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Clinical Trials/NCT02457585
NCT02457585UnknownPhase 2

Anti-tumor Necrosis Factor Therapy Effect on Takayasu Arteritis

Seoul National University Hospital1 site in 1 country11 target enrollmentStarted: March 2015Last updated:
Conditions
Interventions
Drugs

Trial Snapshot

Phase
Phase 2
Enrollment
11
Locations
1
Primary Endpoint
remission induction at 30 weeks

Study Overview

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 Design

Study Type
Interventional
Allocation
Na
Intervention Model
Single Group
Primary Purpose
Treatment
Masking
None

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
Yes

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

Arms & Interventions

experimental group

Experimental

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: remicade (anti tumor necrosis factor inhibitor) (Drug)

Outcomes

Primary Outcomes

remission induction at 30 weeks

Time Frame: 30 weeks

Secondary Outcomes

No secondary outcomes reported

Investigators

Sponsor Class
Other
Responsible Party
Sponsor

Study Sites (1)

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