Axial Spondyloarthritis, Crohn Disease
Conditions
Brief summary
This study aims to assess the effectiveness (specificity and sensitivity) of using magnetic resonance enterography (MRE) as a screening tool for axial spondyloarthritis (axSpA) in patients with Crohns disease. Patients with evidence of axSpA on MRE imaging will be assessed clinically for axSpA (including a dedicated axial magnetic resonance imaging scan of the spine and sacroiliac joints) and will be compared to a group of age and sex-matched control participants with Crohn's disease but with no evidence of axSpA on MRE imaging.
Detailed description
Spondyloarthritis (SpA) is a term that encompasses psoriatic arthritis with axial disease, ankylosing spondylitis and non-radiological axial spondyloarthritis. The prevalence of SpA in the general population is estimated to be between 0.01%-2.5%. SpA patients have a high burden of inflammatory bowel disease (IBD), which primarily includes Crohn's disease (CD) and Ulcerative colitis (UC), with an estimated prevalence of 10%-12%. However, few studies have investigated the converse; the presence of IBD cases with undiagnosed SpA. Untreated SpA may lead to a significant impact on general health and quality of life; therefore early diagnosis and treatment is crucial. Most CD patients will have had a MRE assessment for their CD, which also captures the axial skeleton and can therefore be used to screen for evidence of axial SpA (axSpA). In this study, MRE images from consenting CD subjects will be reviewed for evidence of axSpA. CD patients with evidence of axSpA will then be reviewed in a rheumatology clinic to assess more specifically for SpA. This will include completion of patient reported outcome measures, clinical examination, routine blood tests, human leucocyte antigen (HLA)-B27 genotyping and a dedicated axial magnetic resonance imaging (MRI) scan. The patients will also be consented to participate in the second part of the study which will be to compare these 'cases' statistically to a 'control' group of age- and sex-matched CD subjects without MRE evidence of axSpA. This study aims to: (i) determine the validity, sensitivity and specificity of MRE as a screening tool for axSpA in CD patients using dedicated axial MRI scans with clinical assessment as the gold standard; (ii) devise an algorithm of clinical indices that can be used as a screening tool for axSpA in CD cases.
Interventions
DIAGNOSTIC_TESTMRE review for evidence of axSpA in SIJs
Screening for evidence of axSpA on the MRE scan of patients with Crohn's disease
DIAGNOSTIC_TESTClinical assessment and dedicated MRI of the spine and pelvis
Clinical assessment and dedicated MRI of the spine and pelvis to assess for evidence of axSpA
Sponsors
Merck Sharp & Dohme LLC
Cambridge University Hospitals NHS Foundation Trust
Study design
Observational model
CASE_CONTROL
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
1. Subjects who are willing and able to give informed consent for participation in the study. 2. Male and female subjects aged 18 years or above. 3. Diagnosed by the gastroenterology team with Crohn's disease. 4. MRE imaging since 2015 for their Crohn's disease.
Exclusion criteria
1\. Subjects unwilling or unable to give informed consent.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The Sensitivity and Specificity of MRE as a Screening Tool for Axial Spondyloarthritis in Crohn's Disease | 12 months | We assessed the SIJs on MRE imaging of patients with Crohn's disease (CD) for abnormalities potentially consistent with axial spondyloarthritis (axSpA), using a novel SIJ scoring system of 0-10 (0 = normal SIJs, 1-10 = abnormal SIJs). These patients were then assessed for evidence of axSpA using the Assessment of Spondyloarthritis International Society (ASAS) classification criteria for axSpA, including a dedicated axial MRI of the spine and pelvis. This primary outcome measure assessed the true positive rate (sensitivity) and true negative rate (specificity) of using MRE imaging of patients with CD to identify axSpA. A receiver operating characteristic (ROC) curve was generated using the novel SIJ scoring system of 0-10 and a 'diagnosis of axSpA' or 'no diagnosis of axSpA'. The ROC curve illustrated the true positive rate and true negative rate of using MRE as a screening tool for axSpA for each unit score (0-10) of the SIJ scoring system. This was performed using Stata 16 (2019). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| The Number (and Percentage) of Participants With Evidence of Axial Spondyloarthritis on MRE Imaging Who Fulfill the Modified New York Criteria for Ankylosing Spondylitis | 12 months | Patients with Crohn's disease are at increased risk of developing axial spondyloarthritis (axSpA). MRE imaging is used to assess the extent of Crohn's disease in the small bowel and also captures the sacroiliac joints (SIJs), which are commonly affected in axSpA. The MRE images of participants with Crohn's disease were reviewed for abnormalities in the SIJs potentially consistent with axSpA. These participants were then clinically assessed for axSpA, ankylosing spondylitis (AS) and psoriatic arthritis (PsA). This included a clinical history and examination, blood tests (including HLA-B27 and inflammatory markers) and a dedicated axial MRI of the spine and pelvis. Radiographs of the SIJs, hands and feet were reviewed if available. The 2009 ASAS (Assessment of Spondyloarthritis International Society) classification criteria for axSpA, modified New York criteria for AS and classification for PsA (CASPAR) criteria were then used to classify patients with axSpA, AS and PsA respectively. |
| The Number (and Percentage) of Participants With Evidence of Axial Spondyloarthritis on MRE Imaging Who Fulfill the CASPAR Criteria for Psoriatic Arthritis | 12 months | Patients with Crohn's disease are at increased risk of developing axial spondyloarthritis (axSpA). MRE imaging is used to assess the extent of Crohn's disease in the small bowel and also captures the sacroiliac joints (SIJs), which are commonly affected in axSpA. The MRE images of participants with Crohn's disease were reviewed for abnormalities in the SIJs potentially consistent with axSpA. These participants were then clinically assessed for axSpA, ankylosing spondylitis (AS) and psoriatic arthritis (PsA). This included a clinical history and examination, blood tests (including HLA-B27 and inflammatory markers) and a dedicated axial MRI of the spine and pelvis. Radiographs of the SIJs, hands and feet were reviewed if available. The 2009 ASAS (Assessment of Spondyloarthritis International Society) classification criteria for axSpA, modified New York criteria for AS and classification for PsA (CASPAR) criteria were then used to classify patients with axSpA, AS and PsA respectively. |
| The Number (and Percentage) of Participants With Evidence of Axial Spondyloarthritis on MRE Imaging Who Fulfill the 2009 ASAS Criteria for Axial Spondyloarthritis. | 12 months | Patients with Crohn's disease are at increased risk of developing axial spondyloarthritis (axSpA). MRE imaging is used to assess the extent of Crohn's disease in the small bowel and also captures the sacroiliac joints (SIJs), which are commonly affected in axSpA. The MRE images of participants with Crohn's disease were reviewed for abnormalities in the SIJs potentially consistent with axSpA. These participants were then clinically assessed for axSpA, ankylosing spondylitis (AS) and psoriatic arthritis (PsA). This included a clinical history and examination, blood tests (including HLA-B27 and inflammatory markers) and a dedicated axial MRI of the spine and pelvis. Radiographs of the SIJs, hands and feet were reviewed if available. The 2009 ASAS (Assessment of Spondyloarthritis International Society) classification criteria for axSpA, modified New York criteria for AS and classification for PsA (CASPAR) criteria were then used to classify patients with axSpA, AS and PsA respectively. |
| The Predictive Value of Specific Extra-articular Features With a Diagnosis of Axial Spondyloarthritis in Crohn's Disease | 12 months | The MRE images of participants with Crohn's disease (CD) were reviewed for abnormalities in the SIJs potentially consistent with axSpA. The participants were then clinically assessed for axSpA, ankylosing spondylitis (AS) and psoriatic arthritis (PsA). The clinical assessment included age, sex, smoking status, alcohol consumption, occupation, site of CD, CD disease duration, history of extra-articular manifestations/ features, patient reported outcome measures, blood tests (including HLA B27 and inflammatory markers) and a dedicated axial MRI of the spine and pelvis. The 2009 ASAS (Assessment of Spondyloarthritis International Society) classification criteria for axSpA, modified New York criteria for AS and classification for PsA criteria were then used to classify patients with axSpA, AS and PsA respectively. Logistic regression analyses were performed to assess the association of extra-articular features and site of CD with a diagnosis of axSpA in CD, using Stata 16 (2019). |
