Trial Outcomes & Findings for Imaging Biomarkers in Crohn's Associated Spondyloarthritis (NCT NCT02709694)

NCT ID: NCT02709694

Last Updated: 2021-10-25

Results Overview

MRIs were independently read and scored by 2 expert rheumatologists and 1 newly trained rheumatologist reader, blinded to any clinical information. MRIs were evaluated and scored for presence of bone marrow edema (BME) and structural lesions (erosion, fat metaplasia, backfill and ankylosis) using a validated scoring method originally derived from the Spondyloarthritis Research Consortium of Canada SIJ module. MRI was considered "positive" for presence of sacroiliitis if it met global evaluation, based on the reader's overall evaluation of presence or absence of sacroiliitis by taking into account the contextual signature of both active and structural SIJ lesions. For analysis, MRI positivity for sacroiliitis was defined based on majority-of-readers agreement (≥2 out of 3).

• Recruitment status: COMPLETED
• Target enrollment: 33 participants
• Primary outcome timeframe: one study visit
• Results posted on: 2021-10-25

Participant Flow

Patients were identified by physicians in the study at outpatient IBD clinics at Cornell during scheduled visits and through review of medical records. Gastroenterologists at the IBD clinic and HSS rheumatologists were contacted and asked about potential patients. Flyers were placed in patient rooms so patients could express interest in study. We approached potential subjects via postal and/or email addresses and sent survey questionnaire to determine eligibility. Recruitment done 4/2016-5/2017.

Participant milestones

Measure	Adult Subjects With Crohn's Disease These were consecutive subjects prospectively identified and enrolled from an outpatient clinic of Jill Roberts Center for Inflammatory Bowel Disease (IBD) at a tertiary care academic medical center. Subjects between 18 and 65 were enrolled from April 2016 through May 2017. All subjects met clinical, pathological or radiological criteria for CD. Patients with ulcerative colitis, indeterminate colitis, other inflammatory arthritis (eg, rheumatoid arthritis, systemic lupus erythematosus, psoriatic or reactive arthritis), co-existent autoimmune diseases (eg, celiac disease, Behçet's disease) or skin psoriasis were excluded. All subjects were either biologic naïve or had been off systemic biologics \>6 months prior to enrollment and could remain on non-biologic CD therapy (eg, methotrexate, sulfasalazine, azathioprine or 6-mercaptopurine). Patients could also be on vedolizumab, an antagonist of α4β7 integrin in the intestinal epithelium which has no established efficacy in extra-intestinal manifestations of CD. Other exclusions included malignancy less than 5 years in remission (except for non-melanomatous skin cancer) or having a contraindication to MRI.
Overall Study STARTED	33
Overall Study Any Back Pain	19
Overall Study No Back Pain	14
Overall Study MRI Showing Presence of Sacroiliitis	4
Overall Study MRI Not Showing Sacroiliitis	29
Overall Study Classified as Having Inflammatory Back Pain by the ASAS Criteria	6
Overall Study Not Classified as Having Inflammatory Back Pain by the ASAS Criteria	25
Overall Study Having Bone Marrow Edema Seen in MRI	33
Overall Study Having Erosion (a Structural Lesion) Seen in MRI	33
Overall Study Having Fat Metaplasia Seen in MRI	33
Overall Study Having Backfill (Type of Structural Lesion) Seen in MRI	33
Overall Study Having Ankylosis Seen in MRI	33
Overall Study COMPLETED	33
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Imaging Biomarkers in Crohn's Associated Spondyloarthritis

Baseline characteristics by cohort

Measure	Adult Subjects With Crohn's Disease n=33 Participants These were consecutive subjects prospectively identified and enrolled from an outpatient clinic of Jill Roberts Center for Inflammatory Bowel Disease (IBD) at a tertiary care academic medical center. Subjects between 18 and 65 were enrolled from April 2016 through May 2017. All subjects met clinical, pathological or radiological criteria for CD. Patients with ulcerative colitis, indeterminate colitis, other inflammatory arthritis (eg, rheumatoid arthritis, systemic lupus erythematosus, psoriatic or reactive arthritis), co-existent autoimmune diseases (eg, celiac disease, Behçet's disease) or skin psoriasis were excluded. All subjects were either biologic naïve or had been off systemic biologics \>6 months prior to enrollment and could remain on non-biologic CD therapy (eg, methotrexate, sulfasalazine, azathioprine or 6-mercaptopurine). Patients could also be on vedolizumab, an antagonist of α4β7 integrin in the intestinal epithelium which has no established efficacy in extra-intestinal manifestations of CD. Other exclusions included malignancy less than 5 years in remission (except for non-melanomatous skin cancer) or having a contraindication to MRI.
Age, Categorical <=18 years	0 Participants n=93 Participants
Age, Categorical Between 18 and 65 years	33 Participants n=93 Participants
Age, Categorical >=65 years	0 Participants n=93 Participants
Age, Continuous	36.4 years n=93 Participants
Sex: Female, Male Female	25 Participants n=93 Participants
Sex: Female, Male Male	8 Participants n=93 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=93 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	33 Participants n=93 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=93 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=93 Participants
Race (NIH/OMB) Asian	1 Participants n=93 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=93 Participants
Race (NIH/OMB) Black or African American	4 Participants n=93 Participants
Race (NIH/OMB) White	25 Participants n=93 Participants
Race (NIH/OMB) More than one race	0 Participants n=93 Participants
Race (NIH/OMB) Unknown or Not Reported	3 Participants n=93 Participants
Region of Enrollment United States	33 participants n=93 Participants

PRIMARY outcome

Timeframe: one study visit

MRIs were independently read and scored by 2 expert rheumatologists and 1 newly trained rheumatologist reader, blinded to any clinical information. MRIs were evaluated and scored for presence of bone marrow edema (BME) and structural lesions (erosion, fat metaplasia, backfill and ankylosis) using a validated scoring method originally derived from the Spondyloarthritis Research Consortium of Canada SIJ module. MRI was considered "positive" for presence of sacroiliitis if it met global evaluation, based on the reader's overall evaluation of presence or absence of sacroiliitis by taking into account the contextual signature of both active and structural SIJ lesions. For analysis, MRI positivity for sacroiliitis was defined based on majority-of-readers agreement (≥2 out of 3).

Outcome measures

Measure	Any Back Pain n=19 Participants Subjects with Crohn's Disease with back pain.	No Back Pain n=14 Participants Subjects with Crohn's disease without back pain.	Fat Metaplasia Type of structural lesion seen in MRI.	Backfill Type of structural lesion seen in MRI.	Ankylosis Type of structural lesion seen in MRI.
Number of Participants With MRI Positivity- Global Assessment Positive	4 Participants	0 Participants	—	—	—

PRIMARY outcome

Timeframe: one study visit

Assessment of SpondyloArthritis international Society. Subjects are positive if they fulfill 4 out of following 5 back pain parameters: onset of symptoms <40 years of age, insidious onset of pain, nocturnal pain, improvement with exercise and no improvement with rest.

Outcome measures

Measure	Any Back Pain n=19 Participants Subjects with Crohn's Disease with back pain.	No Back Pain n=14 Participants Subjects with Crohn's disease without back pain.	Fat Metaplasia Type of structural lesion seen in MRI.	Backfill Type of structural lesion seen in MRI.	Ankylosis Type of structural lesion seen in MRI.
Number of Participants With MRI Positivity- ASAS Positive	4 Participants	2 Participants	—	—	—

PRIMARY outcome

Timeframe: one study visit

SpondyloArthritis Caught Early. Positivity based on presence of erosions and fat metaplasia.

Outcome measures

Measure	Any Back Pain n=19 Participants Subjects with Crohn's Disease with back pain.	No Back Pain n=14 Participants Subjects with Crohn's disease without back pain.	Fat Metaplasia Type of structural lesion seen in MRI.	Backfill Type of structural lesion seen in MRI.	Ankylosis Type of structural lesion seen in MRI.
Number of Participants With MRI Positivity- SPACE Positive	0 Participants	0 Participants	—	—	—

PRIMARY outcome

Timeframe: one study visit

Positivity based on presence of bone marrow edema (BME) and/or erosion.

Outcome measures

Measure	Any Back Pain n=19 Participants Subjects with Crohn's Disease with back pain.	No Back Pain n=14 Participants Subjects with Crohn's disease without back pain.	Fat Metaplasia Type of structural lesion seen in MRI.	Backfill Type of structural lesion seen in MRI.	Ankylosis Type of structural lesion seen in MRI.
Number of Participants With MRI Positivity- Morpho Positive	5 Participants	1 Participants	—	—	—

SECONDARY outcome

Timeframe: one study visit

Population: There is not another Arm with "No Back Pain" because this analysis was not done on any patients who identified as having no back pain, since back pain is the primary symptom of axial spondyloarthritis.

Assessment of SpondyloArthritis international Society criteria was utilized to define inflammatory back pain.

Outcome measures

Measure	Any Back Pain n=19 Participants Subjects with Crohn's Disease with back pain.	No Back Pain Subjects with Crohn's disease without back pain.	Fat Metaplasia Type of structural lesion seen in MRI.	Backfill Type of structural lesion seen in MRI.	Ankylosis Type of structural lesion seen in MRI.
Number of Participants With Axial Spondyloarthritis Based on European Spondyloarthropathy Study Group (ESSG) Guidelines	13 Participants	—	—	—	—

SECONDARY outcome

Timeframe: one study visit

Outcome measures

Measure	Any Back Pain n=19 Participants Subjects with Crohn's Disease with back pain.	No Back Pain n=14 Participants Subjects with Crohn's disease without back pain.	Fat Metaplasia Type of structural lesion seen in MRI.	Backfill Type of structural lesion seen in MRI.	Ankylosis Type of structural lesion seen in MRI.
Number of Participants With Current Peripheral Arthritis	14 Participants	4 Participants	—	—	—

SECONDARY outcome

Timeframe: one study visit

Outcome measures

Measure	Any Back Pain n=19 Participants Subjects with Crohn's Disease with back pain.	No Back Pain n=14 Participants Subjects with Crohn's disease without back pain.	Fat Metaplasia Type of structural lesion seen in MRI.	Backfill Type of structural lesion seen in MRI.	Ankylosis Type of structural lesion seen in MRI.
Number of Participants With a History of Peripheral Arthritis	16 Participants	6 Participants	—	—	—

SECONDARY outcome

Timeframe: one study visit

Minimum 0. Maximum 10. A score of 0 = none (no symptoms), and a score of 10 = very severe symptoms.

Outcome measures

Measure	Any Back Pain n=19 Participants Subjects with Crohn's Disease with back pain.	No Back Pain n=14 Participants Subjects with Crohn's disease without back pain.	Fat Metaplasia Type of structural lesion seen in MRI.	Backfill Type of structural lesion seen in MRI.	Ankylosis Type of structural lesion seen in MRI.
Bath Ankylosing Spondylitis Disease Activity Index (BASDAI)	5.3 score on a scale Standard Deviation 1.8	2.4 score on a scale Standard Deviation 1.6	—	—	—

SECONDARY outcome

Timeframe: one study visit

The scale of the BASMI ranges from 0 to 10, where 0 is no mobility limitation and 10 is a very severe limitation.

Outcome measures

Measure	Any Back Pain n=19 Participants Subjects with Crohn's Disease with back pain.	No Back Pain n=14 Participants Subjects with Crohn's disease without back pain.	Fat Metaplasia Type of structural lesion seen in MRI.	Backfill Type of structural lesion seen in MRI.	Ankylosis Type of structural lesion seen in MRI.
Bath Ankylosing Spondylitis Metrology Index (BASMI)	2.9 score on a scale Standard Deviation 0.9	2.1 score on a scale Standard Deviation 0.9	—	—	—

SECONDARY outcome

Timeframe: one study visit

Ankylosing Spondylitis Disease Activity Index C-reactive protein. Higher score indicates worse symptoms. ASDAS-CRP = 0.12 x Back Pain + 0.06 x Duration of Morning Stiffness + 0.11 x Patient Global + 0.07 x Peripheral Pain/Swelling + 0.58 x Ln(CRP+1)

Outcome measures

Measure	Any Back Pain n=19 Participants Subjects with Crohn's Disease with back pain.	No Back Pain n=14 Participants Subjects with Crohn's disease without back pain.	Fat Metaplasia Type of structural lesion seen in MRI.	Backfill Type of structural lesion seen in MRI.	Ankylosis Type of structural lesion seen in MRI.
Ankylosing Spondylitis Disease Activity Index C-reactive Protein (ASDAS-CRP)	3.1 score on a scale Standard Deviation 0.9	2.1 score on a scale Standard Deviation 0.9	—	—	—

SECONDARY outcome

Timeframe: one study visit

Peripheral blood was collected for measurement of CRP.

