Active Sacroiliitis in Ankylosing SpondylitisNCT04329182
Color Doppler Ultrasonography in Evaluation of Active Sacroiliitis in Ankylosing Spondylitis
An observational study of Active Sacroiliitis in Ankylosing Spondylitis, run by Assiut University.
Trial summary
Evaluate the role of color Doppler ultrasonography (CDUS) in detection of active sacroiliitis in Ankylosing Spondylitis patients using MRI of the sacroiliac joints as a gold standard. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Active Sacroiliitis in Ankylosing Spondylitis
- How many people
- 40 participants
- Where
- No sites listed yet
- Study dates
- May 2020to May 2022
- 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 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients involved in the study will be recruited from outpatient clinics and inpatients of Rheumatology, Rehabilitation and Physical Medicine Department, Assiut University Hospitals, Faculty of Medicine. Diagnosed as Ankylosing Spondylitis defined by the modified New York criteria , and classified as axial Spondyloarthritis according to Assessment in SpondyloArthritis International Society classification criteria
Who may be able to join
- Age of patients (≥18 and ≤65 years old).
- Diagnosed as Ankylosing Spondylitis defined by the modified New York criteria , and classified as axial Spondyloarthritis according to Assessment in SpondyloArthritis International Society classification criteria.
Who cannot join
- Diseases mimicking as AS such as :
- Flourosis of spine,
- Diffuse idiopathic skeletal hyperostosis (DISH)
- Degenerative spinal diseases (spondylosis deformans)
- Other seronegative spondyloarthropathy :
- Psoriatic arthritis ,
Show all 13Show fewer
- Reactive Arthritis,
- Enteropathic Arthritis,
- Undifferentiated spondyloarthropathy.
- Other causes of sacroiliitis:
- Osteoarthritis
- Trauma
- Infection
About this study
Official title: Role of Color Doppler Ultrasonography in Evaluation of Active Sacroiliitis in Ankylosing Spondylitis Patients and Its Relation With Disease Activity
Evaluate the role of color Doppler ultrasonography (CDUS) in detection of active sacroiliitis in Ankylosing Spondylitis patients using MRI of the sacroiliac joints as a gold standard.
Evaluate the relation of active sacroiliitis detected by color Doppler ultrasonography (CDUS) with disese activity in patients with ankylosing spondylitis
Read the detailed description
Ankylosing spondylitis (AS) is the prototype of the spondyloarthropathies as a chronic inflammatory rheumatic disease presenting mainly with inflammation of the axial skeleton, peripheral arthritis, and enthesitis.
Sacroiliitis is an important sign of AS, and it is used to describe unilateral or bilateral involvement of the sacroiliac joint (SIJ) .
Early diagnosis of AS is important, since some changes associated with the disease are irreversible, and early diagnosis can also improve the ultimate clinical outcomes.
X-ray and magnetic resonance imaging (MRI) are frequently used as image tools to investigate sacroiliitis in AS patients. X-ray could show the structural lesion of sacroiliac joints (SIJs), but could not show the lesions in the early stage of disease. MRI can quantify active in¬flammatory lesions of SIJs.
However, MRI is relatively expensive and time-consuming, and its routine use in patient visits during ther¬apy would be difficult. Another factor that limits usage of MRI is that an important proportion of AS patients have prostheses. Therefore, an easier and cheaper method is needed to detect the degree of spinal inflammation.
Ultrasonography (US) is an inexpensive, non-invasive and non-radiating technique, which can be used in daily clinical practice .
Musculoskeletal ultrasonography (US) has gained increasing attention in many areas of rheumatology . In the area of spondyloarthropathy, Doppler US has been used frequently to assess enthesitis . It was demonstrated that signs of active sacroiliitis could be detected by the color Doppler ultrasonograpy (CDUS) method including increased vascularization in the posterior SIJ and a lower resistance index (RI). The RI could be a quantitative indicator of active sacroiliitis.
Treatment options to AS are limited and mainly consist of non-steroidal anti-inflammatory drugs (NSAIDs) and physical therapy .Efficacy of dis¬ease-modifying anti-rheumatic drugs (DMARDs) such as methotrexate is uncertain to AS.
The introduction of biologic drugs for treatment of AS has led to effective treatment of disease symptoms and signs. However, the effect of these costly drugs on structural damage in addition to the clinical findings is not clear .
What is being measured
The primary outcome is the main question the study is designed to answer.
color Doppler ultrasonography (CDUS) in detection of active sacroiliitis in Ankylosing Spondylitis patients
- Evaluate the role of color Doppler ultrasonography (CDUS) in detection of active sacroiliitis in Ankylosing Spondylitis patients using MRI of the sacroiliac joints as a gold standard
Measured: two years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Apr 2020
- Study startMay 2020 (estimated)
- Primary completionJan 2022 (estimated)
- Study completionMay 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Active Sacroiliitis in Ankylosing SpondylitisStudies of the same condition, open and under way.
