Psoriasis Clinical Trial
Efficacy of Secukinumab Compared to Adalimumab in Patients With Psoriatic Arthritis
Summary
This was a randomized, double-blind, active controlled, multicenter, parallel-group study evaluating secukinumab monotherapy and adalimumab monotherapy in approximately 850 patients with active psoriatic arthritis (PsA) who are naïve to biologic therapy and are intolerant or having inadequate response to conventional disease modifying anti-rheumatic drugs (also known as non-biologic DMARDs).
Full Description
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 injection (2 x 1 mL PFS) was administered at Baseline, Weeks 1, 2, 3 and 4, followed by dosing every 4 weeks to Week 48.
Adalimumab 40 mg (1 x 0.4 mL PFS) was administered at Baseline followed by dosing every 2 weeks until Week 50.
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.
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There are 156 Locations for this study
Fountain Valley California, 92708, United States
Fullerton California, 92835, United States
La Mesa California, 91942, United States
Upland California, 91786, United States
Bowling Green Kentucky, 42101, United States
Saint Louis Missouri, 63117, United States
Lincoln Nebraska, 68516, United States
Omaha Nebraska, 68114, United States
Rochester New York, 14623, United States
Bethlehem Pennsylvania, 18015, United States
Duncansville Pennsylvania, 16635, United States
Arlington Texas, 76011, United States
Austin Texas, 78731, United States
Dallas Texas, 75231, United States
Mesquite Texas, 75150, United States
Burlington Vermont, 05401, United States
Seattle Washington, 98122, United States
Spokane Washington, 99204, United States
Glendale Wisconsin, 53217, United States
Kogarah New South Wales, 2217, Australia
Maroochydore Queensland, 4558, Australia
Hobart Tasmania, 7000, Australia
Malvern East Victoria, 3145, Australia
Pleven , 5800, Bulgaria
Plovdiv , 4000, Bulgaria
Plovdiv , 4002, Bulgaria
Sofia , 1413, Bulgaria
Sofia , 1606, Bulgaria
Victoria British Columbia, V8V 3, Canada
Winnipeg Manitoba, R3A 1, Canada
Trois-Rivieres Quebec, G8Z 1, Canada
Bruntal , 792 0, Czechia
Praha 2 , 128 5, Czechia
Praha 5 , 150 0, Czechia
Uherske Hradiste , 686 0, Czechia
Zlin , 760 0, Czechia
Frederiksberg , DK-20, Denmark
Tallinn , 10138, Estonia
Tallinn , 13419, Estonia
Tartu , 50406, Estonia
Hyvinkaa , 05800, Finland
Kuopio , 70100, Finland
Brive-la-Gaillarde , 19100, France
Cahors , 46000, France
Chambray les Tours , 37170, France
Le Mans , 72037, France
Orleans , 45100, France
Paris , 75010, France
Poitiers , 86021, France
Bad Doberan , 18209, Germany
Berlin , 10117, Germany
Berlin , 12161, Germany
Berlin , 13353, Germany
Berlin , 14059, Germany
Bochum , 44791, Germany
Erlangen , 91056, Germany
Hamburg , 22415, Germany
Herne , 44649, Germany
Leipzig , 04103, Germany
Magdeburg , 39110, Germany
Osnabruck , 49074, Germany
Schwerin , 19055, Germany
Athens , 115 2, Greece
Athens , 12462, Greece
Thessaloniki , 54642, Greece
Budapest , 1023, Hungary
Budapest , 1027, Hungary
Budapest , 1062, Hungary
Debrecen , 4032, Hungary
Gyor , 9023, Hungary
Kistarcsa , 2143, Hungary
Veszprem , 8200, Hungary
Reykjavik , 108, Iceland
Mumbai Maharashtra, 400 0, India
Nashik Maharashtra, 422 1, India
Secunderabad Telangana, 50000, India
New Delhi , 11002, India
Haifa , 33394, Israel
Haifa , 34362, Israel
Haifa , 35254, Israel
Kfar Saba , 44281, Israel
Petach Tikva , 49100, Israel
Ramat Gan , 52621, Israel
Tel Aviv , 64239, Israel
Arenzano GE, 16011, Italy
Rozzano MI, 20089, Italy
Verona VR, 37126, Italy
Bologna , 40138, Italy
Pisa , 56126, Italy
Torino , 10126, Italy
Seoul Seocho Gu, 06591, Korea, Republic of
Riga , LV-10, Latvia
Valmiera , LV-42, Latvia
Kaunas LTU, LT 50, Lithuania
Klaipeda , LT-92, Lithuania
Siauliai , LT-76, Lithuania
Enschede , 7513 , Netherlands
Sneek , 8601 , Netherlands
Dopiewo , 62 06, Poland
Szczecin , 71-25, Poland
Warszawa , 02 63, Poland
Warszawa , 04141, Poland
Lisboa , 1050-, Portugal
Lisboa , 1649-, Portugal
Ponte de Lima , 4990 , Portugal
Porto , 4099 , Portugal
Porto , 4200 , Portugal
Ekaterinburg , 62002, Russian Federation
Kemerovo , 65002, Russian Federation
Kemerovo , 65005, Russian Federation
Moscow , 11552, Russian Federation
Moscow , 11904, Russian Federation
Nizhny Novgorod , 60301, Russian Federation
Petrozavodsk , 18501, Russian Federation
Rostov on Don , 34402, Russian Federation
Smolensk , 21401, Russian Federation
Yaroslavl , 15000, Russian Federation
Bratislava , 81369, Slovakia
Kosice , 04011, Slovakia
Partizanske , 95801, Slovakia
Topolcany , 95501, Slovakia
Cordoba Andalucia, 14004, Spain
Malaga Andalucia, 29009, Spain
Sevilla Andalucia, 41013, Spain
Badalona Barcelona, 08916, Spain
L Hospitalet De Llobregat Barcelona, 08907, Spain
Sabadell Barcelona, 08208, Spain
Santander Cantabria, 39008, Spain
Barcelona Catalunya, 08036, Spain
Valencia Comunidad Valenciana, 46017, Spain
Merida Extremadura, 06800, Spain
La Coruna Galicia, 15006, Spain
Santiago de Compostela Galicia, 15706, Spain
Bilbao Pais Vasco, 48013, Spain
La Laguna Santa Cruz De Tenerife, 38320, Spain
Baracaldo Vizcaya, 48903, Spain
Barcelona , 08025, Spain
Madrid , 28041, Spain
Madrid , 28942, Spain
Sevilla , 41014, Spain
Valencia , 46026, Spain
Torquay Devon, TQ2 7, United Kingdom
Leytonstone London, E11 1, United Kingdom
Salford Manchester, M6 8H, United Kingdom
Cannock Staffordshire, WS11 , United Kingdom
Stoke on Trent Staffordshire, ST6 7, United Kingdom
Edinburgh , EH4 2, United Kingdom
Glasgow , G31 2, United Kingdom
Hull , HU3 2, United Kingdom
London , NW3 2, United Kingdom
London , SE1 9, United Kingdom
Newcastle Upon Tyne , NE7 7, United Kingdom
Plymouth , PL6 8, United Kingdom
Solihull , B91 2, United Kingdom
Wigan , WN6 9, United Kingdom
Wolverhampton , WV10 , United Kingdom
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