Clinical trial NCT02011386: Novel MRI ANd Biomarkers in GOlimumab-treated Patients With Axial Spondyloarthritis
Official title: Improved Monitoring and Prediction of Clinical Response and Disease Course During Golimumab Therapy of Patients With Axial Spondyloarthritis
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Axial Spondyloarthritis
Lead sponsor: Rigshospitalet, Denmark
Sponsor class: OTHER
Collaborators: name: Merck Sharp & Dohme LLC
First posted: 2013-12-13
Enrollment: 53
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with axial spondyloarthritis with moderate to high disease activity (Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) at least 40 mm), who are going to start treatment with TNF inhibitor.

Brief summary: 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.


Eligibility criteria: 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

Primary outcomes:
measure: Fulfillment of Bath Ankylosing Spondylitis Disease Activity Index 50 Response (BASDAI50)
timeFrame: Week 52
Secondary outcomes:
measure: BASDAI 50% or 2.0 Improvement
timeFrame: Week 16
measure: BASDAI 50% or 2.0 Improvement
timeFrame: Week 52
measure: Ankylosing Spondylitis Disease Activity Score Clinically Important Improvement (ASDAS-CII)
timeFrame: Week 16
measure: Ankylosing Spondylitis Disease Activity Score Clinically Important Improvement (ASDAS-CII)
timeFrame: Week 52
measure: MRI Spine Remission
timeFrame: Week 16
measure: MRI-SPINE-50
timeFrame: Week 16
Other outcomes:
measure: MRI-SIJ-50
timeFrame: Week 16
measure: MRI-PERIPH-50
timeFrame: Week 16
measure: MRI SI Joint Remission
timeFrame: Week 16
measure: MRI Peripheral Joints and Entheses Inflammation Remission
timeFrame: Week 16
Locations:
city: Copenhagen
country: Denmark
facility: Frederiksberg Bispebjerg Hospitals, Dep. of Rheumatology
city: Copenhagen
country: Denmark
facility: Glostrup Hospital, Dep. of Rheumatology
city: Copenhagen
country: Denmark
facility: Herlev Hospital, Dep. of Radiology
city: Copenhagen
country: Denmark
facility: Gentofte Hospital, Dep. of Rheumatology
city: Hillerød
country: Denmark
facility: Nordsjællands Hospital Hillerød, Dep. of Rheumatology
city: Køge
country: Denmark
facility: Køge Hospital, Dep. of Rheumatology
Study officials:
affiliation: Glostrup Hospital, University of Copenhagen
name: Mikkel Østergaard, Professor
role: PRINCIPAL_INVESTIGATOR
References:
citation: Krabbe S, Eshed I, Sorensen IJ, Moller J, Jensen B, Madsen OR, Klarlund M, Pedersen SJ, Ostergaard M. Novel whole-body magnetic resonance imaging response and remission criteria document diminished inflammation during golimumab treatment in axial spondyloarthritis. Rheumatology (Oxford). 2020 Nov 1;59(11):3358-3368. doi: 10.1093/rheumatology/keaa153.
citation: Krabbe S, Ostergaard M, Pedersen SJ, Weber U, Krober G, Makysmowych W, Lambert RGW. Canada-Denmark MRI scoring system of the spine in patients with axial spondyloarthritis: updated definitions, scoring rules and inter-reader reliability in a multiple reader setting. RMD Open. 2019 Oct 13;5(2):e001057. doi: 10.1136/rmdopen-2019-001057. eCollection 2019.