Novel MRI ANd Biomarkers in GOlimumab-treated Patients With Axial Spondyloarthritis

Study Overview
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Brief Summary
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The study investigates different criteria for remission based on MRI and circulating biomarkers for inflammation, cartilage, connective tissue and bone turnover in patients with axial spondyloarthritis treated with Golimumab. Furthermore, the study also investigates factors that affect disease activity, function and participation by use of different questionnaires.

Official Title
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Improved Monitoring and Prediction of Clinical Response and Disease Course During Golimumab Therapy of Patients With Axial Spondyloarthritis

Conditions
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Axial Spondyloarthritis

Intervention / Treatment
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* Drug: Treatment


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Axial spondyloarthritis according to the Assessment of Spondyloarthritis International Society (ASAS) classification criteria for axial spondyloarthritis Sacroiliitis on conventional X-rays or Magnetic Resonance Imaging (MRI). Disease activity assessed by Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) >40 mm despite treatment with Non-Steroidal Anti-Inflammatory Drugs (NSAID). Clinical indication for tumor necrosis factor (TNF) inhibitor treatment by the treating physician. Exclusion Criteria: No contraindications for TNF inhibitor No contraindications for MRI No contraindications in participation in a study

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 85 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Treatment<br>Treatment: Injection Golimumab 50 mg every month on the same date | Drug: Treatment<br> <br> * Other names: Treatment: Injection Golimumab 50 mg every month on the same date;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Fulfillment of Bath Ankylosing Spondylitis Disease Activity Index 50 Response (BASDAI50) | At least 50% reduction in BASDAI score at follow-up compared with BASDAI score at baseline | Week 52 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| BASDAI 50% or 2.0 Improvement | At least 50% decrease or at least an improvement of 2.0 in BASDAI, when measured on a scale with range 0-10. | Week 16 | 
| BASDAI 50% or 2.0 Improvement | At least 50% decrease or at least an improvement of 2.0 in BASDAI, when measured on a scale with range 0-10. | Week 52 | 
| Ankylosing Spondylitis Disease Activity Score Clinically Important Improvement (ASDAS-CII) | Decrease in ASDAS score at follow-up compared with ASDAS score at baseline of at least 1.1. | Week 16 | 
| Ankylosing Spondylitis Disease Activity Score Clinically Important Improvement (ASDAS-CII) | Decrease in ASDAS score at follow-up compared with ASDAS score at baseline of at least 1.1. | Week 52 | 
| MRI Spine Remission | Maximum 1 disco-vertebral unit with inflammation present. | Week 16 | 
| MRI-SPINE-50 | At least 50% reduction in Canada-Denmark (CANDEN) MRI spine inflammation score. | Week 16 |