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Treat-to-target With Secukinumab in Axial Spondyloarthritis (TRACE)

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ClinicalTrials.gov Identifier: NCT03639740
Recruitment Status : Recruiting
First Posted : August 21, 2018
Last Update Posted : January 3, 2019
Sponsor:
Collaborator:
Novartis Healthcare A/S
Information provided by (Responsible Party):
Professor Mikkel Østergaard, Rigshospitalet, Denmark

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

Condition or disease Intervention/treatment Phase
Axial Spondyloarthritis Ankylosing Spondylitis Drug: Secukinumab 150 milligram [Cosentyx] Phase 4

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 88 participants
Intervention Model: Sequential Assignment
Intervention Model Description: Dose will be increased or maintained after predetermined intervals depending on remission
Masking: None (Open Label)
Primary Purpose: Treatment
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)
Estimated Study Start Date : January 15, 2019
Estimated Primary Completion Date : February 2021
Estimated Study Completion Date : February 2021

Resource links provided by the National Library of Medicine

Drug Information available for: Secukinumab

Arm Intervention/treatment
Secukinumab 150 mg 300 mg or tumor necrosis factor inhibitor
Secukinumab 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
Drug: Secukinumab 150 milligram [Cosentyx]
For intervention description: see arm/group description
Other Name: Secukinumab 300 milligram [Cosentyx]




Primary Outcome Measures :
  1. Proportion of patients with a positive change in MRI-inflammation [ Time Frame: Comparison of week 16 and 24 ]
    Assessed with the sum of SPARCC MRI SIJ and spine inflammation indices


Secondary Outcome Measures :
  1. Proportion of patients in remission vs patients not in ASDAS (Ankylosing Spondylitis Disease Activity Score) remission. [ Time Frame: Comparison of week 16 and 24 ]
    as measured by remission (<1.3) / not in ASDAS remission (>1.3)

  2. Changes in ASDAS score (i.e. Ankylosing Spondylitis Disease Activity Score (ASDAS 0.6-7.0)) [ Time Frame: Evaluated from week 0 to 16 and from week 16 to 24 ]
    as measured by changes in ASDAS.

  3. Changes in MRI inflammation scores from week 0 to 16 and week 16 to 24, respectively. [ Time Frame: Week 0 to 16 and week 16 to 24 ]
    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.

  4. Changes in scores/anatomical location of MRI lesions in the spine [ Time Frame: week 16 ]
    as measured by the Canada-Denmark MRI system for assessment of inflammation, fat metaplasia, erosion, and new bone formation.

  5. Changes in scores/anatomical location of MRI lesions in the SIJs [ Time Frame: week 16 ]
    as measured by the SPARCC MRI SIJ Inflammation Index and SPARCC SIJ Structural Score (SSS)

  6. MRI inflammation [ Time Frame: week 16 ]
    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).



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. 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).
  2. 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.
  3. Active disease defined as ASDAS ≥ 2.1 (ASDAS high disease activity).
  4. Total back pain as measured on a visual analogue scale (VAS) scale ≥ 4 0 mm (0-100 mm) at baseline.
  5. Clinical indication for a biologic drug as assessed by the treating physician.
  6. 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.
  7. 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.
  8. 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.
  9. 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.
  10. Male or female patients at least 18 years and less than 70 years of age.
  11. Sufficient contraception for women.
  12. Age ≥18 to <70 years.
  13. Capable of giving informed consent.
  14. Capable of complying with the examination programme of the protocol.

