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A Study to Evaluate Raptiva in Subjects With Chronic Moderate or Worse Plaque Psoriasis Who Have Had an Inadequate Response to an Anti-TNF Agent

1. juli 2015 opdateret af: Genentech, Inc.

A Phase IV Open-Label Study to Evaluate the Efficacy and Safety of 1.0 mg/kg Raptiva (Efalizumab) in Adult Subjects With Chronic Moderate or Worse Plaque Psoriasis Who Have Had an Inadequate Response to an Anti-TNF Agent

This is a Phase IV open-label study to evaluate the efficacy and safety of SC efalizumab in adult subjects (18 years of age and older) with chronic moderate or worse plaque psoriasis who have had an inadequate response to treatment with an anti-TNF agent. The study will consist of a screening period, a treatment period, and an observation period. All subjects will begin in the screening period (the length of which is dependent on the previous anti-TNF agent treatment). Approximately 100 eligible subjects will receive treatment from Day 0 through Day 168.

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

73

Fase

  • Fase 4

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 og ældre (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Beskrivelse

Inclusion Criteria:

  • Have chronic (6 months or greater) moderate or worse plaque psoriasis
  • Have had an inadequate response to at least 12 weeks of treatment with an anti-TNF agent, where an inadequate response is defined as: PGA ratings of moderate (3), severe (4), or very severe (5), and BSA involvement of 5% or greater
  • Be a candidate for systemic therapy or phototherapy in the opinion of the investigator
  • Be naive to efalizumab treatment
  • Weigh no more than 200 kg
  • For women of childbearing potential, use a method of contraception acceptable to the investigator to prevent pregnancy and agree to continue to practice an acceptable method of contraception for the duration of their participation in the study and for 6 weeks after the last dose of efalizumab

Exclusion Criteria:

  • Have a history of psoriatic arthritis that meets one of the following criteria: Is not controlled with non-steroidal anti-inflammatory drugs (NSAIDs);Requires the use of disease modifying antirheumatic drugs (DMARDs), including biologics while enrolled in the study; Please note that if, following enrollment, a subject requires treatment with a DMARD, study drug treatment should be discontinued and the subject should be moved into the observation period of the study. The subject should have the observation period assessments performed at the appropriate intervals as per the protocol
  • Have a history of hypersensitivity to efalizumab or any of its components
  • Are using any excluded therapy
  • Are currently abusing alcohol or illegal drugs
  • Have a history of or an ongoing uncontrolled serious bacterial, viral, fungal, or atypical mycobacterial infection. This includes diagnoses that required more than 2 weeks of therapy, such as endocarditis and osteomyelitis, which have been treated in the past 6 months. In addition, if the subject is currently receiving antibiotics, antivirals, or antifungals for an infection or for suppression or prophylaxis for any diagnosis, the subject will be excluded.
  • Have any history of opportunistic infections (e.g., systemic fungal infections, parasites)
  • Are seropositive for hepatitis B antigen, hepatitis C antibody, or human immunodeficiency virus (HIV). Subjects will undergo testing during screening, and any subjects who are seropositive for hepatitis B antigen, hepatitis C antibody, or HIV will be excluded.
  • Have a history of active tuberculosis or are currently undergoing treatment for tuberculosis. A purified protein derivative (PPD) test will be performed at the screening visit. Subjects with a positive PPD test (not due to BCG vaccination) or chest x-ray will be excluded.
  • Have the presence or history of malignancy, including lymphoproliferative disorders. Subjects with a history of fully resolved basal or squamous cell skin cancer may be enrolled.
  • Are pregnant or lactating women
  • Have a diagnosis of hepatic cirrhosis, regardless of cause or severity
  • Have a history of thrombocytopenia
  • Have a history of clinically significant hemolytic or unexplained anemia
  • Have been exposed to any experimental drugs or treatments within 30 days or 5 half-lives, whichever is longer, prior to the screening visit
  • Have had any previous exposure to efalizumab
  • Have been vaccinated with a live virus or live bacteria within the 14 days prior to the first dose of efalizumab
  • Have any medical condition that, in the judgment of the investigator, would jeopardize the subject's safety following exposure to study drug or would significantly interfere with the subject's ability to comply with the provisions of this protocol

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: N/A
  • Interventionel model: Enkelt gruppeopgave
  • Maskning: Ingen (Åben etiket)

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: 1
Subkutan gentagen dosis

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Proportion of Subjects With a Physician's Global Assessment (PGA) Rating of Clear (0), Almost Clear (1), or Mild (2)
Tidsramme: Day 84
The PGA scale used in this study was: 0=clear, 1=almost clear, 2=mild, 3=moderate, 4=severe, 5=very severe
Day 84

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Proportion of Subjects With a PGA Rating of Clear (0), Almost Clear (1), or Mild (2)
Tidsramme: Day 168
The PGA scale used in this study was: 0=clear, 1=almost clear, 2=mild, 3=moderate, 4=severe, 5=very severe
Day 168
Proportion of Subjects With a PGA Rating of Clear (0) or Almost Clear (1)
Tidsramme: Day 84
The PGA scale used in this study was: 0=clear, 1=almost clear, 2=mild, 3=moderate, 4=severe, 5=very severe
Day 84
Proportion of Subjects With a PGA Rating of Clear (0) or Almost Clear (1)
Tidsramme: Day 168
The PGA scale used in this study was: 0=clear, 1=almost clear, 2=mild, 3=moderate, 4=severe, 5=very severe
Day 168

Samarbejdspartnere og efterforskere

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

Sponsor

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. maj 2006

Primær færdiggørelse (Faktiske)

1. februar 2008

Datoer for studieregistrering

Først indsendt

13. juni 2006

Først indsendt, der opfyldte QC-kriterier

13. juni 2006

Først opslået (Skøn)

15. juni 2006

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Skøn)

23. juli 2015

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

1. juli 2015

Sidst verificeret

1. april 2009

Mere information

Begreber relateret til denne undersøgelse

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • ACD3780g

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

Kliniske forsøg med Psoriasis

Kliniske forsøg med efalizumab

3
Abonner