Treat-to-target With Secukinumab in Axial Spondyloarthritis

NCT03639740 | Unknown Phase 4 DMC

• 2 other identifiers: TRACE2017-004037-93
• Study Type: interventional
• Target: 88
• Locations: 1 country
• Sites: 10

Brief Summary

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

Conditions

Axial Spondyloarthritis; Ankylosing Spondylitis

Outcome Measures

Primary Outcomes (1)

• Proportion of patients with a positive change in MRI-inflammation

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

  Comparison of week 16 and 24

Secondary Outcomes (6)

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

  Comparison of week 16 and 24

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

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

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

  Week 0 to 16 and week 16 to 24

• Changes in scores/anatomical location of MRI lesions in the spine

  week 16

• Changes in scores/anatomical location of MRI lesions in the SIJs

  week 16

Study Arms (1)

Secukinumab 150 mg 300 mg or tumor necrosis factor inhibitor

OTHER

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]

Interventions

Secukinumab 150 milligram [Cosentyx] DRUG

For intervention description: see arm/group description

Also known as: Secukinumab 300 milligram [Cosentyx]

Secukinumab 150 mg 300 mg or tumor necrosis factor inhibitor

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• 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.

You may not qualify if:

• 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.
• 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

Sponsors & Collaborators

• Professor Mikkel Østergaard: lead
• Novartis Healthcare A/S: collaborator

Study Sites (10)

Reumatologisk Afdeling, Aarhus Universitetshospital

Aarhus, 8000, Denmark

NOT YET RECRUITING

Videncenter for Reumatologi og Rygsygdomme, Rigshospitalet - Frederiksberg

Frederiksberg, 2000, Denmark

RECRUITING

Videncenter for Reumatologi og Rygsygdomme, Rigshospitalet Glostrup

Glostrup Municipality, 2600, Denmark

RECRUITING

Kong Christian X´s Gigthospital

Gråsten, 6300, Denmark

NOT YET RECRUITING

Videncenter for Reumatologi og Rygsygdomme, Rigshospitalet - Gentofte

Hellerup, 2900, Denmark

RECRUITING

Videncenter for Reumatologi og Rygsygdomme, Rigshospitalet - Nordsjællands Hospital Hillerød

Hillerød, 3400, Denmark

NOT YET RECRUITING

Reumatologisk Afdeling, Regionshospitalet Nordjylland, Hjørring

Hjørring, 9800, Denmark

NOT YET RECRUITING

Reumatologisk afdeling, Sjællands Universitetshospital, Køge

Køge, 4600, Denmark

NOT YET RECRUITING

Reumatologisk Afdeling, Odense Universitetshospital

Odense, 5000, Denmark

NOT YET RECRUITING

Reumatologisk Afdeling, Regionshospitalet Silkeborg

Silkeborg, 8600, Denmark

NOT YET RECRUITING

MeSH Terms

Conditions

Axial Spondyloarthritis; Spondylitis, Ankylosing

Interventions

secukinumab

Condition Hierarchy (Ancestors)

Spondylarthropathies; Spondylarthritis; Spondylitis; Spinal Diseases; Bone Diseases; Musculoskeletal Diseases; Ankylosis; Joint Diseases; Arthritis

Study Officials

• Mikkel Østergaard, DMSc PhD MD

  Rigshospitalet, Denmark

  PRINCIPAL INVESTIGATOR

• Susanne J Pedersen, MD PhD

  Rigshospitalet, Denmark

  STUDY CHAIR

Central Study Contacts

Mikkel Østergaard, DMSc PhD MD

CONTACT

+45 38633015; mo@dadlnet.dk

Sengül Seven, MD

CONTACT

+45 3863 3014; senguel.seven@regionh.dk

Study Design

• Study Type: interventional
• Phase: phase 4
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor, DMSc, PhD, MD

Model Details: Dose will be increased or maintained after predetermined intervals depending on remission

Study Record Dates

• First Submitted: August 17, 2018
• First Posted: August 21, 2018
• Study Start: January 15, 2019
• Primary Completion: February 1, 2021
• Study Completion: February 1, 2021
• Last Updated: January 3, 2019

Record last verified: 2019-01

Locations

DK (10)