Clinical trial NCT01029847: Adalimumab in Axial Spondyloarthritis (ASIM) - MRI and Biomarkers in Patients With Spondyloarthritis
Official title: Adalimumab in Axial Spondyloarthritis. An Investigation of Whole-body MRI, MRI of Sacroiliac Joints and Spine and Soluble Biomarkers of Joint Inflammation and Damage.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Spondyloarthritis
Keywords: Patients with axial spondyloarthritis
Lead sponsor: Rigshospitalet, Denmark
Sponsor class: OTHER
First posted: 2009-12-10
Enrollment: 49
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.


Eligibility criteria: 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

Primary outcomes:
measure: Change in Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) of 20 mm or 50%
timeFrame: 24 weeks
Secondary outcomes:
measure: 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.
timeFrame: 24 week
Other outcomes:
Locations:
city: Copenhagen
country: Denmark
facility: Dep. of medicine, Herlev Hospital
city: Copenhagen
country: Denmark
facility: Dep. of Radiology, Herlev Hospital
city: Copenhagen
country: Denmark
facility: Dep. of Rheumatology, Frederiksberg and Bispebjerg Hospitals
city: Copenhagen
country: Denmark
facility: Dep. of Rheumatology, Gentofte Hospital
city: Copenhagen
country: Denmark
facility: Dep. of Rheumatology, Hvidovre Hospital
city: Copenhagen
country: Denmark
facility: Dep. of Rheumatologym Glostrup Hospital
city: Hørsholm
country: Denmark
facility: Dep. of Rheumatology, Helsinør Hospital
city: Køge
country: Denmark
facility: Dep. of Rheumatology, Køge Hospital
Study officials:
affiliation: Dep. of Rheumatology, Glostrup Hospital
name: Mikkel Østergaard, Professor
role: PRINCIPAL_INVESTIGATOR
affiliation: Dep. of Rheumatology, Glostrup Hospital
name: Susanne J Pedersen, MD
role: STUDY_CHAIR
affiliation: Dep. of Rheumatoogy, Glostrup Hospital
name: Inge J Sørensen
role: STUDY_CHAIR
References:
citation: Krabbe S, Eshed I, Sorensen IJ, Jensen B, Moller JM, Balding L, Madsen OR, Pedersen SJ, Ostergaard M. Whole-body Magnetic Resonance Imaging Inflammation in Peripheral Joints and Entheses in Axial Spondyloarthritis: Distribution and Changes during Adalimumab Treatment. J Rheumatol. 2020 Jan;47(1):50-58. doi: 10.3899/jrheum.181159. Epub 2019 Apr 1.
citation: Krabbe S, Sorensen IJ, Jensen B, Moller JM, Balding L, Madsen OR, Lambert RGW, Maksymowych WP, Pedersen SJ, Ostergaard M. Inflammatory and structural changes in vertebral bodies and posterior elements of the spine in axial spondyloarthritis: construct validity, responsiveness and discriminatory ability of the anatomy-based CANDEN scoring system in a randomised placebo-controlled trial. RMD Open. 2018 Mar 16;4(1):e000624. doi: 10.1136/rmdopen-2017-000624. eCollection 2018.