An observational study in Crohn's Disease and Spondyloarthritis, sponsored by Hospital for Special Surgery, New York. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2021-10-25.
Sponsored by Hospital for Special Surgery, New York · Observational
In patients with Crohn's Disease, symptoms of inflammatory back pain (IBP) precede changes on plain X-rays by years, and MRI changes of axial inflammation precede development of X-ray changes. Sacroiliitis on MRI without x-ray changes (i.e.Non radiographic SpA) is a valid diagnostic criterion for Spondyloarthritis (SpA) and leads to earlier diagnosis of SpA in patients with IBP. It is unclear when MRI changes occur, and if they precede clinical symptoms of IBP. There are reports of asymptomatic sacroiliitis noted on MRI in Crohn's patients. This is important, as MRI evidence of inflammation may be the first sign of incipient SpA. Inflammation in other regions of the axial skeleton in SpA patients has also been documented, but its significance is unknown. The prospect of undiagnosed and untreated inflammation is concerning, as it can lead to significant morbidity. Moreover, relationship between MRI evidence of axial inflammation-likely a proxy for systemic inflammation- and patient reported outcomes (e.g. ASDAS-CRP= Ankylosing Spondylitis Disease Activity Score- C reactive protein, BASDAI= Bath Ankylosing Spondylitis Disease Activity Index, SF-12 = Short Form- 12, HBI= Hervey Bradshaw Index and PROMIS-29= Patient Reported Outcome Measurement Information System-29), has not been reported. Recent unpublished data from Dr. Longman's lab (collaborator) suggest a distinct intestinal dysbiosis in Crohn's associated SpA. But relationship between this microbiome and MRI changes is yet to be determined.
Identifying inflammation earlier on MRI- in the absence of clinical symptoms will provide an opportunity to intervene early with available therapies, such as- biologics etc. Asymptomatic MRI changes could be a marker of underlying systemic inflammation- which is a risk factor for poor outcomes in Crohn's associated SpA. Studying association between whole spine MRI changes with patient reported outcomes) may facilitate informed clinical decision making to initiate targeted therapy to prevent progression of structural damage. Understanding microbial dysregulation in this population, and correlation with MRI changes, could lead to development of therapy targeted to restore intestinal symbiosis.
IMAGING AND CROHN'S ASSOCIATED SpA: Crohn's disease (CD) is the most common type of inflammatory bowel disease (IBD). It affects an estimated 0.7 million patients in United States and is responsible for 0.2 million hospitalizations each year.1 Although the gastrointestinal tract is the primary site of inflammation, inflammatory arthritis (both peripheral and axial) can affect between 12.8-23% of patients with Crohn's Disease2,3, and axial SpA alone has been reported to effect 6.7% to 18% of Crohn's patients.4 However, in 2 recent studies5,6, radiological sacroiliitis was reported to be present in 27% and 52% in IBD patients. MRI changes of inflammation precede radiological sacroiliitis by years but it is not clear when this occurs. Presence of damage on x-ray in asymptomatic patients may suggest that Crohn's associated axial SpA could be underdiagnosed. Since Crohn's associated SpA often affects younger patients, undertreatment or missed diagnoses could have a significant impact on health related quality of life (HR-QoL) and disability during prime wage earning and child rearing years.7
"Non-radiographic axial spondyloarthritis" is a term used to describe patients with symptomatic SpA who do not have findings on plain x-rays. These patients can have identical symptoms to those with radiographic evidence of cartilage loss and erosions, and anti-TNF (anti-Tumor Necrosis Factor) therapy has been shown to be effective in those with non-radiographic SpA.8 These patients are a clinically relevant subgroup, as 20% of patients with only MRI evidence of sacroiliitis will progress to non-reversible radiographic SpA over two years.9 Therefore, MRI evidence of sacroiliitis, in conjunction with inflammatory back pain is now sufficient to diagnosis SpA. In fact, MRI imaging is a standard component of current SpA diagnostic criteria, (ASAS: Assessment of SpondyloArthritis International Society),10 and MRI changes of sacroiliitis are routinely used to identify SpA patients for clinical trials.11
However, despite these new definitions there is a deficiency of published research evaluating the clinical significance of MRI findings in patients with Crohn's disease. Of all the SpA-associated diseases, Crohn's-associated SpA has a particularly high burden of extra-articular inflammation. Studies suggest only half to two thirds of patients with CT or MRI evidence of inflammation have symptoms of inflammatory back pain.1,12 This suggests that in Crohn's disease, MRI imaging biomarkers may be identifying early disease, analogous to the way that ultrasound can identify subclinical rheumatoid arthritis.13 We therefore hypothesize that in a mixed cohort of Crohn's patients with and without inflammatory back pain, MRI imaging biomarkers will correlate with measures of health status which reflect systemic inflammatory burden, (i.e. BASDAI, SF-12) independent of symptoms of inflammatory back pain.
