Axial SpondyloarthritisIBP/AxSpANCT05327140
Reliability of IBP Criteria & Activity Scores in Patients With AxSpA
An observational study of Axial Spondyloarthritis and Inflammatory Back Pain, run by Zagazig University at 1 site in Egypt.
Trial summary
The current ASAS classification of AxSpA relies either on sacroiliitis on imaging plus one SpA feature (imaging arm) or HLA-B27 antigen plus two SpA features (clinical arm), in a patient with chronic back pain and age at onset of less than 45 years. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Axial Spondyloarthritis, Inflammatory Back Pain
- How many people
- 206 participants
- Where
- 1 siteEgypt
- Study dates
- 20 Aug 2021to 25 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 years and older
- All sexes
- Adult, Older adult
Study population: Group 1 Patients diagnosed as AxSpA according to the ASAS classification criteria for AxSpA. Group 2 Patients diagnosed as chronic (more than 3 months) mechanical back pain, the diagnosis has been made prior to the study by the treating specialist, these patients are herein as a control group.
Who may be able to join
- Group 1
- Patients diagnosed as AxSpA.
- Age > 18 years and < 45 years at onset of the disease. Group 2
- Patients diagnosed as chronic mechanical back pain.
- Age > 18 years and < 45 years at onset of the disease.
Who cannot join
- Patients having acute or subacute back pain.
- Patients having back pain referred from another site.
- Patients with any other autoimmune disease: rheumatoid arthritis, systemic lupus erythematosus, Behçet's disease… etc.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Reliability of Inflammatory Back Pain Criteria and Activity Scores in Patients With Axial Spondyloarthritis
The current ASAS classification of AxSpA relies either on sacroiliitis on imaging plus one SpA feature (imaging arm) or HLA-B27 antigen plus two SpA features (clinical arm), in a patient with chronic back pain and age at onset of less than 45 years. IBP which is a major symptom of SpA depends more on patient's perception which is not usually accurate. As well, disease activity is measured by ASDAS, BASDAI, and BASFAI which depend more on subjective measures. Assessment of reliability of IBP criteria, ASDAS, BASDAI, and BASFAI in diagnosis and evaluation of activity of AxSpA is essential for better health care.
Read the detailed description
Axial spondyloarthritis (AxSpA) is a chronic inflammatory disease that affects the axial skeleton mainly leading to significant pain and disability. Early diagnosis of AxSpA is important for better management of symptoms and to limit spinal damage. The last classification of AxSpA is ASAS classification criteria which relies either on sacroiliitis on imaging plus one SpA feature (imaging arm) or HLA-B27 antigen plus two SpA features (clinical arm), in a patient with chronic back pain and age at onset of less than 45 years. Inflammatory back pain (IBP) is the key clinical symptom of AxSpA and is often present at disease onset. There are different sets of IBP criteria which include the Calin criteria , Berlin criteria, and the Assessment of SpondyloArthritis international Society (ASAS) IBP experts criteria. These sets when assessed by different rheumatologists had different sensitivity and specificity.
As IBP has certain characters, taking the clinical history has been considered as a screening test for patients with chronic back pain to identify patients with AxSpA. But, the value of this screening test has been questioned. Disease activity in AxSpA has been measured by the Bath Ankylosing Spondylitis Disease Activity Index (BASDAI). It has been used extensively since 1994 but with some limitations as it does not include the physician's assessment of the disease and does not assess the impact of specific clinical factors.
The Bath Ankylosing Spondylitis Functional Index (BASFI) has been also developed as an approach to defining and monitoring functional ability in patients with AxSpA. ASAS developed a disease activity score for patient with AxSpA which is called Ankylosing Spondylitis Disease Activity Score (ASDAS) that combines patient-reported assessments with acute phase reactants (C-reactive protein [CRP] or erythrocyte sedimentation rate [ESR]). However, it is based largely on subjective measures, and lacks objective biomarker of disease activity.
The evaluation of disease activity in AxSpA is complex and multifactorial. Also, patients and physicians have different perspectives of the disease and none of the current single-item or combined indexes adequately unifies both perspectives.
