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

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ClinicalTrials.gov Identifier: NCT02771210
Recruitment Status : Active, not recruiting
First Posted : May 13, 2016
Last Update Posted : June 11, 2019
Sponsor:
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )

Brief Summary:
The purpose of this study is 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.

Condition or disease Intervention/treatment Phase
Psoriatic Arthritis Axial Spondyloarthritis Enthesitis Biological: AIN457/Secukinumab Drug: AIN457/Secukinumab Placebo Phase 3

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 204 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Randomized, Double-blind, Placebo-controlled Multicenter Study of Subcutaneous Secukinumab to Demonstrate Efficacy in the Treatment of Enthesitis at the Achilles Tendon up to 1 Year in Adult Patients With Active Psoriatic Arthritis (PsA) and Axial Spondyloarthritis (axSpA) (ACHILLES)
Actual Study Start Date : August 30, 2016
Estimated Primary Completion Date : January 8, 2020
Estimated Study Completion Date : January 8, 2020

Resource links provided by the National Library of Medicine

Drug Information available for: Secukinumab

Arm Intervention/treatment
Experimental: AIN457/Secukinumab
Secukinumab 150 mg s.c. or Secukinumab 300 mg s.c., respective dose will be assigned according to underlying condition, in case of PsA according to severity of concomitant Psoriasis or pre-exposure to anti-TNFα
Biological: AIN457/Secukinumab
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

Placebo Comparator: AIN457/Secukinumab Placebo
Secukinumab Placebo s.c.
Drug: AIN457/Secukinumab Placebo
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




Primary Outcome Measures :
  1. Percentage of patients with resolution of Achilles tendon enthesitis [ Time Frame: Week 24 ]
    To measure the percentage of patients with resolution of Achilles tendon enthesitis as assessed by the respective subcomponent of the Leeds enthesitis index (LEI).


Secondary Outcome Measures :
  1. Heel Pain [ Time Frame: Week 24 ]
    The efficacy of secukinumab is superior to placebo based on the mean change of heel pain measured on a 10-point numerical rating scale.

  2. Percentage of patients with an improvement of bone marrow edema [ Time Frame: Week 24 ]
    The efficacy of secukinumab is superior to placebo based on the percentage of patients with an improvement of bone marrow edema as assessed by the respective subcomponent of the Psoriatic Arthritis Magnetic Resonance Imaging Score (PsAMRIS) in the affected foot at Baseline.

  3. Percentage of patients with resolution of enthesitis [ Time Frame: Week 24 ]
    The efficacy of secukinumab is superior to placebo based on the percentage of patients with resolution of enthesitis as assessed by the Leeds enthesitis index (LEI).

  4. Mean change in Physician's global assessment of disease activity [ Time Frame: Week 24 ]
    The efficacy of secukinumab is superior to placebo based on the mean change in physician's global assessment of disease activity.

  5. Mean change in Patient's global assessment of disease activity [ Time Frame: Week 24 ]
    The efficacy of secukinumab is superior to placebo based on the mean change in patient's global assessment of disease activity.

  6. Mean change in Physician's global assessment of heel enthesiopathy activity [ Time Frame: Week 24 ]
    The efficacy of secukinumab is superior to placebo based on the mean change in physician's global assessment of heel enthesiopathy activity.

  7. Mean change in Patient's global assessment of heel enthesiopathy activity [ Time Frame: Week 24 ]
    The efficacy of secukinumab is superior to placebo based on the mean change in patient's global assessment of heel enthesiopathy activity.

  8. Change in Short Form-36 Physical Component Summary (SF-36 PCS) or Short Form-36 (SF-36) v2 [ Time Frame: Week 24 ]
    The improvement in secukinumab is superior to placebo based on the change from Baseline in Short Form-36 Physical Component Summary (SF-36 PCS) or Short Form-36 (SF-36) v2.

  9. Increase in percentage of patients with resolution of Achilles tendon enthesitis after switching from placebo [ Time Frame: Week 24 - Week 52 ]
    To measure the increase in percentage of patients with resolution of Achilles tendon enthesitis after switching from placebo to secukinumab.

  10. Increase in mean change of Heel Pain in patients after switching from placebo [ Time Frame: Week 24 - Week 52 ]
    To describe the increase in mean change of heel pain in patients after switching from placebo to secukinumab.

  11. Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability] [ Time Frame: 52 weeks ]
    These assessments will be implemented in terms of physical examination and vital signs outcomes, clinical laboratory results, nature and frequency of the observed adverse events and serious adverse events, frequency and severity of any injection site reactions and ECG outcomes. During the first 24 weeks of the study, comparisons between the secukinumab treatment arm and the placebo treatment arm will also take place.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Key Inclusion Criteria:

- 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.

Key Exclusion Criteria:

  • 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.

Other protocol-defined inclusion/exclusion criteria may apply.


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02771210


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Sponsors and Collaborators
Novartis Pharmaceuticals

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Responsible Party: Novartis Pharmaceuticals
ClinicalTrials.gov Identifier: NCT02771210     History of Changes
Other Study ID Numbers: CAIN457F3301
2016-000972-91 ( EudraCT Number )
First Posted: May 13, 2016    Key Record Dates
Last Update Posted: June 11, 2019
Last Verified: June 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Plan Description:

Novartis is committed to sharing with qualified external researchers, access to patient-level data and supporting clinical documents from eligible studies. These requests are reviewed and approved by an independent review panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations.

This trial data availability is according to the criteria and process described on www.clinicalstudydatarequest.com


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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Novartis ( Novartis Pharmaceuticals ):
Active psoriatic arthritis
Axial spondyloarthritides
Subcutaneous
Secukinumab in prefilled syringe
Enthesitis
Achilles tendon
Additional relevant MeSH terms:
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Arthritis
Arthritis, Psoriatic
Spondylarthritis
Enthesopathy
Joint Diseases
Musculoskeletal Diseases
Spondylarthropathies
Spondylitis
Spinal Diseases
Bone Diseases
Psoriasis
Skin Diseases, Papulosquamous
Skin Diseases
Tendinopathy
Muscular Diseases
Tendon Injuries
Wounds and Injuries
Antibodies, Monoclonal
Immunologic Factors
Physiological Effects of Drugs