Efficacy of Secukinumab Compared to Adalimumab in Patients With Psoriatic Arthritis

NCT02745080 | Completed Phase 3 Results FDA Drug

• 2 other identifiers: CAIN457F23662015-004477-32
• Study Type: interventional
• Target: 853
• Locations: 25 countries
• Sites: 153

Brief 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).

Conditions

Psoriatic Arthritis

Keywords

Psoriatic Arthritis; secukinumab; adalimumab; monoclonal antibody; CASPAR

Outcome Measures

Primary Outcomes (1)

• Percentage of Participants Who Achieved an American College of Rheumatology 20% (ACR20) Response at Week 52

  Clinical response, failure to permanently discontinue study medication prematurely, and lack of need for rescue medication was required for a patient to achieve treatment success. The primary endpoint is the proportion of patients with monotherapy ACR20 response at Week 52 where monotherapy ACR20 response is defined as meeting the following 3 conditions: 1. achieving American College of Rheumatology 20 (ACR20) response 2. no permanent study treatment (secukinumab or adalimumab) discontinuation before or at Week 50 (the last dosing visit) 3. no use of conventional disease modifying anti-rheumatic drugs (also known as non-biologic DMARDs) cDMARDs (including Methotrexate (MTX)) after Week 36 (regardless of the starting time of taking cDMARDs)

  Week 52

Secondary Outcomes (4)

• Percentage of Participants Who Achieved a Psoriasis Area and Severity Index (PASI)-90 Response at Week 52

  Week 52

• Percentage of Participants Who Achieved an American College of Rheumatology 50% (ACR50) Response at Week 52

  Week 52

• Change From Baseline in Health Assessment Questionnaire - Disability Index (HAQ-DI Score) at Week 52

  Baseline, Week 52

• Percentage of Participants Who Achieved Resolution of Enthesitis at Week 52

  Week 52

Study Arms (2)

Secukinumab 300 mg s.c.

EXPERIMENTAL

Secukinumab 300 mg administered at Baseline, Weeks 1, 2, 3 and 4, followed by dosing every 4 weeks until Week 48.

Biological: Secukinumab

Adalimumab 40 mg s.c.

ACTIVE COMPARATOR

Adalimumab 40 mg administered at Baseline followed by dosing every 2 weeks until Week 50.

Biological: Adalimumab

Interventions

Secukinumab BIOLOGICAL

Eligible subjects are randomized to one of two treatment arms in a 1:1 ratio

Also known as: AIN457

Secukinumab 300 mg s.c.

Adalimumab BIOLOGICAL

Eligible subjects are randomized to one of two treatment arms in a 1:1 ratio

Adalimumab 40 mg s.c.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Novartis Pharmaceuticals: lead

Study Sites (156)

Novartis Investigative Site

Fountain Valley, California, 92708, United States

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Novartis Investigative Site

Fullerton, California, 92835, United States

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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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St 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

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Plovdiv, 4002, Bulgaria

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Sofia, 1413, Bulgaria

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Sofia, 1606, Bulgaria

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Victoria, British Columbia, V8V 3M9, Canada

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Winnipeg, Manitoba, R3A 1M1, Canada

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Trois-Rivières, Quebec, G8Z 1Y2, Canada

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Novartis Investigative Site

Bruntál, 792 01, Czechia

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Prague, 128 50, Czechia

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Prague, 150 06, Czechia

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Uherské Hradiště, 686 01, Czechia

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Zlín, 760 01, Czechia

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Frederiksberg, DK-2000, Denmark

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Tallinn, 10138, Estonia

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Tallinn, 13419, Estonia

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Tartu, 50406, Estonia

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Hyvinkää, 05800, Finland

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Kuopio, 70100, Finland

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Brive-la-Gaillarde, 19100, France

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Cahors, 46000, France

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Chambray-lès-Tours, 37170, France

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Le Mans, 72037, France

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Orléans, 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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Osnabrück, 49074, Germany

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Schwerin, 19055, Germany

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Athens, 115 27, 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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Győr, 9023, Hungary

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Kistarcsa, 2143, Hungary

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Veszprém, 8200, Hungary

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Reykjavik, 108, Iceland

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Mumbai, Maharashtra, 400 053, India

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Nashik, Maharashtra, 422 101, India

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Secunderabad, Telangana, 500003, India

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New Delhi, 110029, India

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Haifa, 3339419, Israel

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Haifa, 343621, Israel

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Haifa, 3525408, Israel

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Kfar Saba, 4428164, Israel

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Petah Tikva, 49100, Israel

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Ramat Gan, 52621, Israel

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Tel Aviv, 6423906, 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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Riga, LV-1005, Latvia

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Valmiera, LV-4201, Latvia

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Kaunas, LTU, LT 50161, Lithuania

