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Secukinumab versus adalimumab monotherapy in active psoriatic arthritis
NL-OMON45596Phase 3
Key facts
- Status
- Active, not recruiting
- Start
- May 2017
- Countries
- 1
- Sponsor
- Novartis
- Modality
- Monoclonal Antibodies → Antibody-Based Therapeutics
- Conditions
- psoriatic arthritis (PsA)
01
Overview
Phase 3, randomised, double-blind trial in psoriatic arthritis (PsA) comparing Secukinumab monotherapy with Adalimumab monotherapy (2 arms). Primary endpoint: ACR20 response at week 52. Started May 2017; status: active, not recruiting.
02
Design
2 arms- Study design
- RandomizedDouble-blind
Secukinumab monotherapy
Subcutaneous secukinumab monotherapy with matching placebo for blinding.
Adalimumab monotherapy
Subcutaneous adalimumab monotherapy with matching placebo for blinding.
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Who it enrols
Adults with active psoriatic arthritis meeting CASPAR criteria, negative rheumatoid factor and anti-CCP antibodies, and active or documented plaque psoriasis were eligible if symptoms were inadequately controlled by NSAIDs and conventional DMARDs. Patients were excluded for pregnancy or nursing, ongoing infection or malignancy, prior biologic treatment for psoriatic arthritis or psoriasis, prior cell-depleting therapy, use of high-potency opioid analgesics, or prohibited psoriasis medications.
04
Endpoints
Primary
ACR20 response at week 52
Secondary
PASI90 response at week 52
ACR50 response at week 52
Change from baseline in HAQ-DI score at week 52
Resolution of enthesitis at week 52
Safety and tolerability
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