| The Predictive Value of a Particular Site of Crohn's Disease (Colon, Ileum Etc) With a Diagnosis of Axial Spondyloarthritis in Crohn's Disease | 12 months | The MRE images of participants with Crohn's disease (CD) were reviewed for abnormalities in the SIJs potentially consistent with axSpA. The participants were then clinically assessed for axSpA, ankylosing spondylitis (AS) and psoriatic arthritis (PsA). The clinical assessment included age, sex, smoking status, site of CD, CD disease duration, history of extra-articular manifestations/ features, blood tests (including HLA B27 and inflammatory markers) and a dedicated axial MRI of the spine and pelvis. The 2009 ASAS (Assessment of Spondyloarthritis International Society) classification criteria for axSpA, modified New York criteria for AS and classification for PsA criteria were then used to classify patients with axSpA, AS and PsA respectively. Logistic regression analyses were performed to assess the association of extra-articular features and site of CD with a diagnosis of axSpA in CD, using Stata 16 (2019). |
| The Number (and Percentage) of Participants Fulfilling the 2009 ASAS Criteria for axSpA Proceeding to Non-pharmacological and Pharmacological Treatment of Their axSpA, as a Surrogate Measure of Change in Clinical Care as a Result of MRE Screening. | 12 months | This outcome measure focuses on the group of participants who fulfilled the 2009 ASAS classification criteria for axial spondyloarthritis in the ProSpA-CD Assess cases group. A total of 22 participants in the cases group fulfilled the 2009 ASAS classification criteria for axial spondyloarthritis (n=22/90). |
Countries
United Kingdom
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| ProSpA-CD Assess Phase (Cases): Clinical Assessment and Dedicated MRI of the Spine and Pelvis Clinical assessment and dedicated MRI of the spine and pelvis to assess for evidence of axSpA for participants with abnormalities identified in SIJs (cases) on MRE. | 90 |
| ProSpA-CD Assess Phase (Controls): Clinical Assessment and Dedicated MRI of the Spine and Pelvis Clinical assessment and dedicated MRI of the spine and pelvis to assess for evidence of axSpA for participants with normal SIJs (controls) on MRE. Baseline data included for the 71 participants in this group that completed the study. | 71 |
| ProSpA-CD Screen Phase: MRE Review for Evidence of axSpA Only Review of MRE imaging of participants for evidence of axSpA changes. The 7 participants who started the ProSpA-CD Assess phase in the control group but did not complete the study are included in this group. | 98 |
| Total | 259 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 |
|---|---|---|---|---|
| ProSpA-CD Assess Phase | MRI not performed | 0 | 0 | 7 |
Baseline characteristics
| Characteristic | ProSpA-CD Assess Phase (Controls): Clinical Assessment and Dedicated MRI of the Spine and Pelvis | ProSpA-CD Screen Phase: MRE Review for Evidence of axSpA Only | ProSpA-CD Assess Phase (Cases): Clinical Assessment and Dedicated MRI of the Spine and Pelvis | Total |
|---|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 9 Participants | 3 Participants | 15 Participants | 27 Participants |
| Age, Categorical Between 18 and 65 years | 62 Participants | 95 Participants | 75 Participants | 232 Participants |
| Age, Continuous | 43 years | 36 years | 46.5 years | 41 years |
| Race and Ethnicity Not Collected | — | — | — | 0 Participants |
| Region of Enrollment United Kingdom | 71 participants | 98 participants | 90 participants | 259 participants |
| Sex: Female, Male Female | 48 Participants | 64 Participants | 66 Participants | 178 Participants |
| Sex: Female, Male Male | 23 Participants | 34 Participants | 24 Participants | 81 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 259 | 0 / 90 | 0 / 78 |
| other Total, other adverse events | 0 / 259 | 0 / 90 | 0 / 78 |
| serious Total, serious adverse events | 0 / 259 | 0 / 90 | 0 / 78 |
Outcome results
Primary
The Sensitivity and Specificity of MRE as a Screening Tool for Axial Spondyloarthritis in Crohn's Disease
We assessed the SIJs on MRE imaging of patients with Crohn's disease (CD) for abnormalities potentially consistent with axial spondyloarthritis (axSpA), using a novel SIJ scoring system of 0-10 (0 = normal SIJs, 1-10 = abnormal SIJs). These patients were then assessed for evidence of axSpA using the Assessment of Spondyloarthritis International Society (ASAS) classification criteria for axSpA, including a dedicated axial MRI of the spine and pelvis. This primary outcome measure assessed the true positive rate (sensitivity) and true negative rate (specificity) of using MRE imaging of patients with CD to identify axSpA. A receiver operating characteristic (ROC) curve was generated using the novel SIJ scoring system of 0-10 and a 'diagnosis of axSpA' or 'no diagnosis of axSpA'. The ROC curve illustrated the true positive rate and true negative rate of using MRE as a screening tool for axSpA for each unit score (0-10) of the SIJ scoring system. This was performed using Stata 16 (2019).
