Study to Demonstrate the Efficacy (Including Inhibition of Structural Damage), Safety and Tolerability up to 2 Years of Secukinumab in Active Psoriatic Arthritis

NCT02404350 | Completed Phase 3 Results FDA Drug

• 3 other identifiers: CAIN457F23422015-000050-3802404350
• Study Type: interventional
• Target: 997
• Locations: 27 countries
• Sites: 171

Brief Summary

The purpose of this study was to demonstrate efficacy including effect on inhibition of progression of structural damage, safety and tolerability up to 2 years with primary focus at Week 16 (week 24 for structural damage), to support the use of secukinumab pre-filled syringe (PFS) by subcutaneous (s.c.) self-administration with or without loading regimen in subjects with active Psoriatic Arthritis (PsA) despite current or previous NSAID, DMARD therapy and/or previous anti-TNFα therapy. Long term efficacy up to 2 years was based on signs and symptoms of joint/bone structure preservation (X-ray) and improvement in physical function measured by Health Assessment Questionnaire - Disability Index (HAQ-DI©), as well as skin and nail improvement for psoriasis signs.

Conditions

Psoriatic Arthritis

Keywords

Psoriatic Arthritis; Arthritis; Psoriatic; Psoriatic Arthropathy; Spondylitis

Outcome Measures

Primary Outcomes (1)

• Percentage of Participants With Active Psoriatic Arthritis (PsA) Achieving an American College of Rheumatology Response 20 (ACR20) at Week 16

  ACR20 response was defined as having a positive clinical response to treatment (individual improvement) in disease activity if the participant had at least 20% improvement based on tender 78-joint count, swollen 76-joint count and at least 20% improvement in 3 of the following 5 measures: participant's assessment of PsA pain, patient's global assessment of disease activity, physician's global assessment of disease activity, participant's self-assessed disability (Health Assessment Questionnaire Disability Index (HAQ-DI) score), and acute phase reactant evaluated as (high sensitivity c-reactive protein (hsCRP) or erythrocyte sedimentation rate (ESR)).

  Week 16

Secondary Outcomes (8)

• Change From Baseline to Week 24 With Secukinumab Compared With Placebo for Joint/Bone Structural Damage (Using Van Der Heijde Modified Total Sharp Score (mTSS))

  Baseline, Week 24

• Count and Percentage of Patients Achieving Psoriatic Area and Severity Index 75 (PASI75) Response

  Week 16

• Count and Percentage of Patients Achieving Psoriatic Area and Severity Index 90 (PASI90) Response

  16 weeks

• Count and Percentage of Patients Achieving an ACR50 Response

  16 weeks

• Change From Baseline in HAQ-DI© Score

  16 weeks

Study Arms (5)

Secukinumab 150 mg load (Group 1)

EXPERIMENTAL

Secukinumab 150 mg sc injection every week for 4 weeks followed by Secukinumab 150 mg every 4 weeks until week 100 Beginning at Week 52, for subjects whose signs and symptoms were not fully controlled, and who the investigator believed may improve further with an increase in dose, may have had the secukinumab dose increased to 300mg s.c. every 4 weeks until week 100

Biological: Secukinumab

Secukinumab 150 mg no load (Group 2)

EXPERIMENTAL

Secukinumab 150 mg sc injection every 4 weeks until week 100 Beginning at Week 52, for subjects whose signs and symptoms were not fully controlled, and who the investigator believed may improve further with an increase in dose, may have had the secukinumab dose increased to 300mg s.c. every 4 weeks.

Biological: Secukinumab

Secukinumab 300 mg load (Group 3)

EXPERIMENTAL

Secukinumab 300 mg sc injection every week for 4 weeks followed by Secukinumab 300 mg every 4 weeks until week 100

Biological: Secukinumab

Placebo arm 1 (Group 4)

PLACEBO COMPARATOR

Placebo to Secukinumab sc injection every week for 4 weeks followed by placebo to Secukinumab every 4 weeks until week 16. Non-responders will be switched to Secukinumab either 150 or 300 mg sc injection every four weeks until week 100. Responders at week 16 continued receiving placebo until week 24, then were switched to secukinumab 150 or 300 mg sc injection every 4 weeks until week 100. PLEASE NOTE: Placebo arms 1 and 2 belong to the same placebo group (group 4) Beginning at Week 52, for subjects whose signs and symptoms were not fully controlled, and who the investigator believed may improve further with an increase in dose, may have had the secukinumab dose increased to 300mg s.c. every 4 weeks.