- Conditions
- Axial Spondyloarthritis, Inflammatory Back Pain
- 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 |
|---|---|---|
| patients with axial spondyloarthritis | ASAS classification criteria which relies either on sacroiliitis on imaging plus one SpA feature (imaging arm) or HLA-B27 antigen plus two SpA features (clinical arm), in a patient with chronic back pain and age at onset of less than 45 years | |
| patients with mechanical back pain | Patients diagnosed as chronic (more than 3 months) mechanical back pain, the diagnosis has been made prior to the study by the treating specialist, these patients are herein as a control group |
What is being measured
The primary outcome is the main question the study is designed to answer.
assessment of reliability, sensitivity, and specificity of inflammatory back pain criteria (the Assessment of SpondyloArthritis international Society IBP experts criteria) depending on a gold standard which is the global evaluation of the rheumatologist.
Assessment of reliability of each item and the whole set of inflammatory back pain criteria ( the Assessment of SpondyloArthritis international Society (ASAS) IBP experts criteria) depending on a gold standard which is the global evaluation of expert rheumatologist: is it inflammatory or mechanical back pain.
The Assessment of SpondyloArthritis international Society (ASAS) IBP experts criteria includes 5 items: age at onset ≤ 40 years, insidious onset, improvement with exercise, no improvement with rest, pain at night. This set of criteria is achieved if at least four parameters are met.
Measured: 8/2021 to 5/2022
assessment of reliability of Ankylosing Spondylitis Disease Activity Score in axial spondyloarthritis patients.
Ankylosing Spondylitis Disease Activity Score (ASDAS-CRP) includes 4 questions about disease activity (Axial pain, Peripheral Pain/Swelling, Duration of Morning Stiffness, activity of the disease on average during the last week) and CRP. Each question has a score from 0 to 10. 0 means no, and 10 means sever.
ASDAS_CRP = 0.121 × total back pain + 0.110 × patient global + 0.073 × peripheral pain / swelling + 0.058 × duration of morning stiffness + 0.579 × Ln (CRP+1).
ASDAS scores : <1.3 "inactive disease" and <2.1"low disease activity", ≤3.5 "high disease activity", and >3.5 "very high disease activity".
The score is applied to the same group of patients by 2 rheumatologists. The scores of each question and the total score that detected by the two rheumatologists are compared to detect agreement between the two rheumatologist and assess reliability of this score
Measured: 8/2021 to 5/2022
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Apr 2022
- Study start20 Aug 2021
- Primary completion22 Feb 2022
- Study completion25 May 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (12)Papers the sponsor has linked to this study.
- Other trials for Axial SpondyloarthritisStudies of the same condition, open and under way.
- More trials run by Zagazig 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-control
- Time perspective
- Cross-sectional
- Enrolment
- 206 participants (actual)
Sponsor and investigators
- Lead sponsor
- Zagazig University
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Noha Ehab Hamed, Zagazig University
- Investigators
- Eman El-shahawy, Study director, Zagazig UniversityMohamed Mortada, Study director, Zagazig UniversitySafaa Elnaggar, Study director, Zagazig UniversityNoha Hamed, Principal investigator, Zagazig University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05327140
- Sponsor's protocol ID
- ZU-IRB #6983/13-6-2021
- Acronym
- IBP/AxSpA
- Status last verified
- Jan 2023
- First submitted
- 22 Dec 2021
- Last updated
- 25 Jan 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Calin A, Porta J, Fries JF, Schurman DJ. Clinical history as a screening test for ankylosing spondylitis. JAMA. 1977 Jun 13;237(24):2613-4.
PubMed 140252Calin A, Garrett S, Whitelock H, Kennedy LG, O'Hea J, Mallorie P, Jenkinson T. A new approach to defining functional ability in ankylosing spondylitis: the development of the Bath Ankylosing Spondylitis Functional Index. J Rheumatol. 1994 Dec;21(12):2281-5.
