Visilizumab for Treatment of Perianal Fistulas in Crohn's Disease
A Phase 2a, Open-label Study of Visilizumab for Treatment of Perianal Fistulas in Patients With Crohn's Disease
The purpose of the study is to evaluate an intravenous (by injection) investigational medication to treat Crohn's disease in patients with at least one perianal fistula. The research is being conducted at up to 5 clinical research sites in the US and Europe and is open to both men and women ages 18 to 70 years old. Participants in the study will have a number of visits to a research site over a 17 month period. All study-related care and medication is provided to qualified participants at no cost: this includes all visits, examinations and laboratory work.
Visilizumab is a humanized antibody (antibodies are proteins that are normally made by the immune system to help defend the body from infections and other foreign substances) that is directed against T cells. Visilizumab selectively attacks problematic T cells and, in doing so, it may prevent them from causing inflammation. Visilizumab has also been observed to have a suppressive effect on the body's immune system (system in the body that reacts to foreign or occasionally one's own proteins).
Panoramica dello studio
Descrizione dettagliata
Tipo di studio
Iscrizione
Fase
- Fase 2
Contatti e Sedi
Luoghi di studio
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Minnesota
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Rochester, Minnesota, Stati Uniti, 55905
- Mayo Clinic Rochester
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Criteri di partecipazione
Criteri di ammissibilità
Età idonea allo studio
Accetta volontari sani
Sessi ammissibili allo studio
Descrizione
Inclusion Criteria:
- 18-70 years old
- Diagnosis of Crohn's disease with fistula
- Test negative for Clostridium difficile within 3 weeks
- Signed informed consent, including permission to use protected health information.
Exclusion Criteria:
- History of lymphoproliferative disorder or prior malignancy within 5 years or current malignancy
- Pregnant or nursing
- HIV, Hepatitis B or Hepatitis C infection
- Presence of obstructive symptoms, confirmed by endoscopy, within 6 months
- Likely to require surgery in the next 6 months
- Serious or active infections within 1 year
- Active infections that require antibiotic therapy
- Serious infections that require IV antibiotics or hospitalization within 8 weeks
- Started or changed dose of sulfasalazine, 5-aminosalicylic acid (5-ASA), antibiotics, probiotics, or topical therapies for Crohn's within 2 weeks
- Had increased dose of corticosteroids within 2 weeks
- Received a live vaccine within 6 weeks
- Received any monoclonal antibodies or investigational agents within 3 months
- Received cyclosporine or tacrolimus (FK506) within 4 weeks
- Dose change or discontinuation of 6-mercaptopurine, azathioprine, or methotrexate within 4 weeks
- Significant organ dysfunction
- History of lymphoproliferative disorder
- History of tuberculosis, mycobacterial infection, or positive chest x-ray
- History of thrombophlebitis or pulmonary embolus
- History of immune deficiency or autoimmune disorders (other than Crohn's disease)
- History of seizure with subtherapeutic levels of anticonvulsive medication within one week
Piano di studio
Come è strutturato lo studio?
Dettagli di progettazione
- Scopo principale: Trattamento
- Assegnazione: Non randomizzato
- Modello interventistico: Assegnazione di gruppo singolo
- Mascheramento: Nessuno (etichetta aperta)
Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
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Clinical response, defined as external closure of at least 50% of perianal fistulas, without an accompanying increase in dose of concomitant medications, the addition of new medications, or Crohn's Disease-related surgery.
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Misure di risultato secondarie
Misura del risultato |
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Frequency of complete clinical response, confirm internal healing by MRI, duration of disease improvement.
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Collaboratori e investigatori
Sponsor
Collaboratori
Pubblicazioni e link utili
Collegamenti utili
Studiare le date dei record
Studia le date principali
Inizio studio
Completamento primario (Effettivo)
Completamento dello studio (Effettivo)
Date di iscrizione allo studio
Primo inviato
Primo inviato che soddisfa i criteri di controllo qualità
Primo Inserito (Stima)
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Stima)
Ultimo aggiornamento inviato che soddisfa i criteri QC
Ultimo verificato
Maggiori informazioni
Termini relativi a questo studio
Termini MeSH pertinenti aggiuntivi
Altri numeri di identificazione dello studio
- 291-411
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