CLINICAL TRIAL

Infliximab for Aneurysm

Refractory
EnrollingByInvitation · 18+ · All Sexes · San Francisco, CA

This study is evaluating whether a new drug may help prevent the formation of aneurysms in the vertebral arteries.

See full description

About the trial for Aneurysm

Eligible Conditions
Necrosis · Aneurysm · Stroke · Vasculitis · Tumor Necrosis Factor Alpha

Treatment Groups

This trial involves 2 different treatments. Infliximab is the primary treatment being studied. Participants will all receive the same treatment. There is no placebo group. The treatments being tested are in Phase 1 & 2 and have already been tested with other people.

Main TreatmentA portion of participants receive this new treatment to see if it outperforms the control.
Infliximab
DRUG
Control TreatmentAnother portion of participants receive the standard treatment to act as a baseline.

About The Treatment

Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Infliximab
FDA approved

Side Effect Profile for Infliximab

Infliximab
Show all side effects
52%
Laceration
38%
Headache
24%
Bruises
19%
Sore throat
14%
Muscle tension
10%
Nausea
10%
Dizziness
10%
Change in urination
10%
Itchiness
10%
Fatigue
10%
Heartburn
5%
Allergies
5%
Change in appetite
5%
Stomach ache
5%
Bloody stool
5%
Pain in leg
5%
Pain in joints
5%
Vertigo
5%
Syncope
5%
Change in blood pressure
5%
Motor vehicle accident
5%
Chest pain
5%
Numbness
5%
Migraine
5%
Swelling
5%
Menstruation
0%
Chills
0%
Pain in neck
0%
Pregnancy
0%
Back pain
Laceration
52%
Headache
38%
Bruises
24%
Sore throat
19%
Muscle tension
14%
Nausea
10%
Dizziness
10%
Change in urination
10%
Itchiness
10%
Fatigue
10%
Heartburn
10%
Allergies
5%
Change in appetite
5%
Stomach ache
5%
Bloody stool
5%
Pain in leg
5%
Pain in joints
5%
Vertigo
5%
Syncope
5%
Change in blood pressure
5%
Motor vehicle accident
5%
Chest pain
5%
Numbness
5%
Migraine
5%
Swelling
5%
Menstruation
5%
Chills
0%
Pain in neck
0%
Pregnancy
0%
Back pain
0%
This histogram enumerates side effects from a completed 2020 Phase 4 trial (NCT03006393) in the Infliximab ARM group. Side effects include: Laceration with 52%, Headache with 38%, Bruises with 24%, Sore throat with 19%, Muscle tension with 14%.

Eligibility

This trial is for patients born any sex aged 18 and older. There are 2 eligibility criteria to participate in this trial as listed below.

Inclusion & Exclusion Checklist
Mark “yes” if the following statements are true for you:
The patient has a dolichoectactic aneurysm in their vertebral or basilar artery that is not amenable to microsurgical or endovascular treatment. show original
The study drug was administered to participants who were at least 18 years of age at the time of their first dose. show original
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Odds of Eligibility
Unknown<50%
Be sure to apply to 2-3 other trials, as you have a low likelihood of qualifying for this one.Apply To This Trial
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Approximate Timelines

Please note that timelines for treatment and screening will vary by patient
Screening: ~3 weeks
Treatment: varies
Reporting: 12 months
Screening: ~3 weeks
Treatment: Varies
Reporting: 12 months
This trial has approximate timelines as follows: 3 weeks for initial screening, variable treatment timelines, and reporting: 12 months.
View detailed reporting requirements
Trial Expert
Connect with the researchersHop on a 15 minute call & ask questions about:
- What options you have available- The pros & cons of this trial
- Whether you're likely to qualify- What the enrollment process looks like

Measurement Requirements

This trial is evaluating whether Infliximab will improve 1 primary outcome and 4 secondary outcomes in patients with Aneurysm. Measurement will happen over the course of 12 months.