Biological: Secukinumab

Placebo arm 2 (Group 4)

PLACEBO COMPARATOR

Placebo to Secukinumab sc injection every week for 4 weeks followed by placebo to Secukinumab every 4 weeks until week 16. Non-responders were switched to Secukinumab either 150 or 300 mg sc injection every four weeks until week 100. Responders at week 16 continued receiving placebo until week 24, then were switched to secukinumab 150 or 300 mg sc injection every 4 weeks until week 100. PLEASE NOTE: Placebo arms 1 and 2 belong to the same placebo group (group 4) Beginning at Week 52, for subjects whose signs and symptoms were not fully controlled, and who the investigator believed may improve further with an increase in dose, may have had the secukinumab dose increased to 300mg s.c. every 4 weeks.

Biological: Secukinumab

Interventions

Secukinumab BIOLOGICAL

Anti IL-17a monoclonal antibody

Also known as: AIN457

Placebo arm 1 (Group 4); Placebo arm 2 (Group 4); Secukinumab 150 mg load (Group 1); Secukinumab 150 mg no load (Group 2); Secukinumab 300 mg load (Group 3)

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 criteria and with symptoms for at least 6 months with moderate to severe PsA who must have at BSL ≥3 tender joints out of 78 and ≥3 swollen joints out of 76 (dactylitis of a digit counts as one joint each).
• Rheumatoid factor (RF) and anti-cyclic citrullinated peptide (anti-CCP) antibodies negative at screening.
• Diagnosis of active plaque psoriasis or nail changes consistent with psoriasis or a documented history of plaque psoriasis.
• Subjects with PsA should have taken NSAIDs for at least 4 weeks prior to randomization with inadequate control of symptoms or at least one dose if stopped due to intolerance to NSAIDs.-Subjects who are regularly taking NSAIDs as part of their PsA therapy are required to be on a stable dose for at least 2 weeks before study randomization and should remain on a stable dose up to Week 24.
• Subjects taking corticosteroids must be on a stable dose of ≤10 mg/day prednisone or equivalent for at least 2 weeks before randomization and should remain on a stable dose up to Week 24.
• Subjects taking MTX (≤ 25 mg/week) are allowed to continue their medication if the dose is stable for at least 4 weeks before randomization and should remain on a stable dose up to Week 52.
• Subjects on MTX must be on folic acid supplementation at randomization.
• Subjects who are on a DMARD other than MTX must discontinue the DMARD 4 weeks prior to randomization visit except for leflunomide, which has to be discontinued for 8 weeks prior to randomization unless a cholestyramine wash-out has been performed.
• Subjects who have been on a TNFα inhibitor must have experienced an inadequate response to previous or current treatment with a TNFα inhibitor given at an approved dose for at least 3 months or have stopped treatment due to safety/tolerability problems after at least one administration of a TNFα inhibitor.
• Subjects who have previously been treated with TNFα inhibitors (investigational or approved) will be allowed entry into study after appropriate wash-out period prior to randomization

You may not qualify if:

• Chest X-ray or chest MRI with evidence of ongoing infectious or malignant process. - Subjects taking high potency opioid analgesics.
• Previous exposure to secukinumab or other biologic drug directly targeting IL-17 or IL-17 receptor. - Ongoing use of prohibited psoriasis treatments / medications (e.g., topical corticosteroids, UV therapy) at randomization.
• Any intramuscular or intravenous or intra-articular corticosteroid treatment within 4 weeks before randomization.
• Subjects who have ever received biologic immunomodulating agents except for those targeting TNFα (investigational or approved).
• Previous treatment with any cell-depleting therapies including but not limited to anti- CD20, investigational agents

