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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
Seoul National University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Takayasu's Arteritis

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

First Posted
May 18, 2015
Last Updated
May 12, 2017
Sponsor
Seoul National University Hospital
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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

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

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