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

Seoul National University

Status and phase: Unknown; Phase 2

Conditions: Takayasu's Arteritis

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

Study type: Interventional

Funder types: Other

Identifiers

NCT02457585

1312-079-541

Details and patient eligibility

About

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

Full 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

Enrollment: 11 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts 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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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11 participants in 1 patient group

experimental group

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

Treatment:

Drug: remicade (anti tumor necrosis factor inhibitor)