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Axial SpondyloarthritisPhase 4TRACENCT03639740

Treat-to-target With Secukinumab in Axial Spondyloarthritis

A Phase 4 study testing Secukinumab 150 milligram [Cosentyx] in people with Axial Spondyloarthritis and Ankylosing Spondylitis, run by Professor Mikkel Østergaard at 10 sites in Denmark.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

A study of axSpA and AS receiving Secukinumab in a treat-to-target strategy. Read more about this study

Who is it for?
Ages 18 to 70 years
What is being tested?
Secukinumab 150 milligram [Cosentyx]
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
88 participants
Where
10 sitesDenmark
Study dates
15 Jan 2019to Feb 2021
Phase
Phase 4
Are there results?
None posted in the registry

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 to 70 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Diagnosis of axial spondyloarthritis (axSpA) according to the ASAS (Assessment of Spondyloarthritis International Society) criteria and/or ankylosing spondylitis (AS) according to the modified New York criteria as judged by a spondyloarthritis (SpA) rheumatologist (regarding imaging in the criteria, see below).
  • Active inflammation on MRI of the SIJs and/or spine as evaluated by a central SpA imaging expert and/or radiographic modified New York criteria fulfilled as judged by a central SpA imaging expert.
  • Active disease defined as ASDAS ≥ 2.1 (ASDAS high disease activity).
  • Total back pain as measured on a visual analogue scale (VAS) scale ≥ 4 0 mm (0-100 mm) at baseline.
  • Clinical indication for a biologic drug as assessed by the treating physician.
  • Patients should have received at least 2 different NSAIDs at the highest recommended dose for at least 2 weeks each with an inadequate response or failure to respond, or less if therapy had to be reduced due to intolerance, toxicity or contraindications.
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  • Patients on NSAIDs at inclusion should stay on a stable dose from at least 2 weeks before the baseline MRI scans are performed and to the week 24 visit.
  • Patients on synthetic disease-modifying anti-rheumatic drugs (sDMARDs) at inclusion should stay on a stable dose from at least 4 weeks before initiation of secukinumab to the week 24 visit.
  • Patient must be able to understand and communicate with the investigator and comply with the requirements of the study and must provide written, signed and dated informed consent before any study assessment is performed.
  • Male or female patients at least 18 years and less than 70 years of age.
  • Sufficient contraception for women.
  • Age ≥18 to <70 years.
  • Capable of giving informed consent.
  • Capable of complying with the examination programme of the protocol.

Who cannot join

  • Contraindications for secukinumab (described in protocol).
  • Contraindication for TNF inhibitor (described in protocol).
  • Contraindication for MRI (described in protocol).
  • Previous exposure to secukinumab or other biologic drug directly targeting interleukin-17 or interleukin-17 receptor.
  • Previous exposure to TNF inhibitor or drug targeting TNF.
  • Previous exposure to other types of biological disease-modifying anti-rheumatic drugs (bDMARDs) than TNF inhibitor.
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  • Patients taking high-potency opioid analgesics (e.g. methadone, hydromorphone, morphine)
  • Any change in the dose of oral corticosteroids in the last 8 weeks prior to the baseline visit or use of i.v. intramuscular or intra-articular corticosteroid during the last 8 weeks prior to the enrollment visit.
  • Use of any investigational drug and/or devices within 4 weeks before randomization or a period of 5 half-lives of the investigational drug, whichever is longer.
  • Pregnant or nursing (lactating) women, where pregnancy is defined as the state of a female after conception and until the termination of gestation, confirmed by a positive human chorionic gonadotropin (hCG) laboratory test.
  • Women of child-bearing potential, defined as all women physiologically capable of becoming pregnant, unless they are using effective methods of contraception during the entire study or longer if required by locally approved prescribing information (e.g. 20 weeks in EU).
  • Known recent drug or alcohol abuse.
  • Incapable of complying with the examination programme for physical or mental reasons.
  • Failure to provide written consent

Trial locations and contacts

10 sites in 1 country.

Mikkel Østergaard, DMSc PhD MD contact

+45 38633015

mo@dadlnet.dk

Sengül Seven, MD contact

+45 3863 3014

senguel.seven@regionh.dk

10 sites in 1 country

Denmark10 sites, 10 recruiting

  • Reumatologisk Afdeling, Aarhus Universitetshospital

    Aarhus, 8000

    Anne G Loft, MS DMSc

    Not yet recruiting

  • Videncenter for Reumatologi og Rygsygdomme, Rigshospitalet - Frederiksberg

    Frederiksberg, 2000

    Bente Jensen, MD PhD

    Recruiting

  • Videncenter for Reumatologi og Rygsygdomme, Rigshospitalet Glostrup

    Glostrup Municipality, 2600

    Mikkel Østergaard, MD PhD DMSc

    Mikkel Østergaard, MD PhD DMSc

    Recruiting

  • Kong Christian X´s Gigthospital

    Gråsten, 6300

    Oliver Hendricks, MD PhD

    Not yet recruiting

  • Videncenter for Reumatologi og Rygsygdomme, Rigshospitalet - Gentofte

    Hellerup, 2900

    Ole R Madsen, MD PhD DMSc

    Recruiting

  • Videncenter for Reumatologi og Rygsygdomme, Rigshospitalet - Nordsjællands Hospital Hillerød

    Hillerød, 3400

    Jesper Nørregaard, MD DMSc

    Not yet recruiting

  • Reumatologisk Afdeling, Regionshospitalet Nordjylland, Hjørring

    Hjørring, 9800

    Marcin Kowalski, MD PhD

    Not yet recruiting

  • Reumatologisk afdeling, Sjællands Universitetshospital, Køge

    Køge, 4600

    Bo Ejbjerg, MD PhD

    Not yet recruiting

  • Reumatologisk Afdeling, Odense Universitetshospital

    Odense, 5000

    Hans C Horn, consultant

    Not yet recruiting

  • Reumatologisk Afdeling, Regionshospitalet Silkeborg

    Silkeborg, 8600

    Rene Østgaard, MD PhD

    Not yet recruiting

Other trials in Denmark

About this study

Official title: TReat-to-tArget (T2T) With seCukinumab in Axial Spondyloarthritis. IdEntification of MRI and Biochemical Biomarkers for Disease Activity, Treatment Response and Structural Damage Progression (the TRACE Study)

A study of axSpA and AS receiving Secukinumab in a treat-to-target strategy.

