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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT01313221 | Efficacy and Safety of Etanercept 50 mg Once Weekly Plus As Needed Topical Agent in Moderate to Severe Plaque Psoriasis | PHASE3 | COMPLETED | 310 | — | — | Apr 1, 2011 | May 1, 2013 | Mar 15, 2017 | 24 | Canada |
The Psoriasis Area and Severity Index (PASI) score is a combination of the intensity of psoriasis, assessed by the erythema (reddening), induration (plaque thickness) and desquamation (scaling) on a scale from none (0), mild (1), moderate (2), severe (3) or very severe (4), together with the percentage of the area affected, rated on a scale from 0 to 6. PASI scoring is performed at four body areas, the head, arms, trunk, and legs. The total PASI score ranges from 0 to 72. The higher the total score, the more severe the disease. Change from Week 12 to Week 24 is presented as a percentage of the Week 12 value: Week 12 value - Week 24 value / Week 12 value \* 100 so that a positive change indicates improvement. Change was adjusted for treatment using a mixed model.
| Arm | Type | Description |
|---|---|---|
| Etanercept 50 mg BIW | ACTIVE_COMPARATOR | Following 12 weeks of etanercept 50 mg twice weekly, participants were randomized to 50 mg etanercept twice weekly for 12 weeks. |
| Etanercept 50 mg QW + Topical | EXPERIMENTAL | Following 12 weeks of etanercept 50 mg twice weekly, participants were randomized to 50 mg etanercept once weekly plus as needed topical agents. |
| Name | Type | Description |
|---|---|---|
| etanercept | BIOLOGICAL | Administered by subcutaneous injection |
| Topical agents | DRUG | Topical agents prescribed at the discretion of the Principal Investigator and were are limited to the following: * hydrocortisone 2.5% * betamethasone valerate 0.1% * betamethasone dipropionate 0.05% * clobetasol 0.05% * calcitriol * calcipotriol plus betamethsone dipropionate 0.05% |
Inclusion Criteria: * Has had stable moderate to severe plaque psoriasis for at least 6 months (eg, no morphology changes or significant flares of disease activity in the opinion of the investigator). * Has a body surface area (BSA) involvement ≥ 10% and Psoriasis Area and Severity Index (PASI) ≥ 1...