Crhon's disease
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: 1.meet the criterion of Crohns disease, and had Crohns disease for at least 6 months, with Crohns Disease Activity Index (CDAI) scores between 220 and 400. 2.Willing to sign the informed consent, and able to understand the experimental scheme and cooperate with the experimental scheme. 3.Aged 18-60.
Exclusion criteria
Exclusion criteria: 1.received treatment with cyclosporine, methotrexate, or experimental agents within three months before screening. 2.symptomatic stenosis or ileal strictures. 3.stoma. 4.proctocolectomy or total colectomy. 5.a history of allergy to murine proteins. 6.prior treatment with murine,chimeric, or humanized monoclonal antibodies. 7.treatment with parenteral corticosteroids or corticotropin within four weeks before screening. 8.serious complications such as massive hemorrhage of digestive tract, perforation of digestive tract, canceration and intestinal obstruction that are ineffective after conservative medical treatment. 9.Pregnant or lactating patients. 10.patients who can not strictly observe and consciously cooperate with the research requirements of this trial (refer to those who can not cooperate with the diet control or can not use drugs according to the regulations and affect the efficacy). 11.Patients with psychosis.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Clinical efficiency;Mucosa healing rate;Endoscopic response rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| erythrocyte sedimentation rate;C-reactive protein;Nutritional status;Fecal occult blood test;Quality of life;faecal calprotectin; | — |
Countries
China