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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| thalidomide | Experimental | thalidomide 100mg tablet by mouth, every night for 8 weeks |
|
| placebo | Active Comparator | placebo (for thalidomide) 100mg tablet by mouth, every night for 8 weeks |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Thalidomide | Drug |
| ||
| placebo(for thalidomide) |
| Measure | Description | Time Frame |
|---|---|---|
| difference CDAI between thalidomide group and placebo group | 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." | 8 weeks |
| difference SES-CD score between thalidomide group and placebo group | SES-CD means Simple endoscopic score for Crohn's disease ,which predicts long-term prognosis in Crohn's disease patients with clinical remission. | 8weeks |
| Measure | Description | Time Frame |
|---|---|---|
| difference CDAI between different thalidomide dosage group | 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." | 1 year |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Xiang Peng, MM | Contact | 18302076916 | stefaniepx@163.com | |
| Min Zhi, MD | Contact | 13502076916 | merryzhi@163.com |
| Name | Affiliation | Role |
|---|---|---|
| Xiang gao, MD | Sixth Affiliated Hospital, Sun Yat-sen University | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of Gastroenterology | Recruiting | Guangzhou | Guangdong | 510000 | China |
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| ID | Term |
|---|---|
| D003424 | Crohn Disease |
| ID | Term |
|---|---|
| D015212 | Inflammatory Bowel Diseases |
| D005759 | Gastroenteritis |
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
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| ID | Term |
|---|---|
| D013792 | Thalidomide |
| ID | Term |
|---|---|
| D010797 | Phthalimides |
| D010795 | Phthalic Acids |
| D000146 | Acids, Carbocyclic |
| D002264 | Carboxylic Acids |
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sugar pill manufactured to mimic thalidomide 100mg tablet |
|
| difference SES-CD score between different thalidomide dosage group | SES-CD means Simple endoscopic score for Crohn's disease ,which predicts long-term prognosis in Crohn's disease patients with clinical remission. | 1 year |
| D007410 | Intestinal Diseases |
| D009930 |
| Organic Chemicals |
| D010881 | Piperidones |
| D010880 | Piperidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D054833 | Isoindoles |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |