Crohn 's disease
Conditions
Interventions
Experimental group:Adalimumab Solution for Injection
Sponsors
The Second Affiliated Hospital of AFMU
Eligibility
Sex/Gender
All
Age
18 Years to 70 Years
Inclusion criteria
Inclusion criteria: 1. Male or female of complete Chinese descent aged 18 to 70 years (inclusive) at baseline (week 0); 2. Subjects have been diagnosed with Crohn's disease for at least 3 months before baseline (week 0); 3. Subject's hs-CRP>=3 mg/L; 4. The subject has received adequate therapy before, as judged by the investigator, but the subject's Crohn's disease activity index (CDAI) at baseline (week 0) is still >=220 and <=450; 5. Subject's TB screening assessment is negative. If a subject has signs of latent TB infection as assessed at screening, the subject must have completed at least 3 weeks (or as required by local requirements, whichever is longer) of ongoing TB prophylaxis prior to baseline; 6. If you are a woman of childbearing potential, you need to take certain contraceptive measures; 7. Subjects must be able and willing to provide written informed consent and follow the requirements of this study protocol; 8. The principal investigator (or his designee) comprehensively judged that the subject is in good health in other aspects.
Exclusion criteria
Exclusion criteria: 1.Patients who have contraindications to Anjianning® treatment according to the drug label; 2. Patients whom the investigator considers unsuitable for the trial drug due to other reasons.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Proportion of CD patients achieving clinical remission and clinical response;Proportion of subjects who discontinue corticosteroids and achieve clinical remission; | — |
Countries
China
Contacts
Public ContactXin Wang
The Second Affiliated Hospital of AFMU
Outcome results
None listed