Clinical trial · Interventional
Infliximab Therapy for Dolichoectactic Vertebrobasilar Aneurysms
NCT02638701CI-TRIAL-00114343recruitingPhase 1 / Phase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions
Conditions (4)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Aneurysm | — | UNRESOLVED | — |
| Stroke | — | UNRESOLVED | — |
| Tumor Necrosis Factor-alpha | — | UNRESOLVED | — |
| Vasculitis | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Infliximab | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Infliximab treatment
- description
- 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.
- interventionNames
- Drug: Infliximab
Primary outcomes (1)
- measure
- Reduction in aneurysm volume (ml)
- timeFrame
- 12 months
- description
- 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.
Secondary outcomes (4)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: 1. Vertebral and/or basilar artery dolichoectactic aneurysm not amenable to microsurgical or endovascular treatment. 2. Age greater than 18 years at time of first study drug administration. Exclusion Criteria: 1. Use of an anti-TNF or other biologic medication (Including but not limited to abatacept, rituximab, or tocilizumab) within the previous 12 months. 2. The following laboratory parameters at the Screening visit: Neutropenia (absolute neutrophil count \< 1,500/microliter; Thrombocytopenia (platelets \< 100,000/ • Anemia (hemoglobin \< 8 g/dL); Greater than or equal to 3 times the upper limit of normal (ULN) for either of the following liver function tests (LFTs): aspartate transaminase (AST) or alanine transaminase (ALT); Renal insufficiency (serum creatinine\> 2.0 mg/dL) 3. 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. 4. History of positive PPD, positive QuantiFERON®-TB Gold In-Tube Test (QFT-G\_IT), or chest x-ray findings indicative of prior TB infection, without documentation of either treatment for TB infection or chemoprophylaxis for TB exposure 5. Presence of open leg ulcers 6. Chronic or persistent infection including but not limited to human immunodeficiency virus \[HIV\], untreated hepatitis B, listeriosis, TB, or other opportunistic infection). Patients with hepatitis C but without evidence of cirrhosis or significant hepatic dysfunction will be considered for inclusion on a case-by-case basis as will patients with chronic hepatitis B on anti-viral therapy. 7. Active infection or severe infections requiring hospitalization or treatment with intravenous (IV) antibiotics, IV antivirals, or IV antifungals within 30 days prior to randomization, or oral antibiotics, oral antivirals, or oral antifungals within 14 days prior to randomization 8. Receipt of a live vaccine within 4 weeks prior to randomization 9. History of malignancy within the past 5 years other than treated localized carcinoma in situ of the cervix or adequately treated non-metastatic squamous or basal cell skin carcinoma 10. Any medical condition, which, in the opinion of the investigator, would put the subject at risk by participation in the protocol 11. Women of childbearing potential who are sexually active and who do not agree to practice one of the following methods of contraception during the duration of the study: condoms, sponge, foams, jellies, diaphragm or intrauterine device; oral or parenteral contraceptives for 2 months prior to study product administration; a vasectomized partner; abstinence. 12. Pregnant (all women of childbearing potential must have a negative serum pregnancy test) or breastfeeding 13. Any investigational agent within the earlier of 4 weeks or 5 half-lives prior to randomization 14. History of drug or alcohol abuse within 6 months prior to randomization 15. Known allergy or hypersensitivity to any study products 16. Any psychiatric disorder that prevents the subject from providing informed consent 17. Inability or unwillingness to follow the protocol. 18. Unable to undergo MR imaging.
References
Publications (7)
- BACKGROUNDFlemming KD, Wiebers DO, Brown RD Jr, Link MJ, Huston J 3rd, McClelland RL, Christianson TJ. The natural history of radiographically defined vertebrobasilar nonsaccular intracranial aneurysms. Cerebrovasc Dis. 2005;20(4):270-9. doi: 10.1159/000087710. Epub 2005 Aug 22. PMID 16123548
- BACKGROUNDMangrum WI, Huston J 3rd, Link MJ, Wiebers DO, McClelland RL, Christianson TJ, Flemming KD. Enlarging vertebrobasilar nonsaccular intracranial aneurysms: frequency, predictors, and clinical outcome of growth. J Neurosurg. 2005 Jan;102(1):72-9. doi: 10.3171/jns.2005.102.1.0072. PMID 15658099
- BACKGROUNDStarke RM, Raper DM, Ding D, Chalouhi N, Owens GK, Hasan DM, Medel R, Dumont AS. Tumor necrosis factor-alpha modulates cerebral aneurysm formation and rupture. Transl Stroke Res. 2014 Apr;5(2):269-77. doi: 10.1007/s12975-013-0287-9. Epub 2013 Sep 20. PMID 24323710
- BACKGROUNDFerrante A, Giardina AR, Ciccia F, Parrinello G, Licata G, Avellone G, Giardina E, Impastato R, Triolo G. Long-term anti-tumour necrosis factor therapy reverses the progression of carotid intima-media thickness in female patients with active rheumatoid arthritis. Rheumatol Int. 2009 Dec;30(2):193-8. doi: 10.1007/s00296-009-0935-2. PMID 19387646
- BACKGROUNDDel Porto F, Lagana B, Lai S, Nofroni I, Tinti F, Vitale M, Podesta E, Mitterhofer AP, D'Amelio R. Response to anti-tumour necrosis factor alpha blockade is associated with reduction of carotid intima-media thickness in patients with active rheumatoid arthritis. Rheumatology (Oxford). 2007 Jul;46(7):1111-5. doi: 10.1093/rheumatology/kem089. Epub 2007 Apr 20. PMID 17449484
- BACKGROUNDBurns JC, Best BM, Mejias A, Mahony L, Fixler DE, Jafri HS, Melish ME, Jackson MA, Asmar BI, Lang DJ, Connor JD, Capparelli EV, Keen ML, Mamun K, Keenan GF, Ramilo O. Infliximab treatment of intravenous immunoglobulin-resistant Kawasaki disease. J Pediatr. 2008 Dec;153(6):833-8. doi: 10.1016/j.jpeds.2008.06.011. Epub 2008 Jul 30.