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Clinical Trial Name - A Study of the Safety and Effectiveness of CNTO 1275 Compared to Etanercept for the Treatment of M

 
Original Study ID : CR013015
NCT ID : NCT00454584
Brief Title : A Study of the Safety and Effectiveness of CNTO 1275 Compared to Etanercept for the Treatment of Moderate to Severe Plaque Psoriasis
Official Title : A Phase 3, Multicenter, Randomized Study Comparing CNTO 1275 and Etanercept for the Treatment of Moderate to Severe Plaque Psoriasis
Brief Summary :

The purpose of this research study is to compare the effects (good and/or bad) of CNTO 1275 or etanercept on moderate to severe plaque psoriasis.

Source : Centocor, Inc.
Detailed Description :

The purpose of this research study is to compare the effects (good and/or bad) of CNTO 1275 with etanercept on moderate to severe plaque psoriasis. Approximately 650 patients will take part in this study. Etanercept is currently approved for the treatment of moderate to severe psoriasis and sold under the name Etanercept. Patients will be randomly placed into one of three treatments groups receiving subcutaneous injections (under the skin) in the following treatment groups: 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. Patients will be in the study for up to 64 weeks (approximately 16 months). The primary outcome of this trial will be measured by the proportion of patients who achieve a Psoriasis Area and Severity Index (PASI) 75 response at Week 12. Patients will receive 2 subcutaneous (under the skin) 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.

Overall Status : Active, not recruiting
Start Date : March 2007
Official Title : Phase 3
Phase : Interventional
Study Design : Treatment, Randomized, Single Blind, Parallel Assignment, Safety/Efficacy Study
Enrollment : 650
Verification Date : April 2009
First Received Date : March 28, 2007
Trial Eligibility
Criteria :
Inclusion Criteria:

- Have had a diagnosis of plaque-type psoriasis at least 6 months prior to the study

- Have plaque-type psoriasis covering at least 10% of total body surface area

- Have a PASI score of 12 or greater and a PGA score of 3 or greater

- Is a candidate for phototherapy or systemic treatment for psoriasis

- Are candidates for Etanercept according to the approved product labeling

Exclusion Criteria:

- Currently have nonplaque forms of psoriasis

- Have current drug-induced psoriasis

- Have used any therapeutic agent targeted at reducing IL-12 or IL-23

- Have used any investigational drug within the previous 4 weeks

- Have used a biologic within the previous 3 months

- Have previously received etanercept
Gender : Both
Minimum Age : 18 Years
Maximum Age : N/A
Healthy Volunteers : No
OutComes
Primary OutComes
Measure : The proportion of patients who achieve a Psoriasis Area and Severity Index (PASI) 75 response at Week 12.
Secondary OutComes
Measure : Proportion of patients with a Physician Global Assessment (PGA) score of cleared (0) or minimal (1) at Week 12; Proportion of patients with a PASI 90 response at Week 12; Difference between the PASI score achieved with initial treatment and ret
Interventions
Type : Drug
Name : CNTO 1275; Etanercept
 
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