Phase 3
N=498
Study of the Efficacy and Safety of Secukinumab in Participants With Active Psoriatic Arthritis With Axial Skeleton Involvement
Axial Psoratic Arthritis
Bottom Line
View on ClinicalTrials.gov: NCT02721966 ↗Enrolled (actual)
498
Serious AEs
4.9%
Results posted
Aug 2020
Primary outcome: Primary: Percentage of Participants With Response to Treatment (300 mg AIN457) as Assessed by the ASAS20 Criteria at Week 12 — 66.3; 62.9; 31.2 percentage of participants — p=<.0001
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Secukinumab (Biological); Secukinumab and Placebo (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Novartis Pharmaceuticals
- Primary completion
- Jun 2019
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants With Response to Treatment (300 mg AIN457) as Assessed by the ASAS20 Criteria at Week 12 |
66.3; 62.9; 31.2 | <.0001 sig |
| SECONDARY Percentage of Participants With Response to Treatment (150 mg AIN457) as Assessed by the ASAS20 Criteria at Week 12 |
66.3; 62.9; 31.2 | <.0001 sig |
| SECONDARY Percentage of Participants With Response to Treatment (150 mg/300 mg AIN457) as Assessed by the ASAS40 Criteria at Week 12 |
39.5; 43.6; 12.2 | <.0001 sig |
| SECONDARY Percentage of Participants With Response to Treatment as Assessed by BASDAI50 at Week 12 |
32.7; 37.4; 9.8 | <.0001 sig |
| SECONDARY Change From Baseline in Spinal Pain Visual Analog Scale (VAS) - Pain at Any Time |
-28.5; -26.5; -13.6 | <.0001 sig |
| SECONDARY Change From Baseline in Spinal Pain Visual Analog Scale (VAS) - Pain at Night |
-30.3; -30.2; -15.2 | <.0001 sig |
| SECONDARY Change From Baseline Spondyloarthritis Research Consortium of Canada (SPARCC) Enthesitis Index Score at Week 12 |
-2.2; -2.4; -1.7 | 0.0971 |
| SECONDARY Change From Baseline in Health Assessment Questionnaire - Disability Index (HAQ-DI) Score at Week 12 |
-0.330; -0.389; -0.155 | 0.0005 sig |
| SECONDARY Change From Baseline in Functional Assessment of Chronic Illness Therapy Fatigue Scale (FACIT-Fatigue) at Week 12 |
8.0; 7.6; 4.2 | 0.0002 sig |
| SECONDARY Change From Baseline in Spondyloarthritis International Society (ASAS) Health Index at Week 12 |
-2.9; -2.8; -1.2 | <.0001 sig |
| SECONDARY Percentage of Participants With Response to Treatment as Assessed by the ACR20 Criteria at Week 12 |
56.5; 51.6; 18.5 | <.0001 sig |
Summary
The purpose of this study is to demonstrate the efficacy and safety of secukinumab 150 mg or 300 mg in the management of axial manifestations in PsA patients who have failed to respond to at least 2 non-steroidal anti-inflammatory drugs (NSAIDs) over a 4-week period, according to assessment of spondyloarthritis international society (ASAS) recommendations for the treatment of axial spondyloarthritis (AxSpA).
Eligibility Criteria
Inclusion Criteria
- Written informed consent must be obtained before any assessment is performed
- Diagnosis of psoriatic arthritis classified by Classification criteria for psoriatic arthritis (CASPAR) criteria
- Active spinal disease defined by Bath ankylosing spondylitis disease activity index (BASDAI) score ≥ 4
- Spinal Pain visual analog scale (VAS) ≥ 40 (on a VAS 100 scale)
- Inadequate Response to at least 2 non-steroidal anti-inflammatory drugs over a 4 weeks period
Exclusion Criteria
- History of exposure to other IL-17 or IL-23 inhibitor biologic drug
- History of exposure to previous biologic disease modifying anti-rheumatic drugs (DMARDs) (Tumor necrosis factor (TNF) blockers or Ustekinumab)
- Current treatment with disease modifying anti-rheumatic drugs (DMARDs) other than Methotrexate
- Subjects taking high potency opioid analgesics (e.g. methadone, hydromorphone, morphine)
- Chest X-ray or chest magnetic resonance imaging (MRI) with evidence of ongoing infectious or malignant process, obtained within 3 months prior to screening and evaluated by a qualified physician
Other protocol-defined inclusion and exclusion criteria may have applied.
Data sourced from ClinicalTrials.gov (NCT02721966). 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.