MRI IMAGING BIOMARKERS: A POTENTIAL CARDIOVASCULAR RISK FACTOR? The observed discordance between axial inflammation seen on MRI and inflammatory back pain raises a particularly intriguing clinical question: could Crohn's patients with imaging evidence of axial inflammation but without axial symptoms potentially benefit from therapy?
It is very well established that in rheumatoid arthritis and psoriatic arthritis, systemic inflammation is associated with myocardial infarction, stroke and death, and that treating inflammation improves cardiovascular outcomes.14,15.
Recent population based study from Europe and Canada showed increased risk of cardiovascular mortality in patients with Ankylosing Spondylitis.16,17 Despite clear evidence that cardiovascular risk is increased in SpA, how to quantify the increased risk is not straightforward. There is no consistently reliable marker of systemic inflammation in these patients; sedimentation rate (ESR) and C-reactive protein (CRP) may not always reflect ongoing inflammation, especially in patients with non-radiographic axial SpA9. Therefore, accurately measuring the inflammatory burden in Crohn's patients, regardless of musculoskeletal symptoms, is an important area for future research. Initiation of earlier targeted therapy to decrease inflammation may not only prevent incident Crohn's associated SpA, progression of prevalent SpA, with concurrent improvements in HRQoL, but may also improve cardiovascular morbidity and mortality.
In addition, although sacroiliitis is the primary axial feature in SpA, there is increasing evidence that there can also be spinal involvement even in the absence of SI joint inflammation. Recent studies suggest that spinal inflammation can occur in up to one-third of nonradiographic SpA patients with \<5 years of disease duration.18 This could be an important early imaging inflammatory biomarker. To our knowledge there are no published studies evaluating spinal and SI joint MRI imaging biomarkers in Crohn's associated SpA.
THE MICROBIOME: A CORRELATE OF INFLAMMATION IN CROHN'S DISEASE? The etiopathogenesis of Crohn's Disease-associated SpA remains a puzzle. As with other autoimmune diseases, interplay between genetic factors such as HLA B27 (Human Leukocyte Antigen- B27) and environmental factors likely play a role. The joint symptoms of SpA are not consistently correlated with bowel disease flares.19 Intestinal microbiota plays a critical role in evolution of our entire immune system, since axenic laboratory animals (germfree animals raised in sterile environment) were noted to have partial restoration of T cell population when these animals are colonized with filamentous bacteria. A symbiotic relationship between the main bacterial phyla is necessary for proper functioning of immune system, since notable alterations in the intestinal microbiome (i.e. dysbiosis) have been suggested in various autoimmune diseases. Reduction in taxa-diversity (such as, enterobacteriaceae, Bacteroidales and Clostridiales) and expansion of certain phyla in the intestine have been recently reported in a large cohort of new onset treatment-naïve Crohn's disease (CD) patients.20 In addition, Dr. Longman's lab has shown that the expansion of immunologically relevant Enterobacteriaceae correlates with Crohn's related SpA among a mixed group of patients with Crohn's and ulcerative colitis, (in press). However, while these are exciting data, SpA cases were identified using a non-validated clinical diagnosis, without systematic rheumatology evaluation and no imaging studies. This will be first study evaluating the microbiome in a carefully phenotyped cohort of Crohn's associated SpA, who will also have detailed MRI imaging.
623 studies on the registry are indexed under Spondylitis; 83 are open to participants now.
This study's enrollment of 33 is below the median of 202 across 256 observational studies indexed under Spondylitis.
Browse Spondylitis studies →Hospital for Special Surgery, New York is the lead sponsor of 217 studies on the registry; 39 are open to participants now.
Of its 27 completed or terminated interventional studies of FDA-regulated products, 20 (74%) have results posted.
Counted across the registry records on this site, refreshed daily.
Patients will biopsy proven Crohn's disease will be enrolled for the study. 50% (15 patients) will have symptoms of inflammatory back pain and 50% will not.
