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CompletedNCT01571206Updated Jul 31, 2013

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

A Phase 1 interventional study of Infliximab in Ankylosing Spondylitis, sponsored by Celltrion. Completed at 1 site in Korea, Republic of. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2013-07-31.

Sponsored by Celltrion · Phase 1, Interventional, and Treatment

Phase
Phase 1
Study type
Interventional
Enrollment
174
Allocation
Not applicable
Ages
18 Years to 75 Years
Sex
All
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Study summary

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.

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Conditions studied

  • Ankylosing Spondylitis

Keywords

  • AS
  • Biosimilar
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In context

Spondylitis

623 studies on the registry are indexed under Spondylitis; 83 are open to participants now.

This study's enrollment of 174 is above the median of 92 across 349 interventional studies indexed under Spondylitis.

Browse Spondylitis studies →

Lead sponsor

Celltrion is the lead sponsor of 76 studies on the registry; 3 are open to participants now.

Of its 18 completed or terminated interventional studies of FDA-regulated products, 13 (72%) have results posted.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years to 75 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

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  • Patient who has been withdrawn from Study CT-P13 1.1 for any reason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
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Study design

Phase
Phase 1
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
174 participants (actual)

Study arms

  • Active comparator
    CT-P13

    infliximab

    Biological: Infliximab

Interventions

  • BiologicalInfliximab

    CT-P13 (5mg/kg) administered as a 2-hour IV infusion per dose

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What researchers measure

Primary outcomes

  1. 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

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Study locations

1 site
  • Inha University Hospital
    Incheon, Korea, Republic of
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References and documents

Publications

  • Park W, Yoo DH, Miranda P, Brzosko M, Wiland P, Gutierrez-Urena S, Mikazane H, Lee YA, Smiyan S, Lim MJ, Kadinov V, Abud-Mendoza C, Kim H, Lee SJ, Bae Y, Kim S, Braun J. Efficacy and safety of switching from reference infliximab to CT-P13 compared with maintenance of CT-P13 in ankylosing spondylitis: 102-week data from the PLANETAS extension study. Ann Rheum Dis. 2017 Feb;76(2):346-354. doi: 10.1136/annrheumdis-2015-208783. Epub 2016 Apr 26. PubMed 27117698 ↗
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 31, 2013, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT01571206
Lead sponsor
Celltrion
Responsible party
Sponsor
First posted
Apr 5, 2012
Start date
Mar 2012
Primary completion
May 2013
Completion
May 2013
Last update
Jul 31, 2013

Study contacts

Won Park, M.D., Ph.D.
study director · Inha University Hospital

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jul 2013. You cannot join it, but the record below documents what was studied.

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