Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT00574249 | Adalimumab in Combination With Topical Treatment (Calcipotriol/Betamethasone) in Subjects With Moderate to Severe Psoriasis and Insufficient Response to Classic Systemic Treatment | PHASE3 | COMPLETED | 730 | — | — | Nov 1, 2007 | - | Apr 13, 2011 | 131 | Austria, Belgium +13 |
PASI75 is defined as at least a 75% reduction in PASI (Psoriasis Area and Severity Index) score compared with the Baseline PASI score. PASI scores range from 0.0 (best) to 72.0 (worst), with the highest score representing complete erythroderma of the severest degree. The percent decrease in score is calculated as (Week 0 PASI score minus Week 16 PASI score) divided by Week 0 PASI score. Positive percent decreases indicate improvement, with best improvement being 100%. The outcome measure is the percentage of participants who had at least a 75% PASI score decrease.
| Arm | Type | Description |
|---|---|---|
| adalimumab + placebo | ACTIVE_COMPARATOR | adalimumab + placebo (vehicle ointment) |
| adalimumab + calcipotriol/betamethasone | ACTIVE_COMPARATOR | adalimumab + calcipotriol/betamethasone ointment |
| Name | Type | Description |
|---|---|---|
| adalimumab | BIOLOGICAL | subcutaneous injection using prefilled pen/syringe, solution containing 40 mg in 0.8 milliliters; 2 injections given at Baseline (Day 1) then once every other week from Weeks 1 though 15 |
| Calcipotriol/Betamethasone Ointment | DRUG | Topical ointment (calcipotriol 50 mcg/g and betamethasone 500 mcg/g) to be applied once daily to affected psoriasis skin on trunk and extremities for first 4 weeks and as needed from Week 5 through Week 16 |
| placebo (vehicle ointment) | DRUG | Topical vehicle ointment (matching active calcipotriol/betamethasone ointment) to be applied once daily to affected psoriasis skin on trunk and extremities for first 4 weeks and as needed from Week 5 through Week 16 |
Inclusion Criteria: * Subject is \>= 18 years of age * Subject had a clinical diagnosis of chronic plaque psoriasis for at least 6 months, and has moderate to severe plaque psoriasis * Subject must have been treated and failed to respond to, or has a contraindication to, or is intolerant to at leas...