Study of the Efficacy and Safety of Secukinumab in Participants With Active Psoriatic Arthritis With Axial Skeleton Involvement

NCT02721966 | Completed Phase 3 Results

• 2 other identifiers: CAIN457F33022016-000814-31
• Study Type: interventional
• Target: 503
• Locations: 17 countries
• Sites: 78

Brief Summary

The purpose of this study is to demonstrate the efficacy and safety of secukinumab 150 mg or 300 mg in the management of axial manifestations in PsA patients who have failed to respond to at least 2 non-steroidal anti-inflammatory drugs (NSAIDs) over a 4-week period, according to assessment of spondyloarthritis international society (ASAS) recommendations for the treatment of axial spondyloarthritis (AxSpA).

Conditions

Axial Psoratic Arthritis

Keywords

Assessment of spondyloarthritis international society; ASAS; axial; Psoriatic Arthritis; PsA; Magnetic resonance imaging; MRI

Outcome Measures

Primary Outcomes (1)

• Percentage of Participants With Response to Treatment (300 mg AIN457) as Assessed by the ASAS20 Criteria at Week 12

  Purpose of this measure: was to demonstrate that secukinumab 150 mg s.c. is superior to placebo in the achievement of ASAS 20 response at Week 12 after superiority of 300 mg was established ASAS20 was defined as an improvement of ≥20% and absolute improvement of ≥10 unit (0-100 mm VAS) from baseline in ≥3 of the following 4 domains (and absence of deterioration in any domain): patient's global assessment of disease activity (PTGA), pain assessment (total pain score), Bath Ankylosing Spondylitis Functional Index (BASFI), and clinical inflammation (mean of 2 morning stiffness-related scores on the BASDAI)

  at week 12

Secondary Outcomes (10)

• Percentage of Participants With Response to Treatment (150 mg AIN457) as Assessed by the ASAS20 Criteria at Week 12

  at week 12

• Percentage of Participants With Response to Treatment (150 mg/300 mg AIN457) as Assessed by the ASAS40 Criteria at Week 12

  at week 12

• Percentage of Participants With Response to Treatment as Assessed by BASDAI50 at Week 12

  at week 12

• Change From Baseline in Spinal Pain Visual Analog Scale (VAS) - Pain at Any Time

  at baseline, at week 12

• Change From Baseline in Spinal Pain Visual Analog Scale (VAS) - Pain at Night

  at baseline, at week 12

Study Arms (3)

AIN457 150mg

EXPERIMENTAL

Secukinumab dose amount 1 sc injection weekly for 4 weeks followed by Secukinumab dosage amount 1 sc injection every 4 weeks for remaining 44 weeks

Biological: Secukinumab

AIN457 300mg

EXPERIMENTAL

Secukinumab dose amount 2 sc injection weekly for 4 weeks followed by Secukinumab dosage amount 2 sc injection every 4 weeks for remaining 44 weeks

Biological: Secukinumab

AIN457 Placebo

PLACEBO COMPARATOR

Placebo sc injection weekly for 4 weeks and at week 8, followed by Secukinumab 150 mg or 300 mg sc injection every 4 week for remaining 40 weeks.

Biological: Secukinumab; Drug: Secukinumab and Placebo

Interventions

Secukinumab BIOLOGICAL

Anti IL-17a monoclonal antibody

Also known as: AIN457

AIN457 150mg; AIN457 300mg; AIN457 Placebo

Secukinumab and Placebo DRUG

Placebo matching AIN457

AIN457 Placebo

Eligibility Criteria

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

You may qualify if:

• Written informed consent must be obtained before any assessment is performed
• Diagnosis of psoriatic arthritis classified by Classification criteria for psoriatic arthritis (CASPAR) criteria
• Active spinal disease defined by Bath ankylosing spondylitis disease activity index (BASDAI) score ≥ 4
• Spinal Pain visual analog scale (VAS) ≥ 40 (on a VAS 100 scale)
• Inadequate Response to at least 2 non-steroidal anti-inflammatory drugs over a 4 weeks period

You may not qualify if:

• History of exposure to other IL-17 or IL-23 inhibitor biologic drug
• History of exposure to previous biologic disease modifying anti-rheumatic drugs (DMARDs) (Tumor necrosis factor (TNF) blockers or Ustekinumab)
• Current treatment with disease modifying anti-rheumatic drugs (DMARDs) other than Methotrexate
• Subjects taking high potency opioid analgesics (e.g. methadone, hydromorphone, morphine)
• Chest X-ray or chest magnetic resonance imaging (MRI) with evidence of ongoing infectious or malignant process, obtained within 3 months prior to screening and evaluated by a qualified physician

