Efficacy of Secukinumab Compared to Ustekinumab in Adults With Active Psoriatic Arthritis and Fai… (NCT04632927) | Clinical Trial Compass
CompletedPhase 3
Efficacy of Secukinumab Compared to Ustekinumab in Adults With Active Psoriatic Arthritis and Failure of TNFα-Inhibitor Treatment
Germany119 participantsStarted 2020-12-21
Plain-language 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
Who can participate
Age range18 Years – 99 Years
SexALL
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Key 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 TNFα 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.
Key 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
What they're measuring
1
Proportion of Patients With Health Assessment Questionnaire - Disability Index (HAQ-DI) Response at Week 28