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

NCT ID: NCT02840695

Last Updated: 2017-10-30

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

9858 participants

Study Classification

OBSERVATIONAL

Study Start Date

2005-01-31

Study Completion Date

2017-10-24

Brief Summary

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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.

Detailed Description

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Conditions

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Ankylosing Spondylitis Spinal Fractures

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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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

bDMARD treatment

Intervention Type DRUG

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

Interventions

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bDMARD treatment

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

Intervention Type DRUG

Other Intervention Names

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Biological Disease Modifying Drug treatment

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

* age \<30 or \>60 years
Minimum Eligible Age

30 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Uppsala University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

References

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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.

Reference Type DERIVED
PMID: 29288176 (View on PubMed)

Badar 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.

Reference Type DERIVED
PMID: 29273649 (View on PubMed)

Other Identifiers

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bDMARD AS Spinal Fractures

Identifier Type: -

Identifier Source: org_study_id