NCT02457585

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

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
11

participants targeted

Target at below P25 for phase_2

Timeline
Completed

Started Mar 2015

Typical duration for phase_2

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2015

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

May 18, 2015

Completed
11 days until next milestone

First Posted

Study publicly available on registry

May 29, 2015

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2017

Completed
8 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2018

Completed
Last Updated

May 15, 2017

Status Verified

March 1, 2017

Enrollment Period

2.4 years

First QC Date

May 18, 2015

Last Update Submit

May 12, 2017

Conditions

Takayasu's Arteritis

Outcome Measures

Primary Outcomes (1)

  • remission induction at 30 weeks

    30 weeks

Study Arms (1)

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

Drug: remicade (anti tumor necrosis factor inhibitor)

Interventions

remicade (anti tumor necrosis factor inhibitor)DRUG

single arm:remicade treatment group

Also known as: remsima
experimental group

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • active takayasu's arteritis

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Seoul National University Hospital

Seoul, 110-744, South Korea

RECRUITING

Related Publications (1)

  • 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.

    PMID: 30229280DERIVED

MeSH Terms

Conditions

Takayasu Arteritis

Interventions

InfliximabCT-P13

Condition Hierarchy (Ancestors)

Aortic Arch SyndromesAortic DiseasesVascular DiseasesCardiovascular DiseasesArteritisVasculitisSkin Diseases, VascularSkin DiseasesSkin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Antibodies, MonoclonalAntibodiesImmunoglobulinsImmunoproteinsBlood ProteinsProteinsAmino Acids, Peptides, and ProteinsSerum GlobulinsGlobulins

Study Officials

  • Yeong Wook Song, MD,PhD

    Seoul National University Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Sang Jin Lee, MD

CONTACT

82-10-8623-2648dream1331@naver.com

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 18, 2015

First Posted

May 29, 2015

Study Start

March 1, 2015

Primary Completion

August 1, 2017

Study Completion

April 1, 2018

Last Updated

May 15, 2017

Record last verified: 2017-03

Locations

KR(1)