Last updated: March 11, 2013
Last verified: March 2013
History of Changes
  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
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: Randomized, Double-blind, Parallel-group, Phase 1 Study

Resource links provided by NLM:

Drug Information available for: Infliximab
U.S. FDA Resources

Further study details as provided by Celltrion:

Primary Outcome Measures:
  • PK equivalence to remicade [ Time Frame: PK sampling at week 22 ] [ Designated as safety issue: No ]

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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) at Weeks 14, 30 and 54 compared with Baseline [ Time Frame: at week 14, 30 and 54 ] [ Designated as safety issue: No ]
  • Bath Ankylosing Spondylitis Functional Index (BASFI) at Weeks 14, 30 and 54 compared with Baseline [ Time Frame: at week 14, 30 and 54 ] [ Designated as safety issue: No ]
  • Bath Ankylosing Spondylitis Metrology Index (BASMI) at Weeks 14, 30 and 54 compared with Baseline [ Time Frame: at weeks 14, 30 and 54 ] [ Designated as safety issue: No ]
  • Chest expansion at Weeks 14, 30 and 54 compared with Baseline [ Time Frame: at weeks 14, 30 and 54 ] [ Designated as safety issue: No ]
  • Quality of life questionnaire (SF-36) [ Time Frame: at week 14, 30 and 54 ] [ Designated as safety issue: No ]

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

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

Responsible Party: Celltrion
ClinicalTrials.gov Identifier: NCT01220518     History of Changes
Other Study ID Numbers: CT-P13 1.1
Study First Received: October 4, 2010
Last Updated: March 11, 2013
Health Authority: Korea: Food and Drug Administration

Additional relevant MeSH terms:
Autoimmune Diseases
Spondylitis
Spondylitis, Ankylosing
Immune System Diseases
Bone Diseases, Infectious
Infection
Bone Diseases
Musculoskeletal Diseases
Spinal Diseases
Spondylarthropathies
Spondylarthritis
 Ankylosis
Joint Diseases
Arthritis
Infliximab
Dermatologic Agents
Therapeutic Uses
Pharmacologic Actions
Gastrointestinal Agents
Antirheumatic Agents
Anti-Inflammatory Agents

ClinicalTrials.gov processed this record on May 19, 2013