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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT00928512 | Efficacy, Safety and Tolerability of AIN457 in Patients With Rheumatoid Arthritis (RA) Taking Methotrexate (MTX) | PHASE2 | COMPLETED | 237 | — | — | Jul 1, 2009 | Mar 1, 2011 | Oct 30, 2015 | 58 | United States, Belgium +9 |
A participant was considered to have achieved the incidence of response (ACR20 criteria) if he/she had at least a 20% improvement in both the tender and swollen 28-joint counts and had at least 20% improvement in at least 3 of the following 5 measures: patient's assessment of rheumatoid athritis (RA) pain, patient's global assessment of disease activity, physician's global assessment of disease activity, patient's self-assesseddisability (Health Assessment Questionnaire \[HAQ©\] score)and acute phase rectant (C-reactive protein \[hsCRP\]/ESR).
| Arm | Type | Description |
|---|---|---|
| Secukinumab 25mg | EXPERIMENTAL | Secukinumab 25mg s.c. q4wk |
| Secukinumab 75mg | EXPERIMENTAL | Secukinumab 75mg s.c. q4wk |
| Secukinumab 150mg | EXPERIMENTAL | Secukinumab 150mg s. c. q4wk |
| Secukinumab 300mg | EXPERIMENTAL | Secukinumab 300mg s.c. q4wk |
| Secukinumab Placebo | PLACEBO_COMPARATOR | Secukinumab Placebo s.c. q4wk |
| Name | Type | Description |
|---|---|---|
| Secukinmab | DRUG | Secukinumab was supplied as a 150mg lyophiized cake in individual glass vials each. The study drug dose levels were 25mg, 75mg, 150mg and 300mg and was administered subcutaneously. |
| Placebo | DRUG | Secukinumab placebo was supplied as a 150mg lyophiized cake in individual glass vials each. The placebo dose levels were 25mg, 75mg, 150mg and 300mg and was administered subcutaneously. |
Inclusion Criteria: * Presence of RA classified by ACR 1987 revised criteria. Patients with active RA should have been on MTX for at least 3 months and must currently be treated with a stable dose of MTX (\> or =7.5 mg/week - \< or = 25 mg/week) for at least 4 weeks * At Baseline: Disease activity ...