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Trial record 1 of 1 for:    NCT02840695
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Effect of Biological Disease Modifying Anti Rheumatic Drug (bDMARD) Treatment on Spinal Fracture Incidence in Patients With Ankylosing Spondylitis (AS)

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ClinicalTrials.gov Identifier: NCT02840695
Recruitment Status : Completed
First Posted : July 21, 2016
Last Update Posted : October 30, 2017
Information provided by (Responsible Party):
Uppsala University

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.

Condition or disease Intervention/treatment
Ankylosing Spondylitis Spinal Fractures Drug: bDMARD treatment

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Study Type : Observational [Patient Registry]
Actual Enrollment : 9858 participants
Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 10 Years
Official Title: Effect of Biological Disease Modifying Anti Rheumatic Drug (bDMARD) Treatment on Spinal Fracture Incidence in Patients With Ankylosing Spondylitis (AS)
Study Start Date : January 2005
Actual Primary Completion Date : December 2015
Actual Study Completion Date : October 24, 2017

Group/Cohort Intervention/treatment
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
Drug: bDMARD treatment
Treatment with bDMARD includes registered ATC-codes: L04AA and L04AB.
Other Name: Biological Disease Modifying Drug treatment

Primary Outcome Measures :
  1. Spinal fracture [ Time Frame: 10 years ]
    Censored data with occurrence of spinal fracture within 10 years observation

Information from the National Library of Medicine

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Ages Eligible for Study:   30 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients with AS as registered in the Swedish Patient Registry with ICD-9-code 720 or ICD-10 code M45.9.

Inclusion Criteria:

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

Exclusion Criteria:

  • age <30 or >60 years
Additional Information:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Uppsala University
ClinicalTrials.gov Identifier: NCT02840695    
Other Study ID Numbers: bDMARD AS Spinal Fractures
First Posted: July 21, 2016    Key Record Dates
Last Update Posted: October 30, 2017
Last Verified: October 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Additional relevant MeSH terms:
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Spondylitis, Ankylosing
Fractures, Bone
Spinal Fractures
Wounds and Injuries
Bone Diseases, Infectious
Bone Diseases
Musculoskeletal Diseases
Spinal Diseases
Joint Diseases
Axial Spondyloarthritis
Spinal Injuries
Back Injuries