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Clinical Trials/NCT02840695
NCT02840695
Completed
Not Applicable

Effect of Biological Disease Modifying Anti Rheumatic Drug (bDMARD) Treatment on Spinal Fracture Incidence in Patients With Ankylosing Spondylitis (AS)

Uppsala University0 sites9,858 target enrollmentJanuary 2005

Overview

Phase
Not Applicable
Intervention
bDMARD treatment
Conditions
Ankylosing Spondylitis
Sponsor
Uppsala University
Enrollment
9858
Primary Endpoint
Spinal fracture
Status
Completed
Last Updated
8 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
January 2005
End Date
October 24, 2017
Last Updated
8 years ago
Study Type
Observational
Sex
All

Investigators

Sponsor
Uppsala University
Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • age 30-60 years
  • registered diagnosis of ankylosing spondylitis

Exclusion Criteria

  • age \<30 or \>60 years

Arms & Interventions

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

Intervention: bDMARD treatment

Outcomes

Primary Outcomes

Spinal fracture

Time Frame: 10 years

Censored data with occurrence of spinal fracture within 10 years observation

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