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

  • STATUS
    Recruiting
  • End date
    Apr 16, 2023
  • participants needed
    310
  • sponsor
    Novartis Pharmaceuticals
Updated on 21 July 2021
psoriasis
secukinumab
ustekinumab
tumor necrosis factor
arthritis
anti-rheumatic drugs
dactylitis
plaque psoriasis
psoriatic plaque
rheumatoid factor

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 TNF-inhibitor treatment

Details
Condition Psoriasis, PSORIATIC ARTHRITIS, Arthritis, Arthritis and Arthritic Pain, Psoriasis and Psoriatic Disorders, Arthritis and Arthritic Pain (Pediatric)
Treatment Secukinumab, ustekinumab
Clinical Study IdentifierNCT04632927
SponsorNovartis Pharmaceuticals
Last Modified on21 July 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

Diagnosis of PsA as classified by CASPAR criteria for at least 6 months before randomization
Active PsA at baseline defined as 3 tender joints out of 68 and 3 swollen joints out of 66 (dactylitis of a digit counts as one joint each)
Inadequate response or intolerance to previous or current treatment with at least one TNF inhibitor
Inadequate response or intolerance to conventional disease modifying anti-rheumatic drugs (cDMARDs)
Diagnosis of active plaque psoriasis, with at least one psoriatic plaque of 2 cm diameter and/or nail changes consistent with psoriasis and/or documented history of plaque psoriasis
Rheumatoid factor (RF) and anti-cyclic citrullinated peptide (CCP) antibodies negative at screening

Exclusion Criteria

Pregnant or nursing women
Previous exposure to secukinumab, ustekinumab or any other biologic drug directly targeting 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-depleting therapies 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
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