Children, Infliximab, Ulcerative Colitis
Conditions
Brief summary
Pediatric Ulcerative Colitis (UC) patients with moderate to severe disease activity at high risk of colectomy. Early use of biologic agents will likely be more effective. But there were no studies identified that compared a strategy of upfront biologic-based therapy versus gradual step-up therapy. In our study, newly diagnosed moderate to severe pediatric UC patients (6-18 years old) will be randomly divided into infliximab (IFX) treatment group (Top down group, TD) and corticosteroids (CS) treatment group (Step-up group, SU). Mucosal healing rate at week 12 will be compared between the two groups. The relapse rates and sustained durations of remission within one year will also be evaluated.
Detailed description
Pediatric ulcerative colitis (UC) is typically more extensive and has a more active disease course than adult UC. Pediatric UC patients with moderate to severe disease activity at high risk of colectomy. Rapid disease control may improve the prognosis of the disease and reduce the rate of surgery. Early use of biologic agents will likely be more effective. But there were no studies identified that compared a strategy of upfront biologic-based therapy versus gradual step-up therapy. In our study, newly diagnosed moderate to severe pediatric UC patients (6-18 years old) will be randomly divided into infliximab (IFX) treatment group (Top down group, TD) and corticosteroids (CS) treatment group (Step-up group, SU). A decrease of pediatric ulcerative colitis activity index (PUCAI) at least 20 points were defined as Clinical response. Clinical response will be evaluated at week 2 in SU group and week 6 in TD group. For no-responder, treatment plan will be changed. Clinical remission rate at week 10 and mucosal healing rate at week 12 will be compared between the two groups. The relapse rates and sustained durations of remission within one year will also be evaluated.
Interventions
DRUGInfliximab
Infliximab will be administered intravenously at a dose of 5 mg/kg for 0, 2, and 6 weeks, then every 8 weeks for 1 year.
DRUGCorticosteroids
Corticosteroid will be given at a dose of 1-2mg/kg/day (maximum 60 mg/kg/day),oral or intravenously for 12 to 14 weeks.
Sponsors
Children's Hospital of Fudan University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
6 Years to 18 Years
Healthy volunteers
No
Inclusion criteria
1. newly diagnosed UC; 2. moderate to severe disease activity 3. Age: 6 to 18 years old
Exclusion criteria
1. with mild disease activity 2. Have been treated with Corticosteroid or biological agents for UC
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Mucosal healing rate | 12 week after intervention | The Ulcerative Colitis Endoscopic Index of Severity (UCEIS) ≦1 points is defined as mucosal healing. This will be evaluated by inflammatory bowel disease endoscopist. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| The relapse rates | 1 year after intervention | Relapse is defined as an increased in pediatric Ulcerative Colitis activity index (PUCAI) score by 10 points or more after clinical remission or when new Ulcerative Colitis treatment needed to be started due to worsening of symptoms. This will be evaluated by gastroenterologist. |
| Sustained durations of remission | 1 year after intervention | Sustained pediatric Ulcerative Colitis activity index (PUCAI) score \<10 points during follow-up（week 10 to week 54 after intervention). This will be evaluated by gastroenterologist. |
Countries
China
Contacts
Primary ContactCui fang Zheng
Outcome results
None listed