- ICH GCP
- Rejestr badań klinicznych w USA
- Badanie kliniczne NCT02547714
Open-label Study of Subcutaneous Secukinumab to Evaluate Efficacy and Safety in Patients With Plaque Psoriasis Who Had Inadequate Response to Cyclosporine A
A Multi-center, Open-label Study of Subcutaneous Secukinumab to Evaluate Efficacy and Safety for 16 Weeks in Patients With Plaque Psoriasis Who Had Inadequate Response to Cyclosporine A
Przegląd badań
Typ studiów
Zapisy (Rzeczywisty)
Faza
- Faza 4
Kontakty i lokalizacje
Lokalizacje studiów
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Aichi
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Nagoya city, Aichi, Japonia, 467-8602
- Novartis Investigative Site
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Fukuoka
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Fukuoka-city, Fukuoka, Japonia, 814-0180
- Novartis Investigative Site
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Kanagawa
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Isehara-city, Kanagawa, Japonia, 259-1193
- Novartis Investigative Site
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Osaka
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Osaka-city, Osaka, Japonia, 550-0012
- Novartis Investigative Site
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Tochigi
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Shimotsuke-city, Tochigi, Japonia, 329-0498
- Novartis Investigative Site
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Tokyo
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Chiyoda-ku, Tokyo, Japonia, 102-8798
- Novartis Investigative Site
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Itabashi-ku, Tokyo, Japonia, 173-8610
- Novartis Investigative Site
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Itabashi-ku, Tokyo, Japonia, 173-8606
- Novartis Investigative Site
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Minato-ku, Tokyo, Japonia, 105-8471
- Novartis Investigative Site
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Shinagawa-ku, Tokyo, Japonia, 141 8625
- Novartis Investigative Site
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Shinjuku-Ku, Tokyo, Japonia, 169-0073
- Novartis Investigative Site
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Kryteria uczestnictwa
Kryteria kwalifikacji
Wiek uprawniający do nauki
Akceptuje zdrowych ochotników
Płeć kwalifikująca się do nauki
Opis
Inclusion criteria:
- Plaque psoriasis diagnosed for at least 6 months before baseline - Treated with cyclosporine A for at least 12 weeks prior to baseline
Currently treated with cyclosporine A at baseline for psoriasis but is a primary or secondary inadequate response as defined at baseline by:
- PASI score of 10 or greater and
- IGA mod 2011 score of 2 or greater (based on a scale of 0 to 4)
Exclusion Criteria:
- Forms of psoriasis other than plaque (e.g., pustular, erythrodermic and guttate psoriasis). -Drug-induced psoriasis (i.e., new onset or current exacerbation from beta-blockers, calcium channel blockers or lithium).
- Patients who have to discontinue cyclosporine A treatment due to side effects like renal impairment (serum creatinine exceeding 176.8 μmol/L [2.0 mg/dL]) and hypertension at screening.
Other protocol-defined inclusion/exclusion criteria may apply
Plan studiów
Jak projektuje się badanie?
Szczegóły projektu
- Główny cel: Leczenie
- Przydział: Nielosowe
- Model interwencyjny: Zadanie dla jednej grupy
- Maskowanie: Brak (otwarta etykieta)
Broń i interwencje
Grupa uczestników / Arm |
Interwencja / Leczenie |
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Eksperymentalny: Secukinumab (AIN457) 300 mg
Participants received secukinumab 300 mg subcutaneously (s.c.) (two 150 mg injections) on Day 1 and at Weeks 1, 2, 3, 4, 8 and 12.
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Secukinumab was supplied as 150 mg doses, provided in 1 mL prefilled syringes.
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Co mierzy badanie?
Podstawowe miary wyniku
Miara wyniku |
Opis środka |
Ramy czasowe |
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Percentage of Participants Who Achieved ≥ 75% Psoriasis Area and Severity Index (PASI 75)
Ramy czasowe: Week 16
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PASI is a combined assessment of a lesion severity and affected area into a single score: 0 (no disease) to 72 (maximal disease).
