Thalidomide in Pediatric Inflammatory Bowel Diseases. (TALIBDP)
Several open-label studies reported thalidomide efficacy in inducing clinical remission and steroid tapering in refractory Inflammatory Bowel diseases (IBD), both in adults and in children.
This is a randomized placebo controlled (RCT) double blind study, to evaluate the efficacy of thalidomide in inducing clinical remission at 8 weeks in refractory IBD patients aged 2-20 years.
The primary hypotheses of the study is that thalidomide would be more effective than placebo in inducing clinical remission.
The RCT phase is followed by a open-label phase, to further evaluate efficacy and safety of thalidomide in thalidomide responders, with a total follow up of one year.
Inflammatory Bowel Diseases
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
|Official Title:||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.|
- Clinical Remission [ Time Frame: 8°, 12°, 26, 52° weeks ] [ Designated as safety issue: No ]
- Clinical response [ Time Frame: 4°, 8° weeks ] [ Designated as safety issue: No ]
- Steroid dose reduction [ Time Frame: 8°, 12°, 26, 52° weeks ] [ Designated as safety issue: No ]
- Endoscopic remission [ Time Frame: 12°, 26, 52° weeks ] [ Designated as safety issue: No ]
- Adverse effects [ Time Frame: 4°, 8°, 12°, 26, 52° weeks ] [ Designated as safety issue: Yes ]
- Nutritinal indicators [ Time Frame: 8°, 52° ] [ Designated as safety issue: No ]Weight-on-age z-scores (WAZ) 8°, 52° Body Mass Index (BMI) z-scores 8°, 52° Height-on-age z-scores (HAZ) 52°
|Study Start Date:||August 2008|
|Study Completion Date:||June 2012|
|Primary Completion Date:||September 2011 (Final data collection date for primary outcome measure)|
Thalidomide 1.5-2.5 mg/kg/die once a day, at evening.
Placebo Comparator: 2
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|Department of Pediatrics, Ospedale Meyer.|
|Florence., Florence, Italy|
|Anatomy and Hystology, Spedali Civili di Brescia, University of Brescia.|
|Pediatric Gastroenterology Unit, IRCCS Gaslini.|
|Pediatric Gastroenterology Unit, University of Messina.|
|Department of Pediatrics, Ospedali Buzzi.|
|Gastroenterology and Hepatology, University of Pisa.|
|Unit of Biochemistry and Pharmacology, University of Triest.|
|Study Chair:||Alessandro Ventura, MD||IRCCS Burlo Garofolo|
|Study Director:||Marzia Lazzerini, MD||IRCCS Burlo Garofolo|