Crohn’s disease
Conditions
Brief summary
Clinical remission (defined by a CDAI <150) at week 52 (V8) without any flare between week 0 (colonoscopy (V2)) and week 52 (V8). Flare is defined by a CDAI (Addendum 2) above 250 or between 150 points and 250 points with a 70-point increase from baseline (v0 : inclusion) over 2 consecutive weeks and the need to start any new treatment for CD.
Detailed description
Relapse free survival rate from week 0 (V2) to week 52 (V8), Proportion of endoscopic remission (SES-CD ≤2) at week 52 (V8) and change (in %) in endoscopic score (SES-CD) between week 0 (V2) and 52 (V8), Clinical remission defined by a CDAI < 150 at week 52; endoscopic remission defined by a SES-CD ≤ 2., Measures of inflammation: blood cell count, CRP level, fecal calprotectin at week 6 (V3), 12 (V4), 24 (V5), 36 (V6), 48 (V7) and 52 (V8), Microbiota composition and diversity using 16s sequencing technology at week 6 (V3), 12 (V4), 24 (V5), 36 (V6), 48 (V7) and 52 (V8)
Interventions
Sponsors
Assistance Publique Hopitaux De Paris
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Clinical remission (defined by a CDAI <150) at week 52 (V8) without any flare between week 0 (colonoscopy (V2)) and week 52 (V8). Flare is defined by a CDAI (Addendum 2) above 250 or between 150 points and 250 points with a 70-point increase from baseline (v0 : inclusion) over 2 consecutive weeks and the need to start any new treatment for CD. | — |
Secondary
| Measure | Time frame |
|---|---|
| Relapse free survival rate from week 0 (V2) to week 52 (V8), Proportion of endoscopic remission (SES-CD ≤2) at week 52 (V8) and change (in %) in endoscopic score (SES-CD) between week 0 (V2) and 52 (V8), Clinical remission defined by a CDAI < 150 at week 52; endoscopic remission defined by a SES-CD ≤ 2., Measures of inflammation: blood cell count, CRP level, fecal calprotectin at week 6 (V3), 12 (V4), 24 (V5), 36 (V6), 48 (V7) and 52 (V8), Microbiota composition and diversity using 16s sequencing technology at week 6 (V3), 12 (V4), 24 (V5), 36 (V6), 48 (V7) and 52 (V8) | — |
Countries
France
Outcome results
None listed