Sponsors & Collaborators

• Novartis Pharmaceuticals: lead

Study Sites (94)

Novartis Investigative Site

Brussels, 1070, Belgium

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Novartis Investigative Site

Brussels, BE-B-1200, Belgium

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Novartis Investigative Site

Leuven, 3000, Belgium

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Novartis Investigative Site

Rousse, 7002, Bulgaria

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Novartis Investigative Site

Sofia, 1413, Bulgaria

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Novartis Investigative Site

Sofia, 1505, Bulgaria

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Novartis Investigative Site

Sofia, 1784, Bulgaria

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Novartis Investigative Site

Brno, 63800, Czechia

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Novartis Investigative Site

Bruntál, 792 01, Czechia

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Novartis Investigative Site

Plzen-Bory, 30599, Czechia

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Novartis Investigative Site

Uherské Hradiště, 686 01, Czechia

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Novartis Investigative Site

Tallinn, 10138, Estonia

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Novartis Investigative Site

Tartu, 50406, Estonia

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Novartis Investigative Site

Kuopio, 70100, Finland

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Novartis Investigative Site

Kuovola, 45100, Finland

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Novartis Investigative Site

Strasbourg, Cedex, 67098, France

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Novartis Investigative Site

Lyon, 69003, France

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Novartis Investigative Site

Nantes, 44000, France

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Novartis Investigative Site

Paris, 75651, France

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Novartis Investigative Site

Toulouse, 31059, France

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Novartis Investigative Site

Vandœuvre-lès-Nancy, 54511, France

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Novartis Investigative Site

Berlin, 10789, Germany

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Novartis Investigative Site

Bochum, 44791, Germany

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Novartis Investigative Site

Cottbus, 03042, Germany

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Novartis Investigative Site

Hamburg, 22391, Germany

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Novartis Investigative Site

Magdeburg, 39110, Germany

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Novartis Investigative Site

Athens, 115 27, Greece

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Novartis Investigative Site

Athens, 12462, Greece

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Novartis Investigative Site

Budapest, 1023, Hungary

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Novartis Investigative Site

Eger, 3300, Hungary

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Novartis Investigative Site

Hévíz, 8380, Hungary

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Novartis Investigative Site

Miskolc, H-3529, Hungary

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Novartis Investigative Site

Veszprém, 8200, Hungary

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Novartis Investigative Site

Dublin, Ireland

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Novartis Investigative Site

Haifa, 343621, Israel

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Novartis Investigative Site

Kfar Saba, 44281, Israel

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Novartis Investigative Site

Ramat Gan, 52621, Israel

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Novartis Investigative Site

Tel Aviv, 6423906, Israel

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Novartis Investigative Site

Bergamo, BG, 24128, Italy

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Novartis Investigative Site

Milan, MI, 20132, Italy

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Novartis Investigative Site

Torino, TO, 10126, Italy

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Novartis Investigative Site

Torino, TO, 10128, Italy

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Novartis Investigative Site

Verona, VR, 37134, Italy

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Novartis Investigative Site

Bologna, 40138, Italy

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Novartis Investigative Site

Bialystok, 15 351, Poland

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Novartis Investigative Site

Bydgoszcz, 85 168, Poland

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Novartis Investigative Site

Krakow, 31-121, Poland

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Novartis Investigative Site

Piotrkow Trybunalski, 97-300, Poland

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Novartis Investigative Site

Poznan, 60 529, Poland

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Novartis Investigative Site

Poznan, 60-773, Poland

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Novartis Investigative Site

Warsaw, 02637, Poland

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Novartis Investigative Site

Bucharest, 011172, Romania

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Novartis Investigative Site

Bucharest, 030167, Romania

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Novartis Investigative Site

Cluj-Napoca, 400006, Romania

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Novartis Investigative Site

Izhevsk, 426009, Russia

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Novartis Investigative Site

Kazan', 420064, Russia

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Novartis Investigative Site

Khanty-Mansiysk, 628012, Russia

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Novartis Investigative Site

Kursk, 305007, Russia

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Novartis Investigative Site

