This trial is active, not recruiting.

Conditions ankylosing spondylitis, spinal fractures
Treatment bdmard treatment
Sponsor Uppsala University
Start date January 2005
End date December 2015
Trial size 9858 participants
Trial identifier NCT02840695, bDMARD AS Spinal Fractures


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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Observational model cohort
Time perspective prospective
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
bdmard treatment Biological Disease Modifying Drug treatment
Treatment with bDMARD includes registered ATC-codes: L04AA and L04AB.

Primary Outcomes

Spinal fracture
time frame: 10 years

Eligibility Criteria

Male or female participants from 30 years up to 60 years old.

Inclusion Criteria: - age 30-60 years - registered diagnosis of ankylosing spondylitis Exclusion Criteria: - age <30 or >60 years

Additional Information

Official title Effect of Biological Disease Modifying Anti Rheumatic Drug (bDMARD) Treatment on Spinal Fracture Incidence in Patients With Ankylosing Spondylitis (AS)
Trial information was received from ClinicalTrials.gov and was last updated in July 2016.
Information provided to ClinicalTrials.gov by Uppsala University.