Time frame: 12 months
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| ProSpA-CD Assess Phase (Cases + Controls): Clinical Assessment + Dedicated MRI of the Spine + Pelvis | The Sensitivity and Specificity of MRE as a Screening Tool for Axial Spondyloarthritis in Crohn's Disease | Sensitivity | 0.88 Probability |
| ProSpA-CD Assess Phase (Cases + Controls): Clinical Assessment + Dedicated MRI of the Spine + Pelvis | The Sensitivity and Specificity of MRE as a Screening Tool for Axial Spondyloarthritis in Crohn's Disease | Specificity | 0.50 Probability |
| ProSpA-CD Assess Phase (Cases + Controls): Clinical Assessment + Dedicated MRI of the Spine + Pelvis | The Sensitivity and Specificity of MRE as a Screening Tool for Axial Spondyloarthritis in Crohn's Disease | Area Under The Curve | 0.78 Probability |
Secondary
The Number (and Percentage) of Participants Fulfilling the 2009 ASAS Criteria for axSpA Proceeding to Non-pharmacological and Pharmacological Treatment of Their axSpA, as a Surrogate Measure of Change in Clinical Care as a Result of MRE Screening.
This outcome measure focuses on the group of participants who fulfilled the 2009 ASAS classification criteria for axial spondyloarthritis in the ProSpA-CD Assess cases group. A total of 22 participants in the cases group fulfilled the 2009 ASAS classification criteria for axial spondyloarthritis (n=22/90).
Time frame: 12 months
Population: This outcome measure focuses on the group of participants who fulfilled the 2009 ASAS classification criteria for axial spondyloarthritis in the ProSpA-CD Assess cases group. A total of 22 participants in the cases group fulfilled the 2009 ASAS classification criteria for axial spondyloarthritis (n=22/90).
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| ProSpA-CD Assess Phase (Cases + Controls): Clinical Assessment + Dedicated MRI of the Spine + Pelvis | The Number (and Percentage) of Participants Fulfilling the 2009 ASAS Criteria for axSpA Proceeding to Non-pharmacological and Pharmacological Treatment of Their axSpA, as a Surrogate Measure of Change in Clinical Care as a Result of MRE Screening. | Declined Treatment | 1 Participants |
| ProSpA-CD Assess Phase (Cases + Controls): Clinical Assessment + Dedicated MRI of the Spine + Pelvis | The Number (and Percentage) of Participants Fulfilling the 2009 ASAS Criteria for axSpA Proceeding to Non-pharmacological and Pharmacological Treatment of Their axSpA, as a Surrogate Measure of Change in Clinical Care as a Result of MRE Screening. | New Biologic Therapy | 4 Participants |
| ProSpA-CD Assess Phase (Cases + Controls): Clinical Assessment + Dedicated MRI of the Spine + Pelvis | The Number (and Percentage) of Participants Fulfilling the 2009 ASAS Criteria for axSpA Proceeding to Non-pharmacological and Pharmacological Treatment of Their axSpA, as a Surrogate Measure of Change in Clinical Care as a Result of MRE Screening. | Non-Pharmacological Therapy | 5 Participants |
| ProSpA-CD Assess Phase (Cases + Controls): Clinical Assessment + Dedicated MRI of the Spine + Pelvis | The Number (and Percentage) of Participants Fulfilling the 2009 ASAS Criteria for axSpA Proceeding to Non-pharmacological and Pharmacological Treatment of Their axSpA, as a Surrogate Measure of Change in Clinical Care as a Result of MRE Screening. | Continue Established Biological Therapy | 12 Participants |
Secondary
The Number (and Percentage) of Participants With Evidence of Axial Spondyloarthritis on MRE Imaging Who Fulfill the 2009 ASAS Criteria for Axial Spondyloarthritis.
