Adalimumab in Axial Spondyloarthritis (ASIM) - MRI and Biomarkers in Patients With Spondyloarthritis

Study Overview
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Brief Summary
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Investigation of wholebody MRI and circulating biomarkers of inflammation, cartilage and bone metabolism in patients with spondyloarthritis treated with adalimumab. Furthermore to compare ultrasound examination with wholebody MRI etc.

Official Title
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Adalimumab in Axial Spondyloarthritis. An Investigation of Whole-body MRI, MRI of Sacroiliac Joints and Spine and Soluble Biomarkers of Joint Inflammation and Damage.

Conditions
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Spondyloarthritis

Intervention / Treatment
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* Drug: Adalimumab
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Spondyloarthritis (SpA) according to the new ASAS criteria for axial SpA BASDAI > 40 mm despite NSAIDs Clinical indication for treatment with TNF-alpha inhibitor Age > 18 years old and < 85 years old Sufficient contraception for women Capable of giving informed consent Capable of complying with the examination program of the protocol Exclusion Criteria: Pregnancy wish, pregnancy or breast-feeding DMARDs within 4 weeks prior to inclusion Oral, intra-articular or intramuscular glucocorticoid within 4 weeks prior to inclusion The use of other study drugs within 4 weeks prior to inclusion or less than 5 half-lives of the study drug before inclusion if this is more than 4 weeks The use of suspected disease-modifying or immunosuppressive drugs within 4 weeks prior to inclusion DMARDs are allowed during the study, but the dose cannot be changed from 4 weeks prior to inclusion through week Contraindications for TNF-α inhibitor treatment Contraindications for MRI Known recent drug or alcohol abuse Failure to provide written consent Incapable of complying with the examination program for physical or mental reasons

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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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Placebo<br> | Drug: Placebo<br>* sc. inj. placebo every other week, week 0, 2, and 4. Sc. inj. adalimumab 40 mg every other week from week 6. At week 24, clinical non-responders (not fulfilling primary outcome measure) were allowed treatment with other drugs, following local treatment guidelines.<br>|
| Active Comparator: Adalimumab<br>TNF-alpha inhibitor | Drug: Adalimumab<br>* Sc. inj. adalimumab 40 mg every other week for 42 to 48 weeks. At week 24, clinical non-responders (not fulfilling primary outcome measure) were allowed treatment with other drugs, following local treatment guidelines.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) of 20 mm or 50% |  | 24 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of peripheral and axial joints and entheses with inflammation, circulating biomarkers of inflammation, cartilage and bone metabolism, conventional clinical parameters and changes in these during treatment with adalimumab. |  | 24 week | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Patients with axial spondyloarthritis