Crohn Disease
Conditions
Brief summary
With the development and application of biological agents, the treatment effect was considerable degree improvement on refractory corn's disease. However, there are quite a part of the CD patients lost response during treatment of using response. Moreover, due to various reasons, there still a lot limited on the using of biological agents in China, that make quite a part of the refractory CD patients lack of further medical treatment options. There has been a RCT study which prove that thalidomide effect and safety on treating refractory CD or who were lost response by using biological agents in Italy, but the object of study is only limited in children and adolescents. There are some small sample studies also confirmed the efficacy and safety on refractory corn's disease by using thalidomide, but need more RCT evidence.
Detailed description
It will be divided two groups of patients by using randomized, double-blind. One group was treated by thalidomide, the other was placebo. It will be unlocked blind and analysis the effect and safety about thalidomide after 8 weeks. The second, patients still use thalidomide after unlock blind to prove its longtime treatment effect and safety.
Interventions
DRUGThalidomide
DRUGplacebo(for thalidomide)
sugar pill manufactured to mimic thalidomide 100mg tablet
Sponsors
Sixth Affiliated Hospital, Sun Yat-sen University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 50 Years
Healthy volunteers
Yes
Inclusion criteria
* Age 18-50 years old * Diagnosis of patients with CD * Disease in the activity: CDA Ⅰ \> 150 points, endoscopic see active lesions * Refractory: immunosuppressive drugs or biological agents which are used in current treatment is invalid and/or intolerance
Exclusion criteria
* Fiber stenosis caused by gastrointestinal obstruction symptoms * Fistula exclude anal fistula * Pregnancy or lactation * Period of women have fertility program during the study * Treatment not foot eight weeks after last IFX * Central or peripheral nerve disease * Abnormal in liver and renal function * Heart function failure * Malignant tumor * Active tuberculosis
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| difference CDAI between thalidomide group and placebo group | 8 weeks | CDAI means Crohn's Disease Activity Index.The purpose of this crohn's disease activity index (CDAI) calculator is to gauge the progress or lack of progress for people with crohn's disease. The reference article says generally speaking, CDAI scores below 150 indicate a better prognosis than higher scores. |
| difference SES-CD score between thalidomide group and placebo group | 8weeks | SES-CD means Simple endoscopic score for Crohn's disease ,which predicts long-term prognosis in Crohn's disease patients with clinical remission. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| difference CDAI between different thalidomide dosage group | 1 year | CDAI means Crohn's Disease Activity Index.The purpose of this crohn's disease activity index (CDAI) calculator is to gauge the progress or lack of progress for people with crohn's disease. The reference article says generally speaking, CDAI scores below 150 indicate a better prognosis than higher scores. |
| difference SES-CD score between different thalidomide dosage group | 1 year | SES-CD means Simple endoscopic score for Crohn's disease ,which predicts long-term prognosis in Crohn's disease patients with clinical remission. |
Countries
China
Contacts
Primary ContactXiang Peng, MM
Backup ContactMin Zhi, MD
Outcome results
None listed