Study of Efficacy and Safety of Secukinumab in Psoriatic Arthritis and Axial Spondyloarthritis Patients With Active Enthesitis Including One Achilles Tendon Site

NCT02771210 | Completed Phase 3 Results FDA Drug

• 2 other identifiers: CAIN457F33012016-000972-91
• Study Type: interventional
• Target: 204
• Locations: 8 countries
• Sites: 55

Brief Summary

The purpose of this study was to demonstrate efficacy, including effects on inflammation by magnetic resonance imaging (MRI) assessments, of secukinumab on Achilles tendon enthesitis for up to 1 year with a primary focus at Week 24, in patients with active Psoriatic Arthritis and axial Spondyloarthritis despite current or previous non-steroidal anti-inflammatory drugs (NSAID) and/or disease modifying anti-rheumatic drug (DMARD) and/or anti-TNFα therapy.

Conditions

Psoriatic Arthritis; Axial Spondyloarthritis; Enthesitis

Keywords

Active psoriatic arthritis; Axial spondyloarthritides; Subcutaneous; Secukinumab in prefilled syringe; Enthesitis; Achilles tendon; AxSpA; PsA

Outcome Measures

Primary Outcomes (1)

• Number (%) of Patients With Resolution of Achilles Tendon Enthesitis

  Number (%) of patients with resolution of Achilles tendon enthesitis (affected foot) as assessed by respective subcomponent of Leeds enthesitis index (LEI) at Week 24. The primary analysis was performed via a logistic regression model with the factors treatment, country, and stratification factor diagnosis (PsA or axSpA); patients with a missing assessment were considered as responders if they had already met the response criterion at the time of last assessment.

  Week 24

Secondary Outcomes (10)

• Mean Change of Heel Pain

  Week 24

• Number (%) of Patients With Improvement of Bone Marrow Edema

  Week 24

• Number (%) of Patients With Resolution of Enthesitis as Assessed by LEI

  Week 24

• Mean Change of Physician's Global Assessment of Disease Activity

  Week 24

• Mean Change of Patient's Global Assessment of Disease Activity

  Week 24

Study Arms (2)

AIN457/Secukinumab

EXPERIMENTAL

Secukinumab 150 mg s.c. or Secukinumab 300 mg s.c., respective dose was assigned according to underlying condition, in case of PsA according to severity of concomitant Psoriasis or pre-exposure to anti-TNFα

Biological: Secukinumab

AIN457/Secukinumab Placebo

PLACEBO COMPARATOR

Secukinumab Placebo s.c.

Drug: Secukinumab Placebo

Interventions

Secukinumab BIOLOGICAL

Induction: Week 0,1,2,3 150 mg or 300 mg Secukinumab s.c. Maintenance: 150 mg or 300 mg Secukinumab s.c. every 4 weeks starting at Week 4

Also known as: AIN457A

AIN457/Secukinumab

Secukinumab Placebo DRUG

Induction: Week 0,1,2,3 Secukinumab Placebo s.c. Maintenance: Secukinumab Placebo s.c. every 4 weeks starting at Week 4 until Week 24 followed by 150 or 300 mg Secukinumab s.c. every 4 weeks

Also known as: AIN457/Secukinumab Placebo

AIN457/Secukinumab Placebo

Eligibility Criteria

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

You may qualify if:

• \- Patients with Psoriatic arthritis: Diagnosis of Psoriatic arthritis as per the Classification criteria for Psoriatic Arthritis (CASPAR criteria) with symptoms for at least 6 months and active Psoriatic arthritis as assessed by ≥ 1 tender joints out of 78 and ≥ 1 swollen joints out of 76 at Baseline (dactylitis of a digit counts as one joint each).
• \- Patients with Axial Spondyloarthritis: Diagnosis of Axial Spondyloarthritis as per the classification of the Assessment of Spondyloarthritis International Society axial Spondyloarthritis (ASAS) criteria and objective signs of inflammation at Screening (magnetic resonance imaging (MRI) or definite radiographic sacroilitis and/or abnormal C-Reactive Protein) and active disease assessed by total Bath ankylosing spondylitis disease activity index (BASDAI) ≥ 4 (0-10) at Baseline.
• Diagnosis of Achilles tendon enthesitis according to swelling and tenderness at the insertional site of the Achilles tendon into the calcaneus.
• Onset of heel pain ≥ 1 month at Baseline.
• Heel enthesitis that is magnetic resonance imaging (MRI)-positive according to the investigator's judgement.
• Patients who have been exposed to up to two TNFα inhibitors.

You may not qualify if:

• Chest X-ray or chest magnetic resonance imaging (MRI) with evidence of ongoing infectious or malignant process.
• Previous exposure to secukinumab or other biologic drug directly targeting Interleukin (IL)-17 or Interleukin (IL)-17 receptor.
• Ongoing use of psoriasis treatments / medications (e.g. topical corticosteroids, ultraviolet (UV) therapy) at randomization.
• Patients who have previously been exposed to more than two Tumor necrosis factor (TNF) inhibitors (investigational or approved).
• Patients who have ever received biologic immunomodulating agents (investigational or approved), except those targeting Tumor necrosis factor (TNF) inhibitors.
• Pregnant or nursing (lactating) women.
• History of ongoing, chronic or recurrent infectious disease or evidence of tuberculosis infection.

