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 |
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Recruitment Status :
Completed
First Posted : May 13, 2016
Results First Posted : January 27, 2021
Last Update Posted : May 3, 2021
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| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Psoriatic Arthritis Axial Spondyloarthritis Enthesitis | Biological: Secukinumab Drug: Secukinumab Placebo | Phase 3 |
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)
| 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 |
| Arm | Intervention/treatment |
|---|---|
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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
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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 |
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Placebo Comparator: AIN457/Secukinumab Placebo
Secukinumab Placebo s.c.
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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 |
- 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.
- 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").
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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
- 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
- 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").
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| Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
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.
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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Documents provided by Novartis ( Novartis Pharmaceuticals ):
| 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 |
| Studies a U.S. FDA-regulated Drug Product: | Yes |
| Studies a U.S. FDA-regulated Device Product: | No |
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Active psoriatic arthritis Axial spondyloarthritides Subcutaneous Secukinumab in prefilled syringe |
Enthesitis Achilles tendon AxSpA PsA |
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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 |