- ICH GCP
- US-Register für klinische Studien
- Klinische Studie NCT00322439
Observational Safety Study of Etanercept (Enbrel) for Treatment of Psoriasis
9. Mai 2018 aktualisiert von: Amgen
Observational Post-Marketing Safety Surveillance Registry of Enbrel (Etanercept) for Treatment of Psoriasis
This is an observational safety study tracking psoriasis patients on etanercept (Enbrel) for 5 years.
Studienübersicht
Detaillierte Beschreibung
This is a prospective, multi-center, observational surveillance registry to evaluate data on the long-term safety of etanercept (Enbrel) use in the treatment of psoriasis.
Studientyp
Beobachtungs
Einschreibung (Tatsächlich)
2511
Teilnahmekriterien
Forscher suchen nach Personen, die einer bestimmten Beschreibung entsprechen, die als Auswahlkriterien bezeichnet werden. Einige Beispiele für diese Kriterien sind der allgemeine Gesundheitszustand einer Person oder frühere Behandlungen.
Zulassungskriterien
Studienberechtigtes Alter
18 Jahre und älter (Erwachsene, Älterer Erwachsener)
Akzeptiert gesunde Freiwillige
Nein
Studienberechtigte Geschlechter
Alle
Probenahmeverfahren
Wahrscheinlichkeitsstichprobe
Studienpopulation
Patients with plaque psoriasis, who are currently receiving Enbrel or who are intending to start or restart Enbrel therapy at multi-centers.
Beschreibung
Inclusion Criteria:
- Patients with plaque psoriasis
Exclusion Criteria:
- Prior exposure to any tumor necrosis factor (TNF)-inhibitor
- Patients for whom Enbrel is contraindicated
- Patients currently enrolled in or has not yet completed at least 30 days since ending other investigational drug study.
Studienplan
Dieser Abschnitt enthält Einzelheiten zum Studienplan, einschließlich des Studiendesigns und der Messung der Studieninhalte.
Wie ist die Studie aufgebaut?
Designdetails
- Beobachtungsmodelle: Kohorte
- Zeitperspektiven: Interessent
Kohorten und Interventionen
Gruppe / Kohorte |
Intervention / Behandlung |
---|---|
Etanercept
Participants received etanercept (Enbrel) treatment at the dose and regimen determined by the investigator and were evaluated for up to 5 years at 6-month intervals.
During this period, participants may have discontinued etanercept therapy, may have switched to another anti-psoriatic therapy, may have used etanercept in combination with other anti-psoriatic therapies, or may have discontinued any or all antipsoriatic treatments.
|
Observational study - no drug administered
|
Was misst die Studie?
Primäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
---|---|---|
Five-year Cumulative Incidence of Serious Adverse Events and Serious Infectious Events
Zeitfenster: 5 years
|
A serious adverse event (SAE), including a serious infectious event (SIE), is defined as one that suggests a significant hazard or side effect, regardless of the investigator or sponsor's opinion on the relationship to a drug product.
This includes, but may not be limited to, any event that (at any dose) is fatal, life threatening, requires inpatient hospitalization that includes a minimum of an overnight stay or prolongation of existing hospitalization, is a persistent or significant disability/incapacity, or is a congenital anomaly/birth defect.
Cumulative incidences were calculated using Kaplan-Meier methodology for all participants who received at least 1 registry dose of etanercept.
For SAEs and SIEs, time to event was re-defined from calendar time to cumulative time up to the event, excluding time intervals and events when the participant was not on etanercept treatment (ie, based on etenercept exposure time).
|
5 years
|
Sekundäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
---|---|---|
Five-year Cumulative Incidence for Events of Medical Interest (EMIs)
Zeitfenster: 5 years
|
Protocol defined EMIs included: • All malignancies, including basal cell carcinoma (BCC) and squamous cell carcinoma (SCC); • Tuberculosis; • Opportunistic infections treated with intravenous therapy; • Histoplasmosis infections treated with oral antibiotics; • Coccidioidomycosis infections treated with oral antibiotics; • Central nervous system (CNS) demyelinating disorders; • Lupus disease; • Coronary artery disease; • Worsening of psoriasis as defined by change in psoriasis morphology and withdrawal of therapy; • Any event or laboratory abnormality that represents an event of medical significance.
Cumulative incidences were calculated using Kaplan-Meier methods where time to event was defined as the time from the first dose of etanercept to the start date of the first occurrence of the event, regardless of exposure (ie, based on observation time).
