Crohn's Disease Clinical Trial
Official title:
Thalidomide in Inducing and Maintaining Remission of Crohn's Disease
Crohn's disease (CD) is a chronic gastrointestinal inflammatory disease characterized by
relapse and progression. The incidence and prevalence of IBD are increasing in different
regions around the world, indicating its emergence as a global disease. Though modern
medical therapies including immunomodulators and biologic agents have revolutionized
treatment of CD, the occurrence of steroids-dependence and resistance or intolerance to
medical therapy is quite common. The limitation of present therapeutic management and the
high expense of biologic agents leads to the treatment of CD become "refractoriness". The
occurrence rate of steroids-dependence and resistance or intolerance to thiopurine therapy
is quite high during the course of CD. Approximately 38% of cases required surgery within 10
years. Therefore, the management of such refractory CD remains a great therapeutic challenge
for clinicians.
Thalidomide is an oral agent that has immunomodulatory, antiangiogenic and TNF(tumor
necrosis factor)-a- suppressing effects. The potential role for thalidomide in the treatment
of refractory paediatric and adult CD has been investigated in more and more small
open-label studies and retrospective case series. Recently, a randomized controlled trial
showed thalidomide improved clinical remission at 8 weeks of treatment and longer-term
maintenance of remission in pediatric refractory CD. Gerich et al reported in a
retrospective study that thalidomide improved long-term outcomes among 37 refractory CD
adults followed up for a median of 58 months. However, the dose of thalidomide used in these
studies ranged from 50mg/d to 150mg/d, and the occurrence rate of side effects reported
variously but all quite high. The side effects related to the dose of thalidomide were the
major concerns of using it in CD. Moreover, the effect of thalidomide on endoscopic response
including mucosal healing which is a more objective and important outcome in CD was rarely
reported. Therefore the aim of this study is to investigate the efficacy on clinical and
endoscopic response and the adverse effects of using low-dose thalidomide in active adult CD
patients.
n/a
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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