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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

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 12 months

Awards & highlights

Study 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.Check my eligibility

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.See study design

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

Select...

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

Select...

I am over 18 years old.

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Reduction in aneurysm volume (ml)

Secondary outcome measures

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%

Change in urination

10%

Heartburn

10%

Fatigue

10%

Nausea

10%

Dizziness

10%

Itchiness

Menstruation

Pain in joints

Migraine

Stomach ache

Syncope

Chest pain

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

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

~3280

0 / 2Eligibility criteria met

Find a Location

Who is running the clinical trial?

University of California, San FranciscoLead Sponsor

2,505 Previous Clinical Trials

15,237,547 Total Patients Enrolled

7 Trials studying Aneurysm

4,871 Patients Enrolled for Aneurysm

Daniel L Cooke, MDPrincipal InvestigatorUniversity of California, San Francisco

Media Library

Aneurysm Research Study Groups: Infliximab treatment

Aneurysm Clinical Trial 2023: Infliximab Highlights & Side Effects. Trial Name: NCT02638701 — Phase 1 & 2

Frequently Asked Questions

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

Is this investigation enrolling participants at present?

"Clinicaltrials.gov indicates that this clinical trial is not presently recruiting, as it was last updated on April 25th 2022 and first posted July 1st 2018. However, there are more than 1340 other trials actively enrolling patients at the moment."

Answered by AI

What therapeutic purpose is Infliximab typically employed for?

"Infliximab has been demonstrated to be a viable treatment for patients suffering from psoriasis, ankylosing spondylitis and those who have had an inadequate response to conventional therapies."

Answered by AI

What is the peak capacity for individuals to join this medical experiment?

"Unfortunately, enrollment for this clinical trial has ended; the initial post date was July 1st 2018 and it last updated on April 25th 2022. However, there are currently 1292 studies recruiting stroke patients, as well as 48 trials searching for participants to receive Infliximab treatments."

Answered by AI

Does any prior research exist on the efficacy of Infliximab?

"Presently, 48 experiments for Infliximab are in progress. Of those studies 9 have reached the Phase 3 stage. While Houston, Texas is a hub for this research, 420 medical facilities around the world are running tests related to this drug."

Answered by AI

Recent research and studies

Journal of NeurosurgeryJournal

Enlarging Vertebrobasilar Nonsaccular Intracranial Aneurysms: Frequency, Predictors, and Clinical Outcome of Growth

Mangrum, Wells I., John Huston, Michael J. Link, David O. Wiebers, Robyn L. McClelland, Teresa J. H. Christianson, and Kelly D. Flemming. 2005. “Enlarging Vertebrobasilar Nonsaccular Intracranial Aneurysms: Frequency, Predictors, and Clinical Outcome of Growth”. Journal of Neurosurgery. Journal of Neurosurgery Publishing Group (JNSPG). doi:10.3171/jns.2005.102.1.0072.

Translational Stroke ResearchJournal

Tumor Necrosis Factor-α Modulates Cerebral Aneurysm Formation and Rupture

Starke, Robert M., Daniel M. S. Raper, Dale Ding, Nohra Chalouhi, Gary K. Owens, David M. Hasan, Ricky Medel, and Aaron S. Dumont. 2013. “Tumor Necrosis Factor-α Modulates Cerebral Aneurysm Formation and Rupture”. Translational Stroke Research. Springer Science and Business Media LLC. doi:10.1007/s12975-013-0287-9.

Rheumatology InternationalJournal

Long-term Anti-tumour Necrosis Factor Therapy Reverses the Progression of Carotid Intima–media Thickness in Female Patients with Active Rheumatoid Arthritis

Ferrante, A., A. R. Giardina, F. Ciccia, G. Parrinello, G. Licata, G. Avellone, E. Giardina, R. Impastato, and Giovanni Triolo. 2009. “Long-term Anti-tumour Necrosis Factor Therapy Reverses the Progression of Carotid Intima–media Thickness in Female Patients with Active Rheumatoid Arthritis”. Rheumatology International. Springer Science and Business Media LLC. doi:10.1007/s00296-009-0935-2.

RheumatologyJournal