Estimates were adjusted using left truncation methodology to help address any bias due to participants with prior etanercept exposure.
|
5 years
|
Percentage of Participants With a Static Physician's Global Assessment (sPGA) of Psoriasis Score of 0 (Clear) or 1 (Almost Clear)
Zeitfenster: Baseline and at 3 and 5 years
|
The sPGA scale is designed to evaluate the physician's global assessment of the participant's psoriasis based on severity of induration, scaling, and erythema.
The sPGA is assessed on a scale of 0 to 5 (0 = clear, 5 = severe).
|
Baseline and at 3 and 5 years
|
Percentage of Participants With a Patient's Global Assessment of Psoriasis Score of 0 or 1
Zeitfenster: Baseline and at 3 and 5 years
|
The patient's global assessment of psoriasis is a self-administered numeric scale is designed to evaluate participants' perception of their psoriasis on a scale from 0 (good) to 5 (severe).
|
Baseline and at 3 and 5 years
|
Percentage of Participants With a Dermatology Life Quality Index (DLQI) Response
Zeitfenster: Baseline, Year 3 and Year 5
|
The DLQI questionnaire asks participants to evaluate the degree that psoriasis has affected their quality of life in the last week, and includes the following parameters: symptoms and feelings, daily activities, leisure activities, work or school activities, personal relationships and treatment related feelings.
Participants answer 10 questions on a scale from 0 (not at all) to 3 (very much); the range of the total score is 0 to 30.
A score of 21 to 30 means an extremely large effect on the participant's life whereas 0-1 means that the disease has no effect at all.
A DLQI response is defined as a 5 point improvement from Baseline or a score of 0.
|
Baseline, Year 3 and Year 5
|
Euroqol-5D (EQ-5D) Total Score
Zeitfenster: Baseline, Year 3 and Year 5
|
EQ-5D is a self-reported questionnaire that consists of five single-item health domains, mobility, self-care, usual activities, pain/discomfort, and anxiety/depression.
The answers are recorded as choices of 1, 2, or 3 for each question, with 1 signifying no problem, 2 signifying some problem, and 3 signifying major problem.
Using the US scoring algorithm, the possible total EQ-5D score ranges from -0.11 (ie, answered '3' for all questions) to 1.0 (ie, answered '1' for all questions), where 1.0 represents perfect health.
|
Baseline, Year 3 and Year 5
|
Euroqol-5D (EQ-5D) Visual Analog Scale (VAS)
Zeitfenster: Baseline, Year 3 and Year 5
|
The EQ-5D visual analog scale (VAS) is a 100 mm scale with 100 representing 'best imaginable health state' and 0 representing 'worst imaginable health state'.
Participants were asked to indicate on this scale how good or bad their health was today.
|
Baseline, Year 3 and Year 5
|
Healthcare Resource Use
Zeitfenster: Baseline, Year 3 and Year 5
|
This self-administered questionnaire is designed to measure the amount of healthcare resource utilization by the participant in the past 4 weeks. The average answers to the following questions are reported:
|
Baseline, Year 3 and Year 5
|
Work Productivity and Activity Impairment (WPAI)
Zeitfenster: Baseline, Year 3 and Year 5
|
The WPAI questionnaire has six questions to assess whether the participant was currently employed (Q1); how many hours from work were missed due to problems associated with psoriasis (Q2) or any other reason (Q3); hours actually worked (Q4); degree that psoriasis affected productivity while working (Q5); and degree that psoriasis affected regular activities (Q6) over the past 7 days.
Four separate overall scores were calculated, including absenteeism (work time missed due to health), presenteeism (impairment at work due to health), work productivity loss (overall work impairment due to health), and activity impairment due to health.
Each score ranges from 0 to 100 with higher scores indicating greater impairment and less productivity (ie, worse outcomes).
|
Baseline, Year 3 and Year 5
|
Percentage of Body Surface Area Affected by Psoriasis
Zeitfenster: Baseline, Year 3 and Year 5
|
Body Surface Area (BSA) is a numerical score used to measure the physician's assessment of the percentage of the participant's total BSA involved with psoriasis.
|
Baseline, Year 3 and Year 5
|
Mitarbeiter und Ermittler
Hier finden Sie Personen und Organisationen, die an dieser Studie beteiligt sind.
Sponsor
Publikationen und hilfreiche Links
Die Bereitstellung dieser Publikationen erfolgt freiwillig durch die für die Eingabe von Informationen über die Studie verantwortliche Person. Diese können sich auf alles beziehen, was mit dem Studium zu tun hat.
