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Induced Adult Refractory Active Crohn's Disease Clinical Relieving by Using Thalidomide

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ClinicalTrials.gov Identifier: NCT02956538
Recruitment Status : Unknown
Verified November 2016 by Xiang Gao, Sixth Affiliated Hospital, Sun Yat-sen University.
Recruitment status was:  Recruiting
First Posted : November 7, 2016
Last Update Posted : November 7, 2016
Sponsor:
Information provided by (Responsible Party):
Xiang Gao, Sixth Affiliated Hospital, Sun Yat-sen University

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.

Condition or disease Intervention/treatment Phase
Crohn Disease Drug: Thalidomide Drug: placebo(for thalidomide) Early Phase 1

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 72 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: Induced Adult Refractory Active Crohn's Disease Clinical Relieving by Using Thalidomide: A Randomized, Double-blind, Placebo-controlled Multicenter Clinical Study
Study Start Date : October 2016
Estimated Primary Completion Date : October 2018
Estimated Study Completion Date : October 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Crohn's Disease
Drug Information available for: Thalidomide

Arm Intervention/treatment
Experimental: thalidomide
thalidomide 100mg tablet by mouth, every night for 8 weeks
Drug: Thalidomide
Active Comparator: placebo
placebo (for thalidomide) 100mg tablet by mouth, every night for 8 weeks
Drug: placebo(for thalidomide)
sugar pill manufactured to mimic thalidomide 100mg tablet




Primary Outcome Measures :
  1. difference CDAI between thalidomide group and placebo group [ Time Frame: 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."

  2. difference SES-CD score between thalidomide group and placebo group [ Time Frame: 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 Outcome Measures :
  1. difference CDAI between different thalidomide dosage group [ Time Frame: 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."

  2. difference SES-CD score between different thalidomide dosage group [ Time Frame: 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.



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Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02956538


Contacts
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Contact: Xiang Peng, MM 18302076916 stefaniepx@163.com
Contact: Min Zhi, MD 13502076916 merryzhi@163.com

Locations
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China, Guangdong
Department of Gastroenterology Recruiting
Guangzhou, Guangdong, China, 510000
Contact: Xiang Peng, MM    18302076916    stefaniepx@163.com   
Sponsors and Collaborators
Sixth Affiliated Hospital, Sun Yat-sen University
Investigators
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Study Chair: Xiang gao, MD Sixth Affiliated Hospital, Sun Yat-sen University

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Responsible Party: Xiang Gao, Clinical Professor, Sixth Affiliated Hospital, Sun Yat-