Crohn's disease
Conditions
Interventions
Intervention group:Vedolizumab
Sponsors
Run Run Shaw Hospital Affiliated to Zhejiang University School of Medicine
Eligibility
Sex/Gender
All
Age
18 Years to 80 Years
Inclusion criteria
Inclusion criteria: 1. In the opinion of the investigator, the subject is capable of understanding and complying with protocol requirements; 2. The subject signs and dates a written, informed consent form and any required privacy authorization prior to the initiation of any study procedures; 3. Aged 18-80 years; 4. The subject has affirmative diagnosis of moderately to severely active CD established by clinical and endoscopic evidence corroborated by a histopathology report, with a CDAI score of 220 to 450, a SES-CD score of >= 7 and presence of at least one mucosal ulceration during the screening period; * If subject has an ileocolonoscopy procedure within 7 days before signing of the informed consent, the data can be used for screening without repeating the ileocolonoscopy if the following conditions are met: the procedure is video-taped (fulfilling the requirements for central imaging assessments) and the SES-CD score can be recorded; 5. The subject has a CD disease duration < 18 months (disease duration is defined as the time interval between time of enrollment and time of a confirmed diagnosis of CD was made); 6. The subject has CD with involvement of the ileum and/or colon that can be assessed by ileocolonoscopy; 7. The subject has never received immunomodulators as treatment, including but not limited to azathioprine, 6-mercaptopurine, methotrexate, thalidomide, Tacrolimus, and cyclosporin A; 8. The subject has never received biologic therapy (or investigational product) as treatment for IBD, including but not limited to infliximab, adalimumab, vedolizumab, ustekinumab or JAK inhibitors; 9. A male subject who is nonsterilized* and sexually active with a female partner of childbearing potential agrees to use barrier method of contraception (eg, condom with or without spermicide) from signing of informed consent throughout the duration of the study and for 18 weeks after last dose. The female partner of a male subject should also be advised to use a highly effective/effective method of contraception; 10. A female subject of childbearing potential who is sexually active with a nonsterilized* male partner agrees to use a highly effective/effective method of contraception from signing of informed consent throughout the duration of the study and 18 weeks after the last dose.
Exclusion criteria
Exclusion criteria: 1. The subject had extensive colonic resection, subtotal or total colectomy, or small bowel resections or diagnosis of short bowel syndrome; 2. Subject with a positive PML subjective symptom checklist before the administration of the first dose of VDZ; 3. Has an ostomy or stoma (an operation to create an opening from an area inside the body to the outside); 4. Has evidence of fistula or abdominal abscess, with the exception of inactive perianal fistula; Active perianal fistula is defined following the fistula drainage assessment, a fistula is considered active in the presence of drainage upon gentle compression at clinical examination; 5. Has evidence of bowel strictures or stenosis (fulfilling either impassable for endoscopic assessment or demonstrated prestenotic dilatation on radiographic imaging); 6. The subject currently requires or has a planned surgical intervention for CD during the study; 7. The subject has a history or evidence of adenomatous colonic polyps that have not been removed; 8. The subject has a history or evidence of colonic mucosal dysplasia; 9. Requires corticosteroid treatment for diseases other than CD; 10. The subject has active or latent tuberculosis (TB) regardless of treatment history, as evidenced by history of TB or a diagnostic TB test performed during screening that is positive; 11. The subject has chronic hepatitis B (HBV) or hepatitis C (HCV) infection; 12. The subject has any identified congenital or acquired immunodeficiency (eg. common variable immunodeficiency, human immunodeficiency virus infection, organ transplantation); 13. The subject has evidence of active C difficile infection or is having treatment for C difficile infection or other intestinal pathogens; 14. The subject has evidence of an active infection during screening; 15. The subject who is currently enrolled in or plan to participate in any other clinical studies (ie. interventional study) for any marketed or investigational products (including but not restricted to biologics, small molecule compounds); 16. If female, the subject is pregnant or lactating or intending to become pregnant before, during, or within 18 weeks after participating in this study; or intending to donate ova during such time period; 17. The subject has any unstable or uncontrolled cardiovascular, pulmonary, hepatic, renal, GI, genitourinary, hematological, coagulation, immunological, endocrine/metabolic, or other medical disorder that, in the opinion of the Investigator, would confound the study results or compromise subject safety; 18. The subject has a history of hypersensitivity or allergies to vedolizumab or its components; 19. The subject has a history of malignancy; 20. The subject is considered as disadvantaged groups, including subjects who are critically ill, who have psychiatric disorders or cognitive impairment; 21. The subject has any of the following laboratory abnormalities: (1) Hemoglobin level 1200 x 10^9/L; (5) Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) > 3 x the upper limit of normal (ULN); (6) Alkaline phosphatase > 3 x ULN; (7) Serum creatinine > 2 x ULN; 22. The subject has any reason that, in the Investigators opinion, may interfere with compliance with study procedures; 23. The subject is unable to attend all the study visits or comply with study procedures; 24.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Clinical remission rate;Endoscopic remission rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| Deep remission rate;Early endoscopic remission rate;Mucosal healing;Endoscopic response rate;Endoscopic improvement rate;Early clinical remission rate;Enhanced clinical response rate; | — |
Countries
China
Contacts
Public ContactQian Cao
Run Run Shaw Hospital Affiliated to Zhejiang University School of Medicine
Outcome results
None listed