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).

View Full Description

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.

View Eligibility Criteria

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.

Study is for people with:

Psoriasis

Phase:

Phase 3

Estimated Enrollment:

853

Study ID:

NCT02745080

Recruitment Status:

Completed

Sponsor:

Novartis Pharmaceuticals

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There are 156 Locations for this study

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

How clear is this clinincal trial information?

Study is for people with:

Psoriasis

Phase:

Phase 3

Estimated Enrollment:

853

Study ID:

NCT02745080

Recruitment Status:

Completed

Sponsor:


Novartis Pharmaceuticals

How clear is this clinincal trial information?

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