Spinal SpondyloarthropathiesNCT00726765
Diagnostic Criteria in the Diagnosis of Spinal Spondyloarthropathies in Patients With Chronic Low Back Pain (Study P05320)(COMPLETED)
An observational study of Spinal Spondyloarthropathies and Axial Spondyloarthritis, run by Merck Sharp & Dohme LLC.
Trial summary
This is a multi-national, multi-site, observational study to determine which of two strategies, when used by referring physicians is superior in the diagnosis of axial spondyloarthritis (AS) by rheumatologists. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Spinal Spondyloarthropathies, Axial Spondyloarthritis
- How many people
- 1,090 participants
- Where
- No sites listed yet
- Study dates
- Jun 2008to May 2010
- 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: Each of several participating national centers of excellence will establish a network with local primary care physicians or their equivalent who will work with the center of excellence and will provide referrals of suitable patients.
Who may be able to join
- A subject must have back pain of unknown origin, of more than 3 months' duration, and with onset before age 45.
- A subject must be willing to give written informed consent and be able to adhere to visit schedules.
Who cannot join
- Established diagnosis of spondyloarthropathies at the time of referral.
- Any clinically significant condition or situation, other than the condition being studied, that, in the opinion of the investigator, would interfere with the study evaluations or optimal participation in the study.
About this study
Official title: Observational Trial on the Value of Diagnostic Criteria in the Diagnosis of Spinal Spondyloarthropathies in Patients With Chronic Low Back Pain
This is a multi-national, multi-site, observational study to determine which of two strategies, when used by referring physicians is superior in the diagnosis of axial spondyloarthritis (AS) by rheumatologists.
Read the detailed description
Subjects will be selected using a non-probability sampling method. For each center of excellence, the local network of referring physicians will be assigned, according to a random code in a 1:1 ratio, to use one of the two referral strategies for eligible patients.
- Medical subject headings
- Axial Spondyloarthritis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Referral Strategy 1 | Patient meets at least one of the following three criteria: 1. Inflammatory back pain 2. Human leukocyte antigen B27 (HLA-B27) 3. Sacroiliitis demonstrated by imaging (X-ray, magnetic resonance imagining [MRI], bone scan [if previously available]) | |
| Referral Strategy 2 | Patient meets at least two of the following six criteria: 1. Inflammatory back pain 2. HLA-B27 3. Sacroiliitis (on imaging) 4. Family history of AS 5. Good response of back pain to nonsteroidal anti-inflammatory drugs (NSAIDs) 6. Known Extra Articular Manifestations (Uveitis, Iridocyclitis, Psoriasis, Inflammatory Bowel Disease) |
What is being measured
The primary outcome is the main question the study is designed to answer.
To determine which of two referral strategies, when used by referring physicians, is superior in the diagnosis of AS by rheumatologists.
Measured: Approximately 3-6 months
Secondary outcomes (3)
To determine which of the referral criteria proposed, or which combination of referral criteria, is the most successful and workable in the diagnosis of AS when used by referring physicians.
Measured: Approximately 3-6 months
To describe the demographics and disease characteristics of patients diagnosed with AS.
Measured: Approximately 3-6 months
To compare patient-derived data with physician data to determine whether the former alone can serve as effective screening for AS.
Measured: Approximately 3-6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Aug 2008 (estimated)
- Study startJun 2008
- Primary completionMay 2010
- Study completionMay 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Spinal SpondyloarthropathiesStudies of the same condition, open and under way.
- More trials run by Merck Sharp & Dohme LLCThe 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
- 1,090 participants (actual)
Sponsor and investigators
- Lead sponsor
- Merck Sharp & Dohme LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00726765
- Sponsor's protocol ID
- P05320
- Status last verified
- Jan 2016
- First submitted
- 30 Jul 2008
- Last updated
- 21 Jan 2016
- Results posted
- No
- Data monitoring committee
- No
Publications
Sieper J, Srinivasan S, Zamani O, Mielants H, Choquette D, Pavelka K, Loft AG, Geher P, Danda D, Reitblat T, Cantini F, Ancuta C, Erdes S, Raffayova H, Keat A, Gaston JS, Praprotnik S, Vastesaeger N. Comparison of two referral strategies for diagnosis of axial spondyloarthritis: the Recognising and Diagnosing Ankylosing Spondylitis Reliably (RADAR) study. Ann Rheum Dis. 2013 Oct;72(10):1621-7. doi: 10.1136/annrheumdis-2012-201777. Epub 2012 Oct 13.
