Conditions: Psoriasis
Keywords: Psoriasis CNTO 1275 Etanercept Immune diorder Skin disorder
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 903
Healthy volunteers: no

Brief summary:
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), active-controlled, 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.

Arms:
arm 1: Patients will receive CNTO 1275 45 mg at the Weeks 0 and 4 visits. Treatment after Week 12 is dependent on Physician's Global Assessment (PGA) response at Week 12 and initial treatment assignment. arm 2: Patients will receive CNTO 1275 90 mg at the Weeks 0 and 4 visits. Treatment after Week 12 is dependent on PGA response at Week 12 and initial treatment assignment. arm 3: Patients will receive Etanercept 50 mg twice weekly through Week 12. Treatment after Week 12 is dependent on PGA response at Week 12 and initial treatment assignment.

Interventions: intervention 1: CNTO 1275 45 mg intervention 2: CNTO 1275 90 mg intervention 3: Etanercept 50 mg
Intervention descriptions: intervention 1: Type=exact number, number=45, unit=mg, form=injection, route=subcutaneous intervention 2: Type=exact number, number=90, unit=mg, form=injection, route=subcutaneous intervention 3: Type=exact number, number=50, unit=mg, form=injection, route=subcutaneous

Protocol document: