Efficacy Study of T2 Versus AZA to Maintain Clinical and Endoscopic Remission in Postoperative Crohn's Disease
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.
|Study Design:||Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||A Randomized, Controlled, Open-label Study to Assess the Efficacy of T2 Versus Azathioprine for the Maintenance of Clinical and Endoscopic Remission in Subjects With Crohn's Disease After Surgical Resection|
- Clinical Remission: the proportion of patients with CDAI <150 at 26 and 52 weeks [ Time Frame: 52 weeks ] [ Designated as safety issue: No ]
- Endoscopic Remission: the proportion of patients with CDEIS <6 at 26 and 52 weeks [ Time Frame: 52 weeks ] [ Designated as safety issue: No ]
- The time till the clinical relapse of CD(the CDAI >150 or an increase of more than 70 points) [ Time Frame: 52 weeks ] [ Designated as safety issue: No ]
- The time till the histological recurrence(determined by biopsies and endoscopic findings) [ Time Frame: 52 weeks ] [ Designated as safety issue: No ]
- Serum C-reactive protein concentration; Erythrocyte Sedimentation Rate [ Time Frame: 52 weeks ] [ Designated as safety issue: No ]
- The proportion of patients experiencing adverse events [ Time Frame: 52 weeks ] [ Designated as safety issue: Yes ]
|Study Start Date:||November 2009|
|Estimated Study Completion Date:||June 2013|
|Estimated Primary Completion Date:||June 2013 (Final data collection date for primary outcome measure)|
1.5mg/kg/day, PO (per oral),three times a day: until progression or unacceptable toxicity develops
|Active Comparator: AZA||
2.5mg/kg, PO (per oral) one time a day:until progression or unacceptable toxicity develops the first month:1.5mg/kg,PO,one time a day the second month:2.0mg/kg,PO,one time a day since the third month:2.5mg/kg,PO,one time a day
Crohn's disease is characterized by inflammation and ulceration of the small intestine and colon. Patients commonly experience abdominal pain, diarrhea，malnutrition and malaise which result in decreased quality of life and an increased risk of chronic disability and unemployment. Surgical resection is required in approximately 70% of the patients at some time. However, recurrence of the disease after operation occurs in the majority of patients and is a serious limitation of surgical management. Patients' quality of life is often severely diminished. Currently available therapeutic options for the maintenance of remission in Crohn's disease are inadequate. A clear need exists for well-tolerated drugs that can reliably reduce the risk of a disease relapse.
AZA is classical immunomodulator,often applied to hematologic diseases and immune-related diseases,also the most commonly used drug in the maintenance of remission in Crohn's disease, it is indicated in steroid resistant or dependent patients, in those whose frequency of relapse is >1 per year, in patients after induction of remission with IFX, and in patients whose remission were induced by surgical resection. However, AZA may cause some adverse effects,the most serious adverse effect is leucopenia, which can develop suddenly and unpredictably, though it is rare (around 3%).
T2 is a chloroform/methanol extract Tripterygium wilfordii Hook F (TWHF), the traditional Chinese medicine,used in rheumatoid arthritis and nephritis. It has both immunomodulatory and anti-inflammatory activities.Our previous animal studies have revealed that the major component of T2, triptolide, could prevent the development of chronic colitis in interleukin-10 deficient mice. The phase I clinical trial in our institute also demonstrated that T2, or combined with enteral nutrition, is efficient for induction of remission in patients with active Crohn's disease.The common adverse effects of T2 are leucopenia,liver renal toxicity,oligospermia and amenorrhea.
|Contact: Weiming Zhu, PhD,MDfirstname.lastname@example.org|
|General Surgery Institute,Jinling Hospital||Recruiting|
|Nanjing, Jiangsu, China, 210000|
|Contact: Weiming Zhu, PhD,MD +86-25-80860137 email@example.com|
|Principal Investigator: Weiming Zhu, PhD,MD|
|Principal Investigator:||Weiming Zhu, PhD,MD||General Surgery Institute,Jinling Hospital,Nanjing,Jiangsu,China|