Efficacy of Secukinumab Compared to Adalimumab in Patients With Psoriatic Arthritis
Launched by NOVARTIS PHARMACEUTICALS · Apr 19, 2016
Trial Information
Current as of May 12, 2025
Completed
Keywords
ClinConnect Summary
The total maximum study duration, including the screening period was up to 76 weeks.
At Baseline, patients whose eligibility was confirmed were randomized to 1 of 2 groups (1:1): Group 1 (secukinumab 300 mg) or Group 2 (adalimumab 40 mg).
In order to maintain the blind, both groups received 1 or 2 placebo s.c. injections to keep consistency in the number of injections at each dosing visit. Secukinumab (300 mg) was available in 2 x 1.0 mL pre-filled syringes (PFS) and adalimumab was available in 1 x 0.4 mL PFS. Placebo (1.0 and 0.5 mL PFS) was also available.
Secukinumab 300 mg s.c inject...
Gender
ALL
Eligibility criteria
- Key Inclusion Criteria:
- • Diagnosis of PsA classified by CASPAR
- • Rheumatoid factor and anti-CCP antibodies negative
- • Diagnosis of active plaque psoriasis, with at least one psoriatic plaque of \>= 2cm diameter or nail changes consistent with psoriasis or documented history of plaque psoriasis
- • Inadequate control of symptoms with NSAIDs
- • Inadequate control of symptoms with a conventional DMARD.
- Key Exclusion Criteria:
- • Pregnant or nursing women
- • Evidence of ongoing infectious or malignant process
- • Previous exposure to any biologic drug for Psoriatic Arthritis or Psoriasis
- • Subjects taking high potency opioid analgesics
- • Ongoing use of prohibited psoriasis treatments/medications
- • Previous treatment with any cell-depleting therapies including but not limited to anti-CD20 investigational agents.
About Novartis Pharmaceuticals
Novartis Pharmaceuticals is a global healthcare company dedicated to reimagining medicine to improve and extend people's lives. With a strong focus on innovation, Novartis engages in the research, development, and commercialization of a broad range of therapies across various therapeutic areas, including oncology, cardiology, dermatology, and neuroscience. The company is committed to advancing scientific knowledge and patient care through clinical trials that prioritize safety and efficacy. Novartis leverages cutting-edge technology and collaborative partnerships to address unmet medical needs and deliver transformative treatments that enhance patient outcomes worldwide.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Enschede, , Netherlands
Fountain Valley, California, United States
Fullerton, California, United States
Omaha, Nebraska, United States
Rochester, New York, United States
Burlington, Vermont, United States
Plovdiv, , Bulgaria
Berlin, , Germany
Kistarcsa, , Hungary
Madrid, , Spain
London, , United Kingdom
Poitiers, , France
Leipzig, , Germany
Barcelona, Catalunya, Spain
Paris, , France
Cordoba, Andalucia, Spain
Santander, Cantabria, Spain
Barcelona, Catalunya, Spain
Baracaldo, Vizcaya, Spain
Winnipeg, Manitoba, Canada
Verona, Vr, Italy
Sevilla, Andalucia, Spain
Sabadell, Barcelona, Spain
La Coruna, Galicia, Spain
Plymouth, , United Kingdom
Bologna, , Italy
Pisa, , Italy
Austin, Texas, United States
Kogarah, New South Wales, Australia
Hobart, Tasmania, Australia
Petach Tikva, , Israel
Ramat Gan, , Israel
Newcastle Upon Tyne, , United Kingdom
Dallas, Texas, United States
Haifa, , Israel
Seoul, Seocho Gu, Korea, Republic Of
Santiago De Compostela, Galicia, Spain
Bilbao, Pais Vasco, Spain
La Laguna, Santa Cruz De Tenerife, Spain
Bethlehem, Pennsylvania, United States
Mesquite, Texas, United States
Seattle, Washington, United States
Athens, , Greece
Gyor, , Hungary
New Delhi, , India
Frederiksberg, , Denmark
Debrecen, , Hungary
Arenzano, Ge, Italy
Bratislava, , Slovakia
Valencia, Comunidad Valenciana, Spain
Rozzano, Mi, Italy
Klaipeda, , Lithuania
Duncansville, Pennsylvania, United States
Magdeburg, , Germany
Budapest, , Hungary
Bochum, , Germany
Salford, Manchester, United Kingdom
Petrozavodsk, , Russian Federation
Spokane, Washington, United States
Herne, , Germany
Hamburg, , Germany
Veszprem, , Hungary
Wolverhampton, , United Kingdom
Pleven, , Bulgaria
Siauliai, , Lithuania
Sneek, , Netherlands
Tallinn, , Estonia
Ekaterinburg, , Russian Federation
Nizhny Novgorod, , Russian Federation
Orleans, , France
Moscow, , Russian Federation
Yaroslavl, , Russian Federation
Lincoln, Nebraska, United States
Rostov On Don, , Russian Federation
Tel Aviv, , Israel
Kfar Saba, , Israel
Torino, , Italy
Kuopio, , Finland
Kemerovo, , Russian Federation
Szczecin, , Poland
Smolensk, , Russian Federation
Saint Louis, Missouri, United States
Edinburgh, , United Kingdom
Hull, , United Kingdom
Nashik, Maharashtra, India
Leytonstone, London, United Kingdom
Secunderabad, Telangana, India
Kaunas, Ltu, Lithuania
Upland, California, United States
Bowling Green, Kentucky, United States
Trois Rivieres, Quebec, Canada
Erlangen, , Germany
Bad Doberan, , Germany
Schwerin, , Germany
Topolcany, , Slovakia
Mumbai, Maharashtra, India
Sofia, , Bulgaria
Maroochydore, Queensland, Australia
Kosice, , Slovakia
Valmiera, , Latvia
Praha 5, , Czechia
Osnabruck, , Germany
Uherske Hradiste, , Czechia
Hyvinkaa, , Finland
Thessaloniki, , Greece
Malvern East, Victoria, Australia
Lisboa, , Portugal
Merida, Extremadura, Spain
Torquay, Devon, United Kingdom
Glasgow, , United Kingdom
Victoria, British Columbia, Canada
Stoke On Trent, Staffordshire, United Kingdom
Praha 2, , Czechia
Partizanske, , Slovakia
Arlington, Texas, United States
Le Mans, , France
Dopiewo, , Poland
Tartu, , Estonia
Wigan, , United Kingdom
Malaga, Andalucia, Spain
Zlin, , Czechia
Chambray Les Tours, , France
Ponte De Lima, , Portugal
Bruntal, , Czechia
La Mesa, California, United States
Glendale, Wisconsin, United States
Brive La Gaillarde, , France
Cahors, , France
Reykjavik, , Iceland
Riga, , Latvia
Warszawa, , Poland
Porto, , Portugal
Badalona, Barcelona, Spain
L Hospitalet De Llobregat, Barcelona, Spain
Cannock, Staffordshire, United Kingdom
Solihull, , United Kingdom
Patients applied
Trial Officials
Novartis Pharmaceuticals
Study Director
Novartis Pharmaceuticals
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported
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