Exclusion Criteria:
No drug or device intervention. However, participants will receive MRI of their spine, answer questionnaires, provide clinical history as well as blood and stool sample. Joint exams will also be performed on all participants.
Number of Participants With MRI Positivity- Global Assessment Positive
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).
Time frame: one study visit
Number of Participants With MRI Positivity- ASAS Positive
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.
Time frame: one study visit
Number of Participants With MRI Positivity- SPACE Positive
SpondyloArthritis Caught Early. Positivity based on presence of erosions and fat metaplasia.
Time frame: one study visit
Number of Participants With MRI Positivity- Morpho Positive
Positivity based on presence of bone marrow edema (BME) and/or erosion.
Time frame: one study visit
Number of Participants With Axial Spondyloarthritis Based on European Spondyloarthropathy Study Group (ESSG) Guidelines
Assessment of SpondyloArthritis international Society criteria was utilized to define inflammatory back pain.
Time frame: one study visit
Number of Participants With Current Peripheral Arthritis
Time frame: one study visit
Number of Participants With a History of Peripheral Arthritis
Time frame: one study visit
Bath Ankylosing Spondylitis Disease Activity Index (BASDAI)
Minimum 0. Maximum 10. A score of 0 = none (no symptoms), and a score of 10 = very severe symptoms.
Time frame: one study visit
Bath Ankylosing Spondylitis Metrology Index (BASMI)
The scale of the BASMI ranges from 0 to 10, where 0 is no mobility limitation and 10 is a very severe limitation.
Time frame: one study visit
Ankylosing Spondylitis Disease Activity Index C-reactive Protein (ASDAS-CRP)
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)
Time frame: one study visit
CRP (C-reactive Protein)
Peripheral blood was collected for measurement of CRP.
Time frame: one study visit
Duration of Crohn's Disease for Participants
Time frame: one study visit
Number of Participants Using Vedolizumab for Crohn's Disease
Time frame: one study visit
Number of Participants With a Past History of Biologic Use for Crohn's Disease
Time frame: one study visit
Number of Participants Who Have Had Surgery Related to Crohn's Disease
Time frame: one study visit
Crohn's Disease Activity (Harvey Bradshaw Index (HBI) Score)
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
Time frame: one study visit
Number of Participants With Inflammatory Back Pain
Time frame: one study visit
Number of Participants With Current Enthesitis
Time frame: one study visit
Number of Participants With a History of Uveitis
Time frame: one study visit
Number of Participants With a History of Dactylitis
Time frame: one study visit
Number of Participants With HLA-B27 (Human Leukocyte Antigen B-27)
Time frame: one study visit
Ankylosing Spondylitis Disease Activity Index C-reactive Protein (ASDAS-CRP)
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)
Time frame: one study visit
Duration of Crohn's Disease
Time frame: one study visit
Number of Participants With a Prior History of Biologic Use for Crohn's Disease
Time frame: one study visit
Interleukin 2
Concentration of IL-2 in peripheral blood of participants.
Time frame: one study visit
Interleukin 4
Concentration of IL-4 in peripheral blood of participants.
Time frame: one study visit
Interleukin 5
Concentration of IL-5 in peripheral blood of participants.
Time frame: one study visit
Interleukin 6
Concentration of IL-6 in peripheral blood of participants.
Time frame: one study visit
Interleukin 9
Concentration of IL-9 in peripheral blood of participants.
Time frame: one study visit
Interleukin 10
Concentration of IL-10 in peripheral blood of participants.
Time frame: one study visit
Interleukin 13
Concentration of IL-13 in peripheral blood of participants.
Time frame: one study visit
Interleukin 12-23
Concentration of IL 12-23 in peripheral blood of participants.
Time frame: one study visit
Interleukin 17A
Concentration of IL-17A in peripheral blood of participants.
Time frame: one study visit
Interleukin 17F
Concentration of IL-17F in peripheral blood of participants.
Time frame: one study visit
Interleukin 21
Concentration of IL-21 in peripheral blood of participants.
Time frame: one study visit
Interleukin 22
Concentration of IL-22 in peripheral blood of participants.
Time frame: one study visit
Interferon-γ
Concentration of INFγ in peripheral blood of participants.
Time frame: one study visit
TNF-α (Tumor Necrosis Factor)
Concentration of TNF-α in peripheral blood of participants.
