Effect of Biological Disease Modifying Anti Rheumatic Drug (bDMARD) Treatment on Spinal Fracture Incidence in Patients With Ankylosing Spondylitis (AS)
1 other identifier
observational
9,858
0 countries
N/A
Brief Summary
Ankylosing spondylitis (AS) is a rheumatoid disease affecting all segments of the axial skeleton, leading to the complete fusion of all spinal segments - the bamboo-spine. During the last decade biological disease modifying anti-rheumatic drugs (bDMARD) have been successfully introduced to reduce the disease activity. It is unclear whether bDMARD treatment had an effect on spinal fracture risk related to AS. This national registry study will investigate the effect of bDMARD treatment on spinal fracture risk in a national cohort of patients with AS.
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 2005
Longer than P75 for all trials
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2005
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2015
CompletedFirst Submitted
Initial submission to the registry
July 18, 2016
CompletedFirst Posted
Study publicly available on registry
July 21, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
October 24, 2017
CompletedOctober 30, 2017
October 1, 2017
10.9 years
July 18, 2016
October 27, 2017
Conditions
Outcome Measures
Primary Outcomes (1)
Spinal fracture
Censored data with occurrence of spinal fracture within 10 years observation
10 years
Study Arms (1)
AS patients
Patients registered in the Swedish Patient Registry with active AS treated with or without biological DMARD according to the Swedish Prescribed Drugs Registry, with or without spinal fractures
Interventions
Treatment with bDMARD includes registered ATC-codes: L04AA and L04AB.
Eligibility Criteria
Patients with AS as registered in the Swedish Patient Registry with ICD-9-code 720 or ICD-10 code M45.9.
You may qualify if:
- age 30-60 years
- registered diagnosis of ankylosing spondylitis
You may not qualify if:
- age \<30 or \>60 years
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Related Publications (2)
Robinson Y, Olerud C, Willander J. Do biological disease-modifying antirheumatic drugs reduce the spinal fracture risk related to ankylosing spondylitis? A longitudinal multiregistry matched cohort study. BMJ Open. 2017 Dec 28;7(12):e016548. doi: 10.1136/bmjopen-2017-016548.
PMID: 29288176DERIVEDBadar F, Mahmood S. Epidemiology of cancers in Lahore, Pakistan, among children, adolescents and adults, 2010-2012: a cross-sectional study part 2. BMJ Open. 2017 Dec 21;7(12):e016559. doi: 10.1136/bmjopen-2017-016559.
PMID: 29273649DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Target Duration
- 10 Years
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 18, 2016
First Posted
July 21, 2016
Study Start
January 1, 2005
Primary Completion
December 1, 2015
Study Completion
October 24, 2017
Last Updated
October 30, 2017
Record last verified: 2017-10
Data Sharing
- IPD Sharing
- Will not share