Ensayos clínicos

Stricturing CD Participant Criteria

Inclusion Criteria

• Male or nonpregnant, nonlactating females, 16 to 80 years of age at the time of the SOC MRE.
• An established diagnosis of CD by a gastroenterologist[BDHM1] [FJGM2] .
• Documented symptomatic stricturing small bowel CD in reach of colonoscopy (i.e., a portion of the stricture is located within 15 cm of the ileocecal valve anastomosis).
• Anastomotic or naïve small bowel CD stricture(s) at the time of  clinically-indicated CT entergraphy (CTE[FJGM3] ) or MRE, where naïve small bowel stricture is defined by the combination of:
  • localized luminal narrowing (luminal diameter reduction of at least 50% relative to normal adjacent bowel loop);  AND
  • bowel wall thickening (25% increase relative to adjacent unaffected bowel); AND
  • either: maximum associated small bowel dilation (luminal diameter greater than 3 cm) OR inability to pass an adult or pediatric colonoscope through the narrowed area prior to dilation and unequivocal proximal small bowel dilation (but may be less than 3 cm[FJGM4] ). Endoscopic diagnosis of stricture should be within 6 months of MRE.
• An anastomotic stricture is defined the same as a naïve stricture, but at the site of prior intestinal resection with anastomosis.
• Clinical symptoms consistent with obstruction defined by the S-PRO items including abdominal pain after eating (at least often) and dietary restrictions (at least moderate) within 1 month of the SOC MRE[BDHM5] [FJGM6]  or CTE.
• Radiologically confirmed CD stricture (CONSTRICT criteria)1 as determined by SOC MRE or CTE performed according to accepted technical parameters [refs].
• Surgical resection (Aim 1) or SOC endoscopy (Aim 2) of the small bowel stricture scheduled to occur within 3 months of the research MRE.

Exclusion Criteria

• Internal penetrating disease as shown by fistula, abscess, or inflammatory mass (phlegmon)[FJGM7] . A blind-ending sinus is not excluded.
• Gastrointestinal malignancies.
• More than 2 distal ileal strictures at the time of SOC MRE or CTE (where a long segment with multiple areas of narrowing with confluent inflammation between them is counted as 1 stricture, and 2 strictures within 3 cm are counted as a single stricture).
• A terminal ileal stricture in a patient with end ileostomy, where the stricture is confined within the subcutaneous tissues and does not extend intra-abdominally.
• A diverting loop ileostomy proximal to the dominant stricture.
• Total proctocolectomy with an ileoanal or Kock pouch.
• Stricturoplasty in the distal ileum, which is near or adjacent to a stricture[FJGM8].

UC Control Participant Criteria

Inclusion Criteria

• Male or nonpregnant, nonlactating females, 16 to 80 years of age.
• An established diagnosis of UC by a gastroenterologist and confirmed with endoscopy with histology and cross-sectional imaging.
• Patients with UC that have non-affected areas of the colon (e.g., left-sided colitis) are preferred since this would allow sampling of involved and non-involved segments in the same patient.
• Prior CTE or MRE showing absence of small bowel inflammation and perianal disease.

Exclusion Criteria

• Total proctocolectomy with an ileoanal or Kock pouch.
• Diverting loop ileostomy prior to colectomy.
• Completion proctectomies after prior segmental colon resection or presence of a Hartmann’s pouch.

Non-IBD Control Participant Criteria

Inclusion Criteria

• Male or nonpregnant, nonlactating females, 16 to 80 years of age.
• Patient undergoing colon or small bowel resection.
• Prior abdominopelvic CT or MRI showing lack of small bowel inflammation, segmental or diffuse colitis and perianal disease.

Exclusion Criteria

• Diagnosis of IBD.
• Total proctocolectomy with an ileoanal or Kock pouch.
• Diverting loop ileostomy upstream of resection.
• Ongoing chemotherapy or radiotherapy within 3 months of surgery.
• Completion proctectomies after prior segmental colon resection or presence of a Hartmann’s pouchy.
• Hereditary colorectal cancer (CRC) diagnosis. Sporadic cases of CRC are permitted to enroll.

Note: Other protocol defined Inclusion/Exclusion Criteria may apply.

Eligibility last updated 10/4/22. Questions regarding updates should be directed to the study team contact.