Novel MRI ANd Biomarkers in GOlimumab-treated Patients With Axial Spondyloarthritis
NCT ID: NCT02011386
Last Updated: 2020-08-17
Study Results
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View full resultsBasic Information
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COMPLETED
53 participants
OBSERVATIONAL
2013-02-28
2017-02-14
Brief Summary
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Detailed Description
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Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Treatment
Treatment: Injection Golimumab 50 mg every month on the same date
Treatment
Interventions
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Treatment
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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 MRI
* No contraindications in participation in a study
18 Years
85 Years
ALL
No
Sponsors
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Merck Sharp & Dohme LLC
INDUSTRY
Professor Mikkel Østergaard
OTHER
Responsible Party
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Professor Mikkel Østergaard
MD, PhD
Principal Investigators
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Mikkel Østergaard, Professor
Role: PRINCIPAL_INVESTIGATOR
Glostrup Hospital, University of Copenhagen
Locations
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Frederiksberg Bispebjerg Hospitals, Dep. of Rheumatology
Copenhagen, , Denmark
Glostrup Hospital, Dep. of Rheumatology
Copenhagen, , Denmark
Herlev Hospital, Dep. of Radiology
Copenhagen, , Denmark
Gentofte Hospital, Dep. of Rheumatology
Copenhagen, , Denmark
Nordsjællands Hospital Hillerød, Dep. of Rheumatology
Hillerød, , Denmark
Køge Hospital, Dep. of Rheumatology
Køge, , Denmark
Countries
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References
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Lorincz M, Ostergaard M, Wetterslev M, Sorensen IJ, Madsen OR, Christiansen SN, Hetland ML, Bakkegaard M, Klarlund M, Duer A, Boesen M, Gosvig KK, Pedersen SJ. Construct validity and responsiveness of ASAS Health Index assessed in two longitudinal studies of tumour necrosis factor alpha inhibitor initiation and dose reduction in patients with axial spondyloarthritis. RMD Open. 2024 Dec 20;10(4):e004948. doi: 10.1136/rmdopen-2024-004948.
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.
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.
Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Other Identifiers
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MANGO
Identifier Type: -
Identifier Source: org_study_id
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