Outcome measures

Measure	Any Back Pain n=19 Participants Subjects with Crohn's Disease with back pain.	No Back Pain n=14 Participants Subjects with Crohn's disease without back pain.	Fat Metaplasia Type of structural lesion seen in MRI.	Backfill Type of structural lesion seen in MRI.	Ankylosis Type of structural lesion seen in MRI.
CRP (C-reactive Protein)	1.6 mg/L Standard Deviation 2.0	1.7 mg/L Standard Deviation 3.3	—	—	—

SECONDARY outcome

Timeframe: one study visit

Outcome measures

Measure	Any Back Pain n=19 Participants Subjects with Crohn's Disease with back pain.	No Back Pain n=14 Participants Subjects with Crohn's disease without back pain.	Fat Metaplasia Type of structural lesion seen in MRI.	Backfill Type of structural lesion seen in MRI.	Ankylosis Type of structural lesion seen in MRI.
Duration of Crohn's Disease for Participants	11.9 years Standard Deviation 6.7	14.2 years Standard Deviation 10.5	—	—	—

SECONDARY outcome

Timeframe: one study visit

Outcome measures

Measure	Any Back Pain n=19 Participants Subjects with Crohn's Disease with back pain.	No Back Pain n=13 Participants Subjects with Crohn's disease without back pain.	Fat Metaplasia Type of structural lesion seen in MRI.	Backfill Type of structural lesion seen in MRI.	Ankylosis Type of structural lesion seen in MRI.
Number of Participants Using Vedolizumab for Crohn's Disease	3 Participants	4 Participants	—	—	—

SECONDARY outcome

Timeframe: one study visit

Outcome measures

Measure	Any Back Pain n=19 Participants Subjects with Crohn's Disease with back pain.	No Back Pain n=13 Participants Subjects with Crohn's disease without back pain.	Fat Metaplasia Type of structural lesion seen in MRI.	Backfill Type of structural lesion seen in MRI.	Ankylosis Type of structural lesion seen in MRI.
Number of Participants With a Past History of Biologic Use for Crohn's Disease	3 Participants	4 Participants	—	—	—

SECONDARY outcome

Timeframe: one study visit

Population: The number of participants here only adds up to 31, instead of 33, because data was not collected or lost for two participants.

Outcome measures

Measure	Any Back Pain n=18 Participants Subjects with Crohn's Disease with back pain.	No Back Pain n=13 Participants Subjects with Crohn's disease without back pain.	Fat Metaplasia Type of structural lesion seen in MRI.	Backfill Type of structural lesion seen in MRI.	Ankylosis Type of structural lesion seen in MRI.
Number of Participants Who Have Had Surgery Related to Crohn's Disease	10 Participants	9 Participants	—	—	—

SECONDARY outcome

Timeframe: one study visit

HBI consists of five parameters, which are all clinical. These parameters are: patient well-being (previous day). abdominal pain (previous day), number of liquid or soft stools (previous day), abdominal mass, and complications.

Patient well-being is scored with: 0 = very well, 1 = slightly below par, 2 = poor, 3 = very poor, 4 = terrible.

Abdominal pain is scored as: 0 = none, 1 = mild, 2 = moderate, 3 = severe. Abdominal mass is scored as: 0 = none, 1 = dubious, 2 = definite, 3 = definite and tender.

Complications can be answered with "No" (0 points) or by choosing from a list, with each selection being 1 point. The list is: arthralgia, uveitis, erythema nodosum, aphthous ulcer, pyoderma gangrenosum, anal fissures, appearance of a new fistula, abscess.

Calculation formula: sum of the scores of all 5 parameters. < 5 remission 5 - 7 mild activity 8 - 16 moderate activity > 16 severe activity

Outcome measures

Measure	Any Back Pain n=19 Participants Subjects with Crohn's Disease with back pain.	No Back Pain n=14 Participants Subjects with Crohn's disease without back pain.	Fat Metaplasia Type of structural lesion seen in MRI.	Backfill Type of structural lesion seen in MRI.	Ankylosis Type of structural lesion seen in MRI.
Crohn's Disease Activity (Harvey Bradshaw Index (HBI) Score)	9.1 score on a scale Standard Deviation 4.9	6.9 score on a scale Standard Deviation 3.7	—	—	—

SECONDARY outcome

Timeframe: one study visit

Outcome measures

Measure	Any Back Pain n=4 Participants Subjects with Crohn's Disease with back pain.	No Back Pain n=29 Participants Subjects with Crohn's disease without back pain.	Fat Metaplasia Type of structural lesion seen in MRI.	Backfill Type of structural lesion seen in MRI.	Ankylosis Type of structural lesion seen in MRI.
Number of Participants With Inflammatory Back Pain	4 Participants	15 Participants	—	—	—

SECONDARY outcome

Timeframe: one study visit

Outcome measures

Measure	Any Back Pain n=4 Participants Subjects with Crohn's Disease with back pain.	No Back Pain n=29 Participants Subjects with Crohn's disease without back pain.	Fat Metaplasia Type of structural lesion seen in MRI.	Backfill Type of structural lesion seen in MRI.	Ankylosis Type of structural lesion seen in MRI.
Number of Participants With Current Peripheral Arthritis	3 Participants	15 Participants	—	—	—

SECONDARY outcome

Timeframe: one study visit

Outcome measures

Measure	Any Back Pain n=4 Participants Subjects with Crohn's Disease with back pain.	No Back Pain n=29 Participants Subjects with Crohn's disease without back pain.	Fat Metaplasia Type of structural lesion seen in MRI.	Backfill Type of structural lesion seen in MRI.	Ankylosis Type of structural lesion seen in MRI.
Number of Participants With a History of Peripheral Arthritis	4 Participants	18 Participants	—	—	—