Patients with Crohn's disease are at increased risk of developing axial spondyloarthritis (axSpA). MRE imaging is used to assess the extent of Crohn's disease in the small bowel and also captures the sacroiliac joints (SIJs), which are commonly affected in axSpA. The MRE images of participants with Crohn's disease were reviewed for abnormalities in the SIJs potentially consistent with axSpA. These participants were then clinically assessed for axSpA, ankylosing spondylitis (AS) and psoriatic arthritis (PsA). This included a clinical history and examination, blood tests (including HLA-B27 and inflammatory markers) and a dedicated axial MRI of the spine and pelvis. Radiographs of the SIJs, hands and feet were reviewed if available. The 2009 ASAS (Assessment of Spondyloarthritis International Society) classification criteria for axSpA, modified New York criteria for AS and classification for PsA (CASPAR) criteria were then used to classify patients with axSpA, AS and PsA respectively.
Time frame: 12 months
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| ProSpA-CD Assess Phase (Cases + Controls): Clinical Assessment + Dedicated MRI of the Spine + Pelvis | The Number (and Percentage) of Participants With Evidence of Axial Spondyloarthritis on MRE Imaging Who Fulfill the 2009 ASAS Criteria for Axial Spondyloarthritis. | 22 Participants |
Secondary
The Number (and Percentage) of Participants With Evidence of Axial Spondyloarthritis on MRE Imaging Who Fulfill the CASPAR Criteria for Psoriatic Arthritis
Patients with Crohn's disease are at increased risk of developing axial spondyloarthritis (axSpA). MRE imaging is used to assess the extent of Crohn's disease in the small bowel and also captures the sacroiliac joints (SIJs), which are commonly affected in axSpA. The MRE images of participants with Crohn's disease were reviewed for abnormalities in the SIJs potentially consistent with axSpA. These participants were then clinically assessed for axSpA, ankylosing spondylitis (AS) and psoriatic arthritis (PsA). This included a clinical history and examination, blood tests (including HLA-B27 and inflammatory markers) and a dedicated axial MRI of the spine and pelvis. Radiographs of the SIJs, hands and feet were reviewed if available. The 2009 ASAS (Assessment of Spondyloarthritis International Society) classification criteria for axSpA, modified New York criteria for AS and classification for PsA (CASPAR) criteria were then used to classify patients with axSpA, AS and PsA respectively.
Time frame: 12 months
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| ProSpA-CD Assess Phase (Cases + Controls): Clinical Assessment + Dedicated MRI of the Spine + Pelvis | The Number (and Percentage) of Participants With Evidence of Axial Spondyloarthritis on MRE Imaging Who Fulfill the CASPAR Criteria for Psoriatic Arthritis | 8 Participants |
Secondary
The Number (and Percentage) of Participants With Evidence of Axial Spondyloarthritis on MRE Imaging Who Fulfill the Modified New York Criteria for Ankylosing Spondylitis
Patients with Crohn's disease are at increased risk of developing axial spondyloarthritis (axSpA). MRE imaging is used to assess the extent of Crohn's disease in the small bowel and also captures the sacroiliac joints (SIJs), which are commonly affected in axSpA. The MRE images of participants with Crohn's disease were reviewed for abnormalities in the SIJs potentially consistent with axSpA. These participants were then clinically assessed for axSpA, ankylosing spondylitis (AS) and psoriatic arthritis (PsA). This included a clinical history and examination, blood tests (including HLA-B27 and inflammatory markers) and a dedicated axial MRI of the spine and pelvis. Radiographs of the SIJs, hands and feet were reviewed if available. The 2009 ASAS (Assessment of Spondyloarthritis International Society) classification criteria for axSpA, modified New York criteria for AS and classification for PsA (CASPAR) criteria were then used to classify patients with axSpA, AS and PsA respectively.
Time frame: 12 months
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| ProSpA-CD Assess Phase (Cases + Controls): Clinical Assessment + Dedicated MRI of the Spine + Pelvis | The Number (and Percentage) of Participants With Evidence of Axial Spondyloarthritis on MRE Imaging Who Fulfill the Modified New York Criteria for Ankylosing Spondylitis | 8 Participants |
Secondary
The Predictive Value of a Particular Site of Crohn's Disease (Colon, Ileum Etc) With a Diagnosis of Axial Spondyloarthritis in Crohn's Disease
The MRE images of participants with Crohn's disease (CD) were reviewed for abnormalities in the SIJs potentially consistent with axSpA. The participants were then clinically assessed for axSpA, ankylosing spondylitis (AS) and psoriatic arthritis (PsA). The clinical assessment included age, sex, smoking status, site of CD, CD disease duration, history of extra-articular manifestations/ features, blood tests (including HLA B27 and inflammatory markers) and a dedicated axial MRI of the spine and pelvis. The 2009 ASAS (Assessment of Spondyloarthritis International Society) classification criteria for axSpA, modified New York criteria for AS and classification for PsA criteria were then used to classify patients with axSpA, AS and PsA respectively. Logistic regression analyses were performed to assess the association of extra-articular features and site of CD with a diagnosis of axSpA in CD, using Stata 16 (2019).