Read the detailed description

Comparison of reductions in MRI inflammation in the sacroiliac joints and spine from week 16 to 24 in patients who at week 16 are in ASDAS remission (i.e. continue sc. secukinumab 150 mg monthly) vs. not in ASDAS remission (i.e. increase sc. secukinumab 300 mg monthly). ASDAS remission is defined as ASDAS inactive disease i.e. ASDAS<1.3.

Being tested
Secukinumab 150 milligram [Cosentyx]
Medical subject headings
Axial Spondyloarthritis, Spondylitis, Ankylosing

What participants receive

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

  • Secukinumab 150 milligram [Cosentyx]Drug

    Also called Secukinumab 300 milligram [Cosentyx]

    For intervention description: see arm/group description

Study groups in NCT03639740
Study groupRoleWhat they receive
Secukinumab 150 mg 300 mg or tumor necrosis factor inhibitorOtherSecukinumab 150 mg sc. injection once a week for four weeks (induction phase) and thereafter once a month. If patients do not achieve ASDAS remission they get increased dosage of Secukinumab 300 mg sc. injection once a month. If still no ASDAS remission patients change to a TNF-inhibitor
Receives: Drug: Secukinumab 150 milligram [Cosentyx]

What is being measured

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

  1. Proportion of patients with a positive change in MRI-inflammation

    Assessed with the sum of SPARCC MRI SIJ and spine inflammation indices

    Measured: Comparison of week 16 and 24

Secondary outcomes (6)

  1. Proportion of patients in remission vs patients not in ASDAS (Ankylosing Spondylitis Disease Activity Score) remission.

    as measured by remission (<1.3) / not in ASDAS remission (>1.3)

    Measured: Comparison of week 16 and 24

  2. Changes in ASDAS score (i.e. Ankylosing Spondylitis Disease Activity Score (ASDAS 0.6-7.0))

    as measured by changes in ASDAS.

    Measured: Evaluated from week 0 to 16 and from week 16 to 24

  3. Changes in MRI inflammation scores from week 0 to 16 and week 16 to 24, respectively.

    as measured by the SPARCC MRI SIJ and Spine Inflammation indices and the Canada-Denmark MRI system for a positive change in MRI inflammation in the spine as assessed with the Canada-Denmark MRI system for assessment of inflammation.

    Measured: Week 0 to 16 and week 16 to 24

  4. Changes in scores/anatomical location of MRI lesions in the spine

    as measured by the Canada-Denmark MRI system for assessment of inflammation, fat metaplasia, erosion, and new bone formation.

    Measured: week 16

  5. Changes in scores/anatomical location of MRI lesions in the SIJs

    as measured by the SPARCC MRI SIJ Inflammation Index and SPARCC SIJ Structural Score (SSS)

    Measured: week 16

  6. MRI inflammation

    as measured by the SPARCC (Spondyloarthritis Research Consortium of Canada) MRI sacroiliac joint and Spine Inflammation indices and the Canada-Denmark MRI system for assessment of inflammation assessed on cMRI (conventional MRI) i.e. on STIR (short tau inversion recovery) sequences on conventional and novel scan planes and on DWI (Diffusion-weighted imaging) sequences evaluated visually and based on regions of interest (ROIs).

    Measured: week 16

Timeline

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

  1. First posted21 Aug 2018
  2. Study start15 Jan 2019 (estimated)
  3. Primary completionFeb 2021 (estimated)
  4. Study completionFeb 2021 (estimated)

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 4
Primary purpose
Treatment
Intervention model
Sequential
Model description
Dose will be increased or maintained after predetermined intervals depending on remission
Masking
None (open label)
Enrolment
88 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03639740
Sponsor's protocol ID
TRACE
Other IDs
2017-004037-93, 2017
Acronym
TRACE
Status last verified
Jan 2019
First submitted
17 Aug 2018
Last updated
3 Jan 2019
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • Vladimirova N, Ostergaard M, Seven S, Moller JM, Jensen B, Ostgard R, Poggenborg R, Madsen OR, Hendricks O, Brix L, Georgiadis S, Pedersen SJ. Effect of secukinumab dose escalation on MRI-detected inflammation and structural damage in axial spondyloarthritis: a clinical, investigator-initiated, treat-to-target study (TRACE). RMD Open. 2026 Apr 10;12(2):e006774. doi: 10.1136/rmdopen-2026-006774.

    PubMed 41963078

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Secukinumab 150 milligram [Cosentyx] in people with Axial Spondyloarthritis and Ankylosing Spondylitis, run by Professor Mikkel Østergaard at 10 sites in Denmark.

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 14 inclusion and 14 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: status not confirmed, as of the sponsor's last update on 3 Jan 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 10 sites in Denmark. 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. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

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

Are results available for this study?

Results are not available in the source record.

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

Contact Mikkel Østergaard, DMSc PhD MD (+45 38633015, mo@dadlnet.dk), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Proportion of patients with a positive change in MRI-inflammation (time frame: Comparison of week 16 and 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 NCT03639740, which also lists 1 linked publication.

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 Jan 2019.

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