SECONDARY outcome

Timeframe: one study visit

Outcome measures

Measure	Any Back Pain n=4 Participants Subjects with Crohn's Disease with back pain.	No Back Pain n=29 Participants Subjects with Crohn's disease without back pain.	Fat Metaplasia Type of structural lesion seen in MRI.	Backfill Type of structural lesion seen in MRI.	Ankylosis Type of structural lesion seen in MRI.
Number of Participants With Current Enthesitis	1 Participants	8 Participants	—	—	—

SECONDARY outcome

Timeframe: one study visit

Outcome measures

Measure	Any Back Pain n=4 Participants Subjects with Crohn's Disease with back pain.	No Back Pain n=29 Participants Subjects with Crohn's disease without back pain.	Fat Metaplasia Type of structural lesion seen in MRI.	Backfill Type of structural lesion seen in MRI.	Ankylosis Type of structural lesion seen in MRI.
Number of Participants With a History of Uveitis	1 Participants	3 Participants	—	—	—

SECONDARY outcome

Timeframe: one study visit

Outcome measures

Measure	Any Back Pain n=4 Participants Subjects with Crohn's Disease with back pain.	No Back Pain n=29 Participants Subjects with Crohn's disease without back pain.	Fat Metaplasia Type of structural lesion seen in MRI.	Backfill Type of structural lesion seen in MRI.	Ankylosis Type of structural lesion seen in MRI.
Number of Participants With a History of Dactylitis	2 Participants	1 Participants	—	—	—

SECONDARY outcome

Timeframe: one study visit

Outcome measures

Measure	Any Back Pain n=4 Participants Subjects with Crohn's Disease with back pain.	No Back Pain n=29 Participants Subjects with Crohn's disease without back pain.	Fat Metaplasia Type of structural lesion seen in MRI.	Backfill Type of structural lesion seen in MRI.	Ankylosis Type of structural lesion seen in MRI.
Number of Participants With HLA-B27 (Human Leukocyte Antigen B-27)	0 Participants	1 Participants	—	—	—

SECONDARY outcome

Timeframe: one study visit

Peripheral blood was collected for measurement of CRP.

Outcome measures

Measure	Any Back Pain n=4 Participants Subjects with Crohn's Disease with back pain.	No Back Pain n=29 Participants Subjects with Crohn's disease without back pain.	Fat Metaplasia Type of structural lesion seen in MRI.	Backfill Type of structural lesion seen in MRI.	Ankylosis Type of structural lesion seen in MRI.
CRP (C-reactive Protein)	2.6 mg/L Standard Deviation 3.0	1.5 mg/L Standard Deviation 2.6	—	—	—

SECONDARY outcome

Timeframe: one study visit

Minimum 0. Maximum 10. A score of 0 = none (no symptoms), and a score of 10 = very severe symptoms.

Outcome measures

Measure	Any Back Pain n=4 Participants Subjects with Crohn's Disease with back pain.	No Back Pain n=29 Participants Subjects with Crohn's disease without back pain.	Fat Metaplasia Type of structural lesion seen in MRI.	Backfill Type of structural lesion seen in MRI.	Ankylosis Type of structural lesion seen in MRI.
Bath Ankylosing Spondylitis Disease Activity Index (BASDAI)	4.3 score on a scale Standard Deviation 1.7	4.2 score on a scale Standard Deviation 2.4	—	—	—

SECONDARY outcome

Timeframe: one study visit

The scale of the BASMI ranges from 0 to 10, where 0 is no mobility limitation and 10 is a very severe limitation.

Outcome measures

Measure	Any Back Pain n=4 Participants Subjects with Crohn's Disease with back pain.	No Back Pain n=29 Participants Subjects with Crohn's disease without back pain.	Fat Metaplasia Type of structural lesion seen in MRI.	Backfill Type of structural lesion seen in MRI.	Ankylosis Type of structural lesion seen in MRI.
Bath Ankylosing Spondylitis Metrology Index (BASMI)	4.1 score on a scale Standard Deviation 0.7	2.4 score on a scale Standard Deviation 0.8	—	—	—

SECONDARY outcome

Timeframe: one study visit

A higher score indicates worse symptoms. ASDAS-CRP = 0.12 x Back Pain + 0.06 x Duration of Morning Stiffness + 0.11 x Patient Global + 0.07 x Peripheral Pain/Swelling + 0.58 x Ln(CRP+1)

Outcome measures

Measure	Any Back Pain n=4 Participants Subjects with Crohn's Disease with back pain.	No Back Pain n=29 Participants Subjects with Crohn's disease without back pain.	Fat Metaplasia Type of structural lesion seen in MRI.	Backfill Type of structural lesion seen in MRI.	Ankylosis Type of structural lesion seen in MRI.
Ankylosing Spondylitis Disease Activity Index C-reactive Protein (ASDAS-CRP)	3.3 score on a scale Standard Deviation 0.4	2.5 score on a scale Standard Deviation 1.2	—	—	—

SECONDARY outcome

Timeframe: one study visit

Outcome measures

Measure	Any Back Pain n=4 Participants Subjects with Crohn's Disease with back pain.	No Back Pain n=29 Participants Subjects with Crohn's disease without back pain.	Fat Metaplasia Type of structural lesion seen in MRI.	Backfill Type of structural lesion seen in MRI.	Ankylosis Type of structural lesion seen in MRI.
Duration of Crohn's Disease	17.9 years Standard Deviation 3.8	12.2 years Standard Deviation 8.7	—	—	—

SECONDARY outcome

Timeframe: one study visit

HBI consists of five parameters, which are all clinical. These parameters are: patient well-being (previous day). abdominal pain (previous day), number of liquid or soft stools (previous day), abdominal mass, and complications.

Patient well-being is scored with: 0 = very well, 1 = slightly below par, 2 = poor, 3 = very poor, 4 = terrible.

Abdominal pain is scored as: 0 = none, 1 = mild, 2 = moderate, 3 = severe. Abdominal mass is scored as: 0 = none, 1 = dubious, 2 = definite, 3 = definite and tender.

Complications can be answered with "No" (0 points) or by choosing from a list, with each selection being 1 point. The list is: arthralgia, uveitis, erythema nodosum, aphthous ulcer, pyoderma gangrenosum, anal fissures, appearance of a new fistula, abscess.