Allgemeine Veröffentlichungen
- Kimball AB, Pariser D, Yamauchi PS, Menter A, Teller CF, Shi Y, Creamer K, McCroskery P, Kricorian G, Gelfand JM. OBSERVE-5, an Observational Post-Marketing SafetySurveillance Registry of Etanercept for the treatment of Psoriasis: A Model for Studying New Psoriasis Therapies. Psoriasis Forum. 2010;16(3):3-7.
- Kimball AB, Pariser D, Yamauchi PS, Menter A, Teller CF, Shi Y, Yong M, Creamer K, Hooper M, Aras G, Kricorian G, Gelfand JM. OBSERVE-5 interim analysis: an observational postmarketing safety registry of etanercept for the treatment of psoriasis. J Am Acad Dermatol. 2013 May;68(5):756-64. doi: 10.1016/j.jaad.2012.10.055. Epub 2013 Jan 26.
- Kimball AB, Rothman KJ, Kricorian G, Pariser D, Yamauchi PS, Menter A, Teller CF, Aras G, Accortt NA, Hooper M, Rice KC, Gelfand JM. OBSERVE-5: observational postmarketing safety surveillance registry of etanercept for the treatment of psoriasis final 5-year results. J Am Acad Dermatol. 2015 Jan;72(1):115-22. doi: 10.1016/j.jaad.2014.08.050. Epub 2014 Sep 26.
- Kimball AB, Schenfeld J, Accortt NA, Anthony MS, Rothman KJ, Pariser D. Incidence rates of malignancies and hospitalized infectious events in patients with psoriasis with or without treatment and a general population in the U.S.A.: 2005-09. Br J Dermatol. 2014 Feb;170(2):366-73. doi: 10.1111/bjd.12744.
Nützliche Links
Studienaufzeichnungsdaten
Diese Daten verfolgen den Fortschritt der Übermittlung von Studienaufzeichnungen und zusammenfassenden Ergebnissen an ClinicalTrials.gov. Studienaufzeichnungen und gemeldete Ergebnisse werden von der National Library of Medicine (NLM) überprüft, um sicherzustellen, dass sie bestimmten Qualitätskontrollstandards entsprechen, bevor sie auf der öffentlichen Website veröffentlicht werden.
Haupttermine studieren
Studienbeginn (Tatsächlich)
1. Mai 2006
Primärer Abschluss (Tatsächlich)
11. Dezember 2012
Studienabschluss (Tatsächlich)
8. Februar 2013
Studienanmeldedaten
Zuerst eingereicht
5. Mai 2006
Zuerst eingereicht, das die QC-Kriterien erfüllt hat
5. Mai 2006
Zuerst gepostet (Schätzen)
8. Mai 2006
Studienaufzeichnungsaktualisierungen
Letztes Update gepostet (Tatsächlich)
28. Juni 2018
Letztes eingereichtes Update, das die QC-Kriterien erfüllt
9. Mai 2018
Zuletzt verifiziert
1. Mai 2018
Mehr Informationen
Begriffe im Zusammenhang mit dieser Studie
Schlüsselwörter
Zusätzliche relevante MeSH-Bedingungen
- Hautkrankheiten
- Hautkrankheiten, papulosquamös
- Schuppenflechte
- Physiologische Wirkungen von Arzneimitteln
- Agenten des peripheren Nervensystems
- Analgetika
- Agenten des sensorischen Systems
- Entzündungshemmende Mittel, nichtsteroidal
- Analgetika, nicht narkotisch
- Entzündungshemmende Mittel
- Antirheumatika
- Immunsuppressive Mittel
- Immunologische Faktoren
- Magen-Darm-Mittel
- Etanercept
Andere Studien-ID-Nummern
- 20040210
Arzneimittel- und Geräteinformationen, Studienunterlagen
Studiert ein von der US-amerikanischen FDA reguliertes Arzneimittelprodukt
Nein
Studiert ein von der US-amerikanischen FDA reguliertes Geräteprodukt
Nein
Produkt, das in den USA hergestellt und aus den USA exportiert wird
Nein
Diese Informationen wurden ohne Änderungen direkt von der Website clinicaltrials.gov abgerufen. Wenn Sie Ihre Studiendaten ändern, entfernen oder aktualisieren möchten, wenden Sie sich bitte an register@clinicaltrials.gov. Sobald eine Änderung auf clinicaltrials.gov implementiert wird, wird diese automatisch auch auf unserer Website aktualisiert .
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