Efficacy and Safety of Intravenous and Subcutaneous Secukinumab in Moderate to Severe Chronic Plaque-type Psoriasis (STATURE)
2015. március 17. frissítette: Novartis Pharmaceuticals
A Randomized, Double-blind, Double Dummy, Multicenter Study to Assess the Safety, Tolerability and Long-term Efficacy of Intravenous (10mg/kg) and Subcutaneous (300mg) Secukinumab in Subjects With Moderate to Severe Chronic Plaque-type Psoriasis Who Are Partial Responders to Secukinumab
The study will assess the safety and efficacy of intravenous (10mg/kg) and subcutaneous (300mg) secukinumab in moderate to severe chronic plaque-type psoriasis who are partial responders to secukinumab.
A tanulmány áttekintése
Állapot
Befejezve
Körülmények
Beavatkozás / kezelés
Tanulmány típusa
Beavatkozó
Beiratkozás (Tényleges)
43
Fázis
- 3. fázis
Kapcsolatok és helyek
Ez a rész a vizsgálatot végzők elérhetőségeit, valamint a vizsgálat lefolytatásának helyére vonatkozó információkat tartalmazza.
Tanulmányi helyek
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Graz, Ausztria, A-8036
- Novartis Investigative Site
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Vienna, Ausztria, A-1220
- Novartis Investigative Site
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Wels, Ausztria, 4600
- Novartis Investigative Site
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Florida
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Jacksonville, Florida, Egyesült Államok, 32216
- Novartis Investigative Site
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West Palm Beach, Florida, Egyesült Államok, 33409
- Novartis Investigative Site
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Massachusetts
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Boston, Massachusetts, Egyesült Államok, 02111
- Novartis Investigative Site
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Missouri
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St. Louis, Missouri, Egyesült Államok, 63117
- Novartis Investigative Site
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North Carolina
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Greensboro, North Carolina, Egyesült Államok, 27401
- Novartis Investigative Site
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South Carolina
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Greer, South Carolina, Egyesült Államok, 29651
- Novartis Investigative Site
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Rouen, Franciaország, 76031
- Novartis Investigative Site
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Toulouse Cedex, Franciaország, 31059
- Novartis Investigative Site
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Karnataka
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Mangalore, Karnataka, India, 575 004
- Novartis Investigative Site
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Maharashtra
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Nagpur, Maharashtra, India, 440 010
- Novartis Investigative Site
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Nashik, Maharashtra, India, 422 001
- Novartis Investigative Site
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Chiba
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Kisarazu, Chiba, Japán, 292-8535
- Novartis Investigative Site
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Tokyo
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Hachioji-city, Tokyo, Japán, 193-0998
- Novartis Investigative Site
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Minato-ku, Tokyo, Japán, 105-8471
- Novartis Investigative Site
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Shinjuku-ku, Tokyo, Japán, 160-0023
- Novartis Investigative Site
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Ontario
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Barrie, Ontario, Kanada, L4M 6L2
- Novartis Investigative Site
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Waterloo, Ontario, Kanada, N2J 1C4
- Novartis Investigative Site
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Quebec
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Montreal, Quebec, Kanada, H2K 4L5
- Novartis Investigative Site
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Essen, Németország, 45147
- Novartis Investigative Site
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Frankfurt, Németország, 60590
- Novartis Investigative Site
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Hamburg, Németország, 22143
- Novartis Investigative Site
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Luebeck, Németország, 23538
- Novartis Investigative Site
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Mainz, Németország, 55131
- Novartis Investigative Site
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Slovak Republic
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Kosice, Slovak Republic, Szlovákia, 040 15
- Novartis Investigative Site
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Részvételi kritériumok
A kutatók olyan embereket keresnek, akik megfelelnek egy bizonyos leírásnak, az úgynevezett jogosultsági kritériumoknak. Néhány példa ezekre a kritériumokra a személy általános egészségi állapota vagy a korábbi kezelések.
Jogosultsági kritériumok
Tanulmányozható életkorok
18 év és régebbi (Felnőtt, Idősebb felnőtt)
Egészséges önkénteseket fogad
Nem
Tanulmányozható nemek
Összes
Leírás
Inclusion criteria:
- Written Informed Consent must be obtained before any assessment is performed,
- Subject must be able to understand and communicate with the investigator and comply with the requirements of the study.
- Subjects must have participated in the study CAIN457A2304 and have achieved a partial response after twelve weeks of treatment with no major protocol deviations.
