Treat-to-target With Secukinumab in Axial Spondyloarthritis

NCT ID: NCT03639740

Last Updated: 2019-01-03

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE4
• Total Enrollment: 88 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-01-15
• Study Completion Date: 2021-02-28

Brief Summary

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

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.

Conditions

Axial Spondyloarthritis; Ankylosing Spondylitis

Study Design

• Intervention Model: SEQUENTIAL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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

Group Type: OTHER

Secukinumab 150 milligram [Cosentyx]

Intervention Type: DRUG

For intervention description: see arm/group description

Interventions

Secukinumab 150 milligram [Cosentyx]

For intervention description: see arm/group description

Intervention Type: DRUG

Other Intervention Names

Secukinumab 300 milligram [Cosentyx]

Eligibility 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Novartis Healthcare A/S

INDUSTRY

Sponsor Role: collaborator

Professor Mikkel Østergaard

OTHER

Sponsor Role: lead

Responsible Party

Professor Mikkel Østergaard

Professor, DMSc, PhD, MD

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Mikkel Østergaard, DMSc PhD MD

Role: PRINCIPAL_INVESTIGATOR

Rigshospitalet, Denmark

Susanne J Pedersen, MD PhD

Role: STUDY_CHAIR

Rigshospitalet, Denmark

Locations

Reumatologisk Afdeling, Aarhus Universitetshospital

Aarhus, , Denmark

Site Status: NOT_YET_RECRUITING

Videncenter for Reumatologi og Rygsygdomme, Rigshospitalet - Frederiksberg

Frederiksberg, , Denmark

Site Status: RECRUITING

Videncenter for Reumatologi og Rygsygdomme, Rigshospitalet Glostrup

Glostrup Municipality, , Denmark

Site Status: RECRUITING

Kong Christian X´s Gigthospital

Gråsten, , Denmark

Site Status: NOT_YET_RECRUITING

Videncenter for Reumatologi og Rygsygdomme, Rigshospitalet - Gentofte

Hellerup, , Denmark

Site Status: RECRUITING

Videncenter for Reumatologi og Rygsygdomme, Rigshospitalet - Nordsjællands Hospital Hillerød

Hillerød, , Denmark

Site Status: NOT_YET_RECRUITING

Reumatologisk Afdeling, Regionshospitalet Nordjylland, Hjørring

Hjørring, , Denmark

Site Status: NOT_YET_RECRUITING

Reumatologisk afdeling, Sjællands Universitetshospital, Køge

Køge, , Denmark

Site Status: NOT_YET_RECRUITING

Reumatologisk Afdeling, Odense Universitetshospital

Odense, , Denmark

Site Status: NOT_YET_RECRUITING

Reumatologisk Afdeling, Regionshospitalet Silkeborg

Silkeborg, , Denmark

Site Status: NOT_YET_RECRUITING

Countries

Denmark

Central Contacts

Mikkel Østergaard, DMSc PhD MD

Role: CONTACT

mo@dadlnet.dk

+45 38633015

Sengül Seven, MD

Role: CONTACT

senguel.seven@regionh.dk

+45 3863 3014

Facility Contacts

Mikkel Østergaard, MD PhD DMSc

Role: primary

Other Identifiers

2017-004037-93

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

TRACE

Identifier Type: -

Identifier Source: org_study_id