- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT00090129
Onercept in the Treatment and Re-Treatment of Subjects With Moderate to Severe Plaque Psoriasis
21. oktober 2013 opdateret af: EMD Serono
A Multicentre, Randomised, Double-blind, Placebo Controlled Phase III Study of Subcutaneously Administered Onercept in the Treatment and Re-treatment of Subjects With Moderate to Severe Plaque Psoriasis
The is a double-blind, placebo-controlled, randomized, and multicenter study consisting of a first treatment (FT) period followed by either an observation (OB) period and a re-treatment (RT) period or an open-label (OL) treatment period, depending on FT period response, and a 4-week safety follow-up (FU) period.
The purpose of this study is to evaluate the safety and efficacy of onercept, to be administered as 150 milligram (mg) three times a week, compared to matching placebo, for the induction of remission in subjects with moderate to severe plaque psoriasis.
Studieoversigt
Status
Afsluttet
Betingelser
Intervention / Behandling
Undersøgelsestype
Interventionel
Tilmelding (Faktiske)
854
Fase
- Fase 3
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiesteder
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Alberta
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Edmonton, Alberta, Canada, T5J3S9
- Probity Medical Research
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Ontario
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London, Ontario, Canada, N6A 3H7
- Guenther Dermatology Research Center
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Waterloo, Ontario, Canada, N2J 1C4
- Probity Medical Research
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Arkansas
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Little Rock, Arkansas, Forenede Stater, 72205
- Bressnick Gibson Parker Dinehart Sangster Dermatology, P.A.
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California
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Fresno, California, Forenede Stater, 93710
- Associates in Research Inc.
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Irvine, California, Forenede Stater, 92697
- University of California, Irvine
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La Jolla, California, Forenede Stater, 92037
- Therapeutics Clinical Research
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San Francisco, California, Forenede Stater, 94108
- University of California
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Santa Monica, California, Forenede Stater, 90404
- Clinical Research Specialists Inc.
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Vallejo, California, Forenede Stater, 94589
- Solano Clinical Research
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Vista, California, Forenede Stater, 92083
- Dermatology Specialists Inc
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Colorado
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Denver, Colorado, Forenede Stater, 80210
- Colorado Medical Research Center
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Denver, Colorado, Forenede Stater, 80246
- Cherry Creek Research, Inc.
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Longmont, Colorado, Forenede Stater, 80501
- Longmont Clinic PC
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Connecticut
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New Haven, Connecticut, Forenede Stater, 06511
- The Savin Center P.C.
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District of Columbia
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Washington, District of Columbia, Forenede Stater, 20010
- Dermatology Associates, P.C. at the Washington Hospital CTR
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Florida
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Jacksonville, Florida, Forenede Stater, 32216
- Jacksonville Center for Clinical Research
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Jacksonville, Florida, Forenede Stater, 32204
- North Florida Dermatology Associates, P.A.
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Miami, Florida, Forenede Stater, 33144
- International Dermatology Research
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Georgia
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Alpharetta, Georgia, Forenede Stater, 30005
- Atlanta Dermatology Vein & Research Center
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Illinois
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Buffalo Grove, Illinois, Forenede Stater, 60089
- Scott D. Glazer, MD
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Michigan
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Ann Arbor, Michigan, Forenede Stater, 48109
- University of Michigan Department of Dermatology
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Clinton Township, Michigan, Forenede Stater, 48038
- Midwest Cutaneous Research Corporation
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Minnesota
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Fridley, Minnesota, Forenede Stater, 55432
- Minnesota Clinical Study Center
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New Mexico
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Albuquerque, New Mexico, Forenede Stater, 87106
- Academic Dermatology Associates
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North Carolina
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Winston Salem, North Carolina, Forenede Stater, 27157
- Wake Forest Univ School of Medicine
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Winston Salem, North Carolina, Forenede Stater, 27103
- Piedmont Medical Research Associates
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Oregon
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Portland, Oregon, Forenede Stater, 97223
- Oregon Medical Research Center, P.C.
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Portland, Oregon, Forenede Stater, 97210
- Northwest Cutaneous Research Specialist
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Tennessee
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Goodlettsville, Tennessee, Forenede Stater, 37072
- Rivergate Dermatology
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Knoxville, Tennessee, Forenede Stater, 37917
- Saint Mary's Centeral Wing Annex
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Nashville, Tennessee, Forenede Stater, 37221
- Tennessee Clinical Research Center
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Texas
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Austin, Texas, Forenede Stater, 78759
- DermResearch Inc
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Dallas, Texas, Forenede Stater, 75230
- Texas Dermatology Research Institute
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Houston, Texas, Forenede Stater, 77030
- Center for Clinical Studies
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Houston, Texas, Forenede Stater, 77058
- Center for Clinical Studies
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Houston, Texas, Forenede Stater, 77030
- University Texas M.D. Anderson Cancer Center
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Virginia
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Norfolk, Virginia, Forenede Stater, 23507
- Virginia Clinical Research, Inc
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Washington
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Seattle, Washington, Forenede Stater, 98101
- Dermatology Associates P.L.L.C.