PubMed 7699629Deodhar A, Blanco R, Dokoupilova E, Hall S, Kameda H, Kivitz AJ, Poddubnyy D, van de Sande M, Wiksten AS, Porter BO, Richards HB, Haemmerle S, Braun J. Improvement of Signs and Symptoms of Nonradiographic Axial Spondyloarthritis in Patients Treated With Secukinumab: Primary Results of a Randomized, Placebo-Controlled Phase III Study. Arthritis Rheumatol. 2021 Jan;73(1):110-120. doi: 10.1002/art.41477. Epub 2020 Nov 24.
PubMed 32770640Garrett S, Jenkinson T, Kennedy LG, Whitelock H, Gaisford P, Calin A. A new approach to defining disease status in ankylosing spondylitis: the Bath Ankylosing Spondylitis Disease Activity Index. J Rheumatol. 1994 Dec;21(12):2286-91.
PubMed 7699630Machado P, van der Heijde D. How to measure disease activity in axial spondyloarthritis? Curr Opin Rheumatol. 2011 Jul;23(4):339-45. doi: 10.1097/BOR.0b013e3283470f23.
PubMed 21519269Poddubnyy D, Callhoff J, Spiller I, Listing J, Braun J, Sieper J, Rudwaleit M. Diagnostic accuracy of inflammatory back pain for axial spondyloarthritis in rheumatological care. RMD Open. 2018 Dec 5;4(2):e000825. doi: 10.1136/rmdopen-2018-000825. eCollection 2018.
PubMed 30713715Reveille JD. Biomarkers for diagnosis, monitoring of progression, and treatment responses in ankylosing spondylitis and axial spondyloarthritis. Clin Rheumatol. 2015 Jun;34(6):1009-18. doi: 10.1007/s10067-015-2949-3. Epub 2015 May 5.
PubMed 25939520Ritchlin C, Adamopoulos IE. Axial spondyloarthritis: new advances in diagnosis and management. BMJ. 2021 Jan 4;372:m4447. doi: 10.1136/bmj.m4447.
PubMed 33397652Rudwaleit M, Metter A, Listing J, Sieper J, Braun J. Inflammatory back pain in ankylosing spondylitis: a reassessment of the clinical history for application as classification and diagnostic criteria. Arthritis Rheum. 2006 Feb;54(2):569-78. doi: 10.1002/art.21619.
PubMed 16447233Rudwaleit M, Landewe R, van der Heijde D, Listing J, Brandt J, Braun J, Burgos-Vargas R, Collantes-Estevez E, Davis J, Dijkmans B, Dougados M, Emery P, van der Horst-Bruinsma IE, Inman R, Khan MA, Leirisalo-Repo M, van der Linden S, Maksymowych WP, Mielants H, Olivieri I, Sturrock R, de Vlam K, Sieper J. The development of Assessment of SpondyloArthritis international Society classification criteria for axial spondyloarthritis (part I): classification of paper patients by expert opinion including uncertainty appraisal. Ann Rheum Dis. 2009 Jun;68(6):770-6. doi: 10.1136/ard.2009.108217. Epub 2009 Mar 17.
PubMed 19297345Sieper J, van der Heijde D, Landewe R, Brandt J, Burgos-Vagas R, Collantes-Estevez E, Dijkmans B, Dougados M, Khan MA, Leirisalo-Repo M, van der Linden S, Maksymowych WP, Mielants H, Olivieri I, Rudwaleit M. New criteria for inflammatory back pain in patients with chronic back pain: a real patient exercise by experts from the Assessment of SpondyloArthritis international Society (ASAS). Ann Rheum Dis. 2009 Jun;68(6):784-8. doi: 10.1136/ard.2008.101501. Epub 2009 Jan 15.
PubMed 19147614van der Heijde D, Lie E, Kvien TK, Sieper J, Van den Bosch F, Listing J, Braun J, Landewe R; Assessment of SpondyloArthritis international Society (ASAS). ASDAS, a highly discriminatory ASAS-endorsed disease activity score in patients with ankylosing spondylitis. Ann Rheum Dis. 2009 Dec;68(12):1811-8. doi: 10.1136/ard.2008.100826. Epub 2008 Dec 5.
PubMed 19060001
Study at a glance
From the registry record, last updated by the sponsor on 25 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Reliability of Inflammatory Back Pain Criteria and Activity Scores in Patients With Axial Spondyloarthritis
- ClinicalTrials.gov ID
- NCT05327140
- Acronym / sponsor ID
- IBP/AxSpA / ZU-IRB #6983/13-6-2021
- Conditions
- Axial Spondyloarthritis, Inflammatory Back Pain
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 206 participants (actual)
- Lead sponsor
- Zagazig UniversityOther government
- Study start
- 20 Aug 2021 (actual)
- Primary completion
- 22 Feb 2022 (actual)
- Study completion
- 25 May 2022 (actual)
- First posted
- 14 Apr 2022 (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.
The current ASAS classification of AxSpA relies either on sacroiliitis on imaging plus one SpA feature (imaging arm) or HLA-B27 antigen plus two SpA features (clinical arm), in a patient with chronic back pain and age at onset of less than 45 years. IBP which is a major symptom of SpA depends more on patient's perception which is not usually accurate. As well, disease activity is measured by ASDAS, BASDAI, and BASFAI which depend more on subjective measures. Assessment of reliability of IBP criteria, ASDAS, BASDAI, and BASFAI in diagnosis and evaluation of activity of AxSpA is essential for better health care.
Detailed description
Axial spondyloarthritis (AxSpA) is a chronic inflammatory disease that affects the axial skeleton mainly leading to significant pain and disability. Early diagnosis of AxSpA is important for better management of symptoms and to limit spinal damage. The last classification of AxSpA is ASAS classification criteria which relies either on sacroiliitis on imaging plus one SpA feature (imaging arm) or HLA-B27 antigen plus two SpA features (clinical arm), in a patient with chronic back pain and age at onset of less than 45 years. Inflammatory back pain (IBP) is the key clinical symptom of AxSpA and is often present at disease onset. There are different sets of IBP criteria which include the Calin criteria , Berlin criteria, and the Assessment of SpondyloArthritis international Society (ASAS) IBP experts criteria. These sets when assessed by different rheumatologists had different sensitivity and specificity.
As IBP has certain characters, taking the clinical history has been considered as a screening test for patients with chronic back pain to identify patients with AxSpA. But, the value of this screening test has been questioned. Disease activity in AxSpA has been measured by the Bath Ankylosing Spondylitis Disease Activity Index (BASDAI). It has been used extensively since 1994 but with some limitations as it does not include the physician's assessment of the disease and does not assess the impact of specific clinical factors.
The Bath Ankylosing Spondylitis Functional Index (BASFI) has been also developed as an approach to defining and monitoring functional ability in patients with AxSpA. ASAS developed a disease activity score for patient with AxSpA which is called Ankylosing Spondylitis Disease Activity Score (ASDAS) that combines patient-reported assessments with acute phase reactants (C-reactive protein [CRP] or erythrocyte sedimentation rate [ESR]). However, it is based largely on subjective measures, and lacks objective biomarker of disease activity.
The evaluation of disease activity in AxSpA is complex and multifactorial. Also, patients and physicians have different perspectives of the disease and none of the current single-item or combined indexes adequately unifies both perspectives.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| patients with axial spondyloarthritis | – | –ASAS classification criteria which relies either on sacroiliitis on imaging plus one SpA feature (imaging arm) or HLA-B27 antigen plus two SpA features (clinical arm), in a patient with chronic back pain and age at onset of less than 45 years |
| patients with mechanical back pain | – | –Patients diagnosed as chronic (more than 3 months) mechanical back pain, the diagnosis has been made prior to the study by the treating specialist, these patients are herein as a control group |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Group 1 Patients diagnosed as AxSpA according to the ASAS classification criteria for AxSpA. Group 2 Patients diagnosed as chronic (more than 3 months) mechanical back pain, the diagnosis has been made prior to the study by the treating specialist, these patients are herein as a control group.
