Clinical Study of Anti-tumor Necrosis Factor Therapy in Patients With Takayasu Arteritis
NCT ID: NCT02457585
Last Updated: 2017-05-15
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE2
11 participants
INTERVENTIONAL
2015-03-31
2018-04-30
Brief Summary
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This study is single arm (anti Tumor necrosis factor therapy only) clinical trial. Enrolled patients will be 11
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Detailed Description
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This study is single arm (anti Tumor necrosis factor therapy only) clinical trial. Enrolled patients will be 11 patients with active takayasu's arteritis
Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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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
remicade (anti tumor necrosis factor inhibitor)
single arm:remicade treatment group
Interventions
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remicade (anti tumor necrosis factor inhibitor)
single arm:remicade treatment group
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* Liver function abnormality
* heart failure ( New York Heart Association III - IV)
* patients were not consented
18 Years
ALL
Yes
Sponsors
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Seoul National University Hospital
OTHER
Responsible Party
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Principal Investigators
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Yeong Wook Song, MD,PhD
Role: PRINCIPAL_INVESTIGATOR
Seoul National University Hospital
Locations
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Seoul National University Hospital
Seoul, , South Korea
Countries
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Central Contacts
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Facility Contacts
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References
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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.
Other Identifiers
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1312-079-541
Identifier Type: -
Identifier Source: org_study_id
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