Biomarkers in Early-stage Spondyloarthritis
1 other identifier
observational
216
0 countries
N/A
Brief Summary
Axial spondyloarthritis (axSpA) is a group of inflammatory rheumatic conditions with inflammatory back pain caused by inflammation in the sacroiliac joints (SIJ) and back as hallmark. Currently, no laboratory test or biomarker is cable of differentiating between patients with early-stage axSpA and persisting low back pain of other causes. The objective of this study is to investigate the predictive value of baseline levels of the biomarkers Complement C3d and high-sensitive C-reactive protein (HsCRP) identifying bone marrow oedema (BME) at MRI of the SIJ at baseline.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Jan 2015
Longer than P75 for all trials
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2015
CompletedFirst Submitted
Initial submission to the registry
April 21, 2019
CompletedFirst Posted
Study publicly available on registry
September 19, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2020
CompletedOctober 5, 2020
October 1, 2020
5.8 years
April 21, 2019
October 1, 2020
Conditions
Outcome Measures
Primary Outcomes (1)
C3d levels
Baseline levels of C3d between 3 groups
1 month after sampling of C3d
Secondary Outcomes (1)
MRI changes
3 months after sampling of C3d
Study Arms (3)
axSpA
Patients with low back pain ≥three months who a) fulfilled the ASAS definition for a positive MRI scan of sacroiliac joints (definite inflammation) or b) were HLA-B27 positive with at least one concomitant clinical spondyloarthritis feature.
non-axSpA
Patients with a) positive MRI according to the ASAS definition, but no additional clinical spondyloarthritis features, or b) positive HLA-B27 and one clinical spondyloarthritis feature.
Controls
Patients with non-specific low back pain without spondyloarthritis-related features and negative MRI SIJ.
Interventions
Evaluation of C3d levels in EDTA samples from participants
Eligibility Criteria
The study population consists of 216 patients from the SSD cohort. All patients had an MRI of the SI-joints and clinical examination by a rheumatologist before inclusion. Blood samples from the patients were collected in a biobank (MICSA), which is the foundation for the present study.
You may qualify if:
- patients from the Spines of Southern Denmark cohort who underwent MRI, blood samples, and clinical examination by a rheumatologist.
- aged 18-45
You may not qualify if:
- \< 3 months of low back pain
- not wish to participate/ did not sign consent form
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Biospecimen
Blood samples stored in the Molecular Biology of Infectious Agents in the Early Diagnosis of Spondyloarthritis biobank (MICSA). The biobank is hosted by the research group at Graasten Rheumatological Hospital in Denmark. In the present study, we use EDTA plasma 100 microliters to test for levels of C3d.
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Allan Nygaard, MD
Spinecentre of Southern Denmark
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Target Duration
- 1 Month
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 21, 2019
First Posted
September 19, 2019
Study Start
January 1, 2015
Primary Completion
October 1, 2020
Study Completion
October 1, 2020
Last Updated
October 5, 2020
Record last verified: 2020-10
Data Sharing
- IPD Sharing
- Will not share