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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02457585
Recruitment Status : Unknown
Verified March 2017 by Seoul National University Hospital.
Recruitment status was:  Recruiting
First Posted : May 29, 2015
Last Update Posted : May 15, 2017
Sponsor:
Information provided by (Responsible Party):
Seoul National University Hospital

Study Description
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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
Takayasu's Arteritis 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
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Study Type : Interventional  (Clinical Trial)
Estimated 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 : March 2015
Estimated Primary Completion Date : August 2017
Estimated Study Completion Date : April 2018

Resource links provided by the National Library of Medicine

Drug Information available for: Infliximab

Arms and Interventions
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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 Name: remsima


Outcome Measures
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Primary Outcome Measures :
  1. remission induction at 30 weeks [ Time Frame: 30 weeks ]

Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02457585


Contacts
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Contact: Sang Jin Lee, MD 82-10-8623-2648 dream1331@naver.com

Locations
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Korea, Republic of
Seoul National University Hospital Recruiting
Seoul, Korea, Republic of, 110-744
Contact: Sang Jin Lee, MD    82-10-8623-2648    dream1331@naver.com   
Principal Investigator: Yeong Wook Song, MD, PhD         
Sponsors and Collaborators
Seoul National University Hospital
Investigators
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Principal Investigator: Yeong Wook Song, MD,PhD Seoul National University Hospital
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Seoul National University Hospital
ClinicalTrials.gov Identifier: NCT02457585    
Other Study ID Numbers: 1312-079-541
First Posted: May 29, 2015    Key Record Dates
Last Update Posted: May 15, 2017
Last Verified: March 2017
Additional relevant MeSH terms:
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Arteritis
Takayasu Arteritis
Aortic Arch Syndromes
Necrosis
Pathologic Processes
Vasculitis
Vascular Diseases
Cardiovascular Diseases
Aortic Diseases
 Skin Diseases, Vascular
Skin Diseases
Tumor Necrosis Factor Inhibitors
Infliximab
Dermatologic Agents
Gastrointestinal Agents
Antirheumatic Agents
Anti-Inflammatory Agents