Ankylosing SpondylitisNCT02840695
Effect of Biological Disease Modifying Anti Rheumatic Drug (bDMARD) Treatment on Spinal Fracture Incidence in Patients With Ankylosing Spondylitis (AS)
An observational study of Ankylosing Spondylitis and Spinal Fractures, run by Uppsala University.
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. Read more about this study
- Who is it for?
- Ages 30 to 60 years
- Conditions the study is for
- Ankylosing Spondylitis, Spinal Fractures
- What is being tested?
- bDMARD treatment
- How many people
- 9,858 participants
- Where
- No sites listed yet
- Study dates
- Jan 2005to 24 Oct 2017
- How long will I take part?
- 10 Years
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 30 to 60 years
- All sexes
- No healthy volunteers
- Adult
Study population: Patients with AS as registered in the Swedish Patient Registry with ICD-9-code 720 or ICD-10 code M45.9.
Who may be able to join
- age 30-60 years
- registered diagnosis of ankylosing spondylitis
Who cannot join
- age <30 or >60 years
About this study
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.
- Conditions
- Ankylosing Spondylitis, Spinal Fractures
- Being tested
- bDMARD treatment
- Medical subject headings
- Spondylitis, Ankylosing, Spinal Fractures
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
bDMARD treatmentDrug
Also called Biological Disease Modifying Drug treatment
Treatment with bDMARD includes registered ATC-codes: L04AA and L04AB.
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Drug: bDMARD treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Spinal fracture
Censored data with occurrence of spinal fracture within 10 years observation
Measured: 10 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jul 2016 (estimated)
- Study startJan 2005
- Primary completionDec 2015
- Study completion24 Oct 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Ankylosing SpondylitisStudies of the same condition, open and under way.
- More trials run by Uppsala UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 9,858 participants (actual)
- Target duration
- 10 Years
Sponsor and investigators
- Lead sponsor
- Uppsala University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02840695
- Sponsor's protocol ID
- bDMARD AS Spinal Fractures
- Status last verified
- Oct 2017
- First submitted
- 18 Jul 2016
- Last updated
- 30 Oct 2017
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
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.
PubMed 29288176Badar 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.
PubMed 29273649
Study at a glance
From the registry record, last updated by the sponsor on 30 Oct 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Biological Disease Modifying Anti Rheumatic Drug (bDMARD) Treatment on Spinal Fracture Incidence in Patients With Ankylosing Spondylitis (AS)
- ClinicalTrials.gov ID
- NCT02840695
- Acronym / sponsor ID
- bDMARD AS Spinal Fractures
- Conditions
- Ankylosing Spondylitis, Spinal Fractures
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 9,858 participants (actual)
- Lead sponsor
- Uppsala UniversityUniversity, hospital or other
- Study start
- Jan 2005
- Primary completion
- Dec 2015 (actual)
- Study completion
- 24 Oct 2017 (actual)
- First posted
- 21 Jul 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 10 Years
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| AS patients | – | Drug: bDMARD treatmentPatients 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 |
Who may qualify
- Ages
- 30 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- Patients with AS as registered in the Swedish Patient Registry with ICD-9-code 720 or ICD-10 code M45.9.
Key inclusion criteria (2 listed)
- age 30-60 years
- registered diagnosis of ankylosing spondylitis
Key exclusion criteria (1 listed)
- age <30 or >60 years
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| bDMARD treatmentAlso: Biological Disease Modifying Drug treatmentTreatment with bDMARD includes registered ATC-codes: L04AA and L04AB. | Drug | AS patients |
Primary outcome
Spinal fracture
Time frame: 10 years
Censored data with occurrence of spinal fracture within 10 years observation
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Oct 2017.
- Derived from this study: PubMed 29288176Robinson 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.
- Derived from this study: PubMed 29273649Badar 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.
- Individual participant dataSharing planned: No
Related trials for Ankylosing Spondylitis
RecruitingPhase 1
A Study of HB0017 Injection in Healthy Volunteers to Evaluate Safety and Tolerability of a Single Subcutaneous Injection in Low-Body-Weight Subjects; and Pharmacokinetics at Different Subcutaneous Injection Sites at the Same Dose
Psoriasis, Ankylosing Spondylitis
RecruitingObservational study
Pain Phenotyping of Rheumatic Diseases - An Observational Study
Rheumatic Diseases, Lupus Erythematosus, Systemic
RecruitingObservational study
Identification of Serum Level of Glutathione Peroxidase 4
Spondyloarthropathy
Not yet recruitingPhase 1
A Study of GKL-006Allo Injection in Patients With Ankylosing Spondylitis
Ankylosing Spondylitis
Active, not recruitingObservational study
Neuropathic Spinal Pain in Ankylosing Spondylitis
Ankylosing Spondylitis
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Ankylosing Spondylitis and Spinal Fractures, run by Uppsala University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 Oct 2017. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Spinal fracture (time frame: 10 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02840695, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Oct 2017.