Phase
Condition
Arthritis And Arthritic Pain
Joint Injuries
Bone Diseases
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
Rendsburg 2848245, Schleswig-Holstein 2838632 24768
GermanySite Not Available
Novartis Investigative Site
Aachen, 52074
GermanySite Not Available
Novartis Investigative Site
Aachen 3247449, 52074
GermanySite Not Available
Novartis Investigative Site
Bad Bentheim, 48455
GermanySite Not Available
Novartis Investigative Site
Bad Bentheim 2953552, 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 Doberan 2953528, 18209
GermanySite Not Available
Novartis Investigative Site
Bad Pyrmont, 31812
GermanySite Not Available
Novartis Investigative Site
Berlin, 13125
GermanySite Not Available
Novartis Investigative Site
Berlin 2950159, 12435
GermanySite Not Available
Novartis Investigative Site
Bochum, 44791
GermanySite Not Available
Novartis Investigative Site
Bochum 2947416, 44791
GermanySite Not Available
Novartis Investigative Site
Chemnitz, 09130
GermanySite Not Available
Novartis Investigative Site
Cologne 2886242, 50937
GermanySite Not Available
Novartis Investigative Site
Cottbus, 03042
GermanySite Not Available
Novartis Investigative Site
Cottbus 2939811, 03042
GermanySite Not Available
Novartis Investigative Site
Dresden, 01307
GermanySite Not Available
Novartis Investigative Site
Dresden 2935022, 01307
GermanySite Not Available
Novartis Investigative Site
Ehringshausen, 35630
GermanySite Not Available
Novartis Investigative Site
Ehringshausen 2932788, 35630
GermanySite Not Available
Novartis Investigative Site
Erlangen, 91056
GermanySite Not Available
Novartis Investigative Site
Erlangen 2929567, 91056
GermanySite Not Available
Novartis Investigative Site
Frankfurt, 60590
GermanySite Not Available
Novartis Investigative Site
Frankfurt 2925536, 60590
GermanySite Not Available
Novartis Investigative Site
Freiburg, 79106
GermanySite Not Available
Novartis Investigative Site
Freiburg im Breisgau 2925177, 79106
GermanySite Not Available
Novartis Investigative Site
Gommern, 39245
GermanySite Not Available
Novartis Investigative Site
Gommern 2919138, 39245
GermanySite Not Available
Novartis Investigative Site
Gottingen, 37075
GermanySite Not Available
Novartis Investigative Site
Göttingen 2918632, 37075
GermanySite Not Available
Novartis Investigative Site
Hamburg, 22143
GermanySite Not Available
Novartis Investigative Site
Hamburg 2911298, 22391
GermanySite Not Available
Novartis Investigative Site
Herne, 44649
GermanySite Not Available
Novartis Investigative Site
Herne 2905891, 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
Leipzig 2879139, 04103
GermanySite Not Available
Novartis Investigative Site
Ludwigshafen, 67063
GermanySite Not Available
Novartis Investigative Site
Magdeburg, 39104
GermanySite Not Available
Novartis Investigative Site
Magdeburg 2874545, 39104
GermanySite Not Available
Novartis Investigative Site
Mainz, 55131
GermanySite Not Available
Novartis Investigative Site
Mainz 2874225, 55131
GermanySite Not Available
Novartis Investigative Site
Muenchen, 81541
GermanySite Not Available
Novartis Investigative Site
München 2867711, 81541
GermanySite Not Available
Novartis Investigative Site
Planegg, 82152
GermanySite Not Available
Novartis Investigative Site
Planegg 2853463, 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
Novartis Investigative Site
Ratingen 2850174, 40878
GermanySite Not Available

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