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Klaipėda, LT-92288, Lithuania

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Šiauliai, LT-76231, Lithuania

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Enschede, 7513 ER, Netherlands

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Sneek, 8601 ZK, Netherlands

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Dopiewo, 62 069, Poland

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Szczecin, 71-252, Poland

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Warsaw, 02 637, Poland

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Warsaw, 04141, Poland

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Lisbon, 1050-034, Portugal

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Lisbon, 1649-035, Portugal

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Ponte de Lima, 4990 041, Portugal

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Porto, 4099 001, Portugal

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Porto, 4200 319, Portugal

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Novartis Investigative Site

Kemerovo, 650029, Russia

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Kemerovo, 650056, Russia

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Moscow, 115522, Russia

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Moscow, 119049, Russia

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Nizhny Novgorod, 603018, Russia

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Petrozavodsk, 185019, Russia

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Rostov-on-Don, 344022, Russia

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Smolensk, 214019, Russia

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Yaroslavl, 150003, Russia

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Yekaterinburg, 620028, Russia

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Bratislava, 81369, Slovakia

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Košice, 04011, Slovakia

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Partizánske, 95801, Slovakia

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Topoľčany, 95501, Slovakia

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Seoul, Seocho Gu, 06591, South Korea

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Córdoba, Andalusia, 14004, Spain

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Málaga, Andalusia, 29009, Spain

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Seville, Andalusia, 41013, Spain

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Badalona, Barcelona, 08916, Spain

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L'Hospitalet de Llobregat, Barcelona, 08907, Spain

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Sabadell, Barcelona, 08208, Spain

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Bilbao, Basque Country, 48013, Spain

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Santander, Cantabria, 39008, Spain

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Barcelona, Catalonia, 08036, Spain

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Mérida, Extremadura, 06800, Spain

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A Coruña, Galicia, 15006, Spain

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Santiago de Compostela, Galicia, 15706, Spain

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San Cristóbal de La Laguna, Santa Cruz De Tenerife, 38320, Spain

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Valencia, Valencia, 46017, Spain

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Barakaldo, Vizcaya, 48903, Spain

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Barcelona, 08025, Spain

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Madrid, 28041, Spain

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Novartis Investigative Site

Madrid, 28942, Spain

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Seville, 41014, Spain

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Valencia, 46026, Spain

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Torquay, Devon, TQ2 7AA, United Kingdom

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Leytonstone, London, E11 1NR, United Kingdom

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Salford, Manchester, M6 8HD, United Kingdom

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Cannock, Staffordshire, WS11 5XY, United Kingdom

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Stoke-on-Trent, Staffordshire, ST6 7AG, United Kingdom

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Edinburgh, EH4 2XU, United Kingdom

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Glasgow, G31 2ER, United Kingdom

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Hull, HU3 2JZ, United Kingdom

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London, NW3 2QG, United Kingdom

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London, SE1 9RT, United Kingdom

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Newcastle upon Tyne, NE7 7DN, United Kingdom

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Plymouth, PL6 8DH, United Kingdom

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Solihull, B91 2JL, United Kingdom

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Wigan, WN6 9EP, United Kingdom

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Wolverhampton, WV10 0QP, United Kingdom

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Related Publications (2)

• 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.

  PMID: 37097894 DERIVED

• 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.

  PMID: 32386593 DERIVED

Related Links

• Secukinumab versus adalimumab for treatment of active psoriatic arthritis (EXCEED): a double-blind, parallel-group, randomised, active-controlled, phase 3b trial

MeSH Terms

Conditions

Arthritis, Psoriatic

Interventions

secukinumab; Adalimumab

Condition Hierarchy (Ancestors)

Spondylarthropathies; Spondylarthritis; Spondylitis; Spinal Diseases; Bone Diseases; Musculoskeletal Diseases; Arthritis; Joint Diseases; Psoriasis; Skin Diseases, Papulosquamous; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Results Point of Contact

• Title: Study Director
• Organization: Novartis Pharmaceuticals

Novartis.email@novartis.com

862-778-8300

Study Officials

• Novartis Pharmaceuticals

  Novartis Pharmaceuticals

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 1, 2016
• First Posted: April 20, 2016
• Study Start: April 3, 2017
• Primary Completion: December 30, 2019
• Study Completion: December 30, 2019
• Last Updated: January 27, 2021
• Results First Posted: January 27, 2021

Record last verified: 2021-01

Data Sharing

• IPD Sharing: Will share

Locations

DE (13); CZ (5); BU (5); AU (4); IT (6); NL (2); SL (4); FI (2); LI (3); CA (3); LA (2); FR (7); IN (4); PT (5); KR (1); GB (15); RU (10); US (19); PL (4); ES (20); HU (7); IC (1); GR (3); IL (7); DK (1)