A partial response is defined as having achieved ≥ PASI 50 but < 75 response.
Exclusion criteria
- Pregnant women or lactating women
- Forms of psoriasis other than chronic plaque -type
- Ongoing use of prohibited psoriasis treatments
- Ongoing use of other non-psoriasis prohibited treatments
- Previous exposure to any biologic drug directly targeting IL-17 or the IL-17 receptor, except secukinumab in study CAIN457A2304
- Active ongoing inflammation diseases other than psoriasis that might confound the evaluation of the benefits of secukinumab therapy
- UV therapy or excessive exposure to sunlight
Tanulási terv
Ez a rész a vizsgálati terv részleteit tartalmazza, beleértve a vizsgálat megtervezését és a vizsgálat mérését.
Hogyan készül a tanulmány?
Tervezési részletek
- Elsődleges cél: Kezelés
- Kiosztás: Véletlenszerűsített
- Beavatkozó modell: Párhuzamos hozzárendelés
- Maszkolás: Négyszeres
Fegyverek és beavatkozások
Résztvevő csoport / kar |
Beavatkozás / kezelés |
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Kísérleti: AIN457 subcutaneous (s.c.)
During the intravenous (I.V.) period, participants received two 150 mg s.c.
injections of AIN457 at randomization and week 4, and AIN457 placebo I.V. at randomization, week 2 and week 4.
During the maintenance period, participants received 300 mg s.c. of open-label AIN457.
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secukinumab 150mg (2 injections per dose)
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Kísérleti: AIN457 I.V.
During the I.V. period, participants received AIN457 10mg/kg I.V. at randomization, week 2 and week 4, and AIN457 placebo s.c. at randomization and week 4.
During the maintenance period, participants received 300 mg s.c. of open-label AIN457.
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secukinumab 10mg/kg i.v.
regimen
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Mit mér a tanulmány?
Elsődleges eredményintézkedések
Eredménymérő |
Intézkedés leírása |
Időkeret |
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Percentage of Participants (Who Achieved a Partial Response Defined as ≥ 50% But < 75% Improvement in Psoriasis Area and Severity Index (PASI) After 12 Weeks of Treatment in Study AIN457A2304) With 75% Improvement From Baseline in PASI
Időkeret: Week 8
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PASI is a combined assessment of lesion severity and affected area into a single score: 0 (no disease) to 72(maximal disease).
Body is divided into 4 areas for scoring (head, arms, trunk, legs; each area is scored by itself and scores are combined for 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).
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Week 8
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Percentage of Participants (Who Achieved a Partial Response Defined as ≥ 50% But < 75% Improvement in PASI After 12 Weeks of Treatment in Study AIN457A2304) With Investigator's Global Assessment Model 2011 (IGA Mod 2011) 0 or 1 Response
Időkeret: Week 8
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The IGA mod 2011 scale is static, i.e. it referred exclusively to the participant's disease at the time of the 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.
Treatment success was defined as achievement of IGA mod 2001 score of 0 or 1.
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Week 8
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Másodlagos eredményintézkedések
Eredménymérő |
Intézkedés leírása |
Időkeret |
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Percentage of Participants Achieving PASI 50/75/90/100 Response or IGA 0 or 1 Response
Időkeret: Weeks 2, 4, 8, 12, 16, 20, 24, 28, 32, 36 and 40
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PASI is a combined assessment of lesion severity and affected area into a single score: 0 (no disease) to 72 (maximal disease).
Body is divided into 4 areas for scoring (head, arms, trunk, legs; each area is scored by itself and scores are combined for 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, 75, 90 and 100 were defined as participants achieving ≥ 50%, 75%, 90% or 100% improvement from baseline.
The IGA mod 2011 scale is static, i.e. it referred exclusively to the participant's disease at the time of the 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.
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Weeks 2, 4, 8, 12, 16, 20, 24, 28, 32, 36 and 40
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Mean Percent Change From Baseline in PASI Scores
Időkeret: Baseline, weeks 2, 4, 8, 12, 16, 20, 24, 28, 32, 36 and 40
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PASI is a combined assessment of lesion severity and affected area into a single score: 0 (no disease) to 72(maximal disease).
Body is divided into 4 areas for scoring (head, arms, trunk, legs; each area is scored by itself and scores are combined for 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 mean percentage change indicates improvement.