Sponsors & Collaborators

• Novartis Pharmaceuticals: lead

Study Sites (172)

Novartis Investigative Site

Upland, California, 91786, United States

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Novartis Investigative Site

Aurora, Colorado, 80045, United States

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Novartis Investigative Site

Denver, Colorado, 80230, United States

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Novartis Investigative Site

Brandon, Florida, 33511, United States

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Novartis Investigative Site

Tampa, Florida, 33624, United States

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Coeur d'Alene, Idaho, 83814, United States

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Shreveport, Louisiana, 71101, United States

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Brooklyn, New York, 11215, United States

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Rochester, New York, 14623, United States

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Oklahoma City, Oklahoma, 73102, United States

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Novartis Investigative Site

Oklahoma City, Oklahoma, 73103, United States

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Novartis Investigative Site

Portland, Oregon, 97239, United States

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Duncansville, Pennsylvania, 16635, United States

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Wexford, Pennsylvania, 15090, United States

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Wyomissing, Pennsylvania, 19610, United States

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Jackson, Tennessee, 38305, United States

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Kingsport, Tennessee, 37660, United States

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Mesquite, Texas, 75150, United States

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Seattle, Washington, 98101, United States

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Novartis Investigative Site

Seattle, Washington, 98104, United States

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Novartis Investigative Site

Seattle, Washington, 98122, United States

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Spokane, Washington, 99204, United States

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CABA, Buenos Aires, C1221ADC, Argentina

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San Miguel de Tucumán, Tucumán Province, Argentina

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San Miguel de Tucumán, 4000, Argentina

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Graz, 8036, Austria

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Vienna, 1100, Austria

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Vienna, A-1060, Austria

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Vienna, A-1160, Austria

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Vancouver, British Columbia, V5Z 4E8, Canada

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Victoria, British Columbia, V8V 3M9, Canada

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Winnipeg, Manitoba, R3A 1M1, Canada

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St. John's, Newfoundland and Labrador, A1C 5B8, Canada

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Sainte-Foy, Quebec, G1V 3M7, Canada

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Trois-Rivières, Quebec, G8Z 1Y2, Canada

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Vitacura, Santiago Metropolitan, 7640881, Chile

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Santiago, 8207257, Chile

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Bruntál, Czech Republic, 792 01, Czechia

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Ostrava, Czech Republic, 70200, Czechia

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Prague, Czech Republic, 128 50, Czechia

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Prague, Czech Republic, 140 00, Czechia

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Prague, Czech Republic, 140 59, Czechia

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Prague, Czech Republic, 148 00, Czechia

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Uherské Hradiště, 686 01, Czechia

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Odense, 5000 C, Denmark

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Tartu, 50406, Estonia

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Hyvinkää, 05800, Finland

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Aachen, 52064, Germany

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Bad Abbach, 93077, Germany

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Berlin, 13125, Germany

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Berlin, 13353, Germany

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Germering, 82110, Germany

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Gommern, 39245, Germany

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Göttingen, 37075, Germany

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Hamburg, 22081, Germany

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Hamburg, 22143, Germany

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Herne, 44649, Germany

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Leipzig, 04103, Germany

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Lübeck, 23538, Germany

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Nienburg, 31582, Germany

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Athens, GR, 115 27, Greece

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Thessaloniki, GR, 564 29, Greece

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Athens, 115 27, Greece

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Athens, 12462, Greece

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Pátrai, 265 00, Greece

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Guatemala City, 01010, Guatemala

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Guatemala City, 01011, Guatemala

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Budapest, 1036, Hungary

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Budapest, 1062, Hungary

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Eger, 3300, Hungary

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Kistarcsa, 2143, Hungary

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Székesfehérvár, H-8000, Hungary

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Veszprém, 8200, Hungary

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Secunderabad, Andhra Pradesh, 500003, India

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Ahmedabad, Gujarat, 380015, India

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Mumbai, Maharashtra, 400 053, India

