crohn disease
Conditions
Brief summary
clinical assessment of closure (despite gentle finger compression) of all the external openings that were drained at baseline, MRI confirmation of absence of collections > 2 cm of the treated perianal fistulas at week 24
Detailed description
assesment of complete cessation of suppuration, significant reduction of discharge, clinical assessment of closure of all the external openings, severity of perianal Crohn’s disease (Perianal Disease Activity Index PDAI), improvement of Quality of Life Short Inflammatory Bowel Disease Questionnaire (SIBDQ) (QoL), Crohn’s Disease Activity Index (CDAI), reduction of anal incontinence severity (Wexner score), assessment of adverse events, severity, and causal relationship to study product, assessment of quantification of regulatory lymphocyte subsets and soluble inflammatory molecules, cellular composition, secretory activity and transcriptional profile, MRI charasteristics of fistula
Interventions
DRUGSVF 2 inj prep
Sponsors
Centre Hospitalier Regional De Marseille
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| clinical assessment of closure (despite gentle finger compression) of all the external openings that were drained at baseline, MRI confirmation of absence of collections > 2 cm of the treated perianal fistulas at week 24 | — |
Secondary
| Measure | Time frame |
|---|---|
| assesment of complete cessation of suppuration, significant reduction of discharge, clinical assessment of closure of all the external openings, severity of perianal Crohn’s disease (Perianal Disease Activity Index PDAI), improvement of Quality of Life Short Inflammatory Bowel Disease Questionnaire (SIBDQ) (QoL), Crohn’s Disease Activity Index (CDAI), reduction of anal incontinence severity (Wexner score), assessment of adverse events, severity, and causal relationship to study product, assessment of quantification of regulatory lymphocyte subsets and soluble inflammatory molecules, cellular composition, secretory activity and transcriptional profile, MRI charasteristics of fistula | — |
Countries
France
Outcome results
None listed