Download An Efficacy and Safety Study of CNTO 1275 Compared to

An Efficacy and Safety Study of CNTO 1275 Compared to Etanercept
in Patients With Plaque Psoriasis
Status: Completed
Study Phase: Phase 3
Start Date: March 2007 | Completion Date: January 2009
Condition(s): Psoriasis
Full Title of Study
A Phase 3, Multicenter, Randomized Study Comparing CNTO 1275 and Etanercept for
the Treatment of Moderate to Severe Plaque Psoriasis
Overview
The purpose of this study is to compare the efficacy and safety of CNTO 1275 to
etanercept in patients with moderate to severe plaque psoriasis.
Detailed Description
This is a multicenter, randomized (study medication assigned by chance), activecontrolled, parallel, 3-arm study. Patients will be randomly (allocation to treatments
available by chance) assigned in 3:5:5 ratio to receive one of three treatments groups.
The three treatment groups are: Group 1 - CNTO 1275 45 mg dosing at weeks 0 and 4,
Group 2 - CNTO 1275 90 mg dosing at weeks 0 and 4, Group 3 - Etanercept 50 mg two
times per week through week 12. The total duration for each participant will be up to
64 weeks (approximately 16 months). The active-controlled portion of the study is
from Week 0 to Week 12 during which the efficacy and safety of etanercept and 2
dose levels of CNTO 1275 will be evaluated. Treatment after Week 12 is dependent on
Physician's Global Assessment (PGA) response at Week 12 and initial treatment
assignment. Patients will receive 2 subcutaneous injections of CNTO 1275 (either 45
or 90 mg doses) or twice weekly injections of etanercept during the first twelve weeks
of the study. Patients may receive two additional doses of CNTO 1275 (either 45 or 90
mg doses) up to week 44.
Study Details
Study Type: Interventional
Study Design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study,
Intervention Model: Parallel Assignment, Masking: Double Blind (Investigator,
Outcomes Assessor), Primary Purpose: Treatment
Investigator Details
Lead Sponsor: Centocor, Inc.
Study Director: Centocor, Inc. Clinical Trial Centocor, Inc.
Interventions
Drug: CNTO 1275 45 mg
Type=exact number, number=45, unit=mg, form=injection, route=subcutaneous
Drug: CNTO 1275 90 mg
Type=exact number, number=90, unit=mg, form=injection, route=subcutaneous
Drug: Etanercept 50 mg
Type=exact number, number=50, unit=mg, form=injection, route=subcutaneous
Information Source
ID Number: CR013015
NCT Identifier: NCT00454584
Health Authority: United States: Food and Drug Administration
Full Source of Clinical Trial Data: https://clinicaltrials.gov/show/NCT00454584
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
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