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Visilizumab for Treatment of Perianal Fistulas in Crohn's Disease

6. marts 2012 opdateret af: Facet Biotech

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).

Studieoversigt

Status

Afsluttet

Betingelser

Crohns sygdom

Intervention / Behandling

Medicin: Visilizumab

Detaljeret beskrivelse

PDL BioPharma, Inc. was formerly known as Protein Design Labs, Inc.

Undersøgelsestype

Interventionel

Tilmelding

Fase

Fase 2

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

Forenede Stater
- Minnesota
  - Rochester, Minnesota, Forenede Stater, 55905
    - Mayo Clinic Rochester

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

18 år til 70 år (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Beskrivelse

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

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

Primært formål: Behandling
Tildeling: Ikke-randomiseret
Interventionel model: Enkelt gruppeopgave
Maskning: Ingen (Åben etiket)

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
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.

Sekundære resultatmål

Resultatmål
Frequency of complete clinical response, confirm internal healing by MRI, duration of disease improvement.

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Facet Biotech

Samarbejdspartnere

PDL BioPharma, Inc.

Publikationer og nyttige links

Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.

Hjælpsomme links

Related Info

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart

1. februar 2005

Primær færdiggørelse (Faktiske)

1. december 2006

Studieafslutning (Faktiske)