Calculation formula: sum of the scores of all 5 parameters. < 5 remission 5 - 7 mild activity 8 - 16 moderate activity > 16 severe activity

Outcome measures

Measure	Any Back Pain n=4 Participants Subjects with Crohn's Disease with back pain.	No Back Pain n=29 Participants Subjects with Crohn's disease without back pain.	Fat Metaplasia Type of structural lesion seen in MRI.	Backfill Type of structural lesion seen in MRI.	Ankylosis Type of structural lesion seen in MRI.
Crohn's Disease Activity (Harvey Bradshaw Index (HBI) Score)	7.8 score on a scale Standard Deviation 4.9	8.3 score on a scale Standard Deviation 4.5	—	—	—

SECONDARY outcome

Timeframe: one study visit

Outcome measures

Measure	Any Back Pain n=4 Participants Subjects with Crohn's Disease with back pain.	No Back Pain n=28 Participants Subjects with Crohn's disease without back pain.	Fat Metaplasia Type of structural lesion seen in MRI.	Backfill Type of structural lesion seen in MRI.	Ankylosis Type of structural lesion seen in MRI.
Number of Participants Using Vedolizumab for Crohn's Disease	0 Participants	7 Participants	—	—	—

SECONDARY outcome

Timeframe: one study visit

Outcome measures

Measure	Any Back Pain n=4 Participants Subjects with Crohn's Disease with back pain.	No Back Pain n=28 Participants Subjects with Crohn's disease without back pain.	Fat Metaplasia Type of structural lesion seen in MRI.	Backfill Type of structural lesion seen in MRI.	Ankylosis Type of structural lesion seen in MRI.
Number of Participants With a Prior History of Biologic Use for Crohn's Disease	3 Participants	16 Participants	—	—	—

SECONDARY outcome

Timeframe: one study visit

Outcome measures

Measure	Any Back Pain n=4 Participants Subjects with Crohn's Disease with back pain.	No Back Pain n=28 Participants Subjects with Crohn's disease without back pain.	Fat Metaplasia Type of structural lesion seen in MRI.	Backfill Type of structural lesion seen in MRI.	Ankylosis Type of structural lesion seen in MRI.
Number of Participants Who Have Had Surgery Related to Crohn's Disease	3 Participants	16 Participants	—	—	—

SECONDARY outcome

Timeframe: one study visit

Concentration of IL-2 in peripheral blood of participants.

Outcome measures

Measure	Any Back Pain n=6 Participants Subjects with Crohn's Disease with back pain.	No Back Pain n=25 Participants Subjects with Crohn's disease without back pain.	Fat Metaplasia Type of structural lesion seen in MRI.	Backfill Type of structural lesion seen in MRI.	Ankylosis Type of structural lesion seen in MRI.
Interleukin 2	4.7 pg/mL Standard Deviation 2.0	5.6 pg/mL Standard Deviation 7.8	—	—	—

SECONDARY outcome

Timeframe: one study visit

Concentration of IL-4 in peripheral blood of participants.

Outcome measures

Measure	Any Back Pain n=6 Participants Subjects with Crohn's Disease with back pain.	No Back Pain n=25 Participants Subjects with Crohn's disease without back pain.	Fat Metaplasia Type of structural lesion seen in MRI.	Backfill Type of structural lesion seen in MRI.	Ankylosis Type of structural lesion seen in MRI.
Interleukin 4	3.5 pg/mL Standard Deviation 1.6	5.7 pg/mL Standard Deviation 4.6	—	—	—

SECONDARY outcome

Timeframe: one study visit

Concentration of IL-5 in peripheral blood of participants.

Outcome measures

Measure	Any Back Pain n=6 Participants Subjects with Crohn's Disease with back pain.	No Back Pain n=25 Participants Subjects with Crohn's disease without back pain.	Fat Metaplasia Type of structural lesion seen in MRI.	Backfill Type of structural lesion seen in MRI.	Ankylosis Type of structural lesion seen in MRI.
Interleukin 5	3.7 pg/mL Standard Deviation 0.0	3.8 pg/mL Standard Deviation 0.1	—	—	—

SECONDARY outcome

Timeframe: one study visit

Concentration of IL-6 in peripheral blood of participants.

Outcome measures

Measure	Any Back Pain n=6 Participants Subjects with Crohn's Disease with back pain.	No Back Pain n=25 Participants Subjects with Crohn's disease without back pain.	Fat Metaplasia Type of structural lesion seen in MRI.	Backfill Type of structural lesion seen in MRI.	Ankylosis Type of structural lesion seen in MRI.
Interleukin 6	6.2 pg/mL Standard Deviation 7.2	5.1 pg/mL Standard Deviation 6.9	—	—	—

SECONDARY outcome

Timeframe: one study visit

Concentration of IL-9 in peripheral blood of participants.

Outcome measures

Measure	Any Back Pain n=6 Participants Subjects with Crohn's Disease with back pain.	No Back Pain n=25 Participants Subjects with Crohn's disease without back pain.	Fat Metaplasia Type of structural lesion seen in MRI.	Backfill Type of structural lesion seen in MRI.	Ankylosis Type of structural lesion seen in MRI.
Interleukin 9	2.4 pg/mL Standard Deviation 1.5	1.9 pg/mL Standard Deviation 0.9	—	—	—

SECONDARY outcome

Timeframe: one study visit

Concentration of IL-10 in peripheral blood of participants.

Outcome measures

Measure	Any Back Pain n=6 Participants Subjects with Crohn's Disease with back pain.	No Back Pain n=25 Participants Subjects with Crohn's disease without back pain.	Fat Metaplasia Type of structural lesion seen in MRI.	Backfill Type of structural lesion seen in MRI.	Ankylosis Type of structural lesion seen in MRI.
Interleukin 10	31.0 pg/mL Standard Deviation 59.3	6.5 pg/mL Standard Deviation 1.8	—	—	—

SECONDARY outcome

Timeframe: one study visit

Concentration of IL-13 in peripheral blood of participants.

