Secukinumab Safety and Efficacy in Juvenile Psoriatic Arthritis (JPsA) and Enthesitis-related Arthritis (ERA)

Part of paid clinical trials in Los Angeles, California.

Sponsor
Novartis Pharmaceuticals
Study ID
NCT03031782
Phase
PHASE3
Status
Completed

Conditions

  • Enthesitis-related Arthritis
  • Juvenile Psoriatic Arthritis

Eligibility Criteria

Sex
ALL
Age
2 Years - 17 Years
Healthy Volunteers
Not accepted

Interventions

  • secukinumab — DRUG
    secukinumab is a high-affinity fully human monoclonal anti-human antibody that targets IL-17A and neutralizes activity.
  • placebo — OTHER
    Matched placebo to AIN457 for use in the double blind Treatment Period 2

Study Details

This was a double-blind, placebo-controlled, event-driven randomized withdrawal study to investigate the efficacy and safety of secukinumab treatment in the Juvenile Idiopathic Arthritis (JIA) categories of Juvenile Psoriatic Arthritis (JPsA) and Enthesitis-related Arthritis (ERA). The study was divided into 3 parts (plus a post-treatment follow-up period) consisting of open-label, single-arm active treatment in Treatment Periods 1 and 3 and a randomized, double-blind, placebo controlled, event-driven withdrawal design in Treatment Period 2

Key Dates

Start date
May 23, 2017
Status verified
Aug 2022
Primary completion
Oct 7, 2020
Completion
Nov 9, 2020

Study Design

Enrollment
86 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Treatment Period 2 - active
    secukinumab (AIN457 - pre-filled syringe) for patients with a minimum American college of Rheumatology (ACR) 30 response in Treatment Period 1
  • Placebo Comparator: Treatment Period 2 - placebo
    placebo comparator (matched to secukinumab treatment) for patients with a minimum American college of Rheumatology (ACR) 30 response in Treatment Period 1

Primary Outcome Measure

Number of Participants Experiencing a Flare During Treatment Period 2 [ Time Frame: From Week 12 until max Week 104 ]

Locations (4)

FacilityCityStateZIPSite coordinators
Novartis Investigative SiteLos AngelesCalifornia90027-
Novartis Investigative SiteBoiseIdaho83702-
Novartis Investigative SiteCincinnatiOhio45229-
Novartis Investigative SitePortlandOregon97232-

Find similar trials in Los Angeles, CA

By research site
Novartis Investigative Site· Los Angeles, CANovartis Investigative Site· Boise, IDNovartis Investigative Site· Cincinnati, OHNovartis Investigative Site· Portland, OR

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