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

Conditions

Spondyloarthritis

Keywords

Patients with axial spondyloarthritis

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.

Sengül Seven, Susanne Juhl Pedersen, Mikkel Østergaard, Sara Kamp Felbo, Inge Juul Sørensen et al. (7 authors)

Frontiers in Medicine2020-07-1512 citations

10.3389/fmed.2020.00341

Whole-body Magnetic Resonance Imaging Inflammation in Peripheral Joints and Entheses in Axial Spondyloarthritis: Distribution and Changes during Adalimumab Treatment

Simon Krabbe, Iris Eshed, Inge Juul Sørensen, Bente Jensen, Jakob Møllenbach Møller et al. (9 authors)

The Journal of Rheumatology2019-04-0130 citations

10.3899/jrheum.181159

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

Simon Krabbe, Inge Juul Sørensen, Bente Jensen, Jakob Møllenbach Møller, Lone Balding et al. (10 authors)

RMD Open2018-03-0143 citations

10.1136/rmdopen-2017-000624

Interventions

DRUGAdalimumab

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.

DRUGPlacebo

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.

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to 85 Years

Healthy volunteers

No

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

Design outcomes

Primary

Measure	Time frame
Change in Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) of 20 mm or 50%	24 weeks

Secondary

Measure	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

Countries

Denmark

Outcome results

None listed