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

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ClinicalTrials.gov Identifier: NCT02457585
Recruitment Status : Unknown
Verified March 2017 by Seoul National University Hospital.
Recruitment status was:  Recruiting
First Posted : May 29, 2015
Last Update Posted : May 15, 2017
Sponsor:
Information provided by (Responsible Party):
Seoul National University Hospital

Tracking Information
First Submitted Date  ICMJE May 18, 2015
First Posted Date  ICMJE May 29, 2015
Last Update Posted Date May 15, 2017
Study Start Date  ICMJE March 2015
Estimated Primary Completion Date August 2017   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 26, 2015)
remission induction at 30 weeks [ Time Frame: 30 weeks ]
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT02457585 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Clinical Study of Anti-tumor Necrosis Factor Therapy in Patients With Takayasu Arteritis
Official Title  ICMJE Anti-tumor Necrosis Factor Therapy Effect on Takayasu Arteritis
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 Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Takayasu's Arteritis
Intervention  ICMJE Drug: remicade (anti tumor necrosis factor inhibitor)
single arm:remicade treatment group
Other Name: remsima
Study Arms  ICMJE Experimental: 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

Intervention: Drug: remicade (anti tumor necrosis factor inhibitor)
Publications * 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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: May 26, 2015)
11
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE April 2018
Estimated Primary Completion Date August 2017   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Korea, Republic of
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02457585
Other Study ID Numbers  ICMJE 1312-079-541
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Seoul National University Hospital
Study Sponsor  ICMJE Seoul National University Hospital
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Yeong Wook Song, MD,PhD Seoul National University Hospital
PRS Account Seoul National University Hospital
Verification Date March 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP