Trial Outcomes & Findings for MRE as a Screening Tool for axSpA in IBD (NCT NCT03817983)

Results Overview

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).

Recruitment status

COMPLETED

Target enrollment

259 participants

Primary outcome timeframe

12 months

Results posted on

2025-01-14

Participant Flow

Participant milestones

Participant milestones
Measure	ProSpA-CD Screen Phase: MRE Review for Evidence of axSpA Review of magnetic resonance enterography (MRE) imaging for evidence of axSpA in Crohn's disease patients	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.	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 (cases) on MRE.
ProSpA-CD Screen Phase STARTED	259	0	0
ProSpA-CD Screen Phase COMPLETED	259	0	0
ProSpA-CD Screen Phase NOT COMPLETED	0	0	0
ProSpA-CD Assess Phase STARTED	0	90	78
ProSpA-CD Assess Phase COMPLETED	0	90	71
ProSpA-CD Assess Phase NOT COMPLETED	0	0	7

Reasons for withdrawal

Reasons for withdrawal
Measure	ProSpA-CD Screen Phase: MRE Review for Evidence of axSpA Review of magnetic resonance enterography (MRE) imaging for evidence of axSpA in Crohn's disease patients	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.	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 (cases) on MRE.
ProSpA-CD Assess Phase MRI not performed	0	0	7

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	ProSpA-CD Assess Phase (Cases): Clinical Assessment and Dedicated MRI of the Spine and Pelvis n=90 Participants 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.	ProSpA-CD Assess Phase (Controls): Clinical Assessment and Dedicated MRI of the Spine and Pelvis n=71 Participants 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.	ProSpA-CD Screen Phase: MRE Review for Evidence of axSpA Only n=98 Participants 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.	Total n=259 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=90 Participants	0 Participants n=71 Participants	0 Participants n=98 Participants	0 Participants n=259 Participants
Age, Categorical Between 18 and 65 years	75 Participants n=90 Participants	62 Participants n=71 Participants	95 Participants n=98 Participants	232 Participants n=259 Participants
Age, Categorical >=65 years	15 Participants n=90 Participants	9 Participants n=71 Participants	3 Participants n=98 Participants	27 Participants n=259 Participants
Age, Continuous	46.5 years n=90 Participants	43 years n=71 Participants	36 years n=98 Participants	41 years n=259 Participants
Sex: Female, Male Female	66 Participants n=90 Participants	48 Participants n=71 Participants	64 Participants n=98 Participants	178 Participants n=259 Participants
Sex: Female, Male Male	24 Participants n=90 Participants	23 Participants n=71 Participants	34 Participants n=98 Participants	81 Participants n=259 Participants
Race and Ethnicity Not Collected	—	—	—	0 Participants Race and Ethnicity were not collected from any participant.
Region of Enrollment United Kingdom	90 participants n=90 Participants	71 participants n=71 Participants	98 participants n=98 Participants	259 participants n=259 Participants

PRIMARY outcome

Timeframe: 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).

Outcome measures

Outcome measures
Measure	ProSpA-CD Assess Phase (Cases + Controls): Clinical Assessment + Dedicated MRI of the Spine + Pelvis n=161 Participants Clinical assessment and dedicated MRI of the spine and pelvis to assess for evidence of axSpA for participants with abnormalities identified in SIJs (cases) and normal SIJs (controls) on MRE. The sensitivity, specificity and receiver operating characteristic curve of MRE as a screening tool for axSpA in Crohn's disease. Cases and control participants were combined for this statistical analysis.
The Sensitivity and Specificity of MRE as a Screening Tool for Axial Spondyloarthritis in Crohn's Disease Sensitivity	0.88 Probability Interval 0.69 to 0.98
The Sensitivity and Specificity of MRE as a Screening Tool for Axial Spondyloarthritis in Crohn's Disease Specificity	0.50 Probability Interval 0.41 to 0.59
The Sensitivity and Specificity of MRE as a Screening Tool for Axial Spondyloarthritis in Crohn's Disease Area Under The Curve	0.78 Probability Interval 0.65 to 0.86

