- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT02258282
Safety and Efficacy of Etanercept in Patients With Psoriasis
31. marts 2017 opdateret af: Yang Min, Chengdu PLA General Hospital
The purpose of this study is to evaluate safety and efficacy of etanercept in patients with psoriasis who had an unsatisfactory response to traditional DMARDs.
Studieoversigt
Undersøgelsestype
Interventionel
Tilmelding (Forventet)
80
Fase
- Ikke anvendelig
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiesteder
-
-
Sichuan
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Chengdu, Sichuan, Kina, 610083
- General Hospital of Chengdu Military Area Command PLA
-
-
Deltagelseskriterier
Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.
Berettigelseskriterier
Aldre berettiget til at studere
18 år til 75 år (Voksen, Ældre voksen)
Tager imod sunde frivillige
Ingen
Køn, der er berettiget til at studere
Alle
Beskrivelse
Inclusion Criteria:
- has plaque psoriasis and has shown an unsatisfactory response to traditional DMARDs
- 18 to 75 years old
- has PGA of 3 or more at Day 0
- has BSA of 3% or more at Day 0
- has psoriasis severe enough to be eligible to systemic therapy
- 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;
- capable of giving informed consent
- with normal or non clinically significant chest X-ray within 6 months prior to Day 0
- 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:
- 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
- has presence of erythrodermic, pustular or guttate psoriasis
- has had significant infections within the 30 days prior to Day 0
- has received investigational drugs within the four weeks prior to screening or during the study period
- 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
- received systemic antibiotics within the four weeks prior to Day 0
- has been treated with ultraviolet light therapy (UVB, nbUVB) within the two weeks prior to Day 0 or during the study period
- has used infliximab within 14 days of Day 0 or during the study period
- has used other biologic agents for the treatment of psoriasis besides etanercept 8 weeks prior to Day 0 or during the study period
- has had an allergic reaction to infliximab
- 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
- has a known sero-positivity for HIV virus or history of any other immunosuppressive disease
- has active or chronic Hepatitis B or C
- has any mycobacterial disease, patient with a chest X-Ray suggestive of tuberculosis or patient taking anti-tuberculosis medication
- has a known hypersensitivity to etanercept or one of its components
- 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
Studieplan
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Behandling
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Enkelt
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
---|---|
Eksperimentel: Etanercept
Patients under the treatment of 50 mg Etanercept
|
|
Sham-komparator: Control
Patients under the treatment of traditional DMARDs
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Tidsramme |
---|---|
Changes from baseline of Physician's Global Assessment (PGA) at 24 weeks
Tidsramme: At 0 week, 12 weeks, 24 weeks
|
At 0 week, 12 weeks, 24 weeks
|
Sekundære resultatmål
Resultatmål |
Tidsramme |
---|---|
Mean Body Surface Area (BSA)
Tidsramme: At 0 week, 12 weeks, 24 weeks
|
At 0 week, 12 weeks, 24 weeks
|
Mean Psoriasis Area and Severity Index (PASI)
Tidsramme: At 0 week, 12 weeks, 24 weeks
|
At 0 week, 12 weeks, 24 weeks
|
Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Sponsor
Datoer for undersøgelser
Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.
Studer store datoer
Studiestart
1. maj 2014
Primær færdiggørelse (Forventet)
1. december 2022
Studieafslutning (Forventet)
1. december 2022
Datoer for studieregistrering
Først indsendt
3. oktober 2014
Først indsendt, der opfyldte QC-kriterier
6. oktober 2014
Først opslået (Skøn)
7. oktober 2014
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
4. april 2017
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
31. marts 2017
Sidst verificeret
1. marts 2017
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
- Hudsygdomme
- Hudsygdomme, Papulosquamous
- Psoriasis
- Lægemidlers fysiologiske virkninger
- Agenter fra det perifere nervesystem
- Analgetika
- Sensoriske systemagenter
- Anti-inflammatoriske midler, ikke-steroide
- Analgetika, ikke-narkotisk
- Anti-inflammatoriske midler
- Antirheumatiske midler
- Immunsuppressive midler
- Immunologiske faktorer
- Gastrointestinale midler
- Etanercept
Andre undersøgelses-id-numre
- YSP20140688
Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .
Kliniske forsøg med 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
-
Innovaderm Research Inc.AfsluttetPsoriasis i hovedbunden | Pustulær Palmo-plantar Psoriasis | Ikke-pustulær Palmo-plantar Psoriasis | Albue Psoriasis | Psoriasis i underbenetCanada
-
UCB Biopharma S.P.R.L.AfsluttetModerat til svær psoriasis | Generaliseret pustulær psoriasis og erytrodermisk psoriasisJapan
-
TakedaRekrutteringGeneraliseret pustulær psoriasis | Erytrodermisk psoriasisJapan
-
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
Kliniske forsøg med Etanercept
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EMSTrukket tilbageRheumatoid arthritisBrasilien
-
Shanghai Celgen Bio-Pharmaceutical Co.,LtdUkendtPsoriasis | Plaque PsoriasisKina
-
Sunshine Guojian Pharmaceutical (Shanghai) Co.,...AfsluttetAnkyloserende spondylitisKina
-
AmgenAfsluttetArthritis, Reumatoid; Gigt, psoriasisForenede Stater, Puerto Rico
-
Sun Yat-sen UniversityAfsluttet
-
Samsung Bioepis Co., Ltd.AfsluttetRheumatoid arthritisPolen, Det Forenede Kongerige
-
AmgenAfsluttet
-
Sun Pharmaceutical Industries LimitedTrukket tilbage
-
Sun Pharmaceutical Industries LimitedAfsluttet