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Baseline, weeks 2, 4, 8, 12, 16, 20, 24, 28, 32, 36 and 40
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Percentage of Participants in Each IGA Mod 2011 Score Category
Időkeret: Weeks 2, 4, 8, 12, 16, 20, 24, 28, 32, 36 and 40
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The IGA mod 2011 scale is static, i.e. it referred exclusively to the participant's disease at the time of the 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.
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Weeks 2, 4, 8, 12, 16, 20, 24, 28, 32, 36 and 40
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Percentage of Participants Who Achieved Dermatology Life Quality Index (DLQI) of 0 or 1
Időkeret: Baseline, Week 8, Week 16, Week 24, Week 32,up to Week 40
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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 DLQI of 0 or 1 indicates no impairment or little impairment, respectively.
A negative mean percentage change from baseline indicates improvement.
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Baseline, Week 8, Week 16, Week 24, Week 32,up to Week 40
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Mean Percent Change From Baseline in Dermatology Life Quality Index (DLQI) Scores
Időkeret: Baseline, weeks 8, 16, 24, 32 and 40
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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 worts.
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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Baseline, weeks 8, 16, 24, 32 and 40
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Mean Percent Change From Baseline in EuroQOL 5-Dimension Health Status Questionnaire (EQ-5D) Health State Assessment (From 0 to 100)
Időkeret: Baseline, weeks 8, 16, 24, 32 and 40
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The EQ-5D is an instrument used to assess a participant's health status.
The instrument includes a descriptive profile and a visual analog scale (VAS).
The descriptive profile includes 5 dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression.
Each dimension had 3 response levels: no problems, some problems and severe problems.
The VAS is a vertical scale that assesses the health status from 0 (worst possible health state) to 100 (best possible health state).
This outcome measures the percent change in VAS score.
Positive mean percent changes indicate improvement.
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Baseline, weeks 8, 16, 24, 32 and 40
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Number of Participants Who Developed Anti-secukinumab Antibodies
Időkeret: Baseline, weeks 12, 24 and 40
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The development of anti-secunimubab anti-bodies would decrease a participant's ability to respond to secukinumab treatment.
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Baseline, weeks 12, 24 and 40
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Relationship Between Response to AIN457 and Failed Response to Previous Biologic Psoriasis Therapy
Időkeret: End of study
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This outcome measure was not analyzed due to the small sample size of the study (43 participants).
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End of study
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Együttműködők és nyomozók
Itt találhatja meg a tanulmányban érintett személyeket és szervezeteket.
Szponzor
Tanulmányi rekorddátumok
Ezek a dátumok nyomon követik a ClinicalTrials.gov webhelyre benyújtott vizsgálati rekordok és összefoglaló eredmények benyújtásának folyamatát. A vizsgálati feljegyzéseket és a jelentett eredményeket a Nemzeti Orvostudományi Könyvtár (NLM) felülvizsgálja, hogy megbizonyosodjon arról, hogy megfelelnek-e az adott minőség-ellenőrzési szabványoknak, mielőtt közzéteszik őket a nyilvános weboldalon.
Tanulmány főbb dátumok
Tanulmány kezdete
2011. december 1.
Elsődleges befejezés (Tényleges)
2013. április 1.
A tanulmány befejezése (Tényleges)
2013. április 1.
Tanulmányi regisztráció dátumai
Először benyújtva
2011. augusztus 5.
Először nyújtották be, amely megfelel a minőségbiztosítási kritériumoknak
2011. augusztus 8.
Első közzététel (Becslés)
2011. augusztus 9.
Tanulmányi rekordok frissítései
Utolsó frissítés közzétéve (Becslés)
2015. március 18.
Az utolsó frissítés elküldve, amely megfelel a minőségbiztosítási kritériumoknak
2015. március 17.
Utolsó ellenőrzés
2015. március 1.
Több információ
A tanulmányhoz kapcsolódó kifejezések
Kulcsszavak
További vonatkozó MeSH feltételek
Egyéb vizsgálati azonosító számok
- CAIN457A2307
- 2011-002510-36 (EudraCT szám)
Ezt az információt közvetlenül a clinicaltrials.gov webhelyről szereztük be, változtatás nélkül. Ha bármilyen kérése van vizsgálati adatainak módosítására, eltávolítására vagy frissítésére, kérjük, írjon a következő címre: register@clinicaltrials.gov. Amint a változás bevezetésre kerül a clinicaltrials.gov oldalon, ez a webhelyünkön is automatikusan frissül. .