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

NCT ID: NCT02457585

Last Updated: 2017-05-15

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE2

Total Enrollment

11 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-03-31

Study Completion Date

2018-04-30

Brief Summary

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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

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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

Conditions

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Takayasu's Arteritis

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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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

Group Type EXPERIMENTAL

remicade (anti tumor necrosis factor inhibitor)

Intervention Type DRUG

single arm:remicade treatment group

Interventions

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remicade (anti tumor necrosis factor inhibitor)

single arm:remicade treatment group

Intervention Type DRUG

Other Intervention Names

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remsima

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Seoul National University Hospital

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Yeong Wook Song, MD,PhD

Role: PRINCIPAL_INVESTIGATOR

Seoul National University Hospital

Locations

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Seoul National University Hospital

Seoul, , South Korea

Site Status RECRUITING

Countries

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South Korea

Central Contacts

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Sang Jin Lee, MD

Role: CONTACT

82-10-8623-2648

Facility Contacts

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Sang Jin Lee, MD

Role: primary

82-10-8623-2648

References

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Park EH, Lee EY, Lee YJ, Ha YJ, Yoo WH, Choi BY, Paeng JC, Suh HY, Song YW. Infliximab biosimilar CT-P13 therapy in patients with Takayasu arteritis with low dose of glucocorticoids: a prospective single-arm study. Rheumatol Int. 2018 Dec;38(12):2233-2242. doi: 10.1007/s00296-018-4159-1. Epub 2018 Sep 18.

Reference Type DERIVED
PMID: 30229280 (View on PubMed)

Other Identifiers

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1312-079-541

Identifier Type: -

Identifier Source: org_study_id

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