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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT01891864 | Study to Demonstrate Equivalent Efficacy and to Compare Safety of Biosimilar Etanercept (GP2015) and Enbrel | PHASE3 | COMPLETED | 531 | — | — | Jun 1, 2013 | Mar 1, 2015 | Mar 27, 2017 | 74 | Bulgaria, Czechia +10 |
The 95% CI for the Psoriasis Area and Severity Index (PASI) 75 response rate differences at Week12 between GP2015 Etanercept and Enbrel ® Etanercept. PASI 75 response: patients who achieved ≥ 75% improvement (reduction) in PASI score compared to baseline were defined as PASI 75 responders. PASI scores can range from 0, corresponding to no signs of psoriasis up to theoretic maximum of 72.0, which means a higher PASI score reflects a higher psoriasis activity.
| Arm | Type | Description |
|---|---|---|
| GP2015 Etanercept | EXPERIMENTAL | Solution for subcutaneous injection in pre-filled syringe. The drug is administered in a dose of 50 mg twice weekly for the first 12 weeks and 50 mg once weekly thereafter |
| Enbrel ® Etanercept | ACTIVE_COMPARATOR | Solution for subcutaneous injection in pre-filled syringe. The drug is administered in a dose of 50 mg twice weekly for the first 12 weeks and 50 mg once weekly thereafter |
| Name | Type | Description |
|---|---|---|
| GP2015 Etanercept | DRUG | Sandoz has developed GP2015 Etanercept (Sandoz's code for the drug product containing the active ingredient etanercept) to be biosimilar to Enbrel. |
| Enbrel | DRUG | Enbrel is used as reference product to GP2015. |
Inclusion Criteria: * Men or women at least 18 years of age at time of screening * Chronic plaque-type psoriasis diagnosed for at least 6 months before baseline * Moderate to severe psoriasis as defined at baseline by: * PASI score of 10 or greater and, * Investigator´s Global Assessment score...