Adalimumab in Axial Spondyloarthritis (ASIM) - MRI and Biomarkers in Patients With Spondyloarthritis (NCT01029847) | Clinical Trial Compass
CompletedPhase 4
Adalimumab in Axial Spondyloarthritis (ASIM) - MRI and Biomarkers in Patients With Spondyloarthritis
Denmark49 participantsStarted 2009-12
Plain-language summary
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.
Who can participate
Age range18 Years – 85 Years
SexALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
What they're measuring
1
Change in Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) of 20 mm or 50%