Efficacy of Secukinumab Compared to Ustekinumab in Adults With Active Psoriatic Arthritis and Failure of TNFα-Inhibitor Treatment

Last updated: December 12, 2024
Sponsor: Novartis Pharmaceuticals
Overall Status: Completed

Phase

3

Condition

Psoriatic Arthritis

Arthritis And Arthritic Pain

Joint Injuries

Treatment

Ustekinumab

Secukinumab

Clinical Study ID

NCT04632927
CAIN457FDE04
2019-004246-15
  • Ages 18-99
  • All Genders

Study Summary

The purpose of this study is to compare the safety and efficacy of secukinumab and ustekinumab in patients with active psoriatic arthritis who showed failure to previous TNFα-inhibitor treatment

Eligibility Criteria

Inclusion

Key Inclusion Criteria:

  • Diagnosis of PsA as classified by CASPAR criteria for at least 6 months beforerandomization.

  • Active PsA at baseline defined as ≥ 3 tender joints out of 68 and ≥ 3 swollen jointsout of 66 (dactylitis of a digit counts as one joint each).

  • Inadequate response or intolerance to previous or current treatment with at leastone TNFα inhibitor

  • Inadequate response or intolerance to conventional disease modifying anti-rheumaticdrugs (cDMARDs)

  • Diagnosis of active plaque psoriasis, with at least one psoriatic plaque of ≥ 2 cmdiameter and/or nail changes consistent with psoriasis and/or documented history ofplaque psoriasis.

  • Rheumatoid factor (RF) and anti-cyclic citrullinated peptide (CCP) antibodiesnegative at screening.

Exclusion

Key Exclusion Criteria:

  • Pregnant or nursing women,

  • Previous exposure to secukinumab, ustekinumab or any other biologic drug directlytargeting IL-17, IL-17 receptor, IL-12 or IL-23.

  • Patients for whom the use of secukinumab or ustekinumab is contraindicated.

  • Use of any other investigational drug. Previous treatment with any cell-depletingtherapies including but not limited to anti-CD20 or investigational agents

  • Evidence of ongoing infectious or malignant process

  • Subjects receiving high potency opioid analgesics

  • Ongoing use of prohibited psoriasis treatments/medications

Other protocol-defined inclusion/exclusion criteria may apply

Study Design

Total Participants: 119
Treatment Group(s): 2
Primary Treatment: Ustekinumab
Phase: 3
Study Start date:
December 21, 2020
Estimated Completion Date:
October 22, 2024

Connect with a study center

  • Novartis Investigative Site

    Rendsburg, Schleswig Holstein 24768
    Germany

    Site Not Available

  • Novartis Investigative Site

    Aachen, 52074
    Germany

    Site Not Available

  • Novartis Investigative Site

    Bad Bentheim, 48455
    Germany

    Site Not Available

  • Novartis Investigative Site

    Bad Bramstedt, 24576
    Germany

    Site Not Available

  • Novartis Investigative Site

    Bad Doberan, 18209
    Germany

    Site Not Available

  • Novartis Investigative Site

    Bad Pyrmont, 31812
    Germany

    Site Not Available

  • Novartis Investigative Site

    Berlin, 13125
    Germany

    Site Not Available

  • Novartis Investigative Site

    Bochum, 44791
    Germany

    Site Not Available

  • Novartis Investigative Site

    Chemnitz, 09130
    Germany

    Site Not Available

  • Novartis Investigative Site

    Cottbus, 03042
    Germany

    Site Not Available

  • Novartis Investigative Site

    Dresden, 01307
    Germany

    Site Not Available

  • Novartis Investigative Site

    Ehringshausen, 35630
    Germany

    Site Not Available

  • Novartis Investigative Site

    Erlangen, 91056
    Germany

    Site Not Available

  • Novartis Investigative Site

    Frankfurt, 60590
    Germany

    Site Not Available

  • Novartis Investigative Site

    Freiburg, 79106
    Germany

    Site Not Available

  • Novartis Investigative Site

    Gommern, 39245
    Germany

    Site Not Available

  • Novartis Investigative Site

    Gottingen, 37075
    Germany

    Site Not Available

  • Novartis Investigative Site

    Hamburg, 22143
    Germany

    Site Not Available

  • Novartis Investigative Site

    Herne, 44649
    Germany

    Site Not Available

  • Novartis Investigative Site

    Kiel, 24105
    Germany

    Site Not Available

  • Novartis Investigative Site

    Koeln, 51149
    Germany

    Site Not Available

  • Novartis Investigative Site

    Leipzig, 04103
    Germany

    Site Not Available

  • Novartis Investigative Site

    Ludwigshafen, 67063
    Germany

    Site Not Available

  • Novartis Investigative Site

    Magdeburg, 39104
    Germany

    Site Not Available

  • Novartis Investigative Site

    Mainz, 55131
    Germany

    Site Not Available

  • Novartis Investigative Site

    Muenchen, 81541
    Germany

    Site Not Available

  • Novartis Investigative Site

    Planegg, 82152
    Germany

    Site Not Available

  • Novartis Investigative Site

    Potsdam, 14469
    Germany

    Site Not Available

  • Novartis Investigative Site

    Puettlingen/saar, 66346
    Germany

    Site Not Available

  • Novartis Investigative Site

    Ratingen, 40878
    Germany

    Site Not Available

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