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

• Conditions: Inflammatory Bowel Disease Crohn Disease, Ulcerative Colitis; MedDRA version: 6.1Level: PTClassification code 10021972

• Registration Number: EUCTR2005-005414-20-IT
• Lead Sponsor: ISTITUTO PER L INFANZIA BURLO GAROFOLO

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2006-01-31
• Last Update Posted: 19 March 2012

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 124

Inclusion Criteria

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

Exclusion Criteria

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.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified