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Open Label Study Etanercept's Maintenance Dose in Obese Patients With Moderate to Severe Plaque Type Psoriasis
A Single-Center, Open-Label, Pilot Study to Evaluate the Efficacy and Tolerability of Narrow Band UVB Phototherapy in Enhancing Etanercept's Maintenance Dose in Obese Patients With Moderate to Severe Plaque-Type Psoriasis
Studie Overzicht
Toestand
Conditie
Interventie / Behandeling
Gedetailleerde beschrijving
Studietype
Inschrijving (Werkelijk)
Fase
- Niet toepasbaar
Contacten en locaties
Studie Locaties
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California
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San Francisco, California, Verenigde Staten, 94118
- UCSF Psoriasis and Skin Treatment Center
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Deelname Criteria
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
Accepteert gezonde vrijwilligers
Geslachten die in aanmerking komen voor studie
Beschrijving
Inclusion Criteria:
- Nonimmunocompromised males or females 18 years of age or older.
- Must be able to read, understand, and speak basic English.
- Body Surface Area (BSA) involvement of greater than 10%.
- Psoriasis Area and Severity Index greater than 10.
- Obese defined as having a Body Mass Index greater than 30.
- Eligible for systemic therapy, particularly etanercept, and Narrow Band Ultraviolet B in the opinion of the investigator.
- Sign and date the appropriate written informed consent and Health Insurance Portability and Accountability Act authorization
- Negative urine pregnancy test within 7 days before the first dose of etanercept in all women (except those surgically sterile or at least 5 years postmenopausal).
- No evidence of active or latent tuberculosis based on a negative Purified Protein Derivative skin test. Patients with documentation of adequately treated tuberculosis may be enrolled.
- Sexually active subjects of childbearing potential must agree to use medically acceptable form of contraception during screening and throughout the study.
- Willing and able to self-administer subcutaneous injections or to have a qualified person available to administer subcutaneous injections
- Agrees to comply with protocol requirements, attend all regularly study visits and is considered to be a good study subject
- Meets concomitant medication washout requirements
Exclusion Criteria:
- Erythrodermic, pustular, or guttate psoriasis
- Evidence of skin conditions other than psoriasis that would interfere with study-related evaluations of psoriasis.
- Known sensitivity to any component of the study medications.
- Evidence of active infections such as fevers, chills, sweats, or history of untreated Lyme disease and active severe infections within 4 weeks before screening visit, or between the screening and Week 0 visits.
- Evidence of latent or active hepatitis B infection as indicated by positive HBsAg test during the screening visit.
- Personal or first degree family history of neurologic disease.
- Poorly controlled medical condition including, but not limited to, unstable cardiovascular disease, poorly controlled diabetes, recent stroke, history of recurrent infections, or any other condition for which, in the opinion of the investigator, participation in the study would place the subject at risk.
- History of any Tumor Necrosis Factor-α inhibitor use including etanercept, infliximab, and adalimumab within 4 weeks of starting study drug.
- History of non-cutaneous malignancy within the past 5 years.
- History of drug or alcohol abuse. Substance abuse must clearly be documented so those patients with a remote and minor history of drug/alcohol use will still have an opportunity to participate in the study.
- Female subjects who are not postmenopausal for at least 1 year, surgically sterile, or willing to practice effective contraception during the study. Nursing mothers, pregnant women and women planning to become pregnant while on study are to be excluded.
- Plans to receive any live vaccines during the study.
- Evidence of photosensitivity disorder (i.e. polymorphous light eruption).
- Known photosensitivity or known sensitivity to any of the excipients or products to be administered during dosing.
- Current enrollment in another clinical study and treatment with another experimental drug or approved therapy for experimental use within 30 days prior to Week 0
- Cannot commit to all the assessments required by the protocol
- Any disorder that compromises the ability of the subject to give written informed consent and/or to comply with study procedures
- Considered by the investigator, for any reason, to be an unsuitable candidate for study participation.
