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

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Takayasu’s arteritis
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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