The Canadian Children Inflammatory Bowel Disease Network (CIDsCaNN)

Sustained Clinical Remission

Primary outcome: To test the research hypothesis, the primary endpoint is sustained clinical remission, as defined for CD by PCDAI \<10 and for UC as PUCAI \< 10 at each of the 6, 12, and 18 month visits AND physician global assessment of interval disease severity as quiescent at each of these visits. This primary endpoint will be assessed at 18 months, although it is the intent of the network to continue evaluations of the cohort until transfer to adult care.

Other Clinical Outcomes (combination of Pediatric Crohn's Disease Activity Index, Pediatric Ulcerative Colitis Activity Index, physician global assessment of disease activity, serologic inflammatory markers and fecal calprotectin results)

Initial treatment response will be assessed at 30 days using a combination of PCDAI (Pediatric Crohn's Disease Activity Index), PUCAI (Pediatric Ulcerative Colitis Activity Index), physician global assessment of disease activity, serologic inflammatory markers and fecal calprotectin results where applicable. Information from ongoing studies shows that 60% of patients are in a sustained clinical remission by 12 months. These results will identify the percentage of patients at achieve initial treatment response within 30 days.

Assessment of Intestinal Healing

Assessment of intestinal healing will be captured at Network Sites. Sites will be asked annually to record whether or not reassessment via endoscopy and/or MR imaging have/ has been performed and, if so, to record findings using the multi-item measures as at time of diagnosis. After 4 years of study initiation, the results will be analysed to ascertain whether including assessment using endoscopy and/or MR imaging is more accurate than assessing clinical symptoms and signs alone.