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Status unknownNCT02457585Updated May 15, 2017

Clinical Study of Anti-tumor Necrosis Factor Therapy in Patients With Takayasu Arteritis

A Phase 2 interventional study of remicade (anti tumor necrosis factor inhibitor) in Takayasu's Arteritis, sponsored by Seoul National University Hospital. Status unknown at 1 site in Korea, Republic of. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2017-05-15.

Sponsored by Seoul National University Hospital · Phase 2, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Mar 2017), so the status shown — last known as Recruiting — may be out of date.
Phase
Phase 2
Study type
Interventional
Enrollment
11
Allocation
Not applicable
Ages
18 Years and older
Sex
All
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Study summary

Clinical study of anti-tumor necrosis factor therapy in patients with Takayasu arteritis.

This study is single arm (anti Tumor necrosis factor therapy only) clinical trial. Enrolled patients will be 11

Read the detailed description

Clinical study of anti-tumor necrosis factor therapy in patients with Takayasu arteritis.

This study is single arm (anti Tumor necrosis factor therapy only) clinical trial. Enrolled patients will be 11 patients with active takayasu's arteritis

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Conditions studied

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In context

Arteritis

135 studies on the registry are indexed under Arteritis; 26 are open to participants now.

This study's planned enrollment of 11 is below the median of 44 across 65 interventional studies indexed under Arteritis.

Browse Arteritis studies →

Lead sponsor

Seoul National University Hospital is the lead sponsor of 1,860 studies on the registry; 275 are open to participants now.

Of its 12 completed or terminated interventional studies of FDA-regulated products, 2 (17%) have results posted.

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

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
Yes

Inclusion criteria

  • active takayasu's arteritis

Exclusion criteria

Exclusion Criteria:

  • active Tuberculosis
  • Liver function abnormality
  • heart failure ( New York Heart Association III - IV)
  • patients were not consented
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Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
11 participants (estimated)

Study arms

  • Experimental
    experimental group

    anti Tumor necrosis factor treatment group : treatment with remicade 5mg/kg as scheduled (0, 2, 6, 14, 22, 30, 38, 46, 54weeks). evaluation of response at 30weeks by PET CT, acute phase reactants, symptom No placebo group

    Drug: remicade (anti tumor necrosis factor inhibitor)

Interventions

  • Drugremicade (anti tumor necrosis factor inhibitor)

    single arm:remicade treatment group

    Also known as: remsima

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What researchers measure

Primary outcomes

  1. remission induction at 30 weeks

    Time frame: 30 weeks

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Study locations

1 of 1 sites recruiting
  • Seoul National University Hospital
    Seoul, 110-744, Korea, Republic of
    • Sang Jin Lee, MD · Contact · dream1331@naver.com · 82-10-8623-2648
    • Yeong Wook Song, MD, PhD · Principal investigator
    Recruiting
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References and documents

Publications

  • Park EH, Lee EY, Lee YJ, Ha YJ, Yoo WH, Choi BY, Paeng JC, Suh HY, Song YW. Infliximab biosimilar CT-P13 therapy in patients with Takayasu arteritis with low dose of glucocorticoids: a prospective single-arm study. Rheumatol Int. 2018 Dec;38(12):2233-2242. doi: 10.1007/s00296-018-4159-1. Epub 2018 Sep 18. PubMed 30229280 ↗
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 15, 2017, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT02457585
Lead sponsor
Seoul National University Hospital
Responsible party
Sponsor
First posted
May 29, 2015
Start date
Mar 2015
Primary completion
Aug 2017 (estimated)
Completion
Apr 2018 (estimated)
Last update
May 15, 2017

Study contacts

Sang Jin Lee, MD
Contact
dream1331@naver.com
82-10-8623-2648
Yeong Wook Song, MD,PhD
principal investigator · Seoul National University Hospital

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Mar 2017. You cannot join it, but the record below documents what was studied.

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