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Monoclonal Antibodies

Infliximab for Aneurysms

Phase 1 & 2

Waitlist Available

Led By Daniel L Cooke, MD

Research Sponsored by University of California, San Francisco

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Vertebral and/or basilar artery dolichoectactic aneurysm not amenable to microsurgical or endovascular treatment

Age greater than 18 years at time of first study drug administration

Must not have

Purified protein derivative (PPD) test of > 5 mm induration regardless of prior BacilleCalmette Guerin vaccine administration or positive QuantiFERON®-TB Gold In-Tube Test (QFT-G_IT) without documentation of completed treatment or evidence of ongoing treatment of latent tuberculosis (TB) for 30 days. Subjects with active TB infection are excluded

Inability or unwillingness to follow the protocol

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 12 months

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing a new medical therapy for people with dolichoectactic vertebrobasilar aneurysms.

Who is the study for?

This trial is for adults over 18 with a specific type of aneurysm in the brain's arteries that can't be treated with surgery or other common methods. Participants must not have severe kidney issues, recent drug abuse, certain infections like HIV or TB, or liver problems. Women who could get pregnant must use effective contraception and not be breastfeeding.

What is being tested?

The trial tests Infliximab therapy on patients with dolichoectactic vertebrobasilar aneurysms to prevent stroke and brainstem compression. It seeks alternatives to surgical treatments which are often not viable for these patients.

What are the potential side effects?

Infliximab may cause allergic reactions, increase the risk of infections including tuberculosis and hepatitis B reactivation, potential liver enzyme elevation, blood disorders such as neutropenia and thrombocytopenia, and possibly worsen any existing heart failure.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I have a complex aneurysm in my brain that cannot be treated with surgery or through the blood vessels.

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I am over 18 years old.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have a positive TB test but haven't completed or am not undergoing treatment for latent TB.

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I am willing and able to follow the study's requirements.

Select...

I agree to use effective birth control or abstain from sex during the study.

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My kidney function is reduced with a creatinine level over 2.0 mg/dL.

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I haven't taken any experimental drugs within the last 4 weeks.

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I have open sores on my legs.

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I have not used anti-TNF or similar drugs in the last year.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 12 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~12 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and 12 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Reduction in aneurysm volume (ml)

Secondary study objectives

Aneurysm computational fluid dynamic (CFD) metrics: flow velocity (ml/sec)

Aneurysm computational fluid dynamic (CFD) metrics: oscillatory index (0 - 0.5)

Aneurysm computational fluid dynamic (CFD) metrics: shear stress (pascal)

+1 more

Side effects data

From 2020 Phase 4 trial • 42 Patients • NCT03006393

52%

Laceration

38%

Headache

24%

Bruises

19%

Sore throat

14%

Muscle tension

10%

Nausea

10%

Change in urination

10%

Heartburn

10%

Fatigue

10%

Dizziness

10%

Itchiness

Pain in joints

Chest pain

Stomach ache

Syncope

Menstruation

Migraine

Swelling

Bloody stool

Pain in leg

Allergies

Change in blood pressure

Vertigo

Change in appetite

Numbness

Motor vehicle accident

100%

80%

60%

40%

20%

Study treatment Arm

Infliximab

Placebo

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups

Experimental Treatment

Group I: Infliximab treatmentExperimental Treatment1 Intervention

Administer infliximab intravenously to patients with DVB aneurysms (3 mg/kg at 0, 3 and 7 weeks, then at 8-week intervals x 7) for a total of 12-months. Patients will undergo MR imaging at 0, 12, and 24-month time points.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Infliximab

2017

Completed Phase 4

~3350

0 / 9Eligibility criteria met