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

October 27, 2017 updated by: Uppsala University
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

9858

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

30 years to 60 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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.

Description

Inclusion Criteria:

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

Exclusion Criteria:

  • age <30 or >60 years

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

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 Names:
  • Biological Disease Modifying Drug treatment

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Spinal fracture
Time Frame: 10 years
Censored data with occurrence of spinal fracture within 10 years observation
10 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Uppsala University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2005

Primary Completion (Actual)

December 1, 2015

Study Completion (Actual)

October 24, 2017

Study Registration Dates

First Submitted

July 18, 2016

First Submitted That Met QC Criteria

July 18, 2016

First Posted (Estimate)

July 21, 2016

Study Record Updates

Last Update Posted (Actual)

October 30, 2017

Last Update Submitted That Met QC Criteria

October 27, 2017

Last Verified

October 1, 2017

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • bDMARD AS Spinal Fractures

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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