Time frame: one study visit
Mean Number of Sacroiliac Joint (SIJ) Quadrants Affected by BME or Structural Lesions for Each Participant
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.
Time frame: one study visit
Median Number of Sacroiliac Joint (SIJ) Quadrants Affected by BME or Structural Lesions for Each Participant
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.
Time frame: one study visit
Number of Participants With ≥1 Quadrant Affected by BME or Structural Lesions
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.
Time frame: one study visit
Number of Participants With ≥2 Quadrants Affected by BME or Structural Lesions
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.
Time frame: one study visit
Number of Participants With ≥3 Quadrants Affected by BME or Structural Lesions
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.
Time frame: one study visit
Number of Participants With ≥4 Quadrants Affected by BME or Structural Lesions
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.
Time frame: one study visit
Number of Participants With ≥6 Quadrants Affected by BME or Structural Lesions
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.
Time frame: one study visit
Number of Participants With ≥5 Quadrants Affected by BME or Structural Lesions
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.
Time frame: one study visit
Number of Participants With ≥7 Quadrants Affected by BME or Structural Lesions
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.
Time frame: one study visit
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.
| Milestone | Adult Subjects With Crohn's Disease |
|---|---|
| Started | 33 |
| Any back pain | 19 |
| No back pain | 14 |
| Mri showing presence of sacroiliitis | 4 |
| Mri not showing sacroiliitis | 29 |
| Classified as having inflammatory back pain by the asas criteria | 6 |
| Not classified as having inflammatory back pain by the asas criteria | 25 |
| Having bone marrow edema seen in mri | 33 |
| Having erosion (a structural lesion) seen in mri | 33 |
| Having fat metaplasia seen in mri | 33 |
| Having backfill (type of structural lesion) seen in mri | 33 |
| Having ankylosis seen in mri | 33 |
| Completed | 33 |
| Not completed | 0 |
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).
| Participants | Any Back Pain | No Back Pain |
|---|---|---|
| Number of Participants With MRI Positivity- Global Assessment Positive | 4 | 0 |
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.
| Participants | Any Back Pain | No Back Pain |
|---|---|---|
| Number of Participants With MRI Positivity- ASAS Positive | 4 | 2 |
SpondyloArthritis Caught Early. Positivity based on presence of erosions and fat metaplasia.
| Participants | Any Back Pain | No Back Pain |
|---|---|---|
| Number of Participants With MRI Positivity- SPACE Positive | 0 | 0 |
Positivity based on presence of bone marrow edema (BME) and/or erosion.
| Participants | Any Back Pain | No Back Pain |
|---|---|---|
| Number of Participants With MRI Positivity- Morpho Positive | 5 | 1 |
Assessment of SpondyloArthritis international Society criteria was utilized to define inflammatory back pain.
| Participants | Any Back Pain |
|---|---|
| Number of Participants With Axial Spondyloarthritis Based on European Spondyloarthropathy Study Group (ESSG) Guidelines | 13 |
| Participants | Any Back Pain | No Back Pain |
|---|---|---|
| Number of Participants With Current Peripheral Arthritis | 14 | 4 |
| Participants | Any Back Pain | No Back Pain |
|---|---|---|
| Number of Participants With a History of Peripheral Arthritis | 16 | 6 |
Minimum 0. Maximum 10. A score of 0 = none (no symptoms), and a score of 10 = very severe symptoms.
| score on a scale | Any Back Pain | No Back Pain |
|---|---|---|
| Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) | 5.3 ± 1.8 | 2.4 ± 1.6 |
The scale of the BASMI ranges from 0 to 10, where 0 is no mobility limitation and 10 is a very severe limitation.
| score on a scale | Any Back Pain | No Back Pain |
|---|---|---|
| Bath Ankylosing Spondylitis Metrology Index (BASMI) | 2.9 ± 0.9 | 2.1 ± 0.9 |
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)
| score on a scale | Any Back Pain | No Back Pain |
|---|---|---|
| Ankylosing Spondylitis Disease Activity Index C-reactive Protein (ASDAS-CRP) | 3.1 ± 0.9 | 2.1 ± 0.9 |
Peripheral blood was collected for measurement of CRP.
