At a glance
ClinicalIndex Comparison RecordPhase 4Completed· 258 enrolled
Drug / intervention
Secukinumab 300 mg +2 moredrug
Likely dose
Secukinumab 300 mg (as 150 mg × 2) or 150 mg subcutaneous injectionAI-extracted
Key inclusion· 5
- ✓Adults at least 18 years old
- ✓Psoriatic arthritis diagnosed by CASPAR criteria with ≥6 months of symptoms
- ✓Moderate to severe disease with ≥3 tender joints (of 78) and ≥3 swollen joints (of 76) at baseline
- ✓Rheumatoid factor and anti-CCP antibodies negative
Key exclusion· 2
- ✕Evidence of active infection or malignancy on chest X-ray
- ✕Prior receipt of any biologic immunomodulating agents, including TNF-α, IL-6, or IL-12/23 inhibitors
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Randomized, Double-blind, Placebo-controlled, Parallel-group, Multicenter Study to Evaluate the Safety and Efficacy of Secukinumab 300 mg and 150 mg in Adult Patients With Active Psoriatic Arthritis After 16 Weeks of Treatment Compared to Placebo and to Assess the Safety, Tolerability and Efficacy up to 52 Weeks
In Brief
A Phase 4 clinical trial evaluating Secukinumab 300 mg, Secukinumab 150 mg, and 1 other intervention for Psoriatic Arthritis. Completed, enrolled 258 participants across 58 sites in 2 countries.
Detailed Summary
To demonstrate that the efficacy of secukinumab 300 mg at Week 16 was superior to placebo in adult patients with active PsA based on the proportion of patients achieving an American College of Rheumatology 20 (ACR20) response.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsPsoriatic Arthritis
CountriesPuerto Rico, United States
Collaborators--
Timeline
Phase 4CompletedFinished
2017201820192020202120222023202420252026
First PostedJun 2016
Enrollment StartJun 2016
Primary CompletionDec 2018
TodayJul 2026
First PostedJun 14, 2016
Enrollment StartJun 27, 2016
Primary CompletionDec 5, 2018
TodayJul 2, 2026
Enrollment to primary: 2.4 yearsPosted 10.0 years ago
Interventions
Secukinumab 300 mgdrug
150 mg x 2 s.c. injection
Secukinumab 150 mgdrug
150 mg s.c. injection
Placeboother
Placebo