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
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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
Condition or disease | Intervention/treatment | Phase |
---|---|---|
Takayasu's Arteritis | Drug: remicade (anti tumor necrosis factor inhibitor) | Phase 2 |
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 11 participants |
Allocation: | N/A |
Intervention Model: | Single Group Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | Anti-tumor Necrosis Factor Therapy Effect on Takayasu Arteritis |
Study Start Date : | March 2015 |
Estimated Primary Completion Date : | August 2017 |
Estimated Study Completion Date : | April 2018 |

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 |
Drug: remicade (anti tumor necrosis factor inhibitor)
single arm:remicade treatment group
Other Name: remsima |
- remission induction at 30 weeks [ Time Frame: 30 weeks ]

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Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | Yes |
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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02457585
Contact: Sang Jin Lee, MD | 82-10-8623-2648 | dream1331@naver.com |
Korea, Republic of | |
Seoul National University Hospital | Recruiting |
Seoul, Korea, Republic of, 110-744 | |
Contact: Sang Jin Lee, MD 82-10-8623-2648 dream1331@naver.com | |
Principal Investigator: Yeong Wook Song, MD, PhD |
Principal Investigator: | Yeong Wook Song, MD,PhD | Seoul National University Hospital |
Responsible Party: | Seoul National University Hospital |
ClinicalTrials.gov Identifier: | NCT02457585 |
Other Study ID Numbers: |
1312-079-541 |
First Posted: | May 29, 2015 Key Record Dates |
Last Update Posted: | May 15, 2017 |
Last Verified: | March 2017 |
Arteritis Takayasu Arteritis Aortic Arch Syndromes Necrosis Pathologic Processes Vasculitis Vascular Diseases Cardiovascular Diseases Aortic Diseases |
Skin Diseases, Vascular Skin Diseases Tumor Necrosis Factor Inhibitors Infliximab Dermatologic Agents Gastrointestinal Agents Antirheumatic Agents Anti-Inflammatory Agents |