8 Participants Needed

Infliximab for Aneurysms

JG
DL
Overseen ByDaniel L Cooke, MD
Age: 18+
Sex: Any
Trial Phase: Phase 1 & 2
Sponsor: University of California, San Francisco
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Approved in 4 JurisdictionsThis treatment is already approved in other countries

Trial Summary

Will I have to stop taking my current medications?

The trial requires that you have not used an anti-TNF or other biologic medication in the past 12 months. Other medications are not specifically mentioned, so it's best to discuss your current medications with the trial team.

What data supports the effectiveness of the drug infliximab for treating aneurysms?

Infliximab has shown effectiveness in treating conditions like Crohn's disease and rheumatoid arthritis by reducing symptoms and slowing disease progression. It has also been used in patients with Takayasu arteritis, a condition affecting blood vessels, which may suggest potential benefits for vascular-related issues like aneurysms.12345

Is infliximab generally safe for humans?

Infliximab has been studied for conditions like Crohn's disease and rheumatoid arthritis, showing an acceptable safety profile. Common side effects include infusion reactions like headache and fever, and a higher rate of infections, but no increased risk of serious infections or death. Some rare neurological side effects have been reported, and a small percentage of patients may develop mild autoantibodies, which usually resolve after stopping the drug.678910

How does the drug infliximab differ from other treatments for aneurysms?

Infliximab is unique because it is a monoclonal antibody that targets and neutralizes tumor necrosis factor-alpha (TNF-alpha), a protein involved in inflammation, which may play a role in aneurysm development. Unlike conventional treatments, infliximab offers a targeted approach by specifically addressing the inflammatory component of the disease.211121314

What is the purpose of this trial?

Patients harboring dolichoectactic vertebrobasilar (DVB) aneurysms are at risk of suffering SAH, ischemic stroke, and/or brainstem compression and many patients are not offered invasive treatment due to the futility of existing surgical methods. Consequently, there is demand for development of medical therapy for DVB aneurysms

Research Team

DL

Daniel L Cooke, MD

Principal Investigator

University of California, San Francisco

Eligibility Criteria

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.

Inclusion Criteria

I have a complex aneurysm in my brain that cannot be treated with surgery or through the blood vessels.
I am over 18 years old.

Exclusion Criteria

I have not had serious infections or needed strong antibiotics in the last month.
Any medical condition, which, in the opinion of the investigator, would put the subject at risk by participation in the protocol
I have a positive TB test but haven't completed or am not undergoing treatment for latent TB.
See 18 more

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive infliximab intravenously at specified intervals for a total of 12 months

12 months
Visits at 0, 3, 7 weeks, then every 8 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

12 months
MR imaging at 0, 12, and 24 months

Treatment Details

Interventions

  • Infliximab
Trial Overview 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.
Participant Groups
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.

Infliximab is already approved in European Union, United States, Canada, Japan for the following indications:

🇪🇺
Approved in European Union as Remicade for:
  • Ankylosing Spondylitis
  • Crohn's Disease
  • Ulcerative Colitis
  • Psoriatic Arthritis
  • Rheumatoid Arthritis
  • Plaque Psoriasis
🇺🇸
Approved in United States as Remicade for:
  • Ankylosing Spondylitis
  • Crohn's Disease
  • Ulcerative Colitis
  • Psoriatic Arthritis
  • Rheumatoid Arthritis
  • Plaque Psoriasis
🇨🇦
Approved in Canada as Remicade for:
  • Ankylosing Spondylitis
  • Crohn's Disease
  • Ulcerative Colitis
  • Psoriatic Arthritis
  • Rheumatoid Arthritis
  • Plaque Psoriasis
🇯🇵
Approved in Japan as Remicade for:
  • Ankylosing Spondylitis
  • Crohn's Disease
  • Ulcerative Colitis
  • Psoriatic Arthritis
  • Rheumatoid Arthritis
  • Plaque Psoriasis

Find a Clinic Near You

Who Is Running the Clinical Trial?

University of California, San Francisco

Lead Sponsor

Trials
2,636
Recruited
19,080,000+

Findings from Research

In a study of 650 biologic-naïve patients with moderate to severe rheumatoid arthritis, the biosimilar PF-06438179/GP1111 showed similar efficacy to the reference infliximab (Remicade®) at week 14, with ACR20 response rates of 62.7% and 64.1%, respectively, indicating that the biosimilar is an effective alternative.
Both PF-06438179/GP1111 and infliximab-EU had comparable safety profiles and immunogenicity rates, with no significant differences in adverse effects or antibody development, suggesting that the biosimilar is as safe as the reference product.
A randomized controlled trial comparing PF-06438179/GP1111 (an infliximab biosimilar) and infliximab reference product for treatment of moderate to severe active rheumatoid arthritis despite methotrexate therapy.Cohen, SB., Alten, R., Kameda, H., et al.[2019]
Infliximab is an effective treatment for moderately to severely active Crohn disease and rheumatoid arthritis, showing rapid onset of action and disease-modifying activity, particularly in patients who have not responded to other treatments.
While generally well tolerated, infliximab carries risks such as reactivation of tuberculosis and worsening of certain conditions, necessitating careful use in high-risk patients.
Spotlight on infliximab in Crohn disease and rheumatoid arthritis.Siddiqui, MA., Scott, LJ.[2018]
Infliximab is an effective treatment for moderately to severely active Crohn's disease and rheumatoid arthritis, showing rapid onset of action and disease-modifying activity, particularly in patients who have not responded to other treatments.
While generally well tolerated, infliximab carries risks such as reactivation of tuberculosis and worsening of certain conditions, necessitating careful use in high-risk patients.
Infliximab: a review of its use in Crohn's disease and rheumatoid arthritis.Siddiqui, MA., Scott, LJ.[2018]

References

A randomized controlled trial comparing PF-06438179/GP1111 (an infliximab biosimilar) and infliximab reference product for treatment of moderate to severe active rheumatoid arthritis despite methotrexate therapy. [2019]
Effectiveness and safety of infliximab dose escalation in patients with refractory Takayasu arteritis: A real-life experience from a monocentric cohort. [2022]
Spotlight on infliximab in Crohn disease and rheumatoid arthritis. [2018]
Infliximab: a review of its use in Crohn's disease and rheumatoid arthritis. [2018]
Efficacy and safety of TNF-α antagonists and tocilizumab in Takayasu arteritis: multicentre retrospective study of 209 patients. [2022]
Long term safety of infliximab. [2019]
Prescribing patterns and awareness of adverse effects of infliximab: a health survey of gastroenterologists. [2018]
[Brachial plexitis and myelitis and herpes-zoster lumbar plexus disorder in patient treated with infliximab]. [2015]
Infliximab Treatment for Intravenous Immunoglobulin-resistant Kawasaki Disease: a Multicenter Study in Korea. [2020]
[Anti TNF-α (infliximab) treatment for intravenous immunoglobulin (IVIG) resistance patients with acute Kawasaki disease the effects of anticytokine therapy]. [2015]
Ameliorating the effects of Adalimumab on rabbits with experimental cerebral vasospasm after subarachnoid hemorrhage. [2021]
Refractory Takayasu's arteritis successfully treated with the human, monoclonal anti-tumor necrosis factor antibody adalimumab. [2015]
Takayasu's arteritis progression on anti-TNF biologics: a case series. [2021]
Refractory Takayasu arteritis successfully treated with infliximab. [2022]
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