16-week Efficacy and 2-year Safety, Tolerability and Efficacy of Secukinumab in Participants With Active Psoriatic Arthritis
NCT ID: NCT02294227
Last Updated: 2019-07-02
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
341 participants
INTERVENTIONAL
2015-05-29
2017-12-19
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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Secukinumab 150 mg
Secukinumab 150 mg s.c. with loading: Secukinumab 150 mg at Baseline, Weeks 1, 2 and 3, followed by dosing every four weeks starting at Week 4. After primary outcome evaluation, approval and implementation of Amendment 2 Secukinumab dose may have been escalated to 300 mg as judged appropriate by the investigator
Secukinumab
Secukinumab 150 mg (1 mL liquid formulation) in pre-filled syringes were supplied by Novartis. Each secukinumab 300 mg dose was given as two sc injections of secukinumab 150 mg.
Secukinumab 150 mg No load
Secukinumab 150 mg s.c. without loading: Secukinumab 150 mg at baseline, followed by dosing every four weeks starting at Week 4, with Placebo at Weeks 1, 2 and 3. After primary outcome evaluation, approval and implementation of Amendment 2 Secukinumab dose may have been escalated to 300 mg as judged appropriate by the investigator
Secukinumab
Secukinumab 150 mg (1 mL liquid formulation) in pre-filled syringes were supplied by Novartis. Each secukinumab 300 mg dose was given as two sc injections of secukinumab 150 mg.
Placebo
Placebo to Secukinumab at Baseline, Weeks 1, 2 and 3, followed by dosing every four weeks starting at Week 4 until Week 16/24, depending on patients responder status. From Week 16/24, patients were switched to Secukinumab 150 mg every four weeks. After primary outcome evaluation, approval and implementation of Amendment 2 Secukinumab dose may have been escalated to 300 mg as judged appropriate by the investigator
Placebo
Placebo to secukinumab was also available in 1.0 mL liquid formulation in prefilled syringe to match the active drug.
Interventions
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Secukinumab
Secukinumab 150 mg (1 mL liquid formulation) in pre-filled syringes were supplied by Novartis. Each secukinumab 300 mg dose was given as two sc injections of secukinumab 150 mg.
Placebo
Placebo to secukinumab was also available in 1.0 mL liquid formulation in prefilled syringe to match the active drug.
Eligibility Criteria
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Inclusion Criteria
* Rheumatoid factor and anti-cyclic citrullinated peptide (CCP) antibodies negative.
* Diagnosis of active plaque psoriasis or nail changes consistent with psoriasis.
* Inadequate control of symptoms with NSAID.
Exclusion Criteria
* Subjects taking high potency opioid analgesics.
* Previous exposure to secukinumab or other biologic drug directly targeting interleukin-17 (IL-17) or IL-17 receptor.
* Ongoing use of prohibited psoriasis treatments / medications.
* Subjects who have ever received biologic immunomodulating agents except for those targeting TNFα.
* Previous treatment with any cell-depleting therapies.
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
Mesa, Arizona, United States
Novartis Investigative Site
Upland, California, United States
Novartis Investigative Site
Denver, Colorado, United States
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Palm Harbor, Florida, United States
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Sarasota, Florida, United States
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Peoria, Illinois, United States
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Shreveport, Louisiana, United States
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Saint Clair Shores, Michigan, United States
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St Louis, Missouri, United States
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Lincoln, Nebraska, United States
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Albany, New York, United States
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Oklahoma City, Oklahoma, United States
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Duncansville, Pennsylvania, United States
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Charleston, South Carolina, United States
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Greenville, South Carolina, 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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Seattle, Washington, 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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Aalst, , Belgium
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Brussels, , Belgium
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Brussels, , Belgium
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Yvoir, , Belgium
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Plovdiv, , 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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Pointe-Claire, Quebec, Canada
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Trois-Rivières, Quebec, Canada
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Bruntál, Czech Republic, Czechia
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Hlučín, Czech Republic, Czechia
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Prague, Czech Republic, Czechia
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Prague, Czech Republic, Czechia
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Uherské Hradiště, Czech Republic, Czechia
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Le Mans, , France
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Montpellier, , France
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Erlangen, , Germany
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Frankfurt am Main, , Germany
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Göttingen, , Germany
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Hamburg, , Germany
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Hamburg, , Germany
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Herne, , Germany
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Magdeburg, , Germany
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Nienburg, , Germany
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Rozzano, MI, Italy
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Verona, VR, Italy
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Bologna, , Italy
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Bialystok, , Poland
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Dopiewo, , Poland
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Elblag, , Poland
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Lodz, , Poland
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Poznan, , Poland
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Poznan, , Poland
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Petrozavodsk, , 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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Stockholm, , Sweden
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Leytonstone, London, United Kingdom
Countries
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References
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Mease PJ, Warren RB, Nash P, Grouin JM, Lyris N, Willems D, Taieb V, Eells J, McInnes IB. Comparative Effectiveness of Bimekizumab and Secukinumab in Patients with Psoriatic Arthritis at 52 Weeks Using a Matching-Adjusted Indirect Comparison. Rheumatol Ther. 2024 Jun;11(3):817-828. doi: 10.1007/s40744-024-00652-7. Epub 2024 Mar 6.
Pournara E, Kormaksson M, Nash P, Ritchlin CT, Kirkham BW, Ligozio G, Pricop L, Ogdie A, Coates LC, Schett G, McInnes IB. Clinically relevant patient clusters identified by machine learning from the clinical development programme of secukinumab in psoriatic arthritis. RMD Open. 2021 Nov;7(3):e001845. doi: 10.1136/rmdopen-2021-001845.
Kivitz AJ, Nash P, Tahir H, Everding A, Mann H, Kaszuba A, Pellet P, Widmer A, Pricop L, Abrams K. Efficacy and Safety of Subcutaneous Secukinumab 150 mg with or Without Loading Regimen in Psoriatic Arthritis: Results from the FUTURE 4 Study. Rheumatol Ther. 2019 Sep;6(3):393-407. doi: 10.1007/s40744-019-0163-5. Epub 2019 Jun 21.
Related Links
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Introduction to clinical trials conducted by Novartis and to results of completed studies, with the aim of increasing the transparency of Novartis clinical research and making publicly available objective scientific information in a standardised format.
Other Identifiers
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2014-003849-10
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
CAIN457F2336
Identifier Type: -
Identifier Source: org_study_id
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