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Nashik, Maharashtra, 422 101, India

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Pune, Maharashtra, 411007, India

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New Delhi, 110029, India

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Dublin, Ireland

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Ashkelon, 78278, Israel

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Haifa, 343621, Israel

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Kfar Saba, 4428164, Israel

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Petah Tikva, 49100, Israel

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Ramat Gan, 5265601, Israel

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Tel Aviv, 6423906, Israel

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Brescia, BS, 25123, Italy

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Palermo, PA, 90127, Italy

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Pavia, PV, 27100, Italy

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Potenza, PZ, 85100, Italy

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Udine, UD, 33100, Italy

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Riga, LV, LV-1005, Latvia

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Liepāja, LV 3401, Latvia

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Riga, LV 1002, Latvia

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Riga, LV-1038, Latvia

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Valmiera, LV-4201, Latvia

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Kaunas, LT, LT-45130, Lithuania

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Kaunas, LT, LT-50128, Lithuania

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Klaipėda, LT-92288, Lithuania

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Šiauliai, LT-76231, Lithuania

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Vilnius, 09310, Lithuania

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Vilnius, LT-07195, Lithuania

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Mexicali, Estado de Baja California, 21100, Mexico

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Mexico City, Mexico City, 11850, Mexico

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Metepec, State of Mexico, 52140, Mexico

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Mérida, Yucatán, 97070, Mexico

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San Luis Potosí City, 78200, Mexico

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Maastricht, 6229 HX, Netherlands

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Rotterdam, 3079 DZ, Netherlands

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Schiedam, 3118 JH, Netherlands

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Utrecht, 3508 GA, Netherlands

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Manila, National Capital Region, 1000, Philippines

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Manila, 1008, Philippines

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Quezon City, 1102, Philippines

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Chelyabinsk, 454000, Russia

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Chelyabinsk, 454076, Russia

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Kazan', 420064, Russia

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Kemerovo, 650000, Russia

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Moscow, 129301, Russia

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Nizhny Novgorod, 603005, Russia

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Nizhny Novgorod, 603018, Russia

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Orenburg, 460018, Russia

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Rostov-on-Don, 344022, Russia

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Saint Petersburg, 194021, Russia

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Saint Petersburg, 197022, 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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Yekaterinburg, 620137, Russia

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Córdoba, Andalusia, 14004, Spain

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Sabadell, Barcelona, 08208, Spain

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Sant Joan Despí, Barcelona, 08970, Spain

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Bilbao, Basque Country, 48013, Spain

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Barcelona, Catalonia, 08003, Spain

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Barcelona, Catalonia, 08036, Spain

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Santiago de Compostela, Galicia, 15706, Spain

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Vigo, Pontevedra, 36200, Spain

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Alicante, Valencia, 03010, Spain

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Valencia, Valencia, 46026, Spain

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Barakaldo, Vizcaya, 48903, Spain

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Barcelona, 08041, Spain

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Madrid, 28046, Spain

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Stockholm, SE-17176, Sweden

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Bangkoknoi, Bangkok, 10700, Thailand

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Songkhla, Hat Yai, 90110, Thailand

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Khon Kaen, THA, 40002, Thailand

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Bangkok, 10400, Thailand

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Chiang Mai, 50200, Thailand

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Truro, Cornwall, TR1 3LJ, United Kingdom

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Christchurch, Dorset, BH23 2JX, United Kingdom

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London, England, E11 1NR, United Kingdom

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Basingstoke, Hampshire, RG24 9NA, United Kingdom

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Inverness, Invernesshire, IV2 3RE, United Kingdom

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Salford, Manchester, M6 8HD, United Kingdom

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

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Bradford, West Yorkshire, BD5 0NA, United Kingdom

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Bath, BA1 1RL, United Kingdom

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Dundee, DD1 9SY, United Kingdom

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Eastbourne, BN21 2UD, United Kingdom

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Edinburgh, EH4 2XU, United Kingdom

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Glasgow, G31 2ER, United Kingdom

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Leicester, LE1 5WW, United Kingdom