Outcome measures

Measure	Any Back Pain n=6 Participants Subjects with Crohn's Disease with back pain.	No Back Pain n=25 Participants Subjects with Crohn's disease without back pain.	Fat Metaplasia Type of structural lesion seen in MRI.	Backfill Type of structural lesion seen in MRI.	Ankylosis Type of structural lesion seen in MRI.
Interleukin 13	8.9 pg/mL Standard Deviation 6.3	8.9 pg/mL Standard Deviation 4.4	—	—	—

SECONDARY outcome

Timeframe: one study visit

Concentration of IL 12-23 in peripheral blood of participants.

Outcome measures

Measure	Any Back Pain n=6 Participants Subjects with Crohn's Disease with back pain.	No Back Pain n=25 Participants Subjects with Crohn's disease without back pain.	Fat Metaplasia Type of structural lesion seen in MRI.	Backfill Type of structural lesion seen in MRI.	Ankylosis Type of structural lesion seen in MRI.
Interleukin 12-23	214.0 pg/mL Standard Deviation 159.5	259.1 pg/mL Standard Deviation 227.7	—	—	—

SECONDARY outcome

Timeframe: one study visit

Concentration of IL-17A in peripheral blood of participants.

Outcome measures

Measure	Any Back Pain n=6 Participants Subjects with Crohn's Disease with back pain.	No Back Pain n=25 Participants Subjects with Crohn's disease without back pain.	Fat Metaplasia Type of structural lesion seen in MRI.	Backfill Type of structural lesion seen in MRI.	Ankylosis Type of structural lesion seen in MRI.
Interleukin 17A	25.3 pg/mL Standard Deviation 13.1	21.1 pg/mL Standard Deviation 10.5	—	—	—

SECONDARY outcome

Timeframe: one study visit

Concentration of IL-17F in peripheral blood of participants.

Outcome measures

Measure	Any Back Pain n=6 Participants Subjects with Crohn's Disease with back pain.	No Back Pain n=25 Participants Subjects with Crohn's disease without back pain.	Fat Metaplasia Type of structural lesion seen in MRI.	Backfill Type of structural lesion seen in MRI.	Ankylosis Type of structural lesion seen in MRI.
Interleukin 17F	4.8 pg/mL Standard Deviation 2.2	3.8 pg/mL Standard Deviation 3.5	—	—	—

SECONDARY outcome

Timeframe: one study visit

Concentration of IL-21 in peripheral blood of participants.

Outcome measures

Measure	Any Back Pain n=6 Participants Subjects with Crohn's Disease with back pain.	No Back Pain n=25 Participants Subjects with Crohn's disease without back pain.	Fat Metaplasia Type of structural lesion seen in MRI.	Backfill Type of structural lesion seen in MRI.	Ankylosis Type of structural lesion seen in MRI.
Interleukin 21	19.8 pg/mL Standard Deviation 36.2	40.0 pg/mL Standard Deviation 43.2	—	—	—

SECONDARY outcome

Timeframe: one study visit

Concentration of IL-22 in peripheral blood of participants.

Outcome measures

Measure	Any Back Pain n=6 Participants Subjects with Crohn's Disease with back pain.	No Back Pain n=25 Participants Subjects with Crohn's disease without back pain.	Fat Metaplasia Type of structural lesion seen in MRI.	Backfill Type of structural lesion seen in MRI.	Ankylosis Type of structural lesion seen in MRI.
Interleukin 22	15.2 pg/mL Standard Deviation 7.1	16.7 pg/mL Standard Deviation 11.2	—	—	—

SECONDARY outcome

Timeframe: one study visit

Concentration of INFγ in peripheral blood of participants.

Outcome measures

Measure	Any Back Pain n=6 Participants Subjects with Crohn's Disease with back pain.	No Back Pain n=25 Participants Subjects with Crohn's disease without back pain.	Fat Metaplasia Type of structural lesion seen in MRI.	Backfill Type of structural lesion seen in MRI.	Ankylosis Type of structural lesion seen in MRI.
Interferon-γ	75.7 pg/mL Standard Deviation 31.0	79.0 pg/mL Standard Deviation 28.8	—	—	—

SECONDARY outcome

Timeframe: one study visit

Concentration of TNF-α in peripheral blood of participants.

Outcome measures

Measure	Any Back Pain n=6 Participants Subjects with Crohn's Disease with back pain.	No Back Pain n=25 Participants Subjects with Crohn's disease without back pain.	Fat Metaplasia Type of structural lesion seen in MRI.	Backfill Type of structural lesion seen in MRI.	Ankylosis Type of structural lesion seen in MRI.
TNF-α (Tumor Necrosis Factor)	19.5 pg/mL Standard Deviation 15.2	35.4 pg/mL Standard Deviation 94.1	—	—	—

SECONDARY outcome

Timeframe: one study visit

MRIs were independently read and scored by 2 expert rheumatologists and 1 newly trained rheumatologist reader, blinded to any clinical information. MRIs were evaluated and scored for presence of bone marrow edema (BME) and structural lesions (erosion, fat metaplasia, backfill and ankylosis) using a validated scoring method originally derived from the Spondyloarthritis Research Consortium of Canada SIJ module. Readers determined whether BME and the structural lesions were present in each of the quadrants for each participant. There are 2 sacroiliac joints and 4 quadrants for each joint, for a total of 8 quadrants for each participant.

Outcome measures

Measure	Any Back Pain n=33 Participants Subjects with Crohn's Disease with back pain.	No Back Pain n=33 Participants Subjects with Crohn's disease without back pain.	Fat Metaplasia n=33 Participants Type of structural lesion seen in MRI.	Backfill n=33 Participants Type of structural lesion seen in MRI.	Ankylosis n=33 Participants Type of structural lesion seen in MRI.
Mean Number of Sacroiliac Joint (SIJ) Quadrants Affected by BME or Structural Lesions for Each Participant	0.86 Number of Quadrants Affected per Person Standard Deviation 1.45	0.05 Number of Quadrants Affected per Person Standard Deviation 0.15	0.98 Number of Quadrants Affected per Person Standard Deviation 3.55	0.04 Number of Quadrants Affected per Person Standard Deviation 0.23	1.02 Number of Quadrants Affected per Person Standard Deviation 3.45

SECONDARY outcome

Timeframe: one study visit

MRIs were independently read and scored by 2 expert rheumatologists and 1 newly trained rheumatologist reader, blinded to any clinical information. MRIs were evaluated and scored for presence of bone marrow edema (BME) and structural lesions (erosion, fat metaplasia, backfill and ankylosis) using a validated scoring method originally derived from the Spondyloarthritis Research Consortium of Canada SIJ module. Readers determined whether BME and the structural lesions were present in each of the quadrants for each participant. There are 2 sacroiliac joints and 4 quadrants for each joint, for a total of 8 quadrants for each participant.