| mg/L | Any Back Pain | No Back Pain |
|---|---|---|
| CRP (C-reactive Protein) | 1.6 ± 2.0 | 1.7 ± 3.3 |
| years | Any Back Pain | No Back Pain |
|---|---|---|
| Duration of Crohn's Disease for Participants | 11.9 ± 6.7 | 14.2 ± 10.5 |
| Participants | Any Back Pain | No Back Pain |
|---|---|---|
| Number of Participants Using Vedolizumab for Crohn's Disease | 3 | 4 |
| Participants | Any Back Pain | No Back Pain |
|---|---|---|
| Number of Participants With a Past History of Biologic Use for Crohn's Disease | 3 | 4 |
| Participants | Any Back Pain | No Back Pain |
|---|---|---|
| Number of Participants Who Have Had Surgery Related to Crohn's Disease | 10 | 9 |
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
| score on a scale | Any Back Pain | No Back Pain |
|---|---|---|
| Crohn's Disease Activity (Harvey Bradshaw Index (HBI) Score) | 9.1 ± 4.9 | 6.9 ± 3.7 |
| Participants | Global MRI Positive | Global MRI Negative |
|---|---|---|
| Number of Participants With Inflammatory Back Pain | 4 | 15 |
| Participants | Global MRI Positive | Global MRI Negative |
|---|---|---|
| Number of Participants With Current Peripheral Arthritis | 3 | 15 |
| Participants | Global MRI Positive | Global MRI Negative |
|---|---|---|
| Number of Participants With a History of Peripheral Arthritis | 4 | 18 |
| Participants | Global MRI Positive | Global MRI Negative |
|---|---|---|
| Number of Participants With Current Enthesitis | 1 | 8 |
| Participants | Global MRI Positive | Global MRI Negative |
|---|---|---|
| Number of Participants With a History of Uveitis | 1 | 3 |
| Participants | Global MRI Positive | Global MRI Negative |
|---|---|---|
| Number of Participants With a History of Dactylitis | 2 | 1 |
| Participants | Global MRI Positive | Global MRI Negative |
|---|---|---|
| Number of Participants With HLA-B27 (Human Leukocyte Antigen B-27) | 0 | 1 |
Peripheral blood was collected for measurement of CRP.
| mg/L | Global MRI Positive | Global MRI Negative |
|---|---|---|
| CRP (C-reactive Protein) | 2.6 ± 3.0 | 1.5 ± 2.6 |
Minimum 0. Maximum 10. A score of 0 = none (no symptoms), and a score of 10 = very severe symptoms.
| score on a scale | Global MRI Positive | Global MRI Negative |
|---|---|---|
| Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) | 4.3 ± 1.7 | 4.2 ± 2.4 |
The scale of the BASMI ranges from 0 to 10, where 0 is no mobility limitation and 10 is a very severe limitation.
| score on a scale | Global MRI Positive | Global MRI Negative |
|---|---|---|
| Bath Ankylosing Spondylitis Metrology Index (BASMI) | 4.1 ± 0.7 | 2.4 ± 0.8 |
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)
| score on a scale | Global MRI Positive | Global MRI Negative |
|---|---|---|
| Ankylosing Spondylitis Disease Activity Index C-reactive Protein (ASDAS-CRP) | 3.3 ± 0.4 | 2.5 ± 1.2 |
| years | Global MRI Positive | Global MRI Negative |
|---|---|---|
| Duration of Crohn's Disease | 17.9 ± 3.8 | 12.2 ± 8.7 |
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
| score on a scale | Global MRI Positive | Global MRI Negative |
|---|---|---|
| Crohn's Disease Activity (Harvey Bradshaw Index (HBI) Score) | 7.8 ± 4.9 | 8.3 ± 4.5 |
| Participants | Global MRI Positive | Global MRI Negative |
|---|---|---|
| Number of Participants Using Vedolizumab for Crohn's Disease | 0 | 7 |
| Participants | Global MRI Positive | Global MRI Negative |
|---|---|---|
| Number of Participants With a Prior History of Biologic Use for Crohn's Disease | 3 | 16 |
| Participants | Global MRI Positive | Global MRI Negative |
|---|---|---|
| Number of Participants Who Have Had Surgery Related to Crohn's Disease | 3 | 16 |
Concentration of IL-2 in peripheral blood of participants.
| pg/mL | ASAS (Assessment of SpondyloArthritis International Society) MRI Positive | ASAS (Assessment of SpondyloArthritis International Society) MRI Negative |
|---|---|---|
| Interleukin 2 | 4.7 ± 2.0 | 5.6 ± 7.8 |
Concentration of IL-4 in peripheral blood of participants.
