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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)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02771210
Recruitment Status : Completed
First Posted : May 13, 2016
Last Update Posted : September 14, 2020
Sponsor:
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )

Tracking Information
First Submitted Date  ICMJE March 31, 2016
First Posted Date  ICMJE May 13, 2016
Last Update Posted Date September 14, 2020
Actual Study Start Date  ICMJE August 30, 2016
Actual Primary Completion Date December 11, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 10, 2016)
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).
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: May 10, 2016)
  • 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.
  • 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.
  • 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).
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Study of Efficacy and Safety of Secukinumab in Psoriatic Arthritis and Axial Spondyloarthritis Patients With Active Enthesitis Including One Achilles Tendon Site
Official Title  ICMJE 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)
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.
Detailed Description

Primary endpoint is at week 24 but there is 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 will be 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)

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:
Randomized Double-blind
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE
  • Psoriatic Arthritis
  • Axial Spondyloarthritis
  • Enthesitis
Intervention  ICMJE
  • 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
  • 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
Study Arms  ICMJE
  • 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
    Intervention: Biological: Secukinumab
  • Placebo Comparator: AIN457/Secukinumab Placebo
    Secukinumab Placebo s.c.
    Intervention: Drug: Secukinumab Placebo
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: December 20, 2018)
204
Original Estimated Enrollment  ICMJE
 (submitted: May 10, 2016)
200
Actual Study Completion Date  ICMJE December 11, 2019
Actual Primary Completion Date December 11, 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.

Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Bulgaria,   Czechia,   Germany,   Greece,   Italy,   Slovakia,   Spain,   United Kingdom
Removed Location Countries Czech Republic
 
Administrative Information
NCT Number  ICMJE NCT02771210
Other Study ID Numbers  ICMJE CAIN457F3301
2016-000972-91 ( EudraCT Number )
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
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

Responsible Party Novartis ( Novartis Pharmaceuticals )
Study Sponsor  ICMJE Novartis Pharmaceuticals
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Novartis
Verification Date September 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP