N/A
N=33
Imaging Biomarkers in Crohn's Associated Spondyloarthritis
Crohn's Disease · Spondyloarthritis
Bottom Line
View on ClinicalTrials.gov: NCT02709694 ↗Enrolled (actual)
33
Serious AEs
0.0%
Results posted
Oct 2021
Primary outcome: Primary: Number of Participants With MRI Positivity- Global Assessment Positive — 4; 0 Participants
Study Design & Population
- Study type
- Observational
- Phase
- N/A
- Interventions
- No intervention (Other)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Hospital for Special Surgery, New York
- Primary completion
- Jan 2019
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With MRI Positivity- Global Assessment Positive |
4; 0 | — |
| PRIMARY Number of Participants With MRI Positivity- ASAS Positive |
4; 2 | — |
| PRIMARY Number of Participants With MRI Positivity- SPACE Positive |
0; 0 | — |
| PRIMARY Number of Participants With MRI Positivity- Morpho Positive |
5; 1 | — |
| SECONDARY Number of Participants With Axial Spondyloarthritis Based on European Spondyloarthropathy Study Group (ESSG) Guidelines |
13 | — |
| SECONDARY Number of Participants With Current Peripheral Arthritis |
3; 15 | — |
| SECONDARY Number of Participants With a History of Peripheral Arthritis |
4; 18 | — |
| SECONDARY Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) |
4.3; 4.2 | — |
| SECONDARY Bath Ankylosing Spondylitis Metrology Index (BASMI) |
4.1; 2.4 | — |
| SECONDARY Ankylosing Spondylitis Disease Activity Index C-reactive Protein (ASDAS-CRP) |
3.3; 2.5 | — |
| SECONDARY CRP (C-reactive Protein) |
2.6; 1.5 | — |
| SECONDARY Duration of Crohn's Disease for Participants |
11.9; 14.2 | — |
| SECONDARY Number of Participants Using Vedolizumab for Crohn's Disease |
0; 7 | — |
| SECONDARY Number of Participants With a Past History of Biologic Use for Crohn's Disease |
3; 4 | — |
| SECONDARY Number of Participants Who Have Had Surgery Related to Crohn's Disease |
3; 16 | — |
| SECONDARY Crohn's Disease Activity (Harvey Bradshaw Index (HBI) Score) |
7.8; 8.3 | — |
| SECONDARY Number of Participants With Inflammatory Back Pain |
4; 15 | — |
| SECONDARY Number of Participants With Current Enthesitis |
1; 8 | — |
| SECONDARY Number of Participants With a History of Uveitis |
1; 3 | — |
| SECONDARY Number of Participants With a History of Dactylitis |
2; 1 | — |
| SECONDARY Number of Participants With HLA-B27 (Human Leukocyte Antigen B-27) |
0; 1 | — |
| SECONDARY Ankylosing Spondylitis Disease Activity Index C-reactive Protein (ASDAS-CRP) |
3.3; 2.5 | — |
| SECONDARY Duration of Crohn's Disease |
17.9; 12.2 | — |
| SECONDARY Number of Participants With a Prior History of Biologic Use for Crohn's Disease |
3; 16 | — |
| SECONDARY Interleukin 2 |
4.7; 5.6 | — |
| SECONDARY Interleukin 4 |
3.5; 5.7 | — |
| SECONDARY Interleukin 5 |
3.7; 3.8 | — |
| SECONDARY Interleukin 6 |
6.2; 5.1 | — |
| SECONDARY Interleukin 9 |
2.4; 1.9 | — |
| SECONDARY Interleukin 10 |
31.0; 6.5 | — |
| SECONDARY Interleukin 13 |
8.9; 8.9 | — |
| SECONDARY Interleukin 12-23 |
214.0; 259.1 | — |
| SECONDARY Interleukin 17A |
25.3; 21.1 | — |
| SECONDARY Interleukin 17F |
4.8; 3.8 | — |
| SECONDARY Interleukin 21 |
19.8; 40.0 | — |
| SECONDARY Interleukin 22 |
15.2; 16.7 | — |
| SECONDARY Interferon-γ |
75.7; 79.0 | — |
| SECONDARY TNF-α (Tumor Necrosis Factor) |
19.5; 35.4 | — |
| SECONDARY Mean Number of Sacroiliac Joint (SIJ) Quadrants Affected by BME or Structural Lesions for Each Participant |
0.86; 0.05; 0.98; 0.04; 1.02 | — |
| SECONDARY Median Number of Sacroiliac Joint (SIJ) Quadrants Affected by BME or Structural Lesions for Each Participant |
0; 0; 0; 0; 0 | — |
| SECONDARY Number of Participants With ≥1 Quadrant Affected by BME or Structural Lesions |
10; 1; 2; 1; 2 | — |
| SECONDARY Number of Participants With ≥2 Quadrants Affected by BME or Structural Lesions |
7; 0; 1; 0; 2 | — |
| SECONDARY Number of Participants With ≥3 Quadrants Affected by BME or Structural Lesions |
5; 0; 1; 0; 2 | — |
| SECONDARY Number of Participants With ≥4 Quadrants Affected by BME or Structural Lesions |
2; 0; 1; 0; 2 | — |
| SECONDARY Number of Participants With ≥6 Quadrants Affected by BME or Structural Lesions |
1; 0; 1; 0; 2 | — |
| SECONDARY Number of Participants With ≥5 Quadrants Affected by BME or Structural Lesions |
2; 0; 1; 0; 2 | — |
| SECONDARY Number of Participants With ≥7 Quadrants Affected by BME or Structural Lesions |
0; 0; 1; 0; 2 | — |
Summary
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.
Eligibility Criteria
Inclusion Criteria
- Patients with biopsy proven Crohn's Disease
- 50% patients with inflammatory back pain and 50% without inflammatory back pain.
- Age 18 years and above
- English Speaking patients only
Exclusion Criteria
- History of psoriasis, other inflammatory arthritis
- No exposure to biologic agent within the past six months (except Vedolizumab, which exerts its effect locally)
- Contraindication to MRI
- History of malignancy <5 years in remission, (except for non-melanomatous skin cancer).
- Non English speaking
- Unable to comply with study protocol.
- Critically or terminally ill patients
- Pregnancy
Data sourced from ClinicalTrials.gov (NCT02709694). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.