Crohn's disease
Conditions
Interventions
Control Group:Infliximab (analogues), intravenous infusion of 5mg/kg at weeks 0, 2, 6 and every 8 weeks thereafter
Experimental group:Infliximab (Cimzia), is administered intravenously at 5mg/kg every 8 weeks at weeks 0, 2, 6 and thereafter, while azathioprine is taken orally
Sponsors
Children's Hospital,Zhejiang University School of Medicine
Eligibility
Sex/Gender
All
Age
6 Years to 18 Years
Inclusion criteria
Inclusion criteria: 1. The Pediatric Crohn's Disease Activity Index (PCDAI) value at baseline was >= 30. 2. The diagnosis of Crohn's disease must be confirmed by endoscopy and biopsy. 3. None of the patients had received treatment with azathioprine, 6-mercaptopurine or anti-TNF biologics. 4. Patients receiving the following adjuvant treatments were also eligible for participation: aminosalicylates (if the dose was stable for at least 2 weeks before enrollment, it was applicable), enteral nutrition (stable regimen for at least 2 weeks). Rectal, intravenous or oral corticosteroids were not allowed and had to be discontinued for at least 2 weeks before enrollment.
Exclusion criteria
Exclusion criteria: 1. Suffering from short bowel syndrome, ostomy surgery, symptomatic stenosis, abscess, or a recent history of abdominal surgery within the past 6 months. 2. History of tuberculosis or other granulomatous infections, positive chest imaging or positive tuberculin skin test. 3. Recent history of opportunistic infections (within 6 months), active hepatitis B or C infection, or human immunodeficiency virus infection. 4. Multiple sclerosis or cancer. 5. Homozygous mutations in NUDT15 or TPMT genes, or heterozygous mutations in at least one of the above genes.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Clinical remission rate; | — |
Countries
China
Contacts
Public ContactLuo Youyou
Children's Hospital, Zhejiang University School of Medicine
Outcome results
None listed