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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 : Completed
First Posted : May 13, 2016
Results First Posted : January 27, 2021
Last Update Posted : May 3, 2021
Sponsor:
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )

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.

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

Detailed Description:

Primary endpoint was at week 24 but there was no interim Clinical Study Report. While Protocol states at chapter 9.7 that a week 24 analysis may be provided (not mandatory as per protocol), all data has been analyzed at week 52.

Some of the secondary endpoints include the whole study period up to week 52 (to address questions on switching placebo to active drug)

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 204 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Randomized Double-blind
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
Actual Primary Completion Date : December 11, 2019
Actual Study Completion Date : December 11, 2019

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 was assigned according to underlying condition, in case of PsA according to severity of concomitant Psoriasis or pre-exposure to anti-TNFα
Biological: 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
Other Name: AIN457A

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




Primary Outcome Measures :
  1. Number (%) of Patients With Resolution of Achilles Tendon Enthesitis [ Time Frame: Week 24 ]

    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.



Secondary Outcome Measures :
  1. Mean Change of Heel Pain [ Time Frame: Week 24 ]
    Mean change of heel pain from baseline to Week 24 measured by Numeric Rating Scale (NRS) ranging from 0 to 10, with 0 representing no pain and 10 representing worst pain (e.g. "pain as bad as you can imagine" or "worst pain imaginable").

  2. Number (%) of Patients With Improvement of Bone Marrow Edema [ Time Frame: Week 24 ]
    Number (%) of patients with an improvement of bone marrow edema from baseline to Week 24 as assessed by the respective subcomponent of the Psoriatic Arthritis Magnetic Resonance Imaging Score (PsAMRIS) in the affected foot.

  3. Number (%) of Patients With Resolution of Enthesitis as Assessed by LEI [ Time Frame: Week 24 ]
    Number (%) of patients with resolution of enthesitis as assessed by the Leeds enthesitis index (LEI) at Week 24.

  4. Mean Change of Physician's Global Assessment of Disease Activity [ Time Frame: Week 24 ]
    Mean change of physician's global assessment (PhGA) of disease activity from baseline to Week 24 measured by Visual Analog Scale (VAS) ranging from 0 to 100, with 0 representing not severe and 100 representing very severe.

  5. Mean Change of Patient's Global Assessment of Disease Activity [ Time Frame: Week 24 ]
    Mean change of patient's global assessment (PGA) of disease activity from baseline to Week 24 measured by Visual Analog Scale (VAS) ranging from 0 to 100, with 0 representing not severe and 100 representing very severe.

  6. Mean Change of Physician's Assessment of Heel Enthesopathy Activity [ Time Frame: Week 24 ]
    Mean change of physician's assessment of heel enthesopathy activity from baseline to Week 24 measured by Visual Analog Scale (VAS) ranging from 0 to 100, with 0 representing not severe and 100 representing very severe.

  7. Mean Change of Patient's Assessment of Heel Enthesopathy Activity [ Time Frame: Week 24 ]
    Mean change of patient's assessment of heel enthesopathy activity from baseline to Week 24 measured by Visual Analog Scale (VAS) ranging from 0 to 100, with 0 representing not severe and 100 representing very severe.

  8. Mean Change in Short Form-36 (SF-36) v2 [ Time Frame: Week 24 ]

    Mean change in Short Form-36 (SF-36) v2 as an indicator of overall health status

    The SF-36 has eight scaled scores; the scores are weighted sums of the questions in each section. Scores range from 0 - 100 Lower scores = more disability, higher scores = less disability


  9. Percentage of Patients With Resolution of Achilles Tendon Enthesitis After Switching From Placebo to Secukinumab [ Time Frame: Weeks 24 and 52 ]
    Percentage of patients with resolution of Achilles tendon enthesitis (affected foot) after switching from placebo to secukinumab at Week 24

  10. Mean Change of Heel Pain After Switching From Placebo to Secukinumab [ Time Frame: Change from week 24 to week 52 ]
    Mean change of heel pain after switching from placebo to secukinumab from Week 24 to week 52 measured by Numeric Rating Scale (NRS) ranging from 0 to 10, with 0 representing no pain and 10 representing worst pain (e.g. "pain as bad as you can imagine" or "worst pain imaginable").



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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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.

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


Locations
Show Show 55 study locations
Sponsors and Collaborators
Novartis Pharmaceuticals
  Study Documents (Full-Text)

Documents provided by Novartis ( Novartis Pharmaceuticals ):
Study Protocol  [PDF] June 19, 2017
Statistical Analysis Plan  [PDF] June 23, 2016

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Novartis Pharmaceuticals
ClinicalTrials.gov Identifier: NCT02771210    
Other Study ID Numbers: CAIN457F3301
2016-000972-91 ( EudraCT Number )
First Posted: May 13, 2016    Key Record Dates
Results First Posted: January 27, 2021
Last Update Posted: May 3, 2021
Last Verified: April 2021
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
AxSpA
PsA
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