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NCT02840695 Clinical Trial

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

Ankylosing Spondylitis Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT02840695
Other study ID # bDMARD AS Spinal Fractures
Secondary ID
Status Completed
Phase N/A
First received July 18, 2016
Last updated October 27, 2017
Start date January 2005
Est. completion date October 24, 2017

Study information
Verified date October 2017
Source Uppsala University
Contact n/a
Is FDA regulated No
Health authority
Study type Observational [Patient Registry]

Clinical Trial 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.

Recruitment information / eligibility
Status Completed
Enrollment 9858
Est. completion date October 24, 2017
Est. primary completion date December 2015
Accepts healthy volunteers No
Gender All
Age group 30 Years to 60 Years
Eligibility Inclusion Criteria:

- age 30-60 years

- registered diagnosis of ankylosing spondylitis

Exclusion Criteria:

- age <30 or >60 years

Study Design

Related Conditions & MeSH terms

Intervention

Drug:
• bDMARD treatment
Treatment with bDMARD includes registered ATC-codes: L04AA and L04AB.

Locations
Country Name City State
n/a

Sponsors (1)
Lead Sponsor Collaborator
Uppsala University

Outcome
Type Measure Description Time frame Safety issue
Primary Spinal fracture Censored data with occurrence of spinal fracture within 10 years observation 10 years
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