Psoriatic arthritis MedDRA version: 16.1 Level: LLT Classification code 10037160 Term: Psoriatic arthritis System Organ Class: 100000004859
Conditions
Sponsors
Novartis Pharma Services AG
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: • Male or non-pregnant, non-lactating female patients at least 18 years of age • Diagnosis of PsA classified by CASPAR criteri 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 joints out of 76 (dactylitis of a digit counts as one joint each) • Diagnosis of active plaque psoriasis, with at least one psoriatic plaque of =2 cm diameter (but not in intertriginous areas such as armpits, or chest between breasts, or groin) or nail changes consistent with psoriasis or a documented history of plaque psoriasis • Patients should have been on NSAIDs with an inadequate response • Patients who are regularly taking NSAIDs as part of their PsA therapy are required to be on a stable dose • Patients who have been on an anti-TNFa agent (not more than three) must have experienced an inadequate response Other protocol-related inclusion criteria may apply. Are the trial subjects under 18? no Number of subjects for this age range: 0 F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 568 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 32
Exclusion criteria
Exclusion criteria: • Chest X-ray with evidence of ongoing infectious or malignant process • Ongoing use of prohibited psoriasis treatments / medications (e.g., topical corticosteroids, UV therapy) at randomization. • Patients previously treated with any biological immunomodulating agents except for those targeting TNFa • Previous treatment with any cell-depleting therapies Other protocol-related exclusion criteria may apply.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To demonstrate the efficacy of secukinumab 75 or 150 mg at Week 24 is superior to placebo in patients with active PsA based on the proportion of patients achieving an ACR20 response.;Secondary Objective: -proportion of subjects achieving a PASI75 response in the subgroup of subjects who have =3% skin involvement with psoriasis -proportion of subjects achieving a PASI90 response in the subgroup og subjects who have =3% skin involvement with psoriasis -change from baseline in DAS28-CRP for secukinumab 75 or 150mg -change from baseline in SF36-PCS for secukinumab 75 or 150mg -change from baseline in HAQ-DI for secukinumab 75 or 150mg -proportion of subjects achieving ACR50 response on secukinumab 75 or 150mg vs. placebo -Change from baseline for joint/bone structural damage for secukinumab 75 and 150mg -proportion of subjects with dactylitis in the subset of subjects who have dactylitis at baseline -proportion of subjects with enthesitis in the subset of subjects who have enthesitis at baseline -Change from baseline for joint/bone structural damage for secukinumab 75 or 150mg -Overall safety and tolerability of each secukinumab regimen compared to placebo;Primary end point(s): ACR 20;Timepoint(s) of evaluation of this end point: Week 24 | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): 1) PASI75 (in the subgroup of subjects who have =3% skin involvement with psoriasis) 2) PASI90 (in the subgroup of subjects who have =3% skin involvement with psoriasis) 3) DAS28-CRP (for secukinumab 75 or 150mg) 4) SF36-PCS (for secukinumab 75 or 150mg) 5) HAQ-DI (for secukinumab 75 or 150mg) 6) ACR50 response on secukinumab 75 or 150mg vs.placebo 7) Change from baseline for joint/bone structural damage (van der Heijde modified total Sharp score) for secukinumab 75 and 150mg (pooled doses) 8) Proportion of patients with dactylitis in the subset of subjects who have dactylitis at baseline 9) Proportion of patients with enthesitis in the subset of subjects who have enthesitis at baseline 10) Change from baseline for join/bone structural damage (van der Heijde modified total Sharp score) for secukinumab 75 or 150mg;Timepoint(s) of evaluation of this end point: Week 24 | — |
Countries
Argentina, Australia, Belgium, Brazil, Bulgaria, Canada, Czech Republic, Germany, Israel, Italy, Peru, Philippines, Poland, Romania, Russian Federation, Singapore, Slovakia, Thailand, Turkey, United Kingdom, United States
Contacts
Public ContactInformacní služba - klin. hodnocení
Novartis s.r.o.
Outcome results
None listed