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
Last Update Posted : September 14, 2020
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| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Psoriatic Arthritis Axial Spondyloarthritis Enthesitis | Biological: Secukinumab Drug: Secukinumab Placebo | Phase 3 |
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 : | 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 will be 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 |
- 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).
- 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.
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.
| 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.
Other protocol-defined inclusion/exclusion criteria may apply.
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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| 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 |
| Last Update Posted: | September 14, 2020 |
| Last Verified: | September 2020 |
| 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 |
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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 |