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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
  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:


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

ClinicalTrials.gov processed this record on November 25, 2014