- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02457585
Clinical Study of Anti-tumor Necrosis Factor Therapy in Patients With Takayasu Arteritis
Anti-tumor Necrosis Factor Therapy Effect on Takayasu Arteritis
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
Study Overview
Status
Conditions
Intervention / Treatment
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
Enrollment (Anticipated)
Phase
- Phase 2
Contacts and Locations
Study Contact
- Name: Sang Jin Lee, MD
- Phone Number: 82-10-8623-2648
- Email: dream1331@naver.com
Study Locations
-
-
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Seoul, Korea, Republic of, 110-744
- Recruiting
- Seoul National University Hospital
-
Contact:
- Sang Jin Lee, MD
- Phone Number: 82-10-8623-2648
- Email: dream1331@naver.com
-
Principal Investigator:
- Yeong Wook Song, MD, PhD
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: NA
- Interventional Model: SINGLE_GROUP
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
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 |
single arm:remicade treatment group
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
remission induction at 30 weeks
Time Frame: 30 weeks
|
30 weeks
|
Collaborators and Investigators
Investigators
- Principal Investigator: Yeong Wook Song, MD,PhD, Seoul National University Hospital
Publications and helpful links
Study record dates
Study Major Dates
Study Start
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Pathologic Processes
- Cardiovascular Diseases
- Vascular Diseases
- Skin Diseases
- Vasculitis
- Skin Diseases, Vascular
- Aortic Diseases
- Necrosis
- Arteritis
- Takayasu Arteritis
- Aortic Arch Syndromes
- Anti-Inflammatory Agents
- Antirheumatic Agents
- Gastrointestinal Agents
- Dermatologic Agents
- Infliximab
- Tumor Necrosis Factor Inhibitors
Other Study ID Numbers
- 1312-079-541
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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