Key inclusion criteria (5 listed)
- Group 1
- Patients diagnosed as AxSpA.
- Age > 18 years and < 45 years at onset of the disease. Group 2
- Patients diagnosed as chronic mechanical back pain.
- Age > 18 years and < 45 years at onset of the disease.
Key exclusion criteria (3 listed)
- Patients having acute or subacute back pain.
- Patients having back pain referred from another site.
- Patients with any other autoimmune disease: rheumatoid arthritis, systemic lupus erythematosus, Behçet's disease… etc.
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
assessment of reliability, sensitivity, and specificity of inflammatory back pain criteria (the Assessment of SpondyloArthritis international Society IBP experts criteria) depending on a gold standard which is the global evaluation of the rheumatologist.
Time frame: 8/2021 to 5/2022
Assessment of reliability of each item and the whole set of inflammatory back pain criteria ( the Assessment of SpondyloArthritis international Society (ASAS) IBP experts criteria) depending on a gold standard which is the global evaluation of expert rheumatologist: is it inflammatory or mechanical back pain. The Assessment of SpondyloArthritis international Society (ASAS) IBP experts criteria includes 5 items: age at onset ≤ 40 years, insidious onset, improvement with exercise, no improvement with rest, pain at night. This set of criteria is achieved if at least four parameters are met.
assessment of reliability of Ankylosing Spondylitis Disease Activity Score in axial spondyloarthritis patients.
Time frame: 8/2021 to 5/2022
Ankylosing Spondylitis Disease Activity Score (ASDAS-CRP) includes 4 questions about disease activity (Axial pain, Peripheral Pain/Swelling, Duration of Morning Stiffness, activity of the disease on average during the last week) and CRP. Each question has a score from 0 to 10. 0 means no, and 10 means sever. ASDAS_CRP = 0.121 × total back pain + 0.110 × patient global + 0.073 × peripheral pain / swelling + 0.058 × duration of morning stiffness + 0.579 × Ln (CRP+1). ASDAS scores : <1.3 "inactive disease" and <2.1"low disease activity", ≤3.5 "high disease activity", and >3.5 "very high disease activity". The score is applied to the same group of patients by 2 rheumatologists. The scores of each question and the total score that detected by the two rheumatologists are compared to detect agreement between the two rheumatologist and assess reliability of this score
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 25 Jan 2023.
- Background: PubMed 140252Calin A, Porta J, Fries JF, Schurman DJ. Clinical history as a screening test for ankylosing spondylitis. JAMA. 1977 Jun 13;237(24):2613-4.
- Background: PubMed 7699629Calin A, Garrett S, Whitelock H, Kennedy LG, O'Hea J, Mallorie P, Jenkinson T. A new approach to defining functional ability in ankylosing spondylitis: the development of the Bath Ankylosing Spondylitis Functional Index. J Rheumatol. 1994 Dec;21(12):2281-5.
- Background: PubMed 32770640Deodhar A, Blanco R, Dokoupilova E, Hall S, Kameda H, Kivitz AJ, Poddubnyy D, van de Sande M, Wiksten AS, Porter BO, Richards HB, Haemmerle S, Braun J. Improvement of Signs and Symptoms of Nonradiographic Axial Spondyloarthritis in Patients Treated With Secukinumab: Primary Results of a Randomized, Placebo-Controlled Phase III Study. Arthritis Rheumatol. 2021 Jan;73(1):110-120. doi: 10.1002/art.41477. Epub 2020 Nov 24.
- Background: PubMed 7699630Garrett S, Jenkinson T, Kennedy LG, Whitelock H, Gaisford P, Calin A. A new approach to defining disease status in ankylosing spondylitis: the Bath Ankylosing Spondylitis Disease Activity Index. J Rheumatol. 1994 Dec;21(12):2286-91.