Sponsors & Collaborators

• Novartis Pharmaceuticals: lead

Study Sites (55)

Novartis Investigative Site

Plovdiv, 4002, Bulgaria

Location

Novartis Investigative Site

Sofia, 1407, Bulgaria

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Novartis Investigative Site

Sofia, 1413, Bulgaria

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Novartis Investigative Site

Stara Zagora, 6000, Bulgaria

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Novartis Investigative Site

Targovishte, 7700, Bulgaria

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Novartis Investigative Site

Prague, Czech Republic, 140 59, Czechia

Location

Novartis Investigative Site

Brno, 63800, Czechia

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Novartis Investigative Site

Prague, 128 50, Czechia

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Novartis Investigative Site

Uherské Hradiště, 686 01, Czechia

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Novartis Investigative Site

Berlin, 12435, Germany

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Novartis Investigative Site

Berlin, 14059, Germany

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Novartis Investigative Site

Cologne, 50937, Germany

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Novartis Investigative Site

Cottbus, 03042, Germany

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Novartis Investigative Site

Erlangen, 91054, Germany

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Novartis Investigative Site

Frankfurt am Main, 60528, Germany

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Novartis Investigative Site

Hamburg, 22391, Germany

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Novartis Investigative Site

Hamburg, 22415, Germany

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Novartis Investigative Site

Hanover, 30161, Germany

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Novartis Investigative Site

Herne, 44649, Germany

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Novartis Investigative Site

Magdeburg, 39104, Germany

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Novartis Investigative Site

Magdeburg, 39110, Germany

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Novartis Investigative Site

Mainz, 55131, Germany

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Novartis Investigative Site

Wuppertal, 42105, Germany

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Novartis Investigative Site

Heraklion Crete, Greece, 711 10, Greece

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Novartis Investigative Site

Athens, 115 21, Greece

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Novartis Investigative Site

Athens, 115 27, Greece

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Novartis Investigative Site

Thessaloniki, 54642, Greece

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Novartis Investigative Site

Bergamo, BG, 24128, Italy

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Novartis Investigative Site

Milan, MI, 20100, Italy

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Novartis Investigative Site

Potenza, PZ, 85100, 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

Piešťany, 92101, Slovakia

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Novartis Investigative Site

Seville, Andalusia, 41009, Spain

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Novartis Investigative Site

Torrelavega, Cantabria, 39300, Spain

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Novartis Investigative Site

Mérida, Extremadura, 06800, Spain

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Novartis Investigative Site

Ourense, Galicia, 32005, Spain

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Novartis Investigative Site

Santiago de Compostela, Galicia, 15706, Spain

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Novartis Investigative Site

Cartagena, Murcia, 30202, Spain

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Novartis Investigative Site

Vigo, Pontevedra, 36200, Spain

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Novartis Investigative Site

Barakaldo, Vizcaya, 48903, Spain

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Novartis Investigative Site

Madrid, 28040, Spain

Location

Novartis Investigative Site

Madrid, 28046, Spain

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Novartis Investigative Site

Madrid, 28942, Spain

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Novartis Investigative Site

Málaga, 29009, Spain

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Novartis Investigative Site

Pontevedra, 36001, Spain

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Novartis Investigative Site

Truro, Cornwall, TR1 3LJ, United Kingdom

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Novartis Investigative Site

Leytonstone, London, E11 1NR, United Kingdom

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Novartis Investigative Site

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

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Novartis Investigative Site

Barnsley, S75 2EP, United Kingdom

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Novartis Investigative Site

Cheshire, CW1 4QJ, United Kingdom

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Novartis Investigative Site

Hull, HU3 2JZ, United Kingdom

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Novartis Investigative Site

London, NW3 2QG, United Kingdom

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Novartis Investigative Site

Tyne and Wear, NE29 8NH, United Kingdom

Location

Related Publications (3)

• Baraliakos X, Sewerin P, de Miguel E, Pournara E, Kleinmond C, Shekhawat A, Jentzsch C, Wiedon A, Behrens F; ACHILLES study group. Magnetic resonance imaging characteristics in patients with spondyloarthritis and clinical diagnosis of heel enthesitis: post hoc analysis from the phase 3 ACHILLES trial. Arthritis Res Ther. 2022 May 16;24(1):111. doi: 10.1186/s13075-022-02797-8.

  PMID: 35578245 DERIVED

• Behrens F, Sewerin P, de Miguel E, Patel Y, Batalov A, Dokoupilova E, Kleinmond C, Pournara E, Shekhawat A, Jentzsch C, Wiedon A, Baraliakos X; ACHILLES study group. Efficacy and safety of secukinumab in patients with spondyloarthritis and enthesitis at the Achilles tendon: results from a phase 3b trial. Rheumatology (Oxford). 2022 Jul 6;61(7):2856-2866. doi: 10.1093/rheumatology/keab784.

  PMID: 34730795 DERIVED

• Baraliakos X, Sewerin P, de Miguel E, Pournara E, Kleinmond C, Wiedon A, Behrens F. Achilles tendon enthesitis evaluated by MRI assessments in patients with axial spondyloarthritis and psoriatic arthritis: a report of the methodology of the ACHILLES trial. BMC Musculoskelet Disord. 2020 Nov 21;21(1):767. doi: 10.1186/s12891-020-03775-4.

  PMID: 33220702 DERIVED

MeSH Terms

Conditions

Arthritis, Psoriatic; Axial Spondyloarthritis

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; Ankylosis

Results Point of Contact

• Title: Study Director
• 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

Model Details: Randomized Double-blind

Study Record Dates

• First Submitted: March 31, 2016
• First Posted: May 13, 2016
• Study Start: August 30, 2016
• Primary Completion: December 11, 2019
• Study Completion: December 11, 2019
• Last Updated: May 3, 2021
• Results First Posted: January 27, 2021

Record last verified: 2021-04

Locations

IT (6); BU (5); CZ (4); GB (8); DE (14); GR (4); ES (13); SL (1)