Efficacy at 24 Weeks and Long Term Safety, Tolerability and Efficacy up to 2 Years of Secukinumab (AIN457) in Patients With Active Psoriatic Arthritis (PsA)
NCT ID: NCT01392326
Last Updated: 2016-02-04
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
606 participants
INTERVENTIONAL
2011-09-30
2014-10-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Group 1
Secukinumab (75mg)
Secukinumab (75 mg)
Secukinumab (75 mg)
Group 2
Secukinumab (150 mg)
Secukinumab (150 mg)
Secukinumab (150 mg)
Group 3
Placebo Comparator
Placebo Comparator
Interventions
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Secukinumab (75 mg)
Secukinumab (75 mg)
Secukinumab (150 mg)
Secukinumab (150 mg)
Placebo Comparator
Placebo Comparator
Eligibility Criteria
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Inclusion Criteria
* Diagnosis of PsA classified by CASPAR criteria and with symptoms for at least 6 months with moderate to severe PsA who must have at Baseline ≥3 tender joints out of 78 and ≥3 swollen out of 76 (dactylitis of a digit counts as one joint each)
* 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 o plaque psoriasis
Exclusion Criteria
* Subjects who have previously been treated with more than 3 different TNFα inhibitors
* Subjects taking high potency opioid analgesics
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
Anniston, Alabama, United States
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Mesa, Arizona, United States
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Paradise Valley, Arizona, United States
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Upland, California, United States
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Tamarac, Florida, United States
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Newnan, Georgia, United States
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Boston, Massachusetts, United States
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Eagan, Minnesota, United States
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Richmond Heights, Missouri, United States
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Lincoln, Nebraska, United States
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Freehold, New Jersey, United States
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Charlotte, North Carolina, United States
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Oklahoma City, Oklahoma, United States
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Duncansville, Pennsylvania, United States
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Johnston, Rhode Island, United States
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Columbia, South Carolina, United States
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North Charleston, South Carolina, United States
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Jackson, Tennessee, United States
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Benbrook, Texas, United States
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Dallas, Texas, United States
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Dallas, Texas, United States
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Houston, Texas, United States
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Houston, Texas, United States
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Mesquite, Texas, United States
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Seattle, Washington, United States
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Buenos Aires, Buenos Aires, Argentina
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Caba, Buenos Aires, Argentina
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Caba, Buenos Aires, Argentina
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Córdoba, Córdoba Province, Argentina
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Córdoba, Córdoba Province, Argentina
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Córdoba, Córdoba Province, Argentina
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Rosario, Santa Fe Province, Argentina
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Rosario, Santa Fe Province, Argentina
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Maroochydore, Queensland, Australia
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Malvern, Victoria, Australia
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Genk, , Belgium
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Ghent, , Belgium
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Leuven, , Belgium
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Porto Alegre, Rio Grande do Sul, Brazil
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São Paulo, São Paulo, Brazil
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São Paulo, São Paulo, Brazil
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Sevlievo, Bulgaria, Bulgaria
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Sofia, Bulgaria, Bulgaria
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Sofia, Bulgaria, Bulgaria
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Pleven, , Bulgaria
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St. John's, Newfoundland and Labrador, Canada
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St. John's, Newfoundland and Labrador, Canada
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Newmarket, Ontario, Canada
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Waterloo, Ontario, Canada
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Trois-Rivières, Quebec, Canada
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Bruntál, Czech Republic, Czechia
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Uherské Hradiště, Czech Republic, Czechia
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Zlín, Czech Republic, Czechia
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Berlin, Germany, Germany
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Aachen, , Germany
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Cologne, , Germany
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Erlangen, , Germany