- Cannot or do not wish to comply with the protocol washout requirements (please see section below entitled "Washout Period Prior to Week 0).
Studie plan
Hoe is de studie opgezet?
Ontwerpdetails
- Primair doel: Behandeling
- Toewijzing: Gerandomiseerd
- Interventioneel model: Parallelle opdracht
- Masker: Geen (open label)
Wapens en interventies
Deelnemersgroep / Arm |
Interventie / Behandeling |
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Actieve vergelijker: 1 (Etanercept only)
Subjects will only be treated with etanercept.
This is given at the standard FDA approved dosage of 50 mg twice weekly x 3 months then 50 mg once weekly x 3 months.
No UVB will be given.
Sham UVB will not be used because the subjects are not blinded because they often know they are receiving sham UVB due to differences in light intensity and heat.
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Etanercept is given at the standard FDA approved dosage of 50 mg twice weekly x 3 months then 50 mg once weekly x 3 months.
Andere namen:
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Experimenteel: 2 (Etanercept + nb-UVB)
Subjects will receive etanercept. This is given at the standard FDA approved dosage of 50 mg twice weekly x 3 months then 50 mg once weekly x 3 months. In addition, for months 3-6, subjects will receive Narrow Band Ultraviolet B phototherapy three times a week for 12 weeks in addition to the etanercept maintenance dose. The safety and efficacy of the combination therapy will be evaluated by the registered phototherapy nurses at each phototherapy visit and by the study investigator at monthly visits. NB-UVB therapy will be adjusted according to the clinical judgment of the University of California San Francisco Psoriasis Treatment Center phototherapy staff. |
Etanercept is given at the standard FDA approved dosage of 50 mg twice weekly x 3 months then 50 mg once weekly x 3 months.
Andere namen:
Narrow band (310-312 nm) ultraviolet light B phototherapy 3 times a week during Weeks 12-24.
NB-UVB therapy will be adjusted according to the clinical judgment of the University of California San Francisco Psoriasis Treatment Center phototherapy staff
Andere namen:
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Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
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Psoriasis Area Severity Index. This Scale Ranges From 0-72, 0 Being no Disease, and 72 Being Most Severe. The Number of Patients Who Achieved 75% Improvement of Their Psoriasis at the End of 24 Weeks Are Indicated in the Outcomes Data Below.
Tijdsspanne: Weeks 12-24
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Psoriasis area severity index was used to determine the number of patients in each treatment arm who had 75% improvement in their psoriasis.
This scale uses the characteristics of the psoriasis, such as body surface area, redness, thickness, and scaling, to determine the severity score.
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Weeks 12-24
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Medewerkers en onderzoekers
Onderzoekers
- Hoofdonderzoeker: John Koo, MD, UCSF Psoriasis and Skin Treatment Center, Department of Dermatology, University of California, San Francisco
Publicaties en nuttige links
Studie record data
Bestudeer belangrijke data
Studie start
Primaire voltooiing (Werkelijk)
Studie voltooiing (Werkelijk)
Studieregistratiedata
Eerst ingediend
Eerst ingediend dat voldeed aan de QC-criteria
Eerst geplaatst (Schatting)
Updates van studierecords
Laatste update geplaatst (Schatting)
Laatste update ingediend die voldeed aan QC-criteria
Laatst geverifieerd
Meer informatie
Termen gerelateerd aan deze studie
Aanvullende relevante MeSH-voorwaarden
- Huidziektes
- Huidziekten, papulosquameus
- Psoriasis
- Fysiologische effecten van medicijnen
- Agenten van het perifere zenuwstelsel
- Pijnstillers
- Sensorische systeemagenten
- Ontstekingsremmers, niet-steroïde
- Pijnstillers, niet-narcotisch
- Ontstekingsremmende middelen
- Antireumatische middelen
- Immunosuppressieve middelen
- Immunologische factoren
- Gastro-intestinale middelen
- Etanercept
Andere studie-ID-nummers
- KOO - ENBREL-2008
- H5939-31693-01 (Andere identificatie: UCSF Committee for Human Research)
Deze informatie is zonder wijzigingen rechtstreeks van de website clinicaltrials.gov gehaald. Als u verzoeken heeft om uw onderzoeksgegevens te wijzigen, te verwijderen of bij te werken, neem dan contact op met register@clinicaltrials.gov. Zodra er een wijziging wordt doorgevoerd op clinicaltrials.gov, wordt deze ook automatisch bijgewerkt op onze website .
