Study to Demonstrate the Efficacy (Including Inhibition of Structural Damage), Safety and Tolerability up to 2 Years of Secukinumab in Active Psoriatic Arthritis

Completed · Phase 3 · Has a placebo group

Conditions studied: Psoriatic Arthritis

In brief

The purpose of this study was to demonstrate efficacy including effect on inhibition of progression of structural damage, safety and tolerability up to 2 years with primary focus at Week 16 (week 24 for structural damage), to support the use of secukinumab pre-filled syringe (PFS) by subcutaneous (s.c.) self-administration with or without loading regimen in subjects with active Psoriatic Arthritis (PsA) despite current or previous NSAID, DMARD therapy and/or previous anti-TNFα therapy. Long term efficacy up to 2 years was based on signs and symptoms of joint/bone structure preservation (X-ray) and improvement in physical function measured by Health Assessment Questionnaire - Disability Index (HAQ-DI©), as well as skin and nail improvement for psoriasis signs.

Key facts

Study ID

NCT02404350

Run by

Novartis Pharmaceuticals

People needed

997

Starts

2015-08-31

Expected to finish

2019-01-24

Last updated by the study team

2020-04-20

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Diagnosis of PsA classified by CASPAR criteria and with symptoms for at least 6 months with moderate to severe PsA who must have at BSL ≥3 tender joints out of 78 and ≥3 swollen joints out of 76 (dactylitis of a digit counts as one joint each).
• Rheumatoid factor (RF) and anti-cyclic citrullinated peptide (anti-CCP) antibodies negative at screening.
• Diagnosis of active plaque psoriasis or nail changes consistent with psoriasis or a 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 who are regularly taking NSAIDs as part of their PsA therapy are required to be on a stable dose for at least 2 weeks before study randomization and should remain on a stable dose up to Week 24.
• 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 24.
• 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.
• Subjects on MTX must be on folic acid supplementation at randomization.
• Subjects who are on a DMARD other than MTX must discontinue the DMARD 4 weeks prior to randomization visit except for leflunomide, which has to be discontinued for 8 weeks prior to randomization unless a cholestyramine wash-out has been performed.
• Subjects who have been on a TNFα inhibitor must have experienced an inadequate response to previous or current treatment with a TNFα inhibitor given at an approved dose for at least 3 months or have stopped treatment due to safety/tolerability problems after at least one administration of a TNFα inhibitor.
• Subjects who have previously been treated with TNFα inhibitors (investigational or approved) will be allowed entry into study after appropriate wash-out period prior to randomization

You may not qualify if…

• Chest X-ray or chest MRI with evidence of ongoing infectious or malignant process. - Subjects taking high potency opioid analgesics.
• 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.
• Any intramuscular or intravenous or intra-articular corticosteroid treatment within 4 weeks before randomization.
• Subjects who have ever received biologic immunomodulating agents except for those targeting TNFα (investigational or approved).
• Previous treatment with any cell-depleting therapies including but not limited to anti- CD20, investigational agents
• Other protocol-defined exclusion criteria do apply

Where it is running

• Novartis Investigative Site — Aurora, Colorado, United States
• Novartis Investigative Site — Denver, Colorado, United States
• Novartis Investigative Site — Brandon, Florida, United States
• Novartis Investigative Site — Tampa, Florida, United States
• Novartis Investigative Site — Coeur d'Alene, Idaho, United States
• Novartis Investigative Site — Shreveport, Louisiana, United States
• Novartis Investigative Site — Brooklyn, New York, United States
• Novartis Investigative Site — Rochester, New York, United States
• Novartis Investigative Site — Oklahoma City, Oklahoma, United States
• Novartis Investigative Site — Oklahoma City, Oklahoma, United States
• Novartis Investigative Site — Portland, Oregon, United States
• Novartis Investigative Site — Duncansville, Pennsylvania, United States
• Novartis Investigative Site — Wexford, Pennsylvania, United States
• Novartis Investigative Site — Wyomissing, Pennsylvania, United States
• Novartis Investigative Site — Jackson, Tennessee, United States
• Novartis Investigative Site — Kingsport, Tennessee, United States
• Novartis Investigative Site — Mesquite, Texas, United States
• Novartis Investigative Site — Seattle, Washington, United States
• Novartis Investigative Site — Seattle, Washington, United States
• Novartis Investigative Site — Seattle, Washington, United States
• Novartis Investigative Site — Spokane, Washington, United States
• Novartis Investigative Site — CABA, Buenos Aires, Argentina
• Novartis Investigative Site — San Miguel de Tucumán, Tucumán Province, Argentina
• Novartis Investigative Site — San Miguel de Tucumán, Argentina
• Novartis Investigative Site — Upland, California, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.