A Phase III, Randomized, Double-blind, Placebo-controlled Study of Subcutaneous Secukinumab in Autoinjectors, to Demonstrate Efficacy at 24 Weeks and Long Term Safety and Efficacy up to 3.5 Years in Subjects With Active Psoriatic Arthritis

  • STATUS
    Recruiting
  • sponsor
    Novartis
Updated on 23 November 2020

Summary

A Phase III, Randomized, Double-blind, Placebo-controlled Study of Subcutaneous Secukinumab in Autoinjectors, to Demonstrate Efficacy at 24 Weeks and Long Term Safety and Efficacy up to 3.5 Years in Subjects With Active Psoriatic Arthritis

Description

The purpose of this study is to provide 24 - 52 week efficacy, safety and tolerability data, as well as up to 3.5-year efficacy, safety and tolerability data in subjects with active Psoriatic Arthritis despite current or previous nonsteroidal anti-inflammatory drug (NSAID), disease-modifying antirheumatic drug (DMARD) therapy and/or previous anti-tumor necrosis factor alpha (TNFa) therapy.

Novartis Pharmaceuticals 1-888-669-6682
ClinicalTrials.gov identifier: NCT01989468

Details
Clinical Study IdentifierTX139140
SponsorNovartis
Last Modified on23 November 2020

Eligibility

Yes No Not Sure

Inclusion Criteria

Diagnosis of Psoriatic Arthritis (PsA) classified by ClASsification criteria for Psoriatic ARthritis (CASPAR) criteria
Rheumatoid factor and anti-cyclic citrullinated peptide (CCP) antibodies negative
Diagnosis of active plaque psoriasis or nail changes consistent with psoriasis
Inadequate control of symptoms with NSAID

Exclusion Criteria

Chest X-ray or chest magnetic resonance imaging (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 interleukin-17 (IL-17) or IL-17 receptor
Ongoing use of prohibited psoriasis treatments / medications
Subjects who have ever received biologic immunomodulating agents except for those targeting TNFa
Previous treatment with any cell-depleting therapies
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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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