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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT01169844 | Safety and Tolerability of AIN457 in Adults (18-65 Years) With Psoriatic Arthritis | PHASE2 | COMPLETED | 28 | — | — | Jun 1, 2010 | Nov 1, 2012 | Jun 10, 2021 | 6 | Germany, Netherlands +1 |
Adverse events (AEs) were defined as any unfavorable and unintended diagnosis, symptom, sign (including an abnormal laboratory finding), syndrome or disease which either occurs during study, having been absent at baseline, or, if present at baseline, appears to worsen. Serious adverse events (SAEs) were defined as any untoward medical occurrences that result in death, are life threatening, require (or prolong) hospitalization, cause persistent or significant disability/incapacity, result in congenital anomalies or birth defects, or are other conditions which in judgement of investigators represent significant hazards.
| Arm | Type | Description |
|---|---|---|
| AIN457/AIN457 3 mg/kg. | EXPERIMENTAL | Participants who were treated with secukinumab 2x10 mg/kg during the core study were treated with secukinumab at 3mg/kg infused intravenously every 4 weeks during the extension study, over a total period of 52 weeks. |
| Placebo/AIN457 3 mg/kg. | PLACEBO_COMPARATOR | Participants who were treated with placebo during the core study were treated with secukinumab at 3mg/kg infused intravenously every 4 weeks during the extension study, over a total period of 52 weeks. |
| Name | Type | Description |
|---|---|---|
| AIN457A | BIOLOGICAL | - |
| Other | OTHER | - |
Inclusion Criteria: * Patients who participated and completed the core CAIN457A2206 study up to and including the end of the study (EoS) Visit, i.e. Visit 16 (Week 24), were allowed to enter the extension study upon signing informed consent. * Patients who discontinued the core study due to unsatis...