Randomized controlled double-blind Vs. placebo multicentre study on the safety and effectiveness of thalidomide in the treatment of refractory Crohn s disease and ulcerative colitis. - Thalidomide and IBD

ISTITUTO PER L INFANZIA BURLO GAROFOLO0 个研究点目标入组 124 人开始时间: 2006年1月31日最近更新: 2012年3月19日

适应症

试验速览

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•Children, adolescents and young adults aged 2 to 20 with chronic refractory moderate to severe inflammatory bowel disease, referred by the seven pediatric centres participating in the study. Definition of patient with refractory diseasePatients with active disease despite steroid therapy at a dose 2 mg/kg/die for 8 weeks of prednisone maximum 60mg/day or equivalent and/or an immunosuppressive of proven efficacy azathioprine o 6-mercaptopurine for 4 months; methotrexate for 3 months; Infliximab at the dose of 5 mg/kg at week 0,2,6 weeks; cyclosporine at the dose of 2mg/kg/day for 4 weeks or 1 week at 1m/kg/day EV or patients exhibiting intolerance to these drugs which prevent them from continuing treatment.
•Are the trial subjects under 18? yes
•Number of subjects for this age range:
•F.1.2 Adults (18-64 years) no
•F.1.2.1 Number of subjects for this age range
•F.1.3 Elderly (>=65 years) no
•F.1.3.1 Number of subjects for this age range

•a Patients with ileostomy or colostomy. b Disease requiring immediate surgical intervention. c Severe ulcerative colitis or toxic megacolon. d Contraindications to using thalidomide on-going pregnancy, neuropathy e Any of the following conditions active infection, stool culture positive for enteric pathogens, tumors, HIV, transplanted organ, or non-controlled disease of the kidney, liver, endocrine system, heart, blood, nervous system or brain. f Patients being treated with other drugs as part of an experimental study. g Patients treated with infliximab in the previous eight weeks.

发起方

ISTITUTO PER L INFANZIA BURLO GAROFOLO