Klinische onderzoeken op Psoriasis
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ProgenaBiomeIngetrokkenPsoriasis | Psoriasis vulgaris | Psoriasis van de hoofdhuid | Psoriatische plaque | Psoriasis Universalis | Psoriasis gezicht | Psoriasis Nagel | Diffuse psoriasis | Psoriasis Punctata | Psoriasis palmaris | Psoriasis Circinata | Psoriasis annularis | Psoriasis genitale | Geografische psoriasisVerenigde Staten
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Clin4allActief, niet wervendPsoriasis van de hoofdhuid | Psoriasis Nagel | Psoriasis palmaris | Psoriasis genitale | Psoriasis PlantarisFrankrijk
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Alumis IncActief, niet wervendPsoriasis | Plaque Psoriasis | Psoriasis (PsO) | Matige psoriasis | Ernstige psoriasisVerenigde Staten, Canada, Australië, Duitsland, Spanje, Hongarije, Japan, Bulgarije, Polen, Tsjechië, Estland, Letland, Puerto Rico, Portugal, Zuid -Korea, Frankrijk
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Caja Costarricense de Seguro SocialNog niet aan het wervenPsoriasis | Psoriasis (PsO) | Psoriasis artritis | Psoriasis patiëntenCosta Rica
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Innovaderm Research Inc.VoltooidHoofdhuid Psoriasis | Pustuleuze palmoplantaire psoriasis | Niet-pustuleuze palmoplantaire psoriasis | Elleboog Psoriasis | OnderbeenpsoriasisCanada
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AmgenVoltooidPsoriasis-type psoriasis | Psoriasis van het plaquetypeVerenigde Staten
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UCB Biopharma S.P.R.L.VoltooidMatige tot ernstige psoriasis | Gegeneraliseerde pustuleuze psoriasis en erytrodermische psoriasisJapan
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Centre of Evidence of the French Society of DermatologyWervingPsoriasis | Psoriasis vulgaris | Psoriasis van de hoofdhuid | Psoriatische plaque | Psoriasis Universalis | Psoriasis palmaris | Psoriatische erytrodermie | Psoriatische nagel | Psoriasis guttata | Psoriasis omgekeerd | Psoriasis PustuleuzeFrankrijk
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Caja Costarricense de Seguro SocialNog niet aan het wervenPsoriasis | Psoriasis (PsO) | Psoriasis artritisCosta Rica
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Janssen Pharmaceutical K.K.Actief, niet wervendGegeneraliseerde pustuleuze psoriasis | Erytrodermische PsoriasisJapan
Klinische onderzoeken op etanercept
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EMSIngetrokkenReumatoïde artritisBrazilië
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mAbxience Research S.L.Voltooid
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mAbxience Research S.L.WervingReumatoïde artritis (RA)Moldavië, Republiek, Bulgarije, Polen, Roemenië, Servië, Georgië
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Shanghai Celgen Bio-Pharmaceutical Co.,LtdOnbekendPsoriasis | Plaque PsoriasisChina
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PfizerVoltooidMatige tot ernstige psoriasisKorea, republiek van
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AmgenVoltooidArtritis, reumatoïde; Artritis, psoriaticaVerenigde Staten, Puerto Rico
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Sunshine Guojian Pharmaceutical (Shanghai) Co.,...VoltooidSpondylitis ankylopoeticaChina
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AmgenVoltooid
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Sun Yat-sen UniversityVoltooid
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Samsung Bioepis Co., Ltd.VoltooidReumatoïde artritisPolen, Verenigd Koninkrijk