PubMed 23065731
Study at a glance
From the registry record, last updated by the sponsor on 21 Jan 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Observational Trial on the Value of Diagnostic Criteria in the Diagnosis of Spinal Spondyloarthropathies in Patients With Chronic Low Back Pain
- ClinicalTrials.gov ID
- NCT00726765
- Acronym / sponsor ID
- P05320
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,090 participants (actual)
- Lead sponsor
- Merck Sharp & Dohme LLCIndustry (pharma, biotech, devices)
- Study start
- Jun 2008
- Primary completion
- May 2010 (actual)
- Study completion
- May 2010 (actual)
- First posted
- 1 Aug 2008 (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 is a multi-national, multi-site, observational study to determine which of two strategies, when used by referring physicians is superior in the diagnosis of axial spondyloarthritis (AS) by rheumatologists.
Detailed description
Subjects will be selected using a non-probability sampling method. For each center of excellence, the local network of referring physicians will be assigned, according to a random code in a 1:1 ratio, to use one of the two referral strategies for eligible patients.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Referral Strategy 1 | – | –Patient meets at least one of the following three criteria: 1. Inflammatory back pain 2. Human leukocyte antigen B27 (HLA-B27) 3. Sacroiliitis demonstrated by imaging (X-ray, magnetic resonance imagining [MRI], bone scan [if previously available]) |
| Referral Strategy 2 | – | –Patient meets at least two of the following six criteria: 1. Inflammatory back pain 2. HLA-B27 3. Sacroiliitis (on imaging) 4. Family history of AS 5. Good response of back pain to nonsteroidal anti-inflammatory drugs (NSAIDs) 6. Known Extra Articular Manifestations (Uveitis, Iridocyclitis, Psoriasis, Inflammatory Bowel Disease) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Each of several participating national centers of excellence will establish a network with local primary care physicians or their equivalent who will work with the center of excellence and will provide referrals of suitable patients.
Key inclusion criteria (2 listed)
- A subject must have back pain of unknown origin, of more than 3 months' duration, and with onset before age 45.
- A subject must be willing to give written informed consent and be able to adhere to visit schedules.
Key exclusion criteria (2 listed)
- Established diagnosis of spondyloarthropathies at the time of referral.
- Any clinically significant condition or situation, other than the condition being studied, that, in the opinion of the investigator, would interfere with the study evaluations or optimal participation in the study.
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
To determine which of two referral strategies, when used by referring physicians, is superior in the diagnosis of AS by rheumatologists.
Time frame: Approximately 3-6 months
3 secondary outcomes
To determine which of the referral criteria proposed, or which combination of referral criteria, is the most successful and workable in the diagnosis of AS when used by referring physicians.
Time frame: Approximately 3-6 months
To describe the demographics and disease characteristics of patients diagnosed with AS.
Time frame: Approximately 3-6 months
To compare patient-derived data with physician data to determine whether the former alone can serve as effective screening for AS.
Time frame: Approximately 3-6 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 21 Jan 2016.
- Background: PubMed 23065731Sieper J, Srinivasan S, Zamani O, Mielants H, Choquette D, Pavelka K, Loft AG, Geher P, Danda D, Reitblat T, Cantini F, Ancuta C, Erdes S, Raffayova H, Keat A, Gaston JS, Praprotnik S, Vastesaeger N. Comparison of two referral strategies for diagnosis of axial spondyloarthritis: the Recognising and Diagnosing Ankylosing Spondylitis Reliably (RADAR) study. Ann Rheum Dis. 2013 Oct;72(10):1621-7. doi: 10.1136/annrheumdis-2012-201777. Epub 2012 Oct 13.
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 Spinal Spondyloarthropathies and Axial Spondyloarthritis, run by Merck Sharp & Dohme LLC.
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 2 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 21 Jan 2016. 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?
To determine which of two referral strategies, when used by referring physicians, is superior in the diagnosis of AS by rheumatologists. (time frame: Approximately 3-6 months). 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 NCT00726765, which also lists 1 linked publication.
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 21 Jan 2016; AzTrials last refreshed its copy on 8 Nov 2026.