Time frame: 12 months
Population: Logistic regression analysis for the association of the site of Crohn's disease (colon, ileum etc) with axSpA. Statistical significance level was set at 0.05.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| ProSpA-CD Assess Phase (Cases + Controls): Clinical Assessment + Dedicated MRI of the Spine + Pelvis | The Predictive Value of a Particular Site of Crohn's Disease (Colon, Ileum Etc) With a Diagnosis of Axial Spondyloarthritis in Crohn's Disease | Ileal CD and axSpA | 1.01 Odds Ratio |
| ProSpA-CD Assess Phase (Cases + Controls): Clinical Assessment + Dedicated MRI of the Spine + Pelvis | The Predictive Value of a Particular Site of Crohn's Disease (Colon, Ileum Etc) With a Diagnosis of Axial Spondyloarthritis in Crohn's Disease | Colonic CD and axSpA | 1.38 Odds Ratio |
| ProSpA-CD Assess Phase (Cases + Controls): Clinical Assessment + Dedicated MRI of the Spine + Pelvis | The Predictive Value of a Particular Site of Crohn's Disease (Colon, Ileum Etc) With a Diagnosis of Axial Spondyloarthritis in Crohn's Disease | Ileocolonic CD and axSpA | 0.86 Odds Ratio |
Secondary
The Predictive Value of Specific Extra-articular Features With a Diagnosis of Axial Spondyloarthritis in Crohn's Disease
The MRE images of participants with Crohn's disease (CD) were reviewed for abnormalities in the SIJs potentially consistent with axSpA. The participants were then clinically assessed for axSpA, ankylosing spondylitis (AS) and psoriatic arthritis (PsA). The clinical assessment included age, sex, smoking status, alcohol consumption, occupation, site of CD, CD disease duration, history of extra-articular manifestations/ features, patient reported outcome measures, blood tests (including HLA B27 and inflammatory markers) and a dedicated axial MRI of the spine and pelvis. The 2009 ASAS (Assessment of Spondyloarthritis International Society) classification criteria for axSpA, modified New York criteria for AS and classification for PsA criteria were then used to classify patients with axSpA, AS and PsA respectively. Logistic regression analyses were performed to assess the association of extra-articular features and site of CD with a diagnosis of axSpA in CD, using Stata 16 (2019).
Time frame: 12 months
Population: Logistic regression analysis for the association of extra-articular features (psoriasis, uveitis, erythema nodosum and orofacial granulomatosis) with axSpA in CD. Statistical significance level was set at 0.05.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| ProSpA-CD Assess Phase (Cases + Controls): Clinical Assessment + Dedicated MRI of the Spine + Pelvis | The Predictive Value of Specific Extra-articular Features With a Diagnosis of Axial Spondyloarthritis in Crohn's Disease | Psoriasis and axSpA | 4.71 Odds Ratio |
| ProSpA-CD Assess Phase (Cases + Controls): Clinical Assessment + Dedicated MRI of the Spine + Pelvis | The Predictive Value of Specific Extra-articular Features With a Diagnosis of Axial Spondyloarthritis in Crohn's Disease | Uveitis and axSpA | 3.71 Odds Ratio |
| ProSpA-CD Assess Phase (Cases + Controls): Clinical Assessment + Dedicated MRI of the Spine + Pelvis | The Predictive Value of Specific Extra-articular Features With a Diagnosis of Axial Spondyloarthritis in Crohn's Disease | Erythema nodosum and axSpA | 1.29 Odds Ratio |
| ProSpA-CD Assess Phase (Cases + Controls): Clinical Assessment + Dedicated MRI of the Spine + Pelvis | The Predictive Value of Specific Extra-articular Features With a Diagnosis of Axial Spondyloarthritis in Crohn's Disease | Orofacial granulomatosis and axSpA | 1.57 Odds Ratio |