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

NCT01015391 | Unknown

• 1 other identifier: TW2-001
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Crohn's Disease

Keywords

T2; AZA; remission; Crohn's disease

Outcome Measures

Primary Outcomes (2)

• Clinical Remission: the proportion of patients with CDAI <150 at 26 and 52 weeks

  52 weeks

• Endoscopic Remission: the proportion of patients with CDEIS <6 at 26 and 52 weeks

  52 weeks

Secondary Outcomes (4)

• The time till the clinical relapse of CD(the CDAI >150 or an increase of more than 70 points)

  52 weeks

• The time till the histological recurrence(determined by biopsies and endoscopic findings)

  52 weeks

• Serum C-reactive protein concentration; Erythrocyte Sedimentation Rate

  52 weeks

• The proportion of patients experiencing adverse events

  52 weeks

Study Arms (2)

T2

EXPERIMENTAL

Drug: T2

AZA

ACTIVE COMPARATOR

Drug: Azathioprine

Interventions

T2 DRUG

1.5mg/kg/day, PO (per oral),three times a day: until progression or unacceptable toxicity develops

T2

Azathioprine DRUG

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

AZA

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Jinling Hospital, China: lead

Study Sites (1)

General Surgery Institute,Jinling Hospital

Nanjing, Jiangsu, 210000, China

RECRUITING

Related Publications (10)

• Hanauer SB, Korelitz BI, Rutgeerts P, Peppercorn MA, Thisted RA, Cohen RD, Present DH. Postoperative maintenance of Crohn's disease remission with 6-mercaptopurine, mesalamine, or placebo: a 2-year trial. Gastroenterology. 2004 Sep;127(3):723-9. doi: 10.1053/j.gastro.2004.06.002.

  PMID: 15362027 BACKGROUND

• Almer SH, Hjortswang H, Hindorf U. 6-Thioguanine therapy in Crohn's disease--observational data in Swedish patients. Dig Liver Dis. 2009 Mar;41(3):194-200. doi: 10.1016/j.dld.2008.07.314. Epub 2008 Sep 16.

  PMID: 18799369 BACKGROUND

• Goldbach-Mansky R, Wilson M, Fleischmann R, Olsen N, Silverfield J, Kempf P, Kivitz A, Sherrer Y, Pucino F, Csako G, Costello R, Pham TH, Snyder C, van der Heijde D, Tao X, Wesley R, Lipsky PE. Comparison of Tripterygium wilfordii Hook F versus sulfasalazine in the treatment of rheumatoid arthritis: a randomized trial. Ann Intern Med. 2009 Aug 18;151(4):229-40, W49-51. doi: 10.7326/0003-4819-151-4-200908180-00005.

  PMID: 19687490 BACKGROUND

• Peyrin-Biroulet L, Deltenre P, Ardizzone S, D'Haens G, Hanauer SB, Herfarth H, Lemann M, Colombel JF. Azathioprine and 6-mercaptopurine for the prevention of postoperative recurrence in Crohn's disease: a meta-analysis. Am J Gastroenterol. 2009 Aug;104(8):2089-96. doi: 10.1038/ajg.2009.301. Epub 2009 Jun 30.

  PMID: 19568226 BACKGROUND

• Ren J, Tao Q, Wang X, Wang Z, Li J. Efficacy of T2 in active Crohn's disease: a prospective study report. Dig Dis Sci. 2007 Aug;52(8):1790-7. doi: 10.1007/s10620-007-9747-y. Epub 2007 Apr 5.

  PMID: 17410440 BACKGROUND

• Wei X, Gong J, Zhu J, Niu L, Zhu W, Li N, Li J. Therapeutic effects of triptolide on interleukin-10 gene-deficient mice with colitis. Int Immunopharmacol. 2008 Dec 20;8(13-14):1808-12. doi: 10.1016/j.intimp.2008.08.019. Epub 2008 Sep 17.

  PMID: 18804190 BACKGROUND

• Wei X, Gong J, Zhu J, Wang P, Li N, Zhu W, Li J. The suppressive effect of triptolide on chronic colitis and TNF-alpha/TNFR2 signal pathway in interleukin-10 deficient mice. Clin Immunol. 2008 Nov;129(2):211-8. doi: 10.1016/j.clim.2008.07.018. Epub 2008 Aug 30.

  PMID: 18757245 BACKGROUND

• Caprilli R, Gassull MA, Escher JC, Moser G, Munkholm P, Forbes A, Hommes DW, Lochs H, Angelucci E, Cocco A, Vucelic B, Hildebrand H, Kolacek S, Riis L, Lukas M, de Franchis R, Hamilton M, Jantschek G, Michetti P, O'Morain C, Anwar MM, Freitas JL, Mouzas IA, Baert F, Mitchell R, Hawkey CJ; European Crohn's and Colitis Organisation. European evidence based consensus on the diagnosis and management of Crohn's disease: special situations. Gut. 2006 Mar;55 Suppl 1(Suppl 1):i36-58. doi: 10.1136/gut.2005.081950c.

  PMID: 16481630 BACKGROUND

• Travis SP, Stange EF, Lemann M, Oresland T, Chowers Y, Forbes A, D'Haens G, Kitis G, Cortot A, Prantera C, Marteau P, Colombel JF, Gionchetti P, Bouhnik Y, Tiret E, Kroesen J, Starlinger M, Mortensen NJ; European Crohn's and Colitis Organisation. European evidence based consensus on the diagnosis and management of Crohn's disease: current management. Gut. 2006 Mar;55 Suppl 1(Suppl 1):i16-35. doi: 10.1136/gut.2005.081950b.

  PMID: 16481629 BACKGROUND

• Stange EF, Travis SP, Vermeire S, Beglinger C, Kupcinkas L, Geboes K, Barakauskiene A, Villanacci V, Von Herbay A, Warren BF, Gasche C, Tilg H, Schreiber SW, Scholmerich J, Reinisch W; European Crohn's and Colitis Organisation. European evidence based consensus on the diagnosis and management of Crohn's disease: definitions and diagnosis. Gut. 2006 Mar;55 Suppl 1(Suppl 1):i1-15. doi: 10.1136/gut.2005.081950a. No abstract available.

  PMID: 16481628 BACKGROUND

MeSH Terms

Conditions

Crohn Disease

Interventions

Azathioprine

Condition Hierarchy (Ancestors)

Inflammatory Bowel Diseases; Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Intestinal Diseases

Intervention Hierarchy (Ancestors)

Thionucleosides; Sulfur Compounds; Organic Chemicals; Mercaptopurine; Purines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides

Study Officials

• Weiming Zhu, PhD,MD

  General Surgery Institute,Jinling Hospital,Nanjing,Jiangsu,China

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Weiming Zhu, PhD,MD

CONTACT

+86-25-80860137; juwiming@yahoo.com.cn

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: vice director of General surgery institute

Study Record Dates

• First Submitted: November 17, 2009
• First Posted: November 18, 2009
• Study Start: November 1, 2009
• Primary Completion: June 1, 2013
• Study Completion: June 1, 2013
• Last Updated: June 4, 2013

Record last verified: 2013-06

Locations

CN (1)