Clinical Study of Anti-tumor Necrosis Factor Therapy in Patients With Takayasu Arteritis
Primary Purpose
Takayasu's Arteritis
Status
Unknown status
Phase
Phase 2
Locations
Korea, Republic of
Study Type
Interventional
Intervention
remicade (anti tumor necrosis factor inhibitor)
Sponsored by
About this trial
This is an interventional treatment trial for Takayasu's Arteritis
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
Sites / Locations
- Seoul National University HospitalRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
experimental group
Arm 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
Outcomes
Primary Outcome Measures
remission induction at 30 weeks
Secondary Outcome Measures
Full Information
NCT ID
NCT02457585
First Posted
May 18, 2015
Last Updated
May 12, 2017
Sponsor
Seoul National University Hospital
1. Study Identification
Unique Protocol Identification Number
NCT02457585
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
Study Type
Interventional
2. Study Status
Record Verification Date
March 2017
Overall Recruitment Status
Unknown status
Study Start Date
March 2015 (undefined)
Primary Completion Date
August 2017 (Anticipated)
Study Completion Date
April 2018 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Seoul National University Hospital
4. Oversight
Data Monitoring Committee
Yes
5. 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
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Takayasu's Arteritis
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
11 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
experimental group
Arm Type
Experimental
Arm 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
Intervention Type
Drug
Intervention Name(s)
remicade (anti tumor necrosis factor inhibitor)
Other Intervention Name(s)
remsima
Intervention Description
single arm:remicade treatment group
Primary Outcome Measure Information:
Title
remission induction at 30 weeks
Time Frame
30 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Sang Jin Lee, MD
Phone
82-10-8623-2648
Email
dream1331@naver.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Yeong Wook Song, MD,PhD
Organizational Affiliation
Seoul National University Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Seoul National University Hospital
City
Seoul
ZIP/Postal Code
110-744
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sang Jin Lee, MD
Phone
82-10-8623-2648
Email
dream1331@naver.com
First Name & Middle Initial & Last Name & Degree
Yeong Wook Song, MD, PhD
12. IPD Sharing Statement
Citations:
PubMed Identifier
30229280
Citation
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.
Results Reference
derived
Learn more about this trial
Clinical Study of Anti-tumor Necrosis Factor Therapy in Patients With Takayasu Arteritis
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