Phase
Condition
Psoriatic Arthritis
Arthritis And Arthritic Pain
Joint Injuries
Treatment
Ustekinumab
Secukinumab
Clinical Study ID
Ages 18-99 All Genders
Study Summary
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
Connect with a study center
Novartis Investigative Site
Rendsburg, Schleswig Holstein 24768
GermanySite Not Available
Novartis Investigative Site
Aachen, 52074
GermanySite Not Available
Novartis Investigative Site
Bad Bentheim, 48455
GermanySite Not Available
Novartis Investigative Site
Bad Bramstedt, 24576
GermanySite Not Available
Novartis Investigative Site
Bad Doberan, 18209
GermanySite Not Available
Novartis Investigative Site
Bad Pyrmont, 31812
GermanySite Not Available
Novartis Investigative Site
Berlin, 13125
GermanySite Not Available
Novartis Investigative Site
Bochum, 44791
GermanySite Not Available
Novartis Investigative Site
Chemnitz, 09130
GermanySite Not Available
Novartis Investigative Site
Cottbus, 03042
GermanySite Not Available
Novartis Investigative Site
Dresden, 01307
GermanySite Not Available
Novartis Investigative Site
Ehringshausen, 35630
GermanySite Not Available
Novartis Investigative Site
Erlangen, 91056
GermanySite Not Available
Novartis Investigative Site
Frankfurt, 60590
GermanySite Not Available
Novartis Investigative Site
Freiburg, 79106
GermanySite Not Available
Novartis Investigative Site
Gommern, 39245
GermanySite Not Available
Novartis Investigative Site
Gottingen, 37075
GermanySite Not Available
Novartis Investigative Site
Hamburg, 22143
GermanySite Not Available
Novartis Investigative Site
Herne, 44649
GermanySite Not Available
Novartis Investigative Site
Kiel, 24105
GermanySite Not Available
Novartis Investigative Site
Koeln, 51149
GermanySite Not Available
Novartis Investigative Site
Leipzig, 04103
GermanySite Not Available
Novartis Investigative Site
Ludwigshafen, 67063
GermanySite Not Available
Novartis Investigative Site
Magdeburg, 39104
GermanySite Not Available
Novartis Investigative Site
Mainz, 55131
GermanySite Not Available
Novartis Investigative Site
Muenchen, 81541
GermanySite Not Available
Novartis Investigative Site
Planegg, 82152
GermanySite Not Available
Novartis Investigative Site
Potsdam, 14469
GermanySite Not Available
Novartis Investigative Site
Puettlingen/saar, 66346
GermanySite Not Available
Novartis Investigative Site
Ratingen, 40878
GermanySite Not Available
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