- ICH GCP
- US-Register für klinische Studien
- Klinische Studie NCT00967538
Safety and Efficacy of Etanercept in Patients With Psoriasis Who Failed to Respond to Other Biologic Treatments
23. Juli 2014 aktualisiert von: Innovaderm Research Inc.
Safety and Efficacy of Etanercept in Patients With Moderate to Severe Plaque Psoriasis Who Have Shown an Unsatisfactory Response to Adalimumab or Infliximab
The purpose of this study is to evaluate safety and efficacy of etanercept in patients with psoriasis who had an unsatisfactory response to adalimumab and infliximab.
Studienübersicht
Status
Abgeschlossen
Bedingungen
Intervention / Behandlung
Studientyp
Interventionell
Einschreibung (Tatsächlich)
89
Phase
- Phase 4
Kontakte und Standorte
Dieser Abschnitt enthält die Kontaktdaten derjenigen, die die Studie durchführen, und Informationen darüber, wo diese Studie durchgeführt wird.
Studienorte
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Quebec, Kanada, G1V 4X7
- Centre de Recherches Dermatologiques du Quebec Metropolitain
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Alberta
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Calgary, Alberta, Kanada, T2S3B3
- Kirk Barber Research
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British Columbia
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Victoria, British Columbia, Kanada, V8V 3P9
- Percuro Clinical Research Ltd
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Manitoba
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Winnipeg, Manitoba, Kanada, R3C 0N2
- Winnipeg Clinic Dermatology Research
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Newfoundland and Labrador
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St John's, Newfoundland and Labrador, Kanada, A1A 5E8
- Nexus Clinical Research
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St John's, Newfoundland and Labrador, Kanada, A1C 2H5
- New Lab Clinical Research
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Nova Scotia
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Halifax, Nova Scotia, Kanada, B3H 1Z4
- Eastern Canada Cutaneous Research Associates Ltd
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Ontario
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Hamilton, Ontario, Kanada, L8N 1V6
- Dermatrials Research
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London, Ontario, Kanada, N5X 2P1
- Mediprobe Research Inc.
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Markham, Ontario, Kanada, L3P 1A8
- Lynderm Research Inc.
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North York, Ontario, Kanada, M4A 2V6
- Dermatology Associates
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Sudbury, Ontario, Kanada, P3E 5M4
- Sudbury Skin Clinic
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Toronto, Ontario, Kanada, M4V 1R1
- Dr. Jay Brian Taradash
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Quebec
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Montreal, Quebec, Kanada, H2K 4L5
- Innovaderm Research Inc.
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Montreal, Quebec, Kanada, H3A 1A1
- Siena Medical Research
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St-Hyacinthe, Quebec, Kanada, J2S 6L6
- Clinique Esthetique Dr Isabelle Delorme
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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 bis 80 Jahre (Erwachsene, Älterer Erwachsener)
Akzeptiert gesunde Freiwillige
Nein
Studienberechtigte Geschlechter
Alle
Beschreibung
Inclusion Criteria:
- Patient has plaque psoriasis and has shown an unsatisfactory response to adalimumab. Unsatisfactory response is defined as patients who failed to reach a PGA of clear or almost clear (PGA of 0 or 1) following at least 12 weeks with adalimumab at 40 mg EOW; OR
- Patient has plaque psoriasis and has lost his/her satisfactory response to adalimumab. Loss of satisfactory response is defined as patients treated with adalimumab 40 mg EOW for at least 12 weeks, who achieved a PGA of clear or almost clear (PGA of 0 or 1) but lost this PGA response (increase in PGA to 2, 3, 4 or 5) at any time after 12 weeks of adalimumab; OR
- Patient has plaque psoriasis and has lost his/her satisfactory response to infliximab. Loss of satisfactory response is defined as patients treated with at least 3 infliximab infusions at 5 mg/kg, who achieved a PGA of clear or almost clear (PGA of 0 or 1) but lost this PGA response (increase in PGA to 2, 3, 4 or 5) at any time after the 3rd infusion of infliximab;
- Patient's age is 18 to 80 years old;
- Patient has PGA of 3 or more at Day 0;
- Patient has BSA of 3% or more at Day 0;
- Patient has psoriasis severe enough to be eligible to systemic therapy;
- Unless surgically sterile (or at least 1 year post-menopausal for women), or abstinent, patient (male or female) is willing to use an effective method of contraception for at least 30 days before Day 0 and until at least 1 month after the last drug administration;
- Patient capable of giving informed consent;
- Patient with normal or non clinically significant chest X-ray within 6 months prior to Day 0;
- Patient with negative Purified Protein Derivative (PPD) or Quantiferon TB Gold test within 90 days prior to Day 0;
- Female patients of childbearing potential have a negative serum pregnancy test;
- Patient is able to start etanercept per the approved product monograph.