| pg/mL | ASAS (Assessment of SpondyloArthritis International Society) MRI Positive | ASAS (Assessment of SpondyloArthritis International Society) MRI Negative |
|---|---|---|
| Interleukin 4 | 3.5 ± 1.6 | 5.7 ± 4.6 |
Concentration of IL-5 in peripheral blood of participants.
| pg/mL | ASAS (Assessment of SpondyloArthritis International Society) MRI Positive | ASAS (Assessment of SpondyloArthritis International Society) MRI Negative |
|---|---|---|
| Interleukin 5 | 3.7 ± 0.0 | 3.8 ± 0.1 |
Concentration of IL-6 in peripheral blood of participants.
| pg/mL | ASAS (Assessment of SpondyloArthritis International Society) MRI Positive | ASAS (Assessment of SpondyloArthritis International Society) MRI Negative |
|---|---|---|
| Interleukin 6 | 6.2 ± 7.2 | 5.1 ± 6.9 |
Concentration of IL-9 in peripheral blood of participants.
| pg/mL | ASAS (Assessment of SpondyloArthritis International Society) MRI Positive | ASAS (Assessment of SpondyloArthritis International Society) MRI Negative |
|---|---|---|
| Interleukin 9 | 2.4 ± 1.5 | 1.9 ± 0.9 |
Concentration of IL-10 in peripheral blood of participants.
| pg/mL | ASAS (Assessment of SpondyloArthritis International Society) MRI Positive | ASAS (Assessment of SpondyloArthritis International Society) MRI Negative |
|---|---|---|
| Interleukin 10 | 31.0 ± 59.3 | 6.5 ± 1.8 |
Concentration of IL-13 in peripheral blood of participants.
| pg/mL | ASAS (Assessment of SpondyloArthritis International Society) MRI Positive | ASAS (Assessment of SpondyloArthritis International Society) MRI Negative |
|---|---|---|
| Interleukin 13 | 8.9 ± 6.3 | 8.9 ± 4.4 |
Concentration of IL 12-23 in peripheral blood of participants.
| pg/mL | ASAS (Assessment of SpondyloArthritis International Society) MRI Positive | ASAS (Assessment of SpondyloArthritis International Society) MRI Negative |
|---|---|---|
| Interleukin 12-23 | 214.0 ± 159.5 | 259.1 ± 227.7 |
Concentration of IL-17A in peripheral blood of participants.
| pg/mL | ASAS (Assessment of SpondyloArthritis International Society) MRI Positive | ASAS (Assessment of SpondyloArthritis International Society) MRI Negative |
|---|---|---|
| Interleukin 17A | 25.3 ± 13.1 | 21.1 ± 10.5 |
Concentration of IL-17F in peripheral blood of participants.
| pg/mL | ASAS (Assessment of SpondyloArthritis International Society) MRI Positive | ASAS (Assessment of SpondyloArthritis International Society) MRI Negative |
|---|---|---|
| Interleukin 17F | 4.8 ± 2.2 | 3.8 ± 3.5 |
Concentration of IL-21 in peripheral blood of participants.
| pg/mL | ASAS (Assessment of SpondyloArthritis International Society) MRI Positive | ASAS (Assessment of SpondyloArthritis International Society) MRI Negative |
|---|---|---|
| Interleukin 21 | 19.8 ± 36.2 | 40.0 ± 43.2 |
Concentration of IL-22 in peripheral blood of participants.
| pg/mL | ASAS (Assessment of SpondyloArthritis International Society) MRI Positive | ASAS (Assessment of SpondyloArthritis International Society) MRI Negative |
|---|---|---|
| Interleukin 22 | 15.2 ± 7.1 | 16.7 ± 11.2 |
Concentration of INFγ in peripheral blood of participants.
| pg/mL | ASAS (Assessment of SpondyloArthritis International Society) MRI Positive | ASAS (Assessment of SpondyloArthritis International Society) MRI Negative |
|---|---|---|
| Interferon-γ | 75.7 ± 31.0 | 79.0 ± 28.8 |
Concentration of TNF-α in peripheral blood of participants.
| pg/mL | ASAS (Assessment of SpondyloArthritis International Society) MRI Positive | ASAS (Assessment of SpondyloArthritis International Society) MRI Negative |
|---|---|---|
| TNF-α (Tumor Necrosis Factor) | 19.5 ± 15.2 | 35.4 ± 94.1 |
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.