The body is divided into 4 areas for scoring (head, arms, trunk, legs; each area is scored by itself and scores are combined for a final PASI.
For each area, percent of skin involved is estimated: 0 (0%) to 6 (90-100%), and severity is estimated by clinical signs, erythema, induration and desquamation; scale 0 (none) to 4 (maximum).
Final PASI = sum of severity parameters for each area * area score weight of section (head: 0.1, arms: 0.2, body: 0.3, legs: 0.4).
PASI 75 was defined as participants achieving >= 75% improvement from baseline.
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Week 16
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Miary wyników drugorzędnych
Miara wyniku |
Opis środka |
Ramy czasowe |
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Mean Percent Change From Baseline in PASI Score
Ramy czasowe: Week 4
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PASI is a combined assessment of a lesion severity and affected area into a single score: 0 (no disease) to 72 (maximal disease).
The body is divided into 4 areas for scoring (head, arms, trunk, legs; each area is scored by itself and scores are combined for a final PASI.
For each area, percent of skin involved is estimated: 0 (0%) to 6 (90-100%), and severity is estimated by clinical signs, erythema, induration and desquamation; scale 0 (none) to 4 (maximum).
Final PASI = sum of severity parameters for each area * area score weight of section (head: 0.1, arms: 0.2, body: 0.3, legs: 0.4).
A negative change from baseline indicates improvement.
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Week 4
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Percentage of Participants Achieving PASI 50 or PASI 75
Ramy czasowe: Week 4
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PASI is a combined assessment of a lesion severity and affected area into a single score: 0 (no disease) to 72 (maximal disease). The body is divided into 4 areas for scoring (head, arms, trunk, legs; each area is scored by itself and scores are combined for a final PASI. For each area, percent of skin involved is estimated: 0 (0%) to 6 (90-100%), and severity is estimated by clinical signs, erythema, induration and desquamation; scale 0 (none) to 4 (maximum). Final PASI = sum of severity parameters for each area * area score weight of section (head: 0.1, arms: 0.2, body: 0.3, legs: 0.4). PASI 50 and PASI 75 were defined as participants achieving >= 50% or >= 75% improvement from baseline, respectively. |
Week 4
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Percentage of Participants Achieving PASI 90 and Investigator's Global Assessment (IGA) of 0 or 1 Response
Ramy czasowe: Week 16
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PASI is a combined assessment of a lesion severity and affected area into a single score: 0 (no disease) to 72 (maximal disease). The body is divided into 4 areas for scoring (head, arms, trunk, legs; each area is scored by itself and scores are combined for a final PASI. For each area, percent of skin involved is estimated: 0 (0%) to 6 (90-100%), and severity is estimated by clinical signs, erythema, induration and desquamation; scale 0 (none) to 4 (maximum). Final PASI = sum of severity parameters for each area * area score weight of section (head: 0.1, arms: 0.2, body: 0.3, legs: 0.4). PASI 90 was defined as participants achieving >= 90% improvement from baseline. The IGA scale is static, i.e. it referred exclusively to the participant's disease at the time of assessment and did not compare with any of the participant's previous disease states at previous visits. The scores are: 0 = clear, 1 = almost clear, 2 = mild, 3 = moderate and 4 = severe. |
Week 16
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Mean Percent Change From Baseline in Dermatology Life Quality Index (DLQI) Score
Ramy czasowe: Week 16
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The DLQI is a ten item general dermatology disability index designed to assess health-related quality of life in adult participants with skin diseases such as eczema, psoriasis, acne and viral warts.
It is a self-administered questionnaire which includes domains of daily activity, leisure, personal relationships, symptoms and feelings, treatment and school/work activities.
Each domain has 4 response categories ranging from 0 (not at all) to 3 (very much).
"Not relevant" is a valid score also and is scored as 0. The DLQI total score is a sum of all 10 responses.
Scores range from 0 to 30 with higher scores indicating greater health-related quality of life impairment.
