Crohn Disease Clinical Trial
Official title:
Thalidomide, a Novel Immunological Treatment to Modify the Natural History of Paediatric Crohn's Disease: a New Proposal From a Well-established Paediatric Research Network
Crohn's disease (CD) is a life-long inflammatory bowel disease disease with an unknown
pathogenesis. The ultimate goal of therapy is to modify the natural history of CD thus
reducing complications. Thalidomide is a small molecule with immunomodulatory and
anti-angiogenetic properties. It is currently approved for the treatment of erythema nodosum
leprosum, an immunological complication of leprosy and multiple myeloma. It has also been
used in several other inflammatory diseases of the skin and of the mucosal membranes, such as
Behcet disease, oropharyngeal ulcers in AIDS, cutaneous lupus, and graft versus host disease.
Many case series and one pediatric randomized controlled trial proved the efficacy of
thalidomide in the treatment of children with CD refractory to standard treatments. In these
patients, clinical remission was achieved in about 50% of the cases and was maintained for a
mean time superior of 3 years. Mucosal healing after 52 weeks of treatment was observed in
40% of the patients in clinical remission. Moreover, thalidomide was found to have a
steroid-sparing effect and to decrease the need for surgical interventions. The clinical and
endoscopic efficacy of thalidomide was also observed in children with failure to respond or
intolerance to anti-TNF biological drugs.
The aim of this multicentric prospective randomized controlled is to evaluate the efficacy
and safety of thalidomide vs infliximab in changing the natural history of CD in patients
with poor prognostic outcome. Moreover, the study will evaluate the immunological and
genetical mechanisms of CD, the mechanisms of action thalidomide in CD and will the
pharmacokinetics, metabolomics and pharmacogenomics of thalidomide, and their impact on
thalidomide safety and effectiveness.
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