- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT00402818
RESTORE: Raptiva® (Efalizumab) Evaluation of Safety and Treatment Optimization (RESTORE)
RESTORE (Raptiva® (Efalizumab) Evaluation of Safety and Treatment Optimization Registry) Observational, Open-label, Multi-centre, Phase IV Study of Subcutaneously Administered Raptiva® (Efalizumab) in the Treatment of Adult Patients With Moderate to Severe Chronic Plaque Psoriasis Who Are Candidates for Treatment With Raptiva®
RESTORE is an observational, open-label, multi-center, prospective, study enrolling Raptiva® (efalizumab) treated patients with moderate to severe chronic plaque psoriasis. The overall duration of the study is approximately 4 years. Patients will be followed from the time of study enrolment to study/treatment termination; thus active follow-up period will vary across subjects. Raptiva® (efalizumab)treated patients with moderate to severe chronic plaque psoriasis and meeting the inclusion/exclusion criteria specified will be eligible for participation in this study.
Objectives:
- To document and quantify the incidences of adverse events in this patient population
- To explore the association of psoriasis treatments with changes in patient outcomes, quality of life, and treatment compliance.
Studieoversigt
Status
Betingelser
Undersøgelsestype
Tilmelding (Faktiske)
Kontakter og lokationer
Studiesteder
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Ontario
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Mississauga, Ontario, Canada
- Medical Information - Canada
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Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Prøveudtagningsmetode
Studiebefolkning
Beskrivelse
Inclusion Criteria:
- Male or female ≥ 18 years old.
- Have a clinical diagnosis of moderate to severe chronic plaque psoriasis and be a candidate for treatment with Raptiva®.
- Are being treated or are initiating treatment with Raptiva® at time of study enrolment in accordance with the Canadian Product Monograph indication and recommendations.
- Be able to provide written informed consent.
- Agreement to participate in the study, and to disclose any medical events to the Investigator.
- The subject must be willing and able to comply with the protocol requirements for the duration of the study.
Exclusion Criteria:
- Any contra-indication to Raptiva® according to the Canadian Product Monograph.
- Any simultaneous participation in another clinical evaluation trial for psoriasis
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Tidsramme |
---|---|
All serious and unexpected AEs
Tidsramme: During the course of the study
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During the course of the study
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Sekundære resultatmål
Resultatmål |
Tidsramme |
---|---|
Investigator assessed: static Physician's Global Assessment (sPGA). Patient assessed: Dermatology Life Quality Index (DLQI)
Tidsramme: During the course of the study, there are no pre-defined scheduled visits
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During the course of the study, there are no pre-defined scheduled visits
|
Samarbejdspartnere og efterforskere
Sponsor
Efterforskere
- Studieleder: Horia Ijacu, MD, EMD Canada Inc., an affiliate of Merck KGaA, Darmstadt, Germany
Datoer for undersøgelser
Studer store datoer
Studiestart
Primær færdiggørelse (Faktiske)
Studieafslutning (Faktiske)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Skøn)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Skøn)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- 26768
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Kliniske forsøg med Plaque Psoriasis
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ProgenaBiomeRekrutteringPsoriasis | Psoriasis Vulgaris | Psoriasis i hovedbunden | Psoriatisk plak | Psoriasis Universalis | Psoriasis ansigt | Psoriasis negl | Psoriasis Diffusa | Psoriasis Punctata | Psoriasis Palmaris | Psoriasis Circinata | Psoriasis Annularis | Psoriasis Genital | Psoriasis GeographicaForenede Stater
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Clin4allRekrutteringPsoriasis i hovedbunden | Psoriasis negl | Psoriasis Palmaris | Psoriasis Genital | Psoriasis PlantarisFrankrig
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Centre of Evidence of the French Society of DermatologyRekrutteringPsoriasis | Psoriasis Vulgaris | Psoriasis i hovedbunden | Psoriatisk plak | Psoriasis Universalis | Psoriasis Palmaris | Psoriatisk erytrodermi | Psoriasis negl | Psoriasis Guttate | Psoriasis omvendt | Psoriasis pustulærFrankrig
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AmgenAfsluttetPsoriasis-Psoriasis | Plaque-type psoriasisForenede Stater
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Innovaderm Research Inc.AfsluttetPsoriasis i hovedbunden | Pustulær Palmo-plantar Psoriasis | Ikke-pustulær Palmo-plantar Psoriasis | Albue Psoriasis | Psoriasis i underbenetCanada
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UCB Biopharma S.P.R.L.AfsluttetModerat til svær psoriasis | Generaliseret pustulær psoriasis og erytrodermisk psoriasisJapan
-
TakedaRekrutteringGeneraliseret pustulær psoriasis | Erytrodermisk psoriasisJapan
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PfizerAfsluttetPsoriasis Vulgaris | Pustuløs psoriasis | Psoriasis Arthropathica | Erytrodermisk psoriasisJapan
-
Janssen Pharmaceutical K.K.RekrutteringGeneraliseret pustulær psoriasis | Erytrodermisk psoriasisJapan
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Eli Lilly and CompanyAfsluttetGeneraliseret pustulær psoriasis | Erytrodermisk psoriasisJapan