A negative mean percentage change from baseline indicates improvement.
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Week 16
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Percentage of Participants Achieving DLQI 0 or 1
Ramy czasowe: Week 16
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The DLQI is a ten item general dermatology disability index designed to assess health-related quality of life in adult participants with skin diseases such as eczema, psoriasis, acne and viral warts.
It is a self-administered questionnaire which includes domains of daily activity, leisure, personal relationships, symptoms and feelings, treatment and school/work activities.
Each domain has 4 response categories ranging from 0 (not at all) to 3 (very much).
"Not relevant" is a valid score also and is scored as 0. The DLQI total score is a sum of all 10 responses.
Scores range from 0 to 30 with higher scores indicating greater health-related quality of life impairment.
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Week 16
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Współpracownicy i badacze
Sponsor
Daty zapisu na studia
Główne daty studiów
Rozpoczęcie studiów (Rzeczywisty)
Zakończenie podstawowe (Rzeczywisty)
Ukończenie studiów (Rzeczywisty)
Daty rejestracji na studia
Pierwszy przesłany
Pierwszy przesłany, który spełnia kryteria kontroli jakości
Pierwszy wysłany (Oszacować)
Aktualizacje rekordów badań
Ostatnia wysłana aktualizacja (Rzeczywisty)
Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości
Ostatnia weryfikacja
Więcej informacji
Terminy związane z tym badaniem
Słowa kluczowe
Dodatkowe istotne warunki MeSH
Inne numery identyfikacyjne badania
- CAIN457AJP01
Te informacje zostały pobrane bezpośrednio ze strony internetowej clinicaltrials.gov bez żadnych zmian. Jeśli chcesz zmienić, usunąć lub zaktualizować dane swojego badania, skontaktuj się z register@clinicaltrials.gov. Gdy tylko zmiana zostanie wprowadzona na stronie clinicaltrials.gov, zostanie ona automatycznie zaktualizowana również na naszej stronie internetowej .
Badania kliniczne na Secukinumab (AIN457)
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Novartis PharmaceuticalsZakończony
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Tongji HospitalWuhan Central Hospital; Wuhan Hospital of Traditional Chinese MedicineRekrutacyjnyZesztywniające zapalenie stawów kręgosłupa (ZZSK)Chiny
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Novartis PharmaceuticalsRekrutacyjnyOlbrzymiokomórkowe zapalenie tętnicNiemcy
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Novartis PharmaceuticalsZakończonyZapalenie stawów kręgosłupa, zesztywniająceNiemcy, Austria, Dania, Stany Zjednoczone, Australia, Holandia, Polska, Włochy, Bułgaria, Hiszpania, Federacja Rosyjska, Zjednoczone Królestwo, Grecja, Czechy, Kanada, Norwegia, Słowacja, Szwajcaria, Finlandia
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Novartis PharmaceuticalsZakończonyŁuszczyca plackowata | Niealkoholowe stłuszczenie wątrobyNiemcy, Hiszpania
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Novartis PharmaceuticalsZakończonyŁuszczycowe zapalenie stawów | Zapalenie przyczepów ścięgnistych | Osiowa spondyloartropatiaNiemcy, Hiszpania, Zjednoczone Królestwo, Grecja, Bułgaria, Włochy, Czechy, Słowacja
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Novartis PharmaceuticalsZakończonyOsiowe łuszczycowe zapalenie stawówBelgia, Izrael, Hiszpania, Szwajcaria, Grecja, Włochy, Bułgaria, Niemcy, Węgry, Estonia, Zjednoczone Królestwo, Polska, Francja, Czechy, Federacja Rosyjska, Rumunia, Irlandia, Finlandia
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University of PennsylvaniaNovartisRekrutacyjny
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Novartis PharmaceuticalsWycofaneZapalenie błony naczyniowej oka
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Novartis PharmaceuticalsAktywny, nie rekrutującyNieradiograficzne osiowe spondyloartropatiaChiny