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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)

Primary Purpose

Psoriatic Arthritis, Axial Spondyloarthritis, Enthesitis

Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Secukinumab
Secukinumab Placebo
Sponsored by
Novartis Pharmaceuticals
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Psoriatic Arthritis focused on measuring Active psoriatic arthritis, Axial spondyloarthritides, Subcutaneous, Secukinumab in prefilled syringe, Enthesitis, Achilles tendon, AxSpA, PsA

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

AIN457/Secukinumab

AIN457/Secukinumab Placebo

Arm Description

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

Secukinumab Placebo s.c.

Outcomes

Primary Outcome Measures

Number (%) of Patients With Resolution of Achilles Tendon Enthesitis
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

Mean Change of Heel Pain
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
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
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
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
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
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
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
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
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
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").

Full Information

First Posted
March 31, 2016
Last Updated
April 7, 2021
Sponsor
Novartis Pharmaceuticals
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1. Study Identification

Unique Protocol Identification Number
NCT02771210
Brief Title
Study of Efficacy and Safety of Secukinumab in Psoriatic Arthritis and Axial Spondyloarthritis Patients With Active Enthesitis Including One Achilles Tendon Site
Acronym
ACHILLES
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)
Study Type
Interventional

2. Study Status

Record Verification Date
April 2021
Overall Recruitment Status
Completed
Study Start Date
August 30, 2016 (Actual)
Primary Completion Date
December 11, 2019 (Actual)
Study Completion Date
December 11, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Novartis Pharmaceuticals

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.
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)

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Psoriatic Arthritis, Axial Spondyloarthritis, Enthesitis
Keywords
Active psoriatic arthritis, Axial spondyloarthritides, Subcutaneous, Secukinumab in prefilled syringe, Enthesitis, Achilles tendon, AxSpA, PsA

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Model Description
Randomized Double-blind
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
204 (Actual)

8. Arms, Groups, and Interventions

Arm Title
AIN457/Secukinumab
Arm Type
Experimental
Arm Description
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
Arm Title
AIN457/Secukinumab Placebo
Arm Type
Placebo Comparator
Arm Description
Secukinumab Placebo s.c.
Intervention Type
Biological
Intervention Name(s)
Secukinumab
Other Intervention Name(s)
AIN457A
Intervention Description
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
Intervention Type
Drug
Intervention Name(s)
Secukinumab Placebo
Other Intervention Name(s)
AIN457/Secukinumab Placebo
Intervention Description
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 Measure Information:
Title
Number (%) of Patients With Resolution of Achilles Tendon Enthesitis
Description
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.
Time Frame
Week 24
Secondary Outcome Measure Information:
Title
Mean Change of Heel Pain
Description
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").
Time Frame
Week 24
Title
Number (%) of Patients With Improvement of Bone Marrow Edema
Description
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.
Time Frame
Week 24
Title
Number (%) of Patients With Resolution of Enthesitis as Assessed by LEI
Description
Number (%) of patients with resolution of enthesitis as assessed by the Leeds enthesitis index (LEI) at Week 24.
Time Frame
Week 24
Title
Mean Change of Physician's Global Assessment of Disease Activity
Description
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.
Time Frame
Week 24
Title
Mean Change of Patient's Global Assessment of Disease Activity
Description
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.
Time Frame
Week 24
Title
Mean Change of Physician's Assessment of Heel Enthesopathy Activity
Description
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.
Time Frame
Week 24
Title
Mean Change of Patient's Assessment of Heel Enthesopathy Activity
Description
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.
Time Frame
Week 24
Title
Mean Change in Short Form-36 (SF-36) v2
Description
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
Time Frame
Week 24
Title
Percentage of Patients With Resolution of Achilles Tendon Enthesitis After Switching From Placebo to Secukinumab
Description
Percentage of patients with resolution of Achilles tendon enthesitis (affected foot) after switching from placebo to secukinumab at Week 24
Time Frame
Weeks 24 and 52
Title
Mean Change of Heel Pain After Switching From Placebo to Secukinumab
Description
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").
Time Frame
Change from week 24 to week 52

