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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT02016105 | Study to Demonstrate Equivalent Efficacy and to Compare Safety of Biosimilar Adalimumab (GP2017) and Humira | PHASE3 | COMPLETED | 465 | — | — | Dec 1, 2013 | Feb 1, 2016 | May 30, 2017 | 79 | United States, Bulgaria +2 |
The primary variable was the PASI75 response rate at Week 16, defined as the proportion of patients achieving a reduction of 75% or more of the PASI score at Week 16 compared with baseline.
| Arm | Type | Description |
|---|---|---|
| GP2017 Adalimumab | EXPERIMENTAL | Study arm with intervention being studied in the protocol. Adalimumab Solution for subcutaneous injection with an initial dose of 80 mg s.c. in Week 0, followed by 40 mg s.c. eow, starting at Week 1 and ending at Week 51. |
| Humira ® Adalimumab | ACTIVE_COMPARATOR | Humira® Adalimumab as a subcutaneous injection with an initial dose of 80 mg s.c. in Week 0, followed by 40 mg s.c. eow, starting at Week 1 and ending at Week 51. |
| Name | Type | Description |
|---|---|---|
| GP2017 Adalimumab | DRUG | - |
| Humira ® Adalimumab | DRUG | - |
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 randomization * Moderate to severe psoriasis as defined at baseline by: * PASI score of 12 or greater * Investigator´s Global Assessment score...