| Number of Quadrants Affected per Person | Bone Marrow Edema | Erosion | Fat Metaplasia | Backfill | Ankylosis |
|---|---|---|---|---|---|
| Mean Number of Sacroiliac Joint (SIJ) Quadrants Affected by BME or Structural Lesions for Each Participant | 0.86 ± 1.45 | 0.05 ± 0.15 | 0.98 ± 3.55 | 0.04 ± 0.23 | 1.02 ± 3.45 |
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.
| Number of Quadrants Affected per Person | Bone Marrow Edema | Erosion | Fat Metaplasia | Backfill | Ankylosis |
|---|---|---|---|---|---|
| Median Number of Sacroiliac Joint (SIJ) Quadrants Affected by BME or Structural Lesions for Each Participant | 0 (0 to 1.3) | 0 (0 to 0) | 0 (0 to 0) | 0 (0 to 0) | 0 (0 to 0) |
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.
| Participants | Bone Marrow Edema | Erosion | Fat Metaplasia | Backfill | Ankylosis |
|---|---|---|---|---|---|
| Number of Participants With ≥1 Quadrant Affected by BME or Structural Lesions | 10 | 1 | 2 | 1 | 2 |
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.
| Participants | Bone Marrow Edema | Erosion | Fat Metaplasia | Backfill | Ankylosis |
|---|---|---|---|---|---|
| Number of Participants With ≥2 Quadrants Affected by BME or Structural Lesions | 7 | 0 | 1 | 0 | 2 |
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.
| Participants | Bone Marrow Edema | Erosion | Fat Metaplasia | Backfill | Ankylosis |
|---|---|---|---|---|---|
| Number of Participants With ≥3 Quadrants Affected by BME or Structural Lesions | 5 | 0 | 1 | 0 | 2 |
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.
| Participants | Bone Marrow Edema | Erosion | Fat Metaplasia | Backfill | Ankylosis |
|---|---|---|---|---|---|
| Number of Participants With ≥4 Quadrants Affected by BME or Structural Lesions | 2 | 0 | 1 | 0 | 2 |
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.
| Participants | Bone Marrow Edema | Erosion | Fat Metaplasia | Backfill | Ankylosis |
|---|---|---|---|---|---|
| Number of Participants With ≥6 Quadrants Affected by BME or Structural Lesions | 1 | 0 | 1 | 0 | 2 |
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.
| Participants | Bone Marrow Edema | Erosion | Fat Metaplasia | Backfill | Ankylosis |
|---|---|---|---|---|---|
| Number of Participants With ≥5 Quadrants Affected by BME or Structural Lesions | 2 | 0 | 1 | 0 | 2 |
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.
| Participants | Bone Marrow Edema | Erosion | Fat Metaplasia | Backfill | Ankylosis |
|---|---|---|---|---|---|
| Number of Participants With ≥7 Quadrants Affected by BME or Structural Lesions | 0 | 0 | 1 | 0 | 2 |
Collected over 1 year. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Adult Subjects With Crohn's Disease | 0/33 (0%) | 0/33 (0%) | 0/33 (0%) |
| Age, Categorical(Participants) | Adult Subjects With Crohn's Disease |
|---|---|
| <=18 years | 0 |
| Between 18 and 65 years | 33 |
| >=65 years | 0 |
| Age, Continuous(years) | Adult Subjects With Crohn's Disease |
|---|---|
| Median | 36.4 (27.2 to 49.0) |
| Sex: Female, Male(Participants) | Adult Subjects With Crohn's Disease |
|---|---|
| Female | 25 |
| Male | 8 |
| Ethnicity (NIH/OMB)(Participants) | Adult Subjects With Crohn's Disease |
|---|---|
| Hispanic or Latino | 0 |
| Not Hispanic or Latino | 33 |
| Unknown or Not Reported | 0 |
| Race (NIH/OMB)(Participants) | Adult Subjects With Crohn's Disease |
|---|---|
| American Indian or Alaska Native | 0 |
| Asian | 1 |
| Native Hawaiian or Other Pacific Islander | 0 |
| Black or African American | 4 |
| White | 25 |
| More than one race | 0 |
| Unknown or Not Reported | 3 |
| Region of Enrollment(participants) | Adult Subjects With Crohn's Disease |
|---|---|
| United States | 33 |
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Hospital for Special Surgery, New York