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Facility Information:
Facility Name
Novartis Investigative Site
City
Plovdiv
ZIP/Postal Code
4002
Country
Bulgaria
Facility Name
Novartis Investigative Site
City
Sofia
ZIP/Postal Code
1407
Country
Bulgaria
Facility Name
Novartis Investigative Site
City
Sofia
ZIP/Postal Code
1413
Country
Bulgaria
Facility Name
Novartis Investigative Site
City
Stara Zagora
ZIP/Postal Code
6000
Country
Bulgaria
Facility Name
Novartis Investigative Site
City
Targovishte
ZIP/Postal Code
7700
Country
Bulgaria
Facility Name
Novartis Investigative Site
City
Praha 4
State/Province
Czech Republic
ZIP/Postal Code
140 59
Country
Czechia
Facility Name
Novartis Investigative Site
City
Brno
ZIP/Postal Code
63800
Country
Czechia
Facility Name
Novartis Investigative Site
City
Prague 2
ZIP/Postal Code
128 50
Country
Czechia
Facility Name
Novartis Investigative Site
City
Uherske Hradiste
ZIP/Postal Code
686 01
Country
Czechia
Facility Name
Novartis Investigative Site
City
Berlin
ZIP/Postal Code
12435
Country
Germany
Facility Name
Novartis Investigative Site
City
Berlin
ZIP/Postal Code
14059
Country
Germany
Facility Name
Novartis Investigative Site
City
Cottbus
ZIP/Postal Code
03042
Country
Germany
Facility Name
Novartis Investigative Site
City
Erlangen
ZIP/Postal Code
91054
Country
Germany
Facility Name
Novartis Investigative Site
City
Frankfurt am Main
ZIP/Postal Code
60528
Country
Germany
Facility Name
Novartis Investigative Site
City
Hamburg
ZIP/Postal Code
22391
Country
Germany
Facility Name
Novartis Investigative Site
City
Hamburg
ZIP/Postal Code
22415
Country
Germany
Facility Name
Novartis Investigative Site
City
Hannover
ZIP/Postal Code
30161
Country
Germany
Facility Name
Novartis Investigative Site
City
Herne
ZIP/Postal Code
44649
Country
Germany
Facility Name
Novartis Investigative Site
City
Koeln
ZIP/Postal Code
50937
Country
Germany
Facility Name
Novartis Investigative Site
City
Magdeburg
ZIP/Postal Code
39104
Country
Germany
Facility Name
Novartis Investigative Site
City
Magdeburg
ZIP/Postal Code
39110
Country
Germany
Facility Name
Novartis Investigative Site
City
Mainz
ZIP/Postal Code
55131
Country
Germany
Facility Name
Novartis Investigative Site
City
Wuppertal
ZIP/Postal Code
42105
Country
Germany
Facility Name
Novartis Investigative Site
City
Athens
ZIP/Postal Code
115 21
Country
Greece
Facility Name
Novartis Investigative Site
City
Athens
ZIP/Postal Code
115 27
Country
Greece
Facility Name
Novartis Investigative Site
City
Heraklion Crete
ZIP/Postal Code
711 10
Country
Greece
Facility Name
Novartis Investigative Site
City
Thessaloniki
ZIP/Postal Code
54642
Country
Greece
Facility Name
Novartis Investigative Site
City
Bergamo
State/Province
BG
ZIP/Postal Code
24128
Country
Italy
Facility Name
Novartis Investigative Site
City
Milano
State/Province
MI
ZIP/Postal Code
20100
Country
Italy
Facility Name
Novartis Investigative Site
City
Potenza
State/Province
PZ
ZIP/Postal Code
85100
Country
Italy
Facility Name
Novartis Investigative Site
City
Torino
State/Province
TO
ZIP/Postal Code
10128
Country
Italy
Facility Name
Novartis Investigative Site
City
Verona
State/Province
VR
ZIP/Postal Code
37134
Country
Italy
Facility Name
Novartis Investigative Site
City
Bologna
ZIP/Postal Code
40138
Country
Italy
Facility Name
Novartis Investigative Site
City
Piestany
ZIP/Postal Code
92101
Country
Slovakia
Facility Name
Novartis Investigative Site
City
Sevilla
State/Province
Andalucia
ZIP/Postal Code
41009
Country
Spain
Facility Name
Novartis Investigative Site
City
Torrelavega
State/Province
Cantabria
ZIP/Postal Code
39300
Country
Spain
Facility Name
Novartis Investigative Site
City
Merida
State/Province
Extremadura
ZIP/Postal Code
06800
Country
Spain
Facility Name
Novartis Investigative Site
City
Orense
State/Province
Galicia
ZIP/Postal Code
32005
Country
Spain
Facility Name
Novartis Investigative Site
City
Santiago de Compostela
State/Province
Galicia
ZIP/Postal Code
15706
Country
Spain
Facility Name
Novartis Investigative Site
City
Cartagena
State/Province
Murcia
ZIP/Postal Code
30202
Country
Spain
Facility Name
Novartis Investigative Site
City
Vigo
State/Province
Pontevedra
ZIP/Postal Code
36200
Country
Spain
Facility Name
Novartis Investigative Site
City
Baracaldo
State/Province
Vizcaya
ZIP/Postal Code
48903
Country
Spain
Facility Name
Novartis Investigative Site
City
Madrid
ZIP/Postal Code
28040
Country
Spain
Facility Name
Novartis Investigative Site
City
Madrid
ZIP/Postal Code
28046
Country
Spain
Facility Name
Novartis Investigative Site
City
Madrid
ZIP/Postal Code
28942
Country
Spain
Facility Name
Novartis Investigative Site
City
Malaga
ZIP/Postal Code
29009
Country
Spain
Facility Name
Novartis Investigative Site
City
Pontevedra
ZIP/Postal Code
36001
Country
Spain
Facility Name
Novartis Investigative Site
City
Truro
State/Province
Cornwall
ZIP/Postal Code
TR1 3LJ
Country
United Kingdom
Facility Name
Novartis Investigative Site
City
Leytonstone
State/Province
London
ZIP/Postal Code
E11 1NR
Country
United Kingdom
Facility Name
Novartis Investigative Site
City
Stoke on Trent
State/Province
Staffordshire
ZIP/Postal Code
ST6 7AG
Country
United Kingdom
Facility Name
Novartis Investigative Site
City
Barnsley
ZIP/Postal Code
S75 2EP
Country
United Kingdom
Facility Name
Novartis Investigative Site
City
Cheshire
ZIP/Postal Code
CW1 4QJ
Country
United Kingdom
Facility Name
Novartis Investigative Site
City
Hull
ZIP/Postal Code
HU3 2JZ
Country
United Kingdom
Facility Name
Novartis Investigative Site
City
London
ZIP/Postal Code
NW3 2QG
Country
United Kingdom
Facility Name
Novartis Investigative Site
City
Tyne And Wear
ZIP/Postal Code
NE29 8NH
Country
United Kingdom