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	ProSpA-CD Assess Phase (Cases + Controls): Clinical Assessment + Dedicated MRI of the Spine + Pelvis n=90 Participants Clinical assessment and dedicated MRI of the spine and pelvis to assess for evidence of axSpA for participants with abnormalities identified in SIJs (cases) and normal SIJs (controls) on MRE. The sensitivity, specificity and receiver operating characteristic curve of MRE as a screening tool for axSpA in Crohn's disease. Cases and control participants were combined for this statistical analysis.
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 outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	ProSpA-CD Assess Phase (Cases + Controls): Clinical Assessment + Dedicated MRI of the Spine + Pelvis n=90 Participants Clinical assessment and dedicated MRI of the spine and pelvis to assess for evidence of axSpA for participants with abnormalities identified in SIJs (cases) and normal SIJs (controls) on MRE. The sensitivity, specificity and receiver operating characteristic curve of MRE as a screening tool for axSpA in Crohn's disease. Cases and control participants were combined for this statistical analysis.
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 outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	ProSpA-CD Assess Phase (Cases + Controls): Clinical Assessment + Dedicated MRI of the Spine + Pelvis n=90 Participants Clinical assessment and dedicated MRI of the spine and pelvis to assess for evidence of axSpA for participants with abnormalities identified in SIJs (cases) and normal SIJs (controls) on MRE. The sensitivity, specificity and receiver operating characteristic curve of MRE as a screening tool for axSpA in Crohn's disease. Cases and control participants were combined for this statistical analysis.
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 outcome

Timeframe: 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).

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).

Outcome measures

Outcome measures
Measure	ProSpA-CD Assess Phase (Cases + Controls): Clinical Assessment + Dedicated MRI of the Spine + Pelvis n=22 Participants Clinical assessment and dedicated MRI of the spine and pelvis to assess for evidence of axSpA for participants with abnormalities identified in SIJs (cases) and normal SIJs (controls) on MRE. The sensitivity, specificity and receiver operating characteristic curve of MRE as a screening tool for axSpA in Crohn's disease. Cases and control participants were combined for this statistical analysis.
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
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
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
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

SECONDARY outcome

Timeframe: 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.

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).

Outcome measures

Outcome measures
Measure	ProSpA-CD Assess Phase (Cases + Controls): Clinical Assessment + Dedicated MRI of the Spine + Pelvis n=90 Participants Clinical assessment and dedicated MRI of the spine and pelvis to assess for evidence of axSpA for participants with abnormalities identified in SIJs (cases) and normal SIJs (controls) on MRE. The sensitivity, specificity and receiver operating characteristic curve of MRE as a screening tool for axSpA in Crohn's disease. Cases and control participants were combined for this statistical analysis.
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 Interval 0.96 to 14.3
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 Interval 1.14 to 19.46
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 Interval 0.36 to 4.61
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 Interval 0.14 to 18.21

SECONDARY outcome

Timeframe: 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.

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).

Outcome measures

Outcome measures
Measure	ProSpA-CD Assess Phase (Cases + Controls): Clinical Assessment + Dedicated MRI of the Spine + Pelvis n=90 Participants Clinical assessment and dedicated MRI of the spine and pelvis to assess for evidence of axSpA for participants with abnormalities identified in SIJs (cases) and normal SIJs (controls) on MRE. The sensitivity, specificity and receiver operating characteristic curve of MRE as a screening tool for axSpA in Crohn's disease. Cases and control participants were combined for this statistical analysis.
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 Interval 0.38 to 2.64
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 Interval 0.32 to 5.85
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 Interval 0.31 to 2.39

Adverse Events

ProSpA-CD Screen Phase: MRE Review for Evidence of axSpA

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

ProSpA-CD Assess Phase (Cases): Clinical Assessment and Dedicated MRI of the Spine and Pelvis

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

ProSpA-CD Assess Phase (Controls): Clinical Assessment and Dedicated MRI of the Spine and Pelvis

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr Deepak Jadon

Addenbrookes Hospital, Cambridge, UK

Phone: 01223 805000

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place