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Spokane, Washington, Forenede Stater, 99202
- Rockwood Clinic, PS
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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 og ældre (Voksen, Ældre voksen)
Tager imod sunde frivillige
Ingen
Køn, der er berettiget til at studere
Alle
Beskrivelse
Inclusion Criteria:
- Written informed consent, given prior to any study-related procedure not part of the subject's normal medical care, with the understanding that consent may be withdrawn by the subject at any time without prejudice to his or her future medical care
- At least 18 years of age
Female subjects must be neither pregnant nor breast-feeding, and must lack childbearing potential, as defined by either:
- Being post-menopausal (that is at least 12 months passed last menses) or surgically sterile, or
- Using an effective form of contraception (that is, condoms, oral contraceptives or intrauterine device) (Confirmation that the subject is not pregnant must be established by a negative urinary human chorionic gonadotrophin test within 7 days before Study Day 1. A pregnancy test is not required if the subject is post-menopausal or surgically sterile)
- An out-patient status at the time of enrollment
- Plaque psoriasis for at least 12 months
- Plaque psoriasis covering at least 10 percent of total body surface area and a PASI score of 12.0 or more
- Candidate for phototherapy or systemic therapy
- Static Physician's Global Assessment (sPGA) of 3 or more
Exclusion Criteria:
- Use of more than one Non-steroidal anti-inflammatory drug (NSAID) to treat psoriatic arthritis or having a change in chronic NSAID regimen during the 28 days before Study Day 1 to treat psoriatic arthritis
- Previous systemic treatment with biologics, including interferon, and/or cytokines/anti cytokines (for example, anti- tumor necrosis factor-alpha, anti-cluster of differentiation [CD]4, interleukin [IL]-10, IL-1ra, anti-CD11a, etc.) within 3 months before Study Day 1
- Participation in any other investigational study or experimental therapeutic procedure considered to interfere with the study within 3 months before Study Day 1
- Treatment with any systemic corticosteroids or intra-articular corticosteroid injection during the 28 days before Study Day 1
- Experimental or off-label treatments for psoriasis and/or psoriatic arthritis such as azathioprine, hydroxyurea / hydroxycarbamide, mycophenolate, chlorambucil, leflunomide or cyclophosphamide within 1 year prior to Study Day 1
- Treatment with cyclosporin, methotrexate, oral retinoids (that is, acitretin), or fumaric acid esters within 28 days (3 months for acitretin) before Study Day 1
- Treatment with any topical therapies, such as Vitamin D derivatives, corticosteroids, tars and tar oils, dithranol for chronic or short contact therapy, salicylic acid and topical retinoids, within 14 days before Study Day 1
- Phototherapy within 28 days before Study Day 1
- Use of tanning booths within 14 days before Study Day 1
- Abnormal liver function, defined by a total bilirubin greater than or equal to 1.2 times the upper limit of normal values, (except in the case of Gilbert's syndrome), or aspartate aminotransferase, alanine aminotransferase or alkaline phosphatase levels greater than or equal to 2.5 times the upper limit of normal values
Inadequate bone marrow reserve, defined as:
- Leukocytes less than or equal to 3.5 * 10^9 per liter (/L), or
- Thrombocytes less than or equal to 100 * 10^9 /L, or
- Hemoglobin less than or equal to 5 millimole per liter (mmol/L) (8.9 gram per deciliter).
- Abnormal renal function, defined by serum creatinine greater than 150 micromole per liter.
- Sero-positivity for human immunodeficiency virus (HIV), Hepatitis B surface antigen (HBsAg), or Hepatitis C virus (HCV)
- Planned major surgery within the treatment period of the study.
- History of cancer in the preceding 5 years (except adequately treated basal cell carcinoma of the skin or squamous cell carcinoma in situ of the skin). Any history of hematopoietic cancer
- History of active tuberculosis, current active tuberculosis or candidacy for prophylactic therapy for tuberculosis
- Active severe infection (or non-severe infection at the discretion of the Investigator).