Moscow, 115093, Russia

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Novartis Investigative Site

Moscow, 119049, Russia

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Novartis Investigative Site

Moscow, 123182, Russia

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Novartis Investigative Site

Novosibirsk, 630099, Russia

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Novartis Investigative Site

Orenburg, 460000, Russia

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Novartis Investigative Site

Saratov, 410053, Russia

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Novartis Investigative Site

Yaroslavl, 150062, Russia

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Novartis Investigative Site

Elche, Alicante, 03203, Spain

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Novartis Investigative Site

Córdoba, Andalusia, 14004, Spain

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Novartis Investigative Site

Terrassa, Barcelona, 08221, Spain

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Novartis Investigative Site

Santander, Cantabria, 39008, Spain

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Novartis Investigative Site

Salamanca, Castille and León, 37007, Spain

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Novartis Investigative Site

Barcelona, Catalonia, 08003, Spain

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Novartis Investigative Site

Lugo, Galicia, 27003, Spain

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Novartis Investigative Site

Santiago de Compostela, Galicia, 15706, Spain

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Novartis Investigative Site

Las Palmas de Gran Canaria, Las Palmas de G.C, 35020, Spain

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Novartis Investigative Site

El Palmar, Murcia, 30120, Spain

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Novartis Investigative Site

A Coruña, 15006, Spain

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Novartis Investigative Site

Madrid, 28034, Spain

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Novartis Investigative Site

Madrid, 28040, Spain

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Novartis Investigative Site

Pontevedra, 36001, Spain

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Novartis Investigative Site

Seville, 41010, Spain

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Novartis Investigative Site

Vitoria-Gasteiz, 01009, Spain

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Novartis Investigative Site

Fribourg, CH, 1708, Switzerland

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Novartis Investigative Site

Basel, 4031, Switzerland

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Novartis Investigative Site

Sankt Gallen, CH 9007, Switzerland

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Novartis Investigative Site

Zurich, CH 8091, Switzerland

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Novartis Investigative Site

Devon, Barnstaple, EX31 4JB, United Kingdom

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Novartis Investigative Site

Basingstoke, Hampshire, RG24 9NA, United Kingdom

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Novartis Investigative Site

Maidstone, Kent, ME16 9QQ, United Kingdom

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Novartis Investigative Site

Leytonstone, London, E11 1NR, United Kingdom

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Novartis Investigative Site

Bradford, West Yorkshire, BD5 0NA, United Kingdom

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Novartis Investigative Site

Leeds, West Yorkshire, LS7 4SA, United Kingdom

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Novartis Investigative Site

Hull, HU3 2JZ, United Kingdom

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Novartis Investigative Site

Wigan, WN6 9EP, United Kingdom

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Novartis Investigative Site

Wolverhampton, WV10 0QP, United Kingdom

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Related Publications (2)

• Baraliakos X, Pournara E, Coates LC, Navarro-Compan V, Blanco R, O'Brien E, Schulz B, Landewe R. Magnetic resonance imaging characteristics in patients with psoriatic arthritis and axial manifestations from the MAXIMISE cohort. Rheumatology (Oxford). 2024 Jan 4;63(1):85-92. doi: 10.1093/rheumatology/kead162.

  PMID: 37094184 DERIVED

• Baraliakos X, Gossec L, Pournara E, Jeka S, Mera-Varela A, D'Angelo S, Schulz B, Rissler M, Nagar K, Perella C, Coates LC. Secukinumab in patients with psoriatic arthritis and axial manifestations: results from the double-blind, randomised, phase 3 MAXIMISE trial. Ann Rheum Dis. 2021 May;80(5):582-590. doi: 10.1136/annrheumdis-2020-218808. Epub 2020 Dec 17.

  PMID: 33334727 DERIVED

MeSH Terms

Conditions

Arthritis, Psoriatic

Interventions

secukinumab

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

Results Point of Contact

• Title: Study Director
• Organization: Novartis Pharma AG

novartis.email@novartis.com

1-888-669-6682

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

Model Details: 498 patients were randomized in this Phase 3b trial. 5 (of 503) were mis-randomized, i.e. received randomization number but never received study medication. This was a 52-week, randomized, double-blind, double-dummy, placebo-controlled, multicenter study to assess the efficacy of secukinumab 150 mg or 300 mg in patients with AxPsA who had an inadequate response to NSAIDs. The study had 2 treatment periods; a placebo-controlled period from Baseline to Week 12 followed by an active treatment period from Week 12 to Week 52. At Week 12, patients randomized to placebo at Baseline were re-randomized (1:1) to active treatment with secukinumab 150 mg or secukinumab 300 mg.

Study Record Dates

• First Submitted: March 23, 2016
• First Posted: March 29, 2016
• Study Start: October 3, 2016
• Primary Completion: June 26, 2019
• Study Completion: June 26, 2019
• Last Updated: October 1, 2020
• Results First Posted: August 24, 2020

Record last verified: 2020-09

Locations

FR (6); HU (5); IT (6); GB (9); BU (4); RO (3); BE (3); CZ (4); DE (5); GR (2); IE (1); RU (11); ES (2); IL (4); PL (7); CH (4); FI (2)