Takayasu's ArteritisPhase 2NCT02457585
Clinical Study of Anti-tumor Necrosis Factor Therapy in Patients With Takayasu Arteritis
A Phase 2 study testing remicade (anti tumor necrosis factor inhibitor) in people with Takayasu's Arteritis, run by Seoul National University Hospital at 1 site in South Korea.
Trial 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 Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Takayasu's Arteritis
- What is being tested?
- remicade (anti tumor necrosis factor inhibitor)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 11 participants
- Where
- 1 siteSouth Korea
- Study dates
- Mar 2015to Apr 2018
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- active takayasu's arteritis
Who cannot join
- active Tuberculosis
- Liver function abnormality
- heart failure ( New York Heart Association III - IV)
- patients were not consented
Trial locations and contacts
1 site in 1 country.
South Korea1 site, 1 recruiting
- Recruiting
Seoul National University Hospital
Seoul, 110-744
Sang Jin Lee, MD, 82-10-8623-2648, dream1331@naver.com
Yeong Wook Song, MD, PhD
About this study
Official title: 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
Read the 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
- Conditions
- Takayasu's Arteritis
- Being tested
- remicade (anti tumor necrosis factor inhibitor)
- Medical subject headings
- Takayasu Arteritis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
remicade (anti tumor necrosis factor inhibitor)Drug
Also called remsima
single arm:remicade treatment group
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Drug: remicade (anti tumor necrosis factor inhibitor) |
What is being measured
The primary outcome is the main question the study is designed to answer.
remission induction at 30 weeks
Measured: 30 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 May 2015 (estimated)
- Study startMar 2015
- Primary completionAug 2017 (estimated)
- Study completionApr 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Takayasu's ArteritisStudies of the same condition, open and under way.
- More trials run by Seoul National University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 11 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Seoul National University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Yeong Wook Song, MD,PhD, Principal investigator, Seoul National University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02457585
- Sponsor's protocol ID
- 1312-079-541
- Status last verified
- Mar 2017
- First submitted
- 18 May 2015
- Last updated
- 15 May 2017
- Results posted
- No
- Data monitoring committee
- Yes
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.
PubMed 30229280
Study at a glance
From the registry record, last updated by the sponsor on 15 May 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Anti-tumor Necrosis Factor Therapy Effect on Takayasu Arteritis
- ClinicalTrials.gov ID
- NCT02457585
- Acronym / sponsor ID
- 1312-079-541
- Conditions
- Takayasu's Arteritis
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 11 participants (estimated)
- Lead sponsor
- Seoul National University HospitalUniversity, hospital or other
- Study start
- Mar 2015
- Primary completion
- Aug 2017 (estimated)
- Study completion
- Apr 2018 (estimated)
- First posted
- 29 May 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| experimental group | Experimental | Drug: remicade (anti tumor necrosis factor inhibitor)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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- active takayasu's arteritis
Key exclusion criteria (4 listed)
- active Tuberculosis
- Liver function abnormality
- heart failure ( New York Heart Association III - IV)
- patients were not consented
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| remicade (anti tumor necrosis factor inhibitor)Also: remsimasingle arm:remicade treatment group | Drug | experimental group |
Primary outcome
remission induction at 30 weeks
Time frame: 30 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 May 2017.
- Derived from this study: PubMed 30229280Park 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Yeong Wook Song, MD,PhD principal investigator
Seoul National University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing remicade (anti tumor necrosis factor inhibitor) in people with Takayasu's Arteritis, run by Seoul National University Hospital at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 15 May 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Sang Jin Lee, MD (82-10-8623-2648, dream1331@naver.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
remission induction at 30 weeks (time frame: 30 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02457585, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 May 2017.