- Background: PubMed 21519269Machado P, van der Heijde D. How to measure disease activity in axial spondyloarthritis? Curr Opin Rheumatol. 2011 Jul;23(4):339-45. doi: 10.1097/BOR.0b013e3283470f23.
- Background: PubMed 30713715Poddubnyy D, Callhoff J, Spiller I, Listing J, Braun J, Sieper J, Rudwaleit M. Diagnostic accuracy of inflammatory back pain for axial spondyloarthritis in rheumatological care. RMD Open. 2018 Dec 5;4(2):e000825. doi: 10.1136/rmdopen-2018-000825. eCollection 2018.
- Background: PubMed 25939520Reveille JD. Biomarkers for diagnosis, monitoring of progression, and treatment responses in ankylosing spondylitis and axial spondyloarthritis. Clin Rheumatol. 2015 Jun;34(6):1009-18. doi: 10.1007/s10067-015-2949-3. Epub 2015 May 5.
- Background: PubMed 33397652Ritchlin C, Adamopoulos IE. Axial spondyloarthritis: new advances in diagnosis and management. BMJ. 2021 Jan 4;372:m4447. doi: 10.1136/bmj.m4447.
- Background: PubMed 16447233Rudwaleit M, Metter A, Listing J, Sieper J, Braun J. Inflammatory back pain in ankylosing spondylitis: a reassessment of the clinical history for application as classification and diagnostic criteria. Arthritis Rheum. 2006 Feb;54(2):569-78. doi: 10.1002/art.21619.
- Background: PubMed 19297345Rudwaleit M, Landewe R, van der Heijde D, Listing J, Brandt J, Braun J, Burgos-Vargas R, Collantes-Estevez E, Davis J, Dijkmans B, Dougados M, Emery P, van der Horst-Bruinsma IE, Inman R, Khan MA, Leirisalo-Repo M, van der Linden S, Maksymowych WP, Mielants H, Olivieri I, Sturrock R, de Vlam K, Sieper J. The development of Assessment of SpondyloArthritis international Society classification criteria for axial spondyloarthritis (part I): classification of paper patients by expert opinion including uncertainty appraisal. Ann Rheum Dis. 2009 Jun;68(6):770-6. doi: 10.1136/ard.2009.108217. Epub 2009 Mar 17.
- Background: PubMed 19147614Sieper J, van der Heijde D, Landewe R, Brandt J, Burgos-Vagas R, Collantes-Estevez E, Dijkmans B, Dougados M, Khan MA, Leirisalo-Repo M, van der Linden S, Maksymowych WP, Mielants H, Olivieri I, Rudwaleit M. New criteria for inflammatory back pain in patients with chronic back pain: a real patient exercise by experts from the Assessment of SpondyloArthritis international Society (ASAS). Ann Rheum Dis. 2009 Jun;68(6):784-8. doi: 10.1136/ard.2008.101501. Epub 2009 Jan 15.
- Background: PubMed 19060001van der Heijde D, Lie E, Kvien TK, Sieper J, Van den Bosch F, Listing J, Braun J, Landewe R; Assessment of SpondyloArthritis international Society (ASAS). ASDAS, a highly discriminatory ASAS-endorsed disease activity score in patients with ankylosing spondylitis. Ann Rheum Dis. 2009 Dec;68(12):1811-8. doi: 10.1136/ard.2008.100826. Epub 2008 Dec 5.
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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.
Eman El-shahawy study director
Zagazig University
Mohamed Mortada study director
Zagazig University
Safaa Elnaggar study director
Zagazig 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 Axial Spondyloarthritis and Inflammatory Back Pain, run by Zagazig University at 1 site in Egypt.
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 5 inclusion and 3 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 25 Jan 2023. 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 Egypt. 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?
assessment of reliability, sensitivity, and specificity of inflammatory back pain criteria (the Assessment of SpondyloArthritis international Society IBP experts criteria) depending on a gold standard which is the global evaluation of the rheumatologist. (time frame: 8/2021 to 5/2022). The study lists 2 primary outcomes in all. 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 NCT05327140, which also lists 12 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 25 Jan 2023.