- More trials run by Assiut 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
- Case only
- Time perspective
- Cross-sectional
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hassan Salah Eldin Hassan Mohamed Elesseily, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04329182
- Sponsor's protocol ID
- Color Doppler Ultrasonography
- Status last verified
- Mar 2020
- First submitted
- 29 Mar 2020
- Last updated
- 1 Apr 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Apr 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Role of Color Doppler Ultrasonography in Evaluation of Active Sacroiliitis in Ankylosing Spondylitis Patients and Its Relation With Disease Activity
- ClinicalTrials.gov ID
- NCT04329182
- Acronym / sponsor ID
- Color Doppler Ultrasonography
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- May 2020 (estimated)
- Primary completion
- Jan 2022 (estimated)
- Study completion
- May 2022 (estimated)
- First posted
- 1 Apr 2020 (actual)
- 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.
Evaluate the role of color Doppler ultrasonography (CDUS) in detection of active sacroiliitis in Ankylosing Spondylitis patients using MRI of the sacroiliac joints as a gold standard.
Evaluate the relation of active sacroiliitis detected by color Doppler ultrasonography (CDUS) with disese activity in patients with ankylosing spondylitis
Detailed description
Ankylosing spondylitis (AS) is the prototype of the spondyloarthropathies as a chronic inflammatory rheumatic disease presenting mainly with inflammation of the axial skeleton, peripheral arthritis, and enthesitis.
Sacroiliitis is an important sign of AS, and it is used to describe unilateral or bilateral involvement of the sacroiliac joint (SIJ) .
Early diagnosis of AS is important, since some changes associated with the disease are irreversible, and early diagnosis can also improve the ultimate clinical outcomes.
X-ray and magnetic resonance imaging (MRI) are frequently used as image tools to investigate sacroiliitis in AS patients. X-ray could show the structural lesion of sacroiliac joints (SIJs), but could not show the lesions in the early stage of disease. MRI can quantify active in¬flammatory lesions of SIJs.
However, MRI is relatively expensive and time-consuming, and its routine use in patient visits during ther¬apy would be difficult. Another factor that limits usage of MRI is that an important proportion of AS patients have prostheses. Therefore, an easier and cheaper method is needed to detect the degree of spinal inflammation.
Ultrasonography (US) is an inexpensive, non-invasive and non-radiating technique, which can be used in daily clinical practice .
Musculoskeletal ultrasonography (US) has gained increasing attention in many areas of rheumatology . In the area of spondyloarthropathy, Doppler US has been used frequently to assess enthesitis . It was demonstrated that signs of active sacroiliitis could be detected by the color Doppler ultrasonograpy (CDUS) method including increased vascularization in the posterior SIJ and a lower resistance index (RI). The RI could be a quantitative indicator of active sacroiliitis.
Treatment options to AS are limited and mainly consist of non-steroidal anti-inflammatory drugs (NSAIDs) and physical therapy .Efficacy of dis¬ease-modifying anti-rheumatic drugs (DMARDs) such as methotrexate is uncertain to AS.
The introduction of biologic drugs for treatment of AS has led to effective treatment of disease symptoms and signs. However, the effect of these costly drugs on structural damage in addition to the clinical findings is not clear .
Study design
- Observational model
- Case only
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients involved in the study will be recruited from outpatient clinics and inpatients of Rheumatology, Rehabilitation and Physical Medicine Department, Assiut University Hospitals, Faculty of Medicine. Diagnosed as Ankylosing Spondylitis defined by the modified New York criteria , and classified as axial Spondyloarthritis according to Assessment in SpondyloArthritis International Society classification criteria
Key inclusion criteria (2 listed)
- Age of patients (≥18 and ≤65 years old).
- Diagnosed as Ankylosing Spondylitis defined by the modified New York criteria , and classified as axial Spondyloarthritis according to Assessment in SpondyloArthritis International Society classification criteria.
Key exclusion criteria (13 listed)
- Diseases mimicking as AS such as :
- Other seronegative spondyloarthropathy :
- Other causes of sacroiliitis:
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
color Doppler ultrasonography (CDUS) in detection of active sacroiliitis in Ankylosing Spondylitis patients
Time frame: two years
• Evaluate the role of color Doppler ultrasonography (CDUS) in detection of active sacroiliitis in Ankylosing Spondylitis patients using MRI of the sacroiliac joints as a gold standard
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Apr 2020.
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 Active Sacroiliitis in Ankylosing Spondylitis, run by Assiut 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 13 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: status not confirmed, as of the sponsor's last update on 1 Apr 2020. 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?
Results are not available in the source record.
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?
color Doppler ultrasonography (CDUS) in detection of active sacroiliitis in Ankylosing Spondylitis patients (time frame: two years). 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 1 Apr 2020.