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Erlangen, , Germany
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Gommern, , Germany
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Hamburg, , Germany
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Hamburg, , Germany
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Herne, , Germany
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Hildesheim, , Germany
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Leipzig, , Germany
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Nuremberg, , Germany
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Ratingen, , Germany
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Zerbst, , Germany
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Ashkelon, , Israel
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Haifa, , Israel
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Ramat Gan, , Israel
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Tel Aviv, , Israel
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Valeggio sul Mincio, (vr), Italy
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Catania, CT, Italy
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Prato, PO, Italy
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Siena, SI, Italy
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Lipa City, Batangas, Philippines
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Dasmariñas, Cavite, Philippines
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Manila, National Capital Region, Philippines
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Manila, Philippines, Philippines
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Las Piñas, , Philippines
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Manila, , Philippines
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Manila, , Philippines
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Quezon City, , Philippines
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Quezon City, , Philippines
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Bialystok, , Poland
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Warsaw, , Poland
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Bucharest, District 1, Romania
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Iași, Iaşi, Romania
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Bucharest, , Romania
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Cluj-Napoca, , Romania
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Kemerovo, , Russia
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Moscow, , Russia
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Saint Petersburg, , Russia
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Yaroslavl, , Russia
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Yekaterinburg, , Russia
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Yekaterinburg, , Russia
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Singapore, Singapore, Singapore
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Singapore, Singapore, Singapore
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Singapore, Singapore, Singapore
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Piešťany, Slovak Republic, Slovakia
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Lučenec, Slovakia, Slovakia
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Bangkok, Bangkok, Thailand
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Bangkok, , Thailand
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Chiang Mai, , Thailand
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Khon Kaen, , Thailand
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London, England, United Kingdom
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Cannock, Staffordshire, United Kingdom
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Bradford, West Yorkshire, United Kingdom
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Glasgow, , United Kingdom
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London, , United Kingdom
Countries
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References
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Mease PJ, Kavanaugh A, Reimold A, Tahir H, Rech J, Hall S, Geusens P, Pellet P, Delicha EM, Pricop L, Mpofu S; FUTURE 1 study group. Secukinumab Provides Sustained Improvements in the Signs and Symptoms of Psoriatic Arthritis: Final 5-year Results from the Phase 3 FUTURE 1 Study. ACR Open Rheumatol. 2020 Jan;2(1):18-25. doi: 10.1002/acr2.11097. Epub 2019 Nov 14.
Deodhar A, Gladman DD, McInnes IB, Spindeldreher S, Martin R, Pricop L, Porter B, Safi J Jr, Shete A, Bruin G. Secukinumab Immunogenicity over 52 Weeks in Patients with Psoriatic Arthritis and Ankylosing Spondylitis. J Rheumatol. 2020 Apr;47(4):539-547. doi: 10.3899/jrheum.190116. Epub 2019 Jun 15.
Kavanaugh A, Mease PJ, Reimold AM, Tahir H, Rech J, Hall S, Geusens P, Wang Z, Pricop L, Mpofu S; FUTURE-1 Study Group. Secukinumab for Long-Term Treatment of Psoriatic Arthritis: A Two-Year Followup From a Phase III, Randomized, Double-Blind Placebo-Controlled Study. Arthritis Care Res (Hoboken). 2017 Mar;69(3):347-355. doi: 10.1002/acr.23111.
Strand V, Mease P, Gossec L, Elkayam O, van den Bosch F, Zuazo J, Pricop L, Mpofu S; FUTURE 1 study group. Secukinumab improves patient-reported outcomes in subjects with active psoriatic arthritis: results from a randomised phase III trial (FUTURE 1). Ann Rheum Dis. 2017 Jan;76(1):203-207. doi: 10.1136/annrheumdis-2015-209055. Epub 2016 May 11.
Mease PJ, McInnes IB, Kirkham B, Kavanaugh A, Rahman P, van der Heijde D, Landewe R, Nash P, Pricop L, Yuan J, Richards HB, Mpofu S; FUTURE 1 Study Group. Secukinumab Inhibition of Interleukin-17A in Patients with Psoriatic Arthritis. N Engl J Med. 2015 Oct;373(14):1329-39. doi: 10.1056/NEJMoa1412679.
Other Identifiers
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2011-000276-34
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
CAIN457F2306
Identifier Type: -
Identifier Source: org_study_id
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