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London, NW1 2BU, United Kingdom

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London, NW3 2QG, United Kingdom

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London, SE1 9RT, United Kingdom

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Manchester, M13 9WL, United Kingdom

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Oxford, OX3 7LD, United Kingdom

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Portsmouth, PO6 3LY, United Kingdom

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Wigan, WN6 9EP, United Kingdom

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Novartis Investigative Site

Ho Chi Minh City, VNM, 700000, Vietnam

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Novartis Investigative Site

Hanoi, 100000, Vietnam

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Novartis Investigative Site

Ho Chi Minh City, 7000, Vietnam

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Related Publications (6)

• Mease P, van der Heijde D, Landewe R, Mpofu S, Rahman P, Tahir H, Singhal A, Boettcher E, Navarra S, Meiser K, Readie A, Pricop L, Abrams K. Secukinumab improves active psoriatic arthritis symptoms and inhibits radiographic progression: primary results from the randomised, double-blind, phase III FUTURE 5 study. Ann Rheum Dis. 2018 Jun;77(6):890-897. doi: 10.1136/annrheumdis-2017-212687. Epub 2018 Mar 17.

  PMID: 29550766 RESULT

• Mease PJ, Coates LC, Gaillez C, Shew A, Bao W, Ritchlin CT. Relationship of radiographic progression status to low disease activity in patients with psoriatic arthritis receiving secukinumab treatment for two years. Rheumatology (Oxford). 2025 Sep 18:keaf488. doi: 10.1093/rheumatology/keaf488. Online ahead of print.

  PMID: 40973471 DERIVED

• 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.

  PMID: 38446397 DERIVED

• 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.

  PMID: 34795065 DERIVED

• Mease PJ, Landewe R, Rahman P, Tahir H, Singhal A, Boettcher E, Navarra S, Readie A, Mpofu S, Delicha EM, Pricop L, van der Heijde D. Secukinumab provides sustained improvement in signs and symptoms and low radiographic progression in patients with psoriatic arthritis: 2-year (end-of-study) results from the FUTURE 5 study. RMD Open. 2021 Jul;7(2):e001600. doi: 10.1136/rmdopen-2021-001600.

  PMID: 34330846 DERIVED

• van der Heijde D, Mease PJ, Landewe RBM, Rahman P, Tahir H, Singhal A, Boettcher E, Navarra S, Zhu X, Ligozio G, Readie A, Mpofu S, Pricop L. Secukinumab provides sustained low rates of radiographic progression in psoriatic arthritis: 52-week results from a phase 3 study, FUTURE 5. Rheumatology (Oxford). 2020 Jun 1;59(6):1325-1334. doi: 10.1093/rheumatology/kez420.

  PMID: 31586420 DERIVED

MeSH Terms

Conditions

Arthritis, Psoriatic; Arthritis; Spondylitis

Interventions

secukinumab

Condition Hierarchy (Ancestors)

Spondylarthropathies; Spondylarthritis; Spinal Diseases; Bone Diseases; Musculoskeletal Diseases; Joint Diseases; Psoriasis; Skin Diseases, Papulosquamous; Skin Diseases; Skin and Connective Tissue Diseases; Bone Diseases, Infectious; Infections

Results Point of Contact

• Title: Clinical Disclosure Office
• Organization: Novartis Pharmaceuticals

Novartis.email@novartis.com

+1 (862) 778-8300

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: March 16, 2015
• First Posted: March 31, 2015
• Study Start: August 31, 2015
• Primary Completion: August 16, 2017
• Study Completion: January 24, 2019
• Last Updated: April 20, 2020
• Results First Posted: June 28, 2019

Record last verified: 2020-04

Locations

SE (1); VN (3); TH (5); DE (13); RU (15); GR (5); IN (6); GB (21); FI (1); AU (4); CL (2); GU (2); HU (6); US (22); DK (1); IE (1); LA (5); IT (5); LI (6); IL (6); ME (5); PH (3); AR (3); NL (4); CA (6); CZ (7); ES (13)