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Ankylosing SpondylitisPhase 1NCT01220518

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

A Phase 1 study testing Infliximab in people with Ankylosing Spondylitis, run by Celltrion at 1 site in South Korea.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 75 years
Conditions the study is for
Ankylosing Spondylitis
What is being tested?
Infliximab
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
257 participants
Where
1 siteSouth Korea
Study dates
Oct 2010to Jun 2012
Phase
Phase 1
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

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

Who cannot join

  • have total ankylosing of spine
  • have allergies to infliximab
  • serious infection

Trial locations and contacts

1 site in 1 country.

South Korea1 site

  • Inha University Hostpital

    Incheon

Other trials in South Korea

About this study

Official title: Randomized, Double-blind, Parallel-group, Phase 1 Study

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.

Being tested
Infliximab
Medical subject headings
Spondylitis, Ankylosing

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • InfliximabDrug

    Infliximab 5mg/kg is going to be administered for both arm as a 2-hour infusion per dose.

Study groups in NCT01220518
Study groupRoleWhat they receive
CT-P13Active comparatorinfliximab
Receives: Drug: Infliximab
RemicadeActive comparatorinfliximab
Receives: Drug: Infliximab

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. PK equivalence to remicade

    Measured: PK sampling at week 22

Secondary outcomes (7)

  1. Proportion of patients achieving clinical response according to the Assessment of SpondyloArthritis International Society (ASAS) 20% criteria

    Measured: at week 14, 30 and 54

  2. Proportion of patients achieving clinical response according to the Assessment of SpondyloArthritis International Society (ASAS) 40 criteria

    Measured: at week 14, 30 and 54

  3. Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) at Weeks 14, 30 and 54 compared with Baseline

    Measured: at week 14, 30 and 54

  4. Bath Ankylosing Spondylitis Functional Index (BASFI) at Weeks 14, 30 and 54 compared with Baseline

    Measured: at week 14, 30 and 54

  5. Bath Ankylosing Spondylitis Metrology Index (BASMI) at Weeks 14, 30 and 54 compared with Baseline

    Measured: at weeks 14, 30 and 54

  6. Chest expansion at Weeks 14, 30 and 54 compared with Baseline

    Measured: at weeks 14, 30 and 54

  7. Quality of life questionnaire (SF-36)

    Measured: at week 14, 30 and 54

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted14 Oct 2010 (estimated)
  2. Study startOct 2010
  3. Primary completionNov 2011
  4. Study completionJun 2012

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
257 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01220518
Sponsor's protocol ID
CT-P13 1.1
Status last verified
Mar 2013
First submitted
4 Oct 2010
Last updated
12 Mar 2013
Results posted
No
Data monitoring committee
Yes

Publications

  • Eser A, Reinisch W, Schreiber S, Ahmad T, Boulos S, Mould DR. Increased Induction Infliximab Clearance Predicts Early Antidrug Antibody Detection. J Clin Pharmacol. 2021 Feb;61(2):224-233. doi: 10.1002/jcph.1732. Epub 2020 Sep 9.

    PubMed 32905628

  • Park W, Yoo DH, Jaworski J, Brzezicki J, Gnylorybov A, Kadinov V, Sariego IG, Abud-Mendoza C, Escalante WJ, Kang SW, Andersone D, Blanco F, Hong SS, Lee SH, Braun J. Comparable long-term efficacy, as assessed by patient-reported outcomes, safety and pharmacokinetics, of CT-P13 and reference infliximab in patients with ankylosing spondylitis: 54-week results from the randomized, parallel-group PLANETAS study. Arthritis Res Ther. 2016 Jan 20;18:25. doi: 10.1186/s13075-016-0930-4.

    PubMed 26795209

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Infliximab in people with Ankylosing Spondylitis, run by Celltrion at 1 site in South Korea.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 12 Mar 2013. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

PK equivalence to remicade (time frame: PK sampling at week 22). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01220518, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Mar 2013.

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