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Psoriatic ArthritisPhase 3ACHILLESNCT02771210

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

A Phase 3 study testing Secukinumab in people with Psoriatic Arthritis and Axial Spondyloarthritis, run by Novartis Pharmaceuticals at 55 sites in 8 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial 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… Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Secukinumab
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
204 participants
Where
55 sitesin 8 countries
Study dates
30 Aug 2016to 11 Dec 2019
Phase
Phase 3
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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.

Trial locations and contacts

55 sites in 8 countries.

55 sites in 8 countries

Germany14 sites

  • Novartis Investigative Site

    Berlin, 12435

  • Novartis Investigative Site

    Berlin, 14059

  • Novartis Investigative Site

    Cologne, 50937

  • Novartis Investigative Site

    Cottbus, 03042

  • Novartis Investigative Site

    Erlangen, 91054

  • Novartis Investigative Site

    Frankfurt am Main, 60528

  • Novartis Investigative Site

    Hamburg, 22391

  • Novartis Investigative Site

    Hamburg, 22415

  • Novartis Investigative Site

    Hanover, 30161

  • Novartis Investigative Site

    Herne, 44649

  • Novartis Investigative Site

    Magdeburg, 39104

  • Novartis Investigative Site

    Magdeburg, 39110

  • Novartis Investigative Site

    Mainz, 55131

  • Novartis Investigative Site

    Wuppertal, 42105

Other trials in Germany

Spain13 sites

  • Novartis Investigative Site

    Barakaldo, Vizcaya, 48903

  • Novartis Investigative Site

    Cartagena, Murcia, 30202

  • Novartis Investigative Site

    Madrid, 28040

  • Novartis Investigative Site

    Madrid, 28046

  • Novartis Investigative Site

    Madrid, 28942

  • Novartis Investigative Site

    Málaga, 29009

  • Novartis Investigative Site

    Mérida, Extremadura, 06800

  • Novartis Investigative Site

    Ourense, Galicia, 32005

  • Novartis Investigative Site

    Pontevedra, 36001

  • Novartis Investigative Site

    Santiago de Compostela, Galicia, 15706

  • Novartis Investigative Site

    Seville, Andalusia, 41009

  • Novartis Investigative Site

    Torrelavega, Cantabria, 39300

  • Novartis Investigative Site

    Vigo, Pontevedra, 36200

Other trials in Spain

United Kingdom8 sites

  • Novartis Investigative Site

    Barnsley, S75 2EP

  • Novartis Investigative Site

    Cheshire, CW1 4QJ

  • Novartis Investigative Site

    Hull, HU3 2JZ

  • Novartis Investigative Site

    Leytonstone, London, E11 1NR

  • Novartis Investigative Site

    London, NW3 2QG

  • Novartis Investigative Site

    Stoke-on-Trent, Staffordshire, ST6 7AG

  • Novartis Investigative Site

    Truro, Cornwall, TR1 3LJ

  • Novartis Investigative Site

    Tyne and Wear, NE29 8NH

Other trials in United Kingdom

Italy6 sites

  • Novartis Investigative Site

    Bergamo, BG, 24128

  • Novartis Investigative Site

    Bologna, 40138

  • Novartis Investigative Site

    Milan, MI, 20100

  • Novartis Investigative Site

    Potenza, PZ, 85100

  • Novartis Investigative Site

    Torino, TO, 10128

  • Novartis Investigative Site

    Verona, VR, 37134

Other trials in Italy

Bulgaria5 sites

  • Novartis Investigative Site

    Plovdiv, 4002

  • Novartis Investigative Site

    Sofia, 1407

  • Novartis Investigative Site

    Sofia, 1413

  • Novartis Investigative Site

    Stara Zagora, 6000

  • Novartis Investigative Site

    Targovishte, 7700

Other trials in Bulgaria

Czechia4 sites

  • Novartis Investigative Site

    Brno, 63800

  • Novartis Investigative Site

    Prague, Czech Republic, 140 59

  • Novartis Investigative Site

    Prague, 128 50

  • Novartis Investigative Site

    Uherské Hradiště, 686 01

Other trials in Czechia

Greece4 sites

  • Novartis Investigative Site

    Athens, 115 21

  • Novartis Investigative Site

    Athens, 115 27

  • Novartis Investigative Site

    Heraklion Crete, Greece, 711 10

  • Novartis Investigative Site

    Thessaloniki, 54642

Other trials in Greece

Slovakia1 site

  • Novartis Investigative Site

    Piešťany, 92101

Other trials in Slovakia

About this study

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)

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.

Read the 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)

Being tested
Secukinumab, Secukinumab Placebo
Keywords
Active psoriatic arthritis, Axial spondyloarthritides, Subcutaneous, Secukinumab in prefilled syringe, Enthesitis, Achilles tendon, AxSpA, PsA
Medical subject headings
Arthritis, Psoriatic, Axial Spondyloarthritis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • SecukinumabBiological

    Also called AIN457A

    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

  • Secukinumab PlaceboDrug

    Also called AIN457/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

Study groups in NCT02771210
Study groupRoleWhat they receive
AIN457/SecukinumabExperimentalSecukinumab 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
Receives: Biological: Secukinumab
AIN457/Secukinumab PlaceboPlacebo comparatorSecukinumab Placebo s.c.
Receives: Drug: Secukinumab Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: Week 24

Secondary outcomes (10)

  1. 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").

    Measured: Week 24

  2. 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.

    Measured: Week 24

  3. 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.

    Measured: Week 24

  4. 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.

    Measured: Week 24

  5. 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.

    Measured: Week 24

  6. 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.

    Measured: Week 24

  7. 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.

    Measured: Week 24

  8. 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

    Measured: Week 24

  9. 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

    Measured: Weeks 24 and 52

  10. 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").

    Measured: Change from week 24 to week 52

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted13 May 2016 (estimated)
  2. Study start30 Aug 2016
  3. Primary completion11 Dec 2019
  4. Study completion11 Dec 2019

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
Randomized Double-blind
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
204 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02771210
Sponsor's protocol ID
CAIN457F3301
Other IDs
2016-000972-91, 2016
Acronym
ACHILLES
Status last verified
Apr 2021
First submitted
31 Mar 2016
Last updated
3 May 2021
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Undecided: 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

Publications

  • 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.

    PubMed 35578245

  • 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.

    PubMed 34730795

  • 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.

    PubMed 33220702

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Secukinumab in people with Psoriatic Arthritis and Axial Spondyloarthritis, run by Novartis Pharmaceuticals at 55 sites in 8 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 3 May 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 55 sites in Germany, Spain, United Kingdom, Italy, Bulgaria and 3 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 27 Jan 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number (%) of Patients With Resolution of Achilles Tendon Enthesitis (time frame: Week 24). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02771210, which also lists 3 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 May 2021.

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