Ankylosing SpondylitisNCT01302730
Ankylosing Spondylitis and Spondyloarthritis Evaluation Tool Study
An observational study of Ankylosing Spondylitis and Spondylarthritis, run by Stanford University at 1 site in United States.
Trial summary
This study aims to test whether a new instrument (questionnaire) is useful for identifying patients with ankylosing spondylitis. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Ankylosing Spondylitis, Spondylarthritis
- How many people
- 490 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2011to Nov 2013
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: All patients referred to rheumatologist office will be potentially eligible.
Who may be able to join
- Ability to provide informed consent
Who cannot join
- Inability to provide informed consent
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Self-Administered Questionnaire for Early Detection of Axial Spondyloarthritis
This study aims to test whether a new instrument (questionnaire) is useful for identifying patients with ankylosing spondylitis.
- Conditions
- Ankylosing Spondylitis, Spondylarthritis
- Keywords
- ankylosing spondylitis, spondylarthritis, inflammatory back pain, seronegative
- Medical subject headings
- Spondylitis, Ankylosing, Spondylarthritis
What is being measured
The primary outcome is the main question the study is designed to answer.
Physician diagnosis of Ankylosing Spondylitis
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Feb 2011 (estimated)
- Study startApr 2011
- Primary completionMar 2012
- Study completionNov 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ankylosing SpondylitisStudies of the same condition, open and under way.
- More trials run by Stanford 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
- Time perspective
- Prospective
- Enrolment
- 490 participants (actual)
Sponsor and investigators
- Lead sponsor
- Stanford University
- Sponsor type
- University, hospital or other
- Collaborators
- University of California, San Francisco, Oregon Health and Science University, Cedars-Sinai Medical Center
- Responsible party
- Principal investigator, Eswar Krishnan, Stanford University
- Investigators
- Eswar Krishnan, Principal investigator, Stanford University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01302730
- Sponsor's protocol ID
- STANIRB-20278
- Status last verified
- Nov 2013
- First submitted
- 22 Feb 2011
- Last updated
- 8 Nov 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Nov 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Self-Administered Questionnaire for Early Detection of Axial Spondyloarthritis
- ClinicalTrials.gov ID
- NCT01302730
- Acronym / sponsor ID
- STANIRB-20278
- Conditions
- Ankylosing Spondylitis, Spondylarthritis
- Keywords
- ankylosing spondylitis, spondylarthritis, inflammatory back pain, seronegative
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 490 participants (actual)
- Lead sponsor
- Stanford UniversityUniversity, hospital or other
- Collaborators
- University of California, San Francisco, Oregon Health and Science University, Cedars-Sinai Medical Center
- Study start
- Apr 2011
- Primary completion
- Mar 2012 (actual)
- Study completion
- Nov 2013 (actual)
- First posted
- 24 Feb 2011 (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.
This study aims to test whether a new instrument (questionnaire) is useful for identifying patients with ankylosing spondylitis.
Study design
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All patients referred to rheumatologist office will be potentially eligible.
Key inclusion criteria (1 listed)
- Ability to provide informed consent
Key exclusion criteria (1 listed)
- Inability to provide informed consent
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Physician diagnosis of Ankylosing Spondylitis
Time frame: 6 months
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 8 Nov 2013.
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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.
Eswar Krishnan principal investigator
Stanford University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Ankylosing Spondylitis and Spondylarthritis, run by Stanford University at 1 site in United States.
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 1 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 8 Nov 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
Physician diagnosis of Ankylosing Spondylitis (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 8 Nov 2013.