Study to Demonstrate the Efficacy, Safety and Tolerability of Intravenous Secukinumab up to 52 Weeks in Subjects With Active Psoriatic Arthritis

Launched by NOVARTIS PHARMACEUTICALS · Dec 19, 2019

Keywords

ClinConnect Summary

This multicenter study used a randomized, double-blind, placebo-controlled, parallel-group design. A screening (SCR) period running up to 10 weeks before randomization was used to assess subject eligibility followed by a treatment period of 52 weeks.

At baseline, 381 patients with active psoriatic arthritis were randomized to one of the two treatment groups in a 1:1 randomization:

Group 1: Approximately 190 patients with active psoriatic arthritis; These patients received secukinumab 6 mg/kg i.v. at BSL, followed by the administration of secukinumab 3 mg/kg i.v. every four weeks starting ...

Gender

ALL

Eligibility criteria

• Patients eligible for inclusion in this study had to fulfill all of the following criteria:
• • 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 at screening
• • Diagnosis of active plaque psoriasis or nail changes consistent with psoriasis or documented history of plaque psoriasis
• • Subjects with PsA should have taken NSAIDs for at least 4 weeks prior to randomization with inadequate control of symptoms or at least one dose if stopped due to intolerance to NSAIDs
• • Subjects taking corticosteroids must be on a stable dose of ≤10 mg/day prednisone or equivalent for at least 2 weeks before randomization and should remain on a stable dose up to Week 16
• • Subjects taking MTX (≤ 25 mg/week) are allowed to continue their medication if the dose is stable for at least 4 weeks before randomization and should remain on a stable dose up to Week 52.
• Patients fulfilling any of the following criteria are not eligible for inclusion in this study:
• • Chest X-ray or chest MRI with evidence of ongoing infectious or malignant process, obtained within 3 months prior to screening and evaluated by a qualified physician
• • Subjects taking high potency opioid analgesics (e.g. methadone, hydromorphone, morphine)
• • Previous exposure to secukinumab or other biologic drug directly targeting IL-17 or IL-17 receptor
• * Ongoing use of prohibited psoriasis treatments / medications (e.g., topical corticosteroids, UV therapy) at randomization. The following wash-out periods need to be observed:
• • Oral or topical retinoids- 4 weeks
• • Photochemotherapy (e.g. PUVA)- 4 weeks
• • Phototherapy (UVA or UVB)- 2 weeks
• • Topical skin treatments (except in face, eyes, scalp and genital area during screening, only corticosteroids with mild to moderate potency)- 2 weeks
• • Any intramuscular or intravenous corticosteroid treatment within 4 weeks before randomization.
• • Any therapy by intra-articular injections (e.g. corticosteroid) within 4 weeks before randomization.
• • Subjects who have previously been treated with more than 3 different TNF inhibitors (investigational or approved).
• • Subjects who have ever received biologic immunomodulating agents, investigational or approved except for those targeting TNFα.
• • Previous treatment with any cell-depleting therapies including but not limited to anti-CD20 or investigational agents (e.g., CAMPATH, anti-CD4, anti-CD5, anti-CD3, anti-CD19)