Exclusion Criteria:
- Patient has used topical steroids, topical tar preparations, or other anti-psoriatic preparations within the two weeks prior to Day 0 or during the study period, unless patient used topical therapy during the last 4 weeks of the period when the patient lost their satisfactory response to adalimumab or infliximab or when the patient failed to achieve a satisfactory response to adalimumab;
- Patient has presence of erythrodermic, pustular or guttate psoriasis;
- Patient has had significant infections within the 30 days prior to Day 0;
- Patient has received investigational drugs within the four weeks prior to screening or during the study period;
- Patient has been treated with systemic anti-psoriatic drugs such as steroids, retinoids, cyclosporine, PUVA therapy or methotrexate within the four weeks prior to Day 0 or during the study period;
- Patient received systemic antibiotics within the four weeks prior to Day 0;
- Patient has been treated with ultraviolet light therapy (UVB, nbUVB) within the two weeks prior to Day 0 or during the study period;
- Patient has used adalimumab or infliximab within 14 days of Day 0 or during the study period;
- Patient has used other biologic agents for the treatment of psoriasis besides etanercept 8 weeks prior to Day 0 or during the study period;
- Patient has had an allergic reaction to adalimumab, infliximab or etanercept;
- Patient has an unstable or serious medical condition as defined by the investigator or presence of any significant medical condition that might cause this study to be detrimental to the patient;
- Uncontrolled or severe comorbidities such as poorly controlled diabetes mellitus, NYHA class III or IV heart failure, history of myocardial infarction or cerebrovascular accident or transient ischemic attack within three months of screening visit; unstable angina pectoris; uncontrolled hypertension, oxygen-dependent severe pulmonary disease;
- Patient has a known sero-positivity for HIV virus or history of any other immunosuppressive disease;
- Patient has active or chronic Hepatitis B or C;
- Patient has any mycobacterial disease, patient with a chest X-Ray suggestive of tuberculosis or patient taking anti-tuberculosis medication;
- Patient has a known hypersensitivity to etanercept or one of its components;
- Patient has received a live attenuated vaccine within the 12 weeks prior to Day 0 or plans to receive one during the study;
- Current pregnancy or lactation;
- At the investigator
Studienplan
Dieser Abschnitt enthält Einzelheiten zum Studienplan, einschließlich des Studiendesigns und der Messung der Studieninhalte.
Wie ist die Studie aufgebaut?
Designdetails
- Hauptzweck: Behandlung
- Zuteilung: N / A
- Interventionsmodell: Einzelgruppenzuweisung
- Maskierung: Keine (Offenes Etikett)
Waffen und Interventionen
Teilnehmergruppe / Arm |
Intervention / Behandlung |
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Experimental: Etanercept
All patients will receive etanercept 50 mg twice a week for 12 weeks followed by 50 mg once a week for an additional 12 weeks.
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All patients will receive etanercept 50 mg twice a week for 12 weeks followed by 50 mg once a week for an additional 12 weeks.
Andere Namen:
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Was misst die Studie?
Primäre Ergebnismessungen
Ergebnis Maßnahme |
Zeitfenster |
---|---|
Proportion of patients who reach a Physician's Global Assessment (PGA) of clear or almost clear after 12 and 24 weeks of etanercept for patients who have shown an unsatisfactory response to adalimumab 40 mg every other week (EOW).
Zeitfenster: 24 weeks
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24 weeks
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Sekundäre Ergebnismessungen
Ergebnis Maßnahme |
Zeitfenster |
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Proportion of patients who reach a PGA of clear or almost clear after 12 and 24 weeks of etanercept for patients who have lost their satisfactory response to adalimumab 40 mg EOW.
Zeitfenster: 24 weeks
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24 weeks
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Proportion of patients who reach a PGA of clear or almost clear after 12 and 24 weeks of etanercept for patients who have lost their satisfactory response to infliximab.
Zeitfenster: 24 weeks
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24 weeks
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Mean Body Surface Area (BSA) after 12 weeks and 24 weeks of etanercept for patients who have lost their satisfactory response to infliximab.
Zeitfenster: 24 weeks
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24 weeks
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Mean BSA after 12 weeks and 24 weeks of etanercept for patients who have lost their satisfactory response to adalimumab 40 mg EOW.
Zeitfenster: 24 weeks
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24 weeks
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Mean BSA after 12 and 24 weeks of etanercept for patients who have shown an unsatisfactory response to adalimumab 40 mg EOW.
Zeitfenster: 24 weeks
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24 weeks
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Mean Psoriasis Area and Severity Index (PASI) score after 12 weeks and 24 weeks of etanercept for patients who have lost their satisfactory response to infliximab.
Zeitfenster: 24 weeks
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24 weeks
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Mean PASI score after 12 weeks and 24 weeks of etanercept for patients who have lost their satisfactory response to adalimumab 40 mg EOW.
Zeitfenster: 24 weeks
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24 weeks
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Mean PASI score after 12 and 24 weeks of etanercept for patients who have shown an unsatisfactory response to adalimumab 40 mg EOW.
Zeitfenster: 24 weeks
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24 weeks
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Safety of etanercept in patients who have shown an unsatisfactory response to adalimumab, who have lost their satisfactory response to adalimumab or who have lost their satisfactory response to infliximab.
Zeitfenster: 24 weeks
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24 weeks
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Mitarbeiter und Ermittler
Hier finden Sie Personen und Organisationen, die an dieser Studie beteiligt sind.
Sponsor
Mitarbeiter
Ermittler
- Hauptermittler: Ronald B Vender, MD, Dermatrials Research
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
1. September 2009
Primärer Abschluss (Tatsächlich)
1. Juli 2014
Studienabschluss (Tatsächlich)
1. Juli 2014
Studienanmeldedaten
Zuerst eingereicht
26. August 2009
Zuerst eingereicht, das die QC-Kriterien erfüllt hat
27. August 2009
Zuerst gepostet (Schätzen)
28. August 2009
Studienaufzeichnungsaktualisierungen
Letztes Update gepostet (Schätzen)
24. Juli 2014
Letztes eingereichtes Update, das die QC-Kriterien erfüllt
23. Juli 2014
Zuletzt verifiziert
1. Juli 2014
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
- Inno-6011
- CA-2009-0004
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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