- History of any opportunistic infection (for example, viral, fungal, protozoal, or bacterial) in the 6 months preceding Study Day 1 related to any clinical condition of immunodeficiency
- Clinically significant and serious abnormalities on electrocardiography or chest X-ray, (at the discretion of the Investigator)
- Other serious concomitant disorders incompatible with the study. In particular, subjects with congestive heart failure, prior or current history of blood dyscrasia or central nervous system demyelinating disorders should not be included in the study
- History of or current drug (including narcotics) abuse, or current active problems with alcohol abuse
- Requirement for immunization, allergy desensitization or vaccination during the entire study period (it is recommended that these procedures be scheduled at least 14 days prior to Study Day 1 or greater than 3 months after the last injection of study drug), with the exception of killed influenza vaccines which are allowed at any time during the study
- Guttate, erythrodermic or pustular psoriasis as sole or predominant form of psoriasis.
- Evidence of skin conditions other than psoriasis (for example, eczema) that would interfere with psoriasis disease assessments
- Clinically significant psoriasis flares during screening or at the time of enrollment necessitating immediate relief (at the Investigator's discretion)
- Live or killed virus or bacteria vaccines (within 14 days before Study Day 1) with the exception of killed influenza vaccines which are allowed both prior to Study Day 1 and at any time during the study
- Bedridden status
- Previous use of onercept
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: Dobbelt
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
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Placebo komparator: Placebo
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Matching Placebo will be administered subcutaneously three times a week, for 12 weeks in the FT period.
Subjects showing 75 percent improvement in PASI score at Week 12 will be observed for 24 weeks without treatment and then again assigned to either placebo or Onercept (150 mg), subcutaneously three times a week, for 16 weeks.
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Eksperimentel: Onercept
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Onercept will be administered subcutaneously three times a week at a dose of 150 mg, for 12 weeks of first treatment (FT) period.
Subjects showing 75 percent improvement in PASI score at Week 12 will be observed for 24 weeks without treatment or until relapse, whichever occurs first.
Subjects then will be reassigned to either Onercept (150 mg) or placebo, subcutaneously three times a week, for 16 weeks.
Subjects not showing 75 percent improvement in PASI score at Week 12 will receive only Onercept (150 mg) subcutaneously three times a week, for 40 weeks as open-label treatment.
Andre navne:
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Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Tidsramme |
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Percentage of subjects with at least a 75 percent improvement in Psoriatic Area and Severity Index (PASI) score at Week 12
Tidsramme: Week 12
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Week 12
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Percentage of subjects with at least a 75 percent improvement in Psoriatic Area and Severity Index (PASI) score at Week 52
Tidsramme: Week 52
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Week 52
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Sekundære resultatmål
Resultatmål |
Tidsramme |
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Percentage of subjects attaining a Physician's Global Assessment (PGA) rating of Cleared or Almost Cleared at Week 12
Tidsramme: Week 12
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Week 12
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Mean percentage improvement in Psoriatic Area and Severity Index (PASI) Score
Tidsramme: Baseline up to Week 12
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Baseline up to Week 12
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Percentage of subjects with at least a 90 percent improvement in the Psoriatic Area and Severity Index (PASI) score
Tidsramme: Baseline up to Week 12
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Baseline up to Week 12
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Mean percentage improvement in the itching scale
Tidsramme: Baseline up to Week 12
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Baseline up to Week 12
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Change from Baseline in Mean improvement of Dermatology Life Quality Index (DLQI) quality of life assessment at Week 12
Tidsramme: Baseline and Week 12
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Baseline and Week 12
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Median time to relapse
Tidsramme: Week 12 up to Week 36
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Week 12 up to Week 36
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Percentage of subjects attaining a Physician's Global Assessment (PGA) rating of Cleared or Almost Cleared at Week 52
Tidsramme: Week 52
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Week 52
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Mean percentage improvement in Psoriatic Area and Severity Index (PASI) Score
Tidsramme: Baseline up to Week 48
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Baseline up to Week 48
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Mean percentage improvement in Psoriatic Area and Severity Index (PASI) Score up to Week 52
Tidsramme: Baseline up to Week 52
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Baseline up to Week 52
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Mean Psoriatic Area and Severity Index (PASI) score
Tidsramme: Week 36 up to Week 52
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Week 36 up to Week 52
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Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Sponsor
Publikationer og nyttige links
Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.
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. september 2004
Primær færdiggørelse (Faktiske)
1. juni 2005
Studieafslutning (Faktiske)
1. juni 2005
Datoer for studieregistrering
Først indsendt
24. august 2004
Først indsendt, der opfyldte QC-kriterier
25. august 2004
Først opslået (Skøn)
26. august 2004
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Skøn)
22. oktober 2013
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
21. oktober 2013
Sidst verificeret
1. oktober 2013
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- 24979
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 .
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