Phase 3
N=606
Efficacy at 24 Weeks and Long Term Safety, Tolerability and Efficacy up to 2 Years of Secukinumab (AIN457) in Patients With Active Psoriatic Arthritis (PsA)
Psoriatic Arthritis
Bottom Line
View on ClinicalTrials.gov: NCT01392326 ↗Enrolled (actual)
606
Serious AEs
11.9%
Results posted
Feb 2016
Primary outcome: Primary: Percent of Patients Achieving ACR20 Response Criteria on Secukinumab 75 or 150 mg vs. Placebo — 50.5; 50.0; 17.3 % participant — p=<0.0001
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Secukinumab (75 mg) (Drug); Secukinumab (150 mg) (Drug); Placebo Comparator (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Novartis Pharmaceuticals
- Primary completion
- Oct 2014
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percent of Patients Achieving ACR20 Response Criteria on Secukinumab 75 or 150 mg vs. Placebo |
50.5; 50.0; 17.3 | <0.0001 sig |
| SECONDARY Percent of Subjects Achieving a PASI75 Response in the Subgroup of Subjects Who Have ≥3% Skin Involvement With Psoriasis at Baseline |
64.8; 61.1; 8.3 | — |
| SECONDARY Percent of Subjects Achieving a PASI90 Response in the Subgroup of Subjects Who Have ≥3% Skin Involvement With Psoriasis at Baseline |
49.1; 45.4; 3.7 | — |
| SECONDARY Change From Baseline in DAS28-CRP for Secukinumab 75 or 150 mg |
-1.67; -1.62; -0.77 | — |
| SECONDARY Change From Baseline in SF36-PCS for Secukinumab 75 or 150 mg |
5.41; 5.91; 1.82 | — |
| SECONDARY Change From Baseline in HAQ-DI for Secukinumab 75 or 150 mg |
-0.41; -0.40; -0.17 | — |
| SECONDARY Percent of Patients Achieving ACR50 Response Criteria on Secukinumab 75 or 150 mg vs. Placebo |
30.7; 34.7; 7.4 | — |
| SECONDARY Change From Baseline for Joint/Bone Structural Damage (Van Der Heijde Modified Total Sharp Score) for Secukinumab 75 and 150 mg (Pooled Doses) |
0.02; 0.13; 0.57 | — |
| SECONDARY Percent of Patients With Dactylitis in the Subset of Subjects Who Have Dactylitis at Baseline |
43.3; 51.9; 84.5 | — |
| SECONDARY Percent of Patients With Enthesitis in the Subset of Subjects Who Have Enthesitis at Baseline |
51.2; 54.0; 87.2 | — |
Summary
This study will assess the efficacy and safety of secukinumab in patients with active psoriatic arthritis who are intolerant to or have had an inadequate response to NSAIDs, DMARDs and / or TNFα inhibitor therapy.
Eligibility Criteria
Inclusion criteria
- Male or non-pregnant, non-lactating female patients at least 18 years of age
- Diagnosis of PsA classified by CASPAR criteria and with symptoms for at least 6 months with moderate to severe PsA who must have at Baseline ≥3 tender joints out of 78 and ≥3 swollen out of 76 (dactylitis of a digit counts as one joint each)
- Rheumatoid factor and anti-CCP antibodies negative
- Diagnosis of active plaque psoriasis, with at least one psoriatic plaque of ≥2cm diameter or nail changes consistent with psoriasis or documented history o plaque psoriasis
Exclusion criteria
- Chest X-ray with evidence of ongoing infectious or malignant process
- Subjects who have previously been treated with more than 3 different TNFα inhibitors
- Subjects taking high potency opioid analgesics
- Subjects who have ever received biologic immunomodulating agents except for those targeting TNFα Other protocol-defined inclusion/exclusion criteria may apply
Data sourced from ClinicalTrials.gov (NCT01392326). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.