Ulcerative colitis in adults, Ulcerative colitis in children over 6 years old, Crohn's disease in adults, Fistulizing Crohn's disease in adults, Crohn's disease in children over 6 years old,
Conditions
Interventions
Ulcerative colitis in adults:The first administration of Anbait was 5 mg/kg, the same dose will be given at the 2nd and 6th weeks,and then every 8 weeks subsequently.
Ulcerative colitis in children over 6 years old:The first administration of Anbait was 5 mg/kg, the same dose will be given at the 2nd and 6th weeks,and then every 8 weeks subsequently.
Crohn's disease in adults:The first administration of Anbait was 5 mg/kg, the same dose will be given at the 2nd and 6th weeks,and then every 8 weeks subsequently.
Fistulizing Crohn's disease in adults:The first administration of Anbait was 5 mg/kg, the same dose will be given at the 2nd and 6th weeks,and then every 8 weeks subsequently.
Crohn's disease in children over 6 years old:The first administration of Anbait was 5 mg/kg, the same dose will be given at the 2nd and 6th weeks,and then every 8 weeks subsequently.
Sponsors
The Second Affiliated Hospital of Air Force Medical University of the People's Liberation Army of China
Eligibility
Sex/Gender
All
Age
6 Years to No maximum
Inclusion criteria
Inclusion criteria: Adult moderate-to-severe active ulcerative colitis Inclusion criteria: 1. Age >=18 years; 2. Suffering from ulcerative colitis at the time of screening and with a duration of at least 3 months; 3. Previously diagnosed with ulcerative colitis by biopsy; 4. Confirmed to have active colitis during sigmoidoscopy examination at the time of screening; 5. Active ulcerative colitis; 6. Male patients with sexual activity and female patients with sexual activity or fertility must take adequate contraceptive measures during the study period and within 6 months after the last infusion. Pediatric moderate-to-severe ulcerative colitis Inclusion criteria: 1. 6 years old = 18 weeks of patients; 2. Clearly diagnosed with moderate-to-severe active Crohn's disease according to the "Chinese Guidelines for the Diagnosis and Treatment of Crohn's Disease (2023 · Guangzhou)" [based on the Crohn's Disease Activity Index (CDAI) score]; 3. Patients prescribed Anbiter® (infliximab injection) by the doctor after thorough risk/benefit assessment; 4. Patients must sign an authorization form (or informed consent form, if applicable) voluntarily and agree to disclose and use anonymous personal health information obtained after participating in this study; 5. Male patients with sexual activity and female patients with sexual activity or fertility must take adequate contraceptive measures during the study period and within 6 months after the last infusion. Fistulizing Crohn's disease in adults Inclusion criteria: 1. Age >= 18 years; 2. Able to understand and comply with the protocol; 3. Patient or authorized person signs the informed consent form; 4. At least 3 months of clinical, endoscopic and/or pathological diagnosis of CD history before enrollment; 5. Discovery of a single or multiple fistulas for at least 2 weeks before enrollment; 6. Male patients with sexual activity and female patients with sexual activity or fertility must take adequate contraceptive measures during the study period and within 6 months after the last infusion. Moderate-to-severe active Crohn's disease in children over 6 years old Inclusion criteria: 1. 6 years old <= age<= 17 years; 2. Diagnosed with Crohn's disease for at least 3 months before screening, accompanied by gastritis, duodenitis, colitis, ileitis or ileocolitis confirmed by endoscopy and biopsy; 3. Despite being adequately treated with immunomodulators (i.e., AZA, 6-MP or MTX), still suffering from active Crohn's disease.
Exclusion criteria
Exclusion criteria: Adult moderate to severe active ulcerative colitis Exclusion criteria: 1. The patient plans to undergo surgical resection of all or part of the colon during the study period; 2. The patient has undergone surgery for active gastrointestinal bleeding, peritonitis, intestinal obstruction, or an abscess in the abdominal cavity or pancreas that requires drainage within 2 months prior to screening; 3. The patient is participating in another clinical study; 4. The patient is considered to be at risk and not suitable for participation in the study by the investigator. Pediatric moderate to severe ulcerative colitis Exclusion criteria: 1. History of latent or active TB; 2. Vaccination with live virus or bacteria within 3 months prior to screening; 3. Having or having had a severe infection within 3 months prior to screening; 4. Previously treated with infliximab; 5. Participating in another clinical study; 6. The investigator considers there to be a risk and the patient is not suitable for participation in the study. Adult moderate to severe active Crohn's disease Exclusion criteria: 1. Patients with any contraindications as specified in the Anbiet® (infliximab injection) instructions; 2. Patients who have received other tumor necrosis factor alpha (TNF-a) inhibitors within 12 weeks prior to the first use of Anbiet® (infliximab injection); 3. Participating in another clinical study; 4. The investigator considers there to be a risk and the patient is not suitable for participation in the study. Adult fistulizing Crohn's disease Exclusion criteria: 1. Having ulcerative colitis or other types of enteritis; 2. Having a perianal abscess > 2 cm, or an abscess that the investigator considers requires drainage; 3. Having symptomatic intestinal stenosis or having an ileal or colonic stoma; 4. Having active or latent infection; 5. Participating in another clinical study; 6. The investigator considers there to be a risk and the patient is not suitable for participation in the study. Moderate to severe active Crohn's disease in children over 6 years old Exclusion criteria: 1. Complications of diseases that may require surgical intervention; 2. Having undergone intestinal diversion surgery and having an ostomy placed within 3 months prior to screening; 3.Have positive fecal tests for intestinal pathogens including Entamoeba histolytica, Clostridium difficile, Shigella genus, and Salmonella genus.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Clinical response rate;Clinical remission rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| Adverse events, AE; | — |
Countries
China
Contacts
Public ContactWang Xin
The Second Affiliated Hospital of Air Force Medical University of the People's Liberation Army of China
Outcome results
None listed