Efficacy Study of T2 Versus AZA to Maintain Clinical and Endoscopic Remission in Postoperative Crohn's Disease

• Status: Unknown status
• Trial end date: 2013-06-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to see whether T2 versus Azathioprine is able to maintain the clinical and endoscopic remission in subjects with Crohn's disease after surgery-induced remission.

The side effects related to T2 and AZA will also be monitored throughout the study.

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Jinling Hospital, China
• Treatments: Azathioprine

Criteria

Inclusion Criteria:

• Subjects should have a definitive diagnosis of Crohn's disease, based on WHO criteria

• Subjects having curative resection/ileocolonic anastomosis，pathologically diagnosed as Crohn's disease

• Lesions located in ileum or ileocecal region

• Males and females ≥ 18 years old, including women who are not pregnant or lactating at the time of enrollment.

• Body weight between 40 and 100 kg, inclusive.

• Subjects should have a CDAI score <150 at week 0

• Able to swallow tablets

• Are capable of providing written informed consent and obtained at the time of enrollment

• Willing to adhere to the study visit schedule and other protocol requirements.

Exclusion Criteria:

• Bacterial,viral or other microbial infection(including HIV)

• any of the following medications taken within 12 weeks before surgery: cyclosporine, tacrolimus, sirolimus, mycophenolate mofetil, or other investigational drugs

• any of ongoing therapy for Crohn's disease with: 5-ASA compounds, steroids, immune modifiers, systemic antibiotics, and tube feeding

• Needing orally administered corticosteroids for the treatment of other diseases. Inhaled or dermatologic preparations are acceptable.

• Previous or current use of infliximab.

• current use of prescription doses or chronic/frequent use of NSAIDs

• Treatment with narcotic pain medications. (Anti-diarrheal agents such as loperamide and diphenoxylate are permitted, providing that the dose is not increased during the study period.)

• With an ileal or colonic stoma.

• History of pancreatitis, except for subjects with a known but removed cause(such as gallstone pancreatitis)

• WBC <3.0 x 109/L, hemoglobin <80 g/L, Platelets<50,000/mm3 at the time of enrollment (or within the previous 6 months, if known)

• History of abnormal liver function tests, including AST or ALT >1.5 times upper limit of normal, alkaline phosphatase >2 times upper limit of normal, total bilirubin >2.5 mg/dL at screening (or within the previous 6 months, if known)

• With short bowel syndrome (defined as requiring oral or parenteral supplemental or total nutrition to maintain stable body weight, or more than 100 cm of small bowel resected)

• History of malignancy

• Women who are pregnant or lactating at the time of enrollment, or who intend to be during the study period.

• Participation in other clinical trial within the past 6 months