Reduction in aneurysm volume (ml)
12 MONTHS
Our primary outcome for assessing the effectiveness of the infliximab treatment will be the reduction in aneurysm volume over the treatment course based on the 0 and 12 month MR scans. DVB aneurysm volume will be assessed by review of standardized 1.5 mm slices in the axial plane. The contour of the aneurysm using time-of-flight MR angiography sequences will generate a cross-sectional area at each slice level. The volume will be estimated by summing the imputed volume of each slice. Standard T1- and T2-weighted sequences will also be obtained, as well as iron-sensitive sequencing.
12 MONTHS
Aneurysm computational fluid dynamic (CFD) metrics: oscillatory index (0 - 0.5)
12 MONTHS
The investigators will capture MR-based, quantitative changes in the aneurysm computational fluid dynamics (CFD) metrics including oscillatory shear (OSI) index post 12-month IV infliximab administration. The investigators will compare pre- and post-treatment CFD metrics using baseline and interval MR angiographic data. Such data is important in predication of aneurysm growth. OSI ranges from 0 to 0.5, where 0 describes a total unidirectional WSS and the latter a purely unsteady, oscillatory shear flow with a net amount of zero WSS. Areas of high OSI are predisposed to endothelial dysfunction.
12 MONTHS
Aneurysm computational fluid dynamic (CFD) metrics: flow velocity (ml/sec)
12 MONTHS
The investigators will capture MR-based, quantitative changes in the aneurysm computational fluid dynamics (CFD) metrics including flow velocity post 12-month IV infliximab administration. The investigators will compare pre- and post-treatment flow velocities using baseline and interval MR angiographic data. Such data is important in predication of aneurysm growth.
12 MONTHS
Aneurysm computational fluid dynamic (CFD) metrics: shear stress (pascal)
12 MONTHS
The investigators will capture MR-based, quantitative changes in the aneurysm computational fluid dynamics (CFD) metrics including wall shear stress post 12-month IV infliximab administration. The investigators will compare pre- and post-treatment CFD metrics using baseline and interval MR angiographic data. Such data is important in predication of aneurysm growth.
12 MONTHS
Aneurysm wall enhancement (ratio of signal post:signal pre contrast)
12 MONTHS
Continued improvements in higher field MR imaging have generated series noting the ability to not only resolve aneurysmal wall enhancement, but also the presence of such findings to reliably predict aneurysm growth and correlate with symptomatic events. To perform wall enhancement, the patient will first be scanned at 3T/7T using T1 weighted 3D black blood MRI technique (SPACE). Gadolinium will be injected and a 3D isotropic, high-resolution first-pass contrast-enhanced MR angiogram (CEMRA) will be obtained; immediately following that a post-contrast SPACE will be acquired. Contrast enhancement of the vessel wall will be graded as 0-2 scale or quantified by an enhancement ratio (Signal-post/Sigal-pre). Wall thickness can be estimated by the full width half maximal (FWHM) of the line profile across the vessel wall.
12 MONTHS

Who is running the study

Principal Investigator
D. L. C.
Prof. Daniel L. Cooke, Assistant Professor of Radiology and Biomedical Imaging
University of California, San Francisco

Patient Q & A Section

Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What are common treatments for aneurysm?

Many patients with aortic aneurysms never seek medical care, and are treated with medications that do not repair the aneurysm. This is in contrast to other vascular disorders in which patients often receive some sort of medical treatment.

Anonymous Patient Answer

What causes aneurysm?

Aneurysms are often caused by a combination of genetic conditions (e.g., connective tissue diseases, familial polyposis colon cancer), infections (e.g., HIV), inflammation, and injury (e.g., trauma)... What causes aneurysms? answer: Aneurysms occur most frequently in women because of repeated trauma and connective tissue diseases, and because of genetics and the use of oral contraceptives.

Anonymous Patient Answer

What is aneurysm?

