Efficacy of Secukinumab Compared to Adalimumab in Patients With Psoriatic Arthritis
NCT ID: NCT02745080
Last Updated: 2021-01-27
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
853 participants
INTERVENTIONAL
2017-04-03
2019-12-30
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Secukinumab 300 mg s.c.
Secukinumab 300 mg administered at Baseline, Weeks 1, 2, 3 and 4, followed by dosing every 4 weeks until Week 48.
Secukinumab
Eligible subjects are randomized to one of two treatment arms in a 1:1 ratio
Adalimumab 40 mg s.c.
Adalimumab 40 mg administered at Baseline followed by dosing every 2 weeks until Week 50.
Adalimumab
Eligible subjects are randomized to one of two treatment arms in a 1:1 ratio
Interventions
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Secukinumab
Eligible subjects are randomized to one of two treatment arms in a 1:1 ratio
Adalimumab
Eligible subjects are randomized to one of two treatment arms in a 1:1 ratio
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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.
Exclusion Criteria
* 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.
18 Years
ALL
No
Sponsors
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Novartis Pharmaceuticals
INDUSTRY
Responsible Party
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Principal Investigators
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Novartis Pharmaceuticals
Role: STUDY_DIRECTOR
Novartis Pharmaceuticals
Locations
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Novartis Investigative Site
Fountain Valley, California, United States
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Fullerton, California, United States
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La Mesa, California, United States
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Upland, California, United States
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Bowling Green, Kentucky, United States
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St Louis, Missouri, United States
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Lincoln, Nebraska, United States
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Omaha, Nebraska, United States
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Rochester, New York, United States
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Bethlehem, Pennsylvania, United States
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Duncansville, Pennsylvania, United States
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Arlington, Texas, United States
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Austin, Texas, United States
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Dallas, Texas, United States
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Mesquite, Texas, United States
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Burlington, Vermont, United States
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Seattle, Washington, United States
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Spokane, Washington, United States
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Glendale, Wisconsin, United States
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Kogarah, New South Wales, Australia
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Maroochydore, Queensland, Australia
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Hobart, Tasmania, Australia
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Malvern East, Victoria, Australia
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Pleven, , Bulgaria
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Plovdiv, , Bulgaria
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Plovdiv, , Bulgaria
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Sofia, , Bulgaria
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Sofia, , Bulgaria
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Victoria, British Columbia, Canada
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Winnipeg, Manitoba, Canada
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Trois-Rivières, Quebec, Canada
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Bruntál, , Czechia
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Prague, , Czechia
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Prague, , Czechia
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Uherské Hradiště, , Czechia
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Zlín, , Czechia
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Frederiksberg, , Denmark
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Tallinn, , Estonia
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Tallinn, , Estonia
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Tartu, , Estonia
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Hyvinkää, , Finland
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Kuopio, , Finland
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Brive-la-Gaillarde, , France
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Cahors, , France
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Chambray-lès-Tours, , France
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Le Mans, , France
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Orléans, , France
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Paris, , France
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Poitiers, , France
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Bad Doberan, , Germany
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Berlin, , Germany
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Berlin, , Germany
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Berlin, , Germany
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Berlin, , Germany
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Bochum, , Germany
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Erlangen, , Germany
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Hamburg, , Germany
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Herne, , Germany
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Leipzig, , Germany
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Magdeburg, , Germany
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Osnabrück, , Germany
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Schwerin, , Germany
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Athens, , Greece
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Athens, , Greece
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Thessaloniki, , Greece
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Budapest, , Hungary
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Budapest, , Hungary
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Budapest, , Hungary
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Debrecen, , Hungary
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Győr, , Hungary
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Kistarcsa, , Hungary
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Veszprém, , Hungary
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Reykjavik, , Iceland
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Mumbai, Maharashtra, India
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Nashik, Maharashtra, India
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Secunderabad, Telangana, India
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New Delhi, , India
