Clincosm LogoSign in Get a demo

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

Sponsor
Seoul National University Hospital (Other)
Overall Status
Unknown status
CT.gov ID
NCT02457585
Collaborator
(none)
11
Enrollment
1
Location
1
Arm
37
Duration (Months)
0.3
Patients Per Site Per Month

Study Details

Study Description

Brief 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

Condition or Disease Intervention/Treatment Phase
  • Drug: remicade (anti tumor necrosis factor inhibitor)
 Phase 2

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

Study Design

Study Type:
Interventional
Anticipated Enrollment :
11 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Anti-tumor Necrosis Factor Therapy Effect on Takayasu Arteritis
Study Start Date :
Mar 1, 2015
Anticipated Primary Completion Date :
Aug 1, 2017
Anticipated Study Completion Date :
Apr 1, 2018

Arms and Interventions

Arm Intervention/Treatment
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)
single arm:remicade treatment group
Other Names:
  • remsima

    		•

    Outcome Measures

    Primary Outcome Measures

    1. remission induction at 30 weeks [30 weeks]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    Inclusion Criteria:
    • active takayasu's arteritis
    Exclusion Criteria:

    • active Tuberculosis

    • Liver function abnormality

    • heart failure ( New York Heart Association III - IV)

    • patients were not consented

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Seoul National University Hospital Seoul Korea, Republic of 110-744

    Sponsors and Collaborators

    • Seoul National University Hospital

    Investigators

    • Principal Investigator: Yeong Wook Song, MD,PhD, Seoul National University Hospital

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Seoul National University Hospital
    ClinicalTrials.gov Identifier:
    NCT02457585
    Other Study ID Numbers:
    • 1312-079-541
    First Posted:
    May 29, 2015
    Last Update Posted:
    May 15, 2017
    Last Verified:
    Mar 1, 2017
    Additional relevant MeSH terms:
    Arteritis
    Takayasu Arteritis
    Aortic Arch Syndromes
    Necrosis
    Tumor Necrosis Factor Inhibitors
    Infliximab

    Study Results

    No Results Posted as of May 15, 2017