12. IPD Sharing Statement

Plan to Share IPD
Undecided
IPD Sharing 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
Citations:
PubMed Identifier
35578245
Citation
Baraliakos X, Sewerin P, de Miguel E, Pournara E, Kleinmond C, Shekhawat A, Jentzsch C, Wiedon A, Behrens F; ACHILLES study group. Magnetic resonance imaging characteristics in patients with spondyloarthritis and clinical diagnosis of heel enthesitis: post hoc analysis from the phase 3 ACHILLES trial. Arthritis Res Ther. 2022 May 16;24(1):111. doi: 10.1186/s13075-022-02797-8.
Results Reference
derived
PubMed Identifier
34730795
Citation
Behrens F, Sewerin P, de Miguel E, Patel Y, Batalov A, Dokoupilova E, Kleinmond C, Pournara E, Shekhawat A, Jentzsch C, Wiedon A, Baraliakos X; ACHILLES study group. Efficacy and safety of secukinumab in patients with spondyloarthritis and enthesitis at the Achilles tendon: results from a phase 3b trial. Rheumatology (Oxford). 2022 Jul 6;61(7):2856-2866. doi: 10.1093/rheumatology/keab784.
Results Reference
derived
PubMed Identifier
33220702
Citation
Baraliakos X, Sewerin P, de Miguel E, Pournara E, Kleinmond C, Wiedon A, Behrens F. Achilles tendon enthesitis evaluated by MRI assessments in patients with axial spondyloarthritis and psoriatic arthritis: a report of the methodology of the ACHILLES trial. BMC Musculoskelet Disord. 2020 Nov 21;21(1):767. doi: 10.1186/s12891-020-03775-4.
Results Reference
derived

Learn more about this trial

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

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