Outcome measures

Measure	Any Back Pain n=33 Participants Subjects with Crohn's Disease with back pain.	No Back Pain n=33 Participants Subjects with Crohn's disease without back pain.	Fat Metaplasia n=33 Participants Type of structural lesion seen in MRI.	Backfill n=33 Participants Type of structural lesion seen in MRI.	Ankylosis n=33 Participants Type of structural lesion seen in MRI.
Median Number of Sacroiliac Joint (SIJ) Quadrants Affected by BME or Structural Lesions for Each Participant	0 Number of Quadrants Affected per Person Interval 0.0 to 1.3	0 Number of Quadrants Affected per Person Interval 0.0 to 0.0	0 Number of Quadrants Affected per Person Interval 0.0 to 0.0	0 Number of Quadrants Affected per Person Interval 0.0 to 0.0	0 Number of Quadrants Affected per Person Interval 0.0 to 0.0

SECONDARY outcome

Timeframe: one study visit

Population: These Arms/Groups indicate which specific lesion is being looked at in the MRIs by the readers. Each of the 33 participants in the trial had their MRIs looked at for each of the lesions, therefore the overall number of participants analyzed is 33 for each Arm/Group. The count of participants indicates how many participants had at least 1 quadrant affected by a given lesion.

MRIs were independently read and scored by 2 expert rheumatologists and 1 newly trained rheumatologist reader, blinded to any clinical information. MRIs were evaluated and scored for presence of bone marrow edema (BME) and structural lesions (erosion, fat metaplasia, backfill and ankylosis) using a validated scoring method originally derived from the Spondyloarthritis Research Consortium of Canada SIJ module. Readers determined whether BME and the structural lesions were present in each of the quadrants for each participant. There are 2 sacroiliac joints and 4 quadrants for each joint, for a total of 8 quadrants for each participant. A quadrant is deemed affected if concordantly reported by ≥ 2/3 readers.

Outcome measures

Measure	Any Back Pain n=33 Participants Subjects with Crohn's Disease with back pain.	No Back Pain n=33 Participants Subjects with Crohn's disease without back pain.	Fat Metaplasia n=33 Participants Type of structural lesion seen in MRI.	Backfill n=33 Participants Type of structural lesion seen in MRI.	Ankylosis n=33 Participants Type of structural lesion seen in MRI.
Number of Participants With ≥1 Quadrant Affected by BME or Structural Lesions	10 Participants	1 Participants	2 Participants	1 Participants	2 Participants

SECONDARY outcome

Timeframe: one study visit

Population: These Arms/Groups indicate which specific lesion is being looked at in the MRIs by the readers. Each of the 33 participants in the trial had their MRIs looked at for each of the lesions, therefore the overall number of participants analyzed is 33 for each Arm/Group. The count of participants indicates how many participants had at least 2 quadrants affected by a given lesion.

MRIs were independently read and scored by 2 expert rheumatologists and 1 newly trained rheumatologist reader, blinded to any clinical information. MRIs were evaluated and scored for presence of bone marrow edema (BME) and structural lesions (erosion, fat metaplasia, backfill and ankylosis) using a validated scoring method originally derived from the Spondyloarthritis Research Consortium of Canada SIJ module. Readers determined whether BME and the structural lesions were present in each of the quadrants for each participant. There are 2 sacroiliac joints and 4 quadrants for each joint, for a total of 8 quadrants for each participant. A quadrant is deemed affected if concordantly reported by ≥ 2/3 readers.

Outcome measures

Measure	Any Back Pain n=33 Participants Subjects with Crohn's Disease with back pain.	No Back Pain n=33 Participants Subjects with Crohn's disease without back pain.	Fat Metaplasia n=33 Participants Type of structural lesion seen in MRI.	Backfill n=33 Participants Type of structural lesion seen in MRI.	Ankylosis n=33 Participants Type of structural lesion seen in MRI.
Number of Participants With ≥2 Quadrants Affected by BME or Structural Lesions	7 Participants	0 Participants	1 Participants	0 Participants	2 Participants

SECONDARY outcome

Timeframe: one study visit

Population: These Arms/Groups indicate which specific lesion is being looked at in the MRIs by the readers. Each of the 33 participants in the trial had their MRIs looked at for each of the lesions, therefore the overall number of participants analyzed is 33 for each Arm/Group. The count of participants indicates how many participants had at least 3 quadrants affected by a given lesion.

MRIs were independently read and scored by 2 expert rheumatologists and 1 newly trained rheumatologist reader, blinded to any clinical information. MRIs were evaluated and scored for presence of bone marrow edema (BME) and structural lesions (erosion, fat metaplasia, backfill and ankylosis) using a validated scoring method originally derived from the Spondyloarthritis Research Consortium of Canada SIJ module. Readers determined whether BME and the structural lesions were present in each of the quadrants for each participant. There are 2 sacroiliac joints and 4 quadrants for each joint, for a total of 8 quadrants for each participant. A quadrant is deemed affected if concordantly reported by ≥ 2/3 readers.

Outcome measures

Measure	Any Back Pain n=33 Participants Subjects with Crohn's Disease with back pain.	No Back Pain n=33 Participants Subjects with Crohn's disease without back pain.	Fat Metaplasia n=33 Participants Type of structural lesion seen in MRI.	Backfill n=33 Participants Type of structural lesion seen in MRI.	Ankylosis n=33 Participants Type of structural lesion seen in MRI.
Number of Participants With ≥3 Quadrants Affected by BME or Structural Lesions	5 Participants	0 Participants	1 Participants	0 Participants	2 Participants

SECONDARY outcome

Timeframe: one study visit

Population: These Arms/Groups indicate which specific lesion is being looked at in the MRIs by the readers. Each of the 33 participants in the trial had their MRIs looked at for each of the lesions, therefore the overall number of participants analyzed is 33 for each Arm/Group. The count of participants indicates how many participants had at least 4 quadrants affected by a given lesion.