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Haifa, , Israel
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Haifa, , Israel
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Haifa, , Israel
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Kfar Saba, , Israel
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Petah Tikva, , Israel
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Ramat Gan, , Israel
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Tel Aviv, , Israel
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Arenzano, GE, Italy
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Rozzano, MI, Italy
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Verona, VR, Italy
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Bologna, , Italy
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Pisa, , Italy
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Torino, , Italy
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Riga, , Latvia
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Valmiera, , Latvia
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Kaunas, LTU, Lithuania
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Klaipėda, , Lithuania
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Šiauliai, , Lithuania
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Enschede, , Netherlands
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Sneek, , Netherlands
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Dopiewo, , Poland
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Szczecin, , Poland
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Warsaw, , Poland
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Warsaw, , Poland
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Lisbon, , Portugal
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Lisbon, , Portugal
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Ponte de Lima, , Portugal
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Porto, , Portugal
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Porto, , Portugal
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Kemerovo, , Russia
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Kemerovo, , Russia
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Moscow, , Russia
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Moscow, , Russia
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Nizhny Novgorod, , Russia
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Petrozavodsk, , Russia
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Rostov-on-Don, , Russia
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Smolensk, , Russia
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Yaroslavl, , Russia
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Yekaterinburg, , Russia
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Bratislava, , Slovakia
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Košice, , Slovakia
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Partizánske, , Slovakia
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Topoľčany, , Slovakia
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Seoul, Seocho Gu, South Korea
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Córdoba, Andalusia, Spain
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Málaga, Andalusia, Spain
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Seville, Andalusia, Spain
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Badalona, Barcelona, Spain
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L'Hospitalet de Llobregat, Barcelona, Spain
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Sabadell, Barcelona, Spain
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Bilbao, Basque Country, Spain
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Santander, Cantabria, Spain
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Barcelona, Catalonia, Spain
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Mérida, Extremadura, Spain
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A Coruña, Galicia, Spain
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Santiago de Compostela, Galicia, Spain
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San Cristóbal de La Laguna, Santa Cruz De Tenerife, Spain
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Valencia, Valencia, Spain
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Barakaldo, Vizcaya, Spain
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Barcelona, , Spain
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Madrid, , Spain
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Madrid, , Spain
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Seville, , Spain
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Valencia, , Spain
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Torquay, Devon, United Kingdom
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Leytonstone, London, United Kingdom
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Salford, Manchester, United Kingdom
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Cannock, Staffordshire, United Kingdom
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Stoke-on-Trent, Staffordshire, United Kingdom
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Edinburgh, , United Kingdom
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Glasgow, , United Kingdom
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Hull, , United Kingdom
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London, , United Kingdom
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London, , United Kingdom
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Newcastle upon Tyne, , United Kingdom
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Plymouth, , United Kingdom
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Solihull, , United Kingdom
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Wigan, , United Kingdom
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Wolverhampton, , United Kingdom
Countries
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References
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Kaeley GS, Schett G, Conaghan PG, McGonagle D, Behrens F, Goupille P, Gaillez C, Parikh B, Bakewell C. Enthesitis in patients with psoriatic arthritis treated with secukinumab or adalimumab: a post hoc analysis of the EXCEED study. Rheumatology (Oxford). 2024 Jan 4;63(1):41-49. doi: 10.1093/rheumatology/kead181.
McInnes IB, Behrens F, Mease PJ, Kavanaugh A, Ritchlin C, Nash P, Masmitja JG, Goupille P, Korotaeva T, Gottlieb AB, Martin R, Ding K, Pellet P, Mpofu S, Pricop L; EXCEED Study Group. Secukinumab versus adalimumab for treatment of active psoriatic arthritis (EXCEED): a double-blind, parallel-group, randomised, active-controlled, phase 3b trial. Lancet. 2020 May 9;395(10235):1496-1505. doi: 10.1016/S0140-6736(20)30564-X.
Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Related Links
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Secukinumab versus adalimumab for treatment of active psoriatic arthritis (EXCEED): a double-blind, parallel-group, randomised, active-controlled, phase 3b trial
Other Identifiers
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2015-004477-32
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
CAIN457F2366
Identifier Type: -
Identifier Source: org_study_id
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