Five-Year Observation of Remicade Treatment for Plaque Psoriasis in Austria (Study P04900)
15. juli 2015 opdateret af: Merck Sharp & Dohme LLC
Real Life Treatment Regimen of Remicade (Infliximab) in Austria, Monitored Over 5 Years in Plaque Psoriasis Therapy
Prospective, open-label-, 1-arm, multicenter observational study to determine the dose and interval of Infliximab infusions for subjects with plaque psoriasis.
Studieoversigt
Detaljeret beskrivelse
This study population was chosen from a non-probability sample.
Undersøgelsestype
Observationel
Tilmelding (Faktiske)
26
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
Prøveudtagningsmetode
Ikke-sandsynlighedsprøve
Studiebefolkning
Adult subjects with moderate-to-severe plaque psoriasis will receive Infliximab induction therapy in specialized centers.
Beskrivelse
Inclusion Criteria:
- According to the European Summary of Product Characteristics (SPC): Adult subjects with moderate-to-severe plaque psoriasis who failed to respond to, or who have a contraindication to, or are intolerant to other systematic therapy including cyclosporine, methotrexate, or Psoralen-ultraviolet-A light (PUVA).
Exclusion Criteria:
According to the European SPC:
- Subjects with tuberculosis or other severe infections such as sepsis, abscesses, and opportunistic infections.
- Subjects with moderate-to-severe heart failure (New York Heart Association (NYHA) class III/IV).
- Subjects with a history of hypersensitivity to Infliximab or to other murine proteins or to any of the excipients.
- Subjects with elevated liver enzymes (>5 upper limit of normal (ULN)).
Studieplan
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Observationsmodeller: Kohorte
- Tidsperspektiver: Fremadrettet
Kohorter og interventioner
Gruppe / kohorte |
Intervention / Behandling |
|---|---|
|
Infliximab
Subjects with plaque psoriasis will receive Infliximab initial induction therapy consisting of 3 Infliximab infusions at weeks 0, 2, and 6 given in specialized centers.
A maximum of 6 maintenance infusions will be given in doses and intervals due to the discretion of the physicians.
|
Infliximab initial induction therapy consisting of 3 Infliximab infusions at weeks 0, 2, and 6 given in specialized centers.
A maximum of 6 maintenance infusions will be given in doses and intervals due to the discretion of the physicians.
Andre navne:
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Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Number of Therapies That Were Applied as Induction, Maintenance, or Episodic Therapies After One Infusion of Infliximab
Tidsramme: Maximum 2 years
|
The types of therapies were assessed according to the following criteria: Induction therapy: first infusion given at Week 0 (Baseline). Second infusion given at Week 2 (+/- 7 days). Third infusion given at Week 6 (+/- 7 days). Maintenance therapy: given in approximately 8-week (56-day) intervals (time window +4 weeks to -2 weeks). One infusion given out of the time window was accepted to be classified as maintenance therapy, if the remaining infusions were given within the time window (8 weeks, +4 to -2 weeks). Episodic Therapy: given out of time frame (> 12 weeks). |
Maximum 2 years
|
Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Mean Time Interval Between Infliximab Infusions During Maintenance Treatment Following Induction Therapy
Tidsramme: Maximum 2 years
|
Maximum 2 years
|
|
|
Median Time Interval Between Infliximab Infusions During Maintenance Treatment Following Induction Therapy
Tidsramme: Maximum 2 years
|
Maximum 2 years
|
|
|
Mean Dose of Infliximab
Tidsramme: Maximum 2 years
|
Maximum 2 years
|
|
|
Median Dose of Infliximab
Tidsramme: Maximum 2 years
|
Maximum 2 years
|
|
|
Mean Percent Change From Baseline in Body Surface Area (BSA) Involved With Psoriasis After Treatment With Infliximab
Tidsramme: Baseline and Infusion 9
|
BSA estimation was determined using the participant's handprint (palmar surface of palms plus five digits).
The number of handprints that covered the affected skin area was counted.
One handprint was approximately equivalent to 1 percent of the BSA; therefore, BSA was calculated in percentages.
The change from Baseline in BSA was calculated by subtracting Baseline from infusion 9.
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Baseline and Infusion 9
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Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Sponsor
Samarbejdspartnere
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. oktober 2006
Primær færdiggørelse (Faktiske)
1. juni 2010
Studieafslutning (Faktiske)
1. juni 2010
Datoer for studieregistrering
Først indsendt
25. juli 2008
Først indsendt, der opfyldte QC-kriterier
25. juli 2008
Først opslået (Skøn)
30. juli 2008
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Skøn)
28. juli 2015
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
15. juli 2015
Sidst verificeret
1. juli 2015
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- P04900
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