Exclusion Criteria:

  1. Contraindications for secukinumab (described in protocol).
  2. Contraindication for TNF inhibitor (described in protocol).
  3. Contraindication for MRI (described in protocol).
  4. Previous exposure to secukinumab or other biologic drug directly targeting interleukin-17 or interleukin-17 receptor.
  5. Previous exposure to TNF inhibitor or drug targeting TNF.
  6. Previous exposure to other types of biological disease-modifying anti-rheumatic drugs (bDMARDs) than TNF inhibitor.
  7. Patients taking high-potency opioid analgesics (e.g. methadone, hydromorphone, morphine)
  8. 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.
  9. 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.
  10. 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.
  11. 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).
  12. Known recent drug or alcohol abuse.
  13. Incapable of complying with the examination programme for physical or mental reasons.
  14. Failure to provide written consent

Information from the National Library of Medicine

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): NCT03639740


Contacts
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Contact: Mikkel Østergaard, DMSc PhD MD +45 38633015 mo@dadlnet.dk
Contact: Sengül Seven, MD +45 3863 3014 senguel.seven@regionh.dk

Locations
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Denmark
Reumatologisk Afdeling, Aarhus Universitetshospital Not yet recruiting
Aarhus, Denmark, 8000
Principal Investigator: Anne G Loft, MS DMSc         
Videncenter for Reumatologi og Rygsygdomme, Rigshospitalet - Frederiksberg Recruiting
Frederiksberg, Denmark, 2000
Principal Investigator: Bente Jensen, MD PhD         
Videncenter for Reumatologi og Rygsygdomme, Rigshospitalet Glostrup Recruiting
Glostrup, Denmark, 2600
Contact: Mikkel Østergaard, MD PhD DMSc         
Principal Investigator: Mikkel Østergaard, MD PhD DMSc         
Sub-Investigator: Susanne J Pedersen, MD PhD         
Sub-Investigator: Sengül Seven, MD         
Sub-Investigator: Inge J Sørensen, MD PhD         
Kong Christian X´s Gigthospital Not yet recruiting
Gråsten, Denmark, 6300
Principal Investigator: Oliver Hendricks, MD PhD         
Videncenter for Reumatologi og Rygsygdomme, Rigshospitalet - Gentofte Recruiting
Hellerup, Denmark, 2900
Principal Investigator: Ole R Madsen, MD PhD DMSc         
Videncenter for Reumatologi og Rygsygdomme, Rigshospitalet - Nordsjællands Hospital Hillerød Not yet recruiting
Hillerød, Denmark, 3400
Principal Investigator: Jesper Nørregaard, MD DMSc         
Reumatologisk Afdeling, Regionshospitalet Nordjylland, Hjørring Not yet recruiting
Hjørring, Denmark, 9800
Principal Investigator: Marcin Kowalski, MD PhD         
Reumatologisk afdeling, Sjællands Universitetshospital, Køge Not yet recruiting
Køge, Denmark, 4600
Principal Investigator: Bo Ejbjerg, MD PhD         
Reumatologisk Afdeling, Odense Universitetshospital Not yet recruiting
Odense, Denmark, 5000
Principal Investigator: Hans C Horn, consultant         
Reumatologisk Afdeling, Regionshospitalet Silkeborg Not yet recruiting
Silkeborg, Denmark, 8600
Principal Investigator: Rene Østgaard, MD PhD         
Sponsors and Collaborators
Professor Mikkel Østergaard
Novartis Healthcare A/S
Investigators
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Principal Investigator: Mikkel Østergaard, DMSc PhD MD Rigshospitalet, Denmark
Study Chair: Susanne J Pedersen, MD PhD Rigshospitalet, Denmark
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Responsible Party: Professor Mikkel Østergaard, Professor, DMSc, PhD, MD, Rigshospitalet, Denmark
ClinicalTrials.gov Identifier: NCT03639740    
Other Study ID Numbers: TRACE
2017-004037-93 ( EudraCT Number )
First Posted: August 21, 2018    Key Record Dates
Last Update Posted: January 3, 2019
Last Verified: January 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Additional relevant MeSH terms:
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Spondylitis
Spondylitis, Ankylosing
Spondylarthritis
Bone Diseases, Infectious
Infection
Bone Diseases
Musculoskeletal Diseases
Spinal Diseases
Spondylarthropathies
Ankylosis
Joint Diseases
Arthritis
Antibodies, Monoclonal
Immunologic Factors
Physiological Effects of Drugs