Treat-to-target With Secukinumab in Axial Spondyloarthritis
- Sponsor
- Professor Mikkel Østergaard
- Study ID
- NCT03639740
- Phase
- PHASE4
- Status
- Unknown
Conditions
Eligibility Criteria
- Sex
- ALL
- Age
- 18 Years - 70 Years
- Healthy Volunteers
- Not accepted
Interventions
- Secukinumab 150 milligram [Cosentyx] — DRUGFor intervention description: see arm/group description
Study Details
A study of axSpA and AS receiving Secukinumab in a treat-to-target strategy.
Key Dates
- Start date
- Jan 15, 2019
- Status verified
- Jan 2019
- Primary completion
- Feb 28, 2021
- Completion
- Feb 28, 2021
Study Design
- Enrollment
- 88 participants (estimated)
- Intervention model
- SEQUENTIAL
- Primary purpose
- TREATMENT
Arms
- Other: Secukinumab 150 mg 300 mg or tumor necrosis factor inhibitorSecukinumab 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
Primary Outcome Measure
Proportion of patients with a positive change in MRI-inflammation [ Time Frame: Comparison of week 16 and 24 ]
Central Contacts
- Mikkel Østergaard, DMSc PhD MD+45 38633015
- Sengül Seven, MD+45 3863 3014
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