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

Phase 2

• Conditions: Takayasu's Arteritis
• Interventions: Drug: remicade (anti tumor necrosis factor inhibitor)

• Registration Number: NCT02457585
• Lead Sponsor: Seoul National University Hospital

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 Timeline

• Study Start: 2015-03
• Study First Submitted: 2015-05-18
• Study First Submitted QC: 2015-05-26
• Study First Posted: 2015-05-29
• Status Verified: 2017-03
• Last Update Submitted: 2017-05-12
• Last Update Posted: 2017-05-15
• Primary Completion: 2017-08
• Study Completion: 2018-04

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 11

Inclusion Criteria

• active takayasu's arteritis

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Exclusion Criteria

• active Tuberculosis
• Liver function abnormality
• heart failure ( New York Heart Association III - IV)
• patients were not consented

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
experimental group	remicade (anti tumor necrosis factor inhibitor)	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

Primary Outcome Measures

Name	Time	Method
remission induction at 30 weeks	30 weeks

Trial Locations

Locations (1)

Seoul National University Hospital; 🇰🇷 Seoul, Korea, Republic of