MRIs were independently read and scored by 2 expert rheumatologists and 1 newly trained rheumatologist reader, blinded to any clinical information. MRIs were evaluated and scored for presence of bone marrow edema (BME) and structural lesions (erosion, fat metaplasia, backfill and ankylosis) using a validated scoring method originally derived from the Spondyloarthritis Research Consortium of Canada SIJ module. Readers determined whether BME and the structural lesions were present in each of the quadrants for each participant. There are 2 sacroiliac joints and 4 quadrants for each joint, for a total of 8 quadrants for each participant. A quadrant is deemed affected if concordantly reported by ≥ 2/3 readers.

Outcome measures

Measure	Any Back Pain n=33 Participants Subjects with Crohn's Disease with back pain.	No Back Pain n=33 Participants Subjects with Crohn's disease without back pain.	Fat Metaplasia n=33 Participants Type of structural lesion seen in MRI.	Backfill n=33 Participants Type of structural lesion seen in MRI.	Ankylosis n=33 Participants Type of structural lesion seen in MRI.
Number of Participants With ≥4 Quadrants Affected by BME or Structural Lesions	2 Participants	0 Participants	1 Participants	0 Participants	2 Participants

SECONDARY outcome

Timeframe: one study visit

Population: These Arms/Groups indicate which specific lesion is being looked at in the MRIs by the readers. Each of the 33 participants in the trial had their MRIs looked at for each of the lesions, therefore the overall number of participants analyzed is 33 for each Arm/Group. The count of participants indicates how many participants had at least 6 quadrants affected by a given lesion.

MRIs were independently read and scored by 2 expert rheumatologists and 1 newly trained rheumatologist reader, blinded to any clinical information. MRIs were evaluated and scored for presence of bone marrow edema (BME) and structural lesions (erosion, fat metaplasia, backfill and ankylosis) using a validated scoring method originally derived from the Spondyloarthritis Research Consortium of Canada SIJ module. Readers determined whether BME and the structural lesions were present in each of the quadrants for each participant. There are 2 sacroiliac joints and 4 quadrants for each joint, for a total of 8 quadrants for each participant. A quadrant is deemed affected if concordantly reported by ≥ 2/3 readers.

Outcome measures

Measure	Any Back Pain n=33 Participants Subjects with Crohn's Disease with back pain.	No Back Pain n=33 Participants Subjects with Crohn's disease without back pain.	Fat Metaplasia n=33 Participants Type of structural lesion seen in MRI.	Backfill n=33 Participants Type of structural lesion seen in MRI.	Ankylosis n=33 Participants Type of structural lesion seen in MRI.
Number of Participants With ≥6 Quadrants Affected by BME or Structural Lesions	1 Participants	0 Participants	1 Participants	0 Participants	2 Participants

SECONDARY outcome

Timeframe: one study visit

Population: These Arms/Groups indicate which specific lesion is being looked at in the MRIs by the readers. Each of the 33 participants in the trial had their MRIs looked at for each of the lesions, therefore the overall number of participants analyzed is 33 for each Arm/Group. The count of participants indicates how many participants had at least 5 quadrants affected by a given lesion.

MRIs were independently read and scored by 2 expert rheumatologists and 1 newly trained rheumatologist reader, blinded to any clinical information. MRIs were evaluated and scored for presence of bone marrow edema (BME) and structural lesions (erosion, fat metaplasia, backfill and ankylosis) using a validated scoring method originally derived from the Spondyloarthritis Research Consortium of Canada SIJ module. Readers determined whether BME and the structural lesions were present in each of the quadrants for each participant. There are 2 sacroiliac joints and 4 quadrants for each joint, for a total of 8 quadrants for each participant. A quadrant is deemed affected if concordantly reported by ≥ 2/3 readers.

Outcome measures

Measure	Any Back Pain n=33 Participants Subjects with Crohn's Disease with back pain.	No Back Pain n=33 Participants Subjects with Crohn's disease without back pain.	Fat Metaplasia n=33 Participants Type of structural lesion seen in MRI.	Backfill n=33 Participants Type of structural lesion seen in MRI.	Ankylosis n=33 Participants Type of structural lesion seen in MRI.
Number of Participants With ≥5 Quadrants Affected by BME or Structural Lesions	2 Participants	0 Participants	1 Participants	0 Participants	2 Participants

SECONDARY outcome

Timeframe: one study visit

Population: These Arms/Groups indicate which specific lesion is being looked at in the MRIs by the readers. Each of the 33 participants in the trial had their MRIs looked at for each of the lesions, therefore the overall number of participants analyzed is 33 for each Arm/Group. The count of participants indicates how many participants had at least 7 quadrants affected by a given lesion.

MRIs were independently read and scored by 2 expert rheumatologists and 1 newly trained rheumatologist reader, blinded to any clinical information. MRIs were evaluated and scored for presence of bone marrow edema (BME) and structural lesions (erosion, fat metaplasia, backfill and ankylosis) using a validated scoring method originally derived from the Spondyloarthritis Research Consortium of Canada SIJ module. Readers determined whether BME and the structural lesions were present in each of the quadrants for each participant. There are 2 sacroiliac joints and 4 quadrants for each joint, for a total of 8 quadrants for each participant. A quadrant is deemed affected if concordantly reported by ≥ 2/3 readers.

Outcome measures

Measure	Any Back Pain n=33 Participants Subjects with Crohn's Disease with back pain.	No Back Pain n=33 Participants Subjects with Crohn's disease without back pain.	Fat Metaplasia n=33 Participants Type of structural lesion seen in MRI.	Backfill n=33 Participants Type of structural lesion seen in MRI.	Ankylosis n=33 Participants Type of structural lesion seen in MRI.
Number of Participants With ≥7 Quadrants Affected by BME or Structural Lesions	0 Participants	0 Participants	1 Participants	0 Participants	2 Participants

Adverse Events

Adult Subjects With Crohn's Disease

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. Lisa Mandl

Hospital for Special Surgery

Phone: (212) 774-2960

Email: mandll@hss.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place