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A Study of the Safety and Efficacy of Ustekinumab (CNTO 1275) in Patients With Moderate to Severe Psoriasis Status: Completed Study Phase: Phase 3 Start Date: May 2005 | Completion Date: October 2011 Condition(s): Psoriasis Full Title of Study A Phase 3, Multicenter, Randomized, Double-blind, Placebo-controlled Trial Evaluating the Efficacy and Safety of CNTO 1275 in the Treatment of Subjects With Moderate to Severe Plaque-type Psoriasis. Overview The primary objective of this study is to evaluate the efficacy and safety of ustekinumab (CNTO 1275) in the treatment of patients with moderate to severe plaque psoriasis. Detailed Description Although numerous therapeutic options exist for the treatment of psoriasis, there is still a significant unmet medical need due to the limited effectiveness and/or significant side effect profile of current treatment options. Preclinical studies and early phase clinical studies suggest that interleukins-12 and -23, two molecules that are part of the communication network in the immune system, may play an important role in psoriasis. Ustekinumab (CNTO 1275) is a monoclonal antibody directed against interleukins -12 and -23. This is a randomized (study drug assigned by chance like flipping a coin), double blind (neither physician nor patient knows the name of the assigned drug), parallel-group, multicenter study to determine the effectiveness and safety of two different doses of ustekinumab (CNTO 1275) administered subcutaneously (under the skin) as compared with placebo in patients with moderate to severe plaque-type psoriasis (the most common type of psoriasis). The hypothesis is that ustekinumab (CNTO 1275) will be more effective in treatment of psoriasis than placebo, that the improvement in psoriasis will result in an improved quality of life for treated patients and that ustekinumab (CNTO 1275) will be generally well tolerated. Patients will receive ustekinumab (CNTO 1275), 45 or 90 mg, or placebo administered subcutaneously at weeks 0 and 4 weeks then every 12 weeks thereafter until week 52. For patients who partially respond to the starting regimen, the dosing interval may be adjusted to every 8 weeks. Patients will enter long term extension portion of the study at week 52 during which patients will continue to receive treatment with ustekinumab (CNTO 1275) and will be followed for a total of up to 264 weeks from the initial (week 0) administration of study agent. The dose of ustekinumab (CNTO 1275) will be 45 or 90 mg or placebo administered subcutaneously at weeks 0 and 4 weeks then every 12 weeks thereafter. For patients who partially respond to the starting regimen, the dosing interval may be adjusted to every 8 weeks. Study Details Study Type: Interventional Study Design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment Investigator Details Lead Sponsor: Centocor Research & Development, Inc. Study Director: Centocor, Inc. Clinical Trial Centocor, Inc. Trial Location Details Facility: Birmingham, United States Facility: Little Rock, United States Facility: La Jolla, United States Facility: Los Angeles, United States Facility: San Diego, United States Facility: Jacksonville, United States Facility: Miami, United States Facility: Normal, United States Facility: Skokie, United States Facility: Indianapolis, United States Facility: Louisville, United States Facility: Andover, United States Facility: Boston, United States Facility: Port Huron, United States Facility: Saint Louis, United States Facility: Las Vegas, United States Facility: New Brunswick, United States Facility: New York, United States Facility: Winston Salem, United States Facility: Cleveland, United States Facility: Portland, United States Facility: Philadelphia, United States Facility: Plymouth Meeting, United States Facility: Mt. Pleasant, United States Facility: Nashville, United States Facility: Houston, United States Facility: San Antonio, United States Facility: Salt Lake City, United States Facility: Graz, Austria Facility: Innsbruck, Austria Facility: Wien, Austria Facility: Calgary, Canada Facility: Edmonton, Canada Facility: Surrey, Canada Facility: Vancouver, Canada Facility: Moncton, Canada Facility: Halifax, Canada Facility: Barrie, Canada Facility: Hamilton, Canada Facility: London, Canada Facility: North Bay, Canada Facility: Toronto, Canada Facility: Waterloo, Canada Facility: Windsor, Canada Facility: Montreal, Canada Facility: Sainte-Foy, Canada Facility: Sherbrooke, Canada Facility: Nice, France Facility: Berlin, Germany Facility: Brandenburg, Germany Facility: Dresden, Germany Facility: Erlangen, Germany Facility: Frankfurt, Germany Facility: Hamburg, Germany Facility: Kiel, Germany Facility: Mainz, Germany Facility: Munchen, Germany Facility: Genève, Switzerland Facility: Zurich N/A, Switzerland Facility: London, United Kingdom Facility: Salford, United Kingdom Facility: Southampton Trials Carried Out, United Kingdom Interventions Drug: Placebo; Ustekinumab (CNTO 1275) 45 or 90 mg Placebo at Weeks 0 and 4 and blinded SC injections of ustekinumab, 45 or 90 mg, at Weeks 12 and 16; followed by a dosing regimen to be determined by patient's response status for Weeks 28 to 52; followed by unblinded dosing that may be adjusted at the investigator's discretion for Weeks 52 to 264 Drug: Ustekinumab (CNTO 1275) 45 mg Ustekinumab, 45 mg, at Weeks 0 and 4 and every 12 weeks for Weeks 16 to 28. Followed by a dosing regimen to be determined by patient's response status for Weeks 28 to 52; followed by unblinded dosing that may be adjusted at the investigator's discretion for Weeks 52 to 264 Drug: Ustekinumab (CNTO 1275) 90 mg Ustekinumab, 90 mg, at Weeks 0 and 4 and every 12 weeks for Weeks 16 to 28. Followed by a dosing regimen to be determined by patient's response status for Weeks 28 to 52; followed by unblinded dosing that may be adjusted at the investigator's discretion for Weeks 52 to 264 Information Source ID Number: CR006325 NCT Identifier: NCT00307437 Health Authority: United States: Food and Drug Administration Full Source of Clinical Trial Data: https://clinicaltrials.gov/show/NCT00307437 ClinicalTrials.gov processed this data on October 12, 2016 Clinical trials entries are delivered from the US National Institutes of Health and are not reviewed separately by this site. Please see the full source link above for retrieving further details from the government database.