Ulcerative colitis
Conditions
Brief summary
Safety of biological treatment with vedolizumab and infliximab defined by the number of drug-related adverse events (AEs).
Detailed description
1. Clinical response - decrease in PUCAI value by min. 20 points 2. Clinical remission - PUCAI value < 10 points 3. Mucosal remission - Mayo endoscopic score = 0 4. Clinical response in the total Mayo scale - reduction of at least 3 points 5. Clinical remission in the Mayo total scale - value ≤ 2 points 6. Clinical response in the partial Mayo scale - reduction of at least 2 points 7. Clinical remission in the Mayo partial scale - value ≤ 2 points
Interventions
DRUGINFLIXIMAB
Sponsors
Instytut Pomnik Centrum Zdrowia Dziecka
Eligibility
Sex/Gender
All
Age
0 Years to 17 Years
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Safety of biological treatment with vedolizumab and infliximab defined by the number of drug-related adverse events (AEs). | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Clinical response - decrease in PUCAI value by min. 20 points 2. Clinical remission - PUCAI value < 10 points 3. Mucosal remission - Mayo endoscopic score = 0 4. Clinical response in the total Mayo scale - reduction of at least 3 points 5. Clinical remission in the Mayo total scale - value ≤ 2 points 6. Clinical response in the partial Mayo scale - reduction of at least 2 points 7. Clinical remission in the Mayo partial scale - value ≤ 2 points | — |
Countries
Poland
Outcome results
None listed