Aneurysms can progress rapidly, with rupture occurring often in the sixth decade. Aneurysms have variable definitions, including enlargement of the abdominal aorta. The prevalence of aneurysms has been reported to be up to six per 1000 persons in the general American population.

Anonymous Patient Answer

What are the signs of aneurysm?

Symptoms typically experienced by women consist of a sudden change in the quality of the breath when lying down. The symptoms worsen when lying down and can change in a gradual manner. The symptoms also worsen after lying down for a few minutes but can return to normal after a minute or so. Symptoms of a ruptured aneurysm include bleeding gums of varying degrees and coughing up blood. An unruptured aneurysm can not be detected by symptoms and does not produce external bleeding. The presence of either signs or symptoms is an indication that further medical tests should be carried out.

Anonymous Patient Answer

Can aneurysm be cured?

The authors concluded that more work defining optimal treatment modalities of endovascular interventions for AAA is warranted to allow a more precise prediction of their outcomes. More experience is crucial to refine treatment modalities and refine the follow up process.

Anonymous Patient Answer

How many people get aneurysm a year in the United States?

[In the US], approximately 750,000 AAA patients, defined by an incidence of 2 per 1,000 person-years, are living over 6 years after the diagnosis. Over 300,000 cases of AAA were surgically repaired each year in 2000 and 2000. AAA, with age and gender distributions very similar to those reported from the U.K. and Denmark, accounts for a significant proportion of all [surgery and] cardiovascular case-fatality among men and is a major cause of cardiovascular mortality, especially among younger individuals.

Anonymous Patient Answer

What is the average age someone gets aneurysm?

It is an uncommon disease in middle-age individuals, and in women younger than 35 years of age. An aortic aneurysm has a [life expectancy of less than 10 years.](https://www.e-Medicine.com/med/pages/health/conditions/cardiovascular/aortic-aneurysm.

Anonymous Patient Answer

What is infliximab?

The effects of infliximab on aneurysm expansion are complex, but most likely the result of its induction of circulating antibodies against the ECM in inflamed areas of the arterial wall.

Anonymous Patient Answer

What is the latest research for aneurysm?

There is very little new data to offer on the surgery, management, or treatment of aneurysms. Most of the research that has been completed on arterial aneurysms focuses on identifying the characteristics of arterial aneurysms and optimizing their management. The main focus for new research should be on the development of noninvasive approaches for determining the correct amount of treatment required. A major impediment to further knowledge and understanding of arterial aneuysms is a lack of aneurysms seen in clinical trials and the difficulty in obtaining the appropriate patient population to evaluate specific treatments. All new randomized controlled trials should be considered for the proper evaluation of specific therapies and devices.

Anonymous Patient Answer

What are the common side effects of infliximab?

The common side effects of infliximab can be grouped in three categories: general, immune cell-related, and infection-related. General side effects include nausea, vomiting, and diarrhoea which are typically transient and usually related to infusion rate, and can be anticipated. Immune and infection-related side effects typically occur after week 2 and are associated with increased serum concentrations of infliximab and are transient as tolerance builds, and usually are due to increased infusional rate.

Anonymous Patient Answer

Have there been any new discoveries for treating aneurysm?

There seem to be three types of aneurysms: large, small, and muscular aneurysms. Muscle aneurysms are the most common. New discoveries are being made to treat aneurysms, with surgical revascularization being the current treatment method. It is also possible to use [Ouya, H.H., (1990). A study of cerebral aneurysms revisited. Neurology & Neurosurgery, 23, 1025-1030; Au, L., Chan, P.H., & Wang, R.L. (1993), New avenues for treating cerebral aneurysms. Neurosurgery, 31, 585-591; and O'Neill, D.J.

Anonymous Patient Answer

How does infliximab work?

Infliximab has been shown to be effective for the treatment of a wide variety of diseases, including aneurysms, and in our study the aneurysm activity of infliximab was significantly reduced.

Anonymous Patient Answer
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