Brief Title
Clinical Study of Anti-tumor Necrosis Factor Therapy in Patients With Takayasu Arteritis
Official Title
Anti-tumor Necrosis Factor Therapy Effect on Takayasu Arteritis
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
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 Phase
Phase 2
Study Type
Interventional
Primary Outcome
remission induction at 30 weeks
Condition
Takayasu's Arteritis
Intervention
remicade (anti tumor necrosis factor inhibitor)
Study Arms / Comparison Groups
experimental group
Description: 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
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Recruitment Status
Drug
Estimated Enrollment
11
Start Date
March 2015
Completion Date
April 2018
Primary Completion Date
August 2017
Eligibility Criteria
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
Gender
All
Ages
18 Years - N/A
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Contacts
Yeong Wook Song, MD,PhD, 82-10-8623-2648, [email protected]
Location Countries
Korea, Republic of
Location Countries
Korea, Republic of
Administrative Informations
NCT ID
NCT02457585
Organization ID
1312-079-541
Responsible Party
Sponsor
Study Sponsor
Seoul National University Hospital
Study Sponsor
Yeong Wook Song, MD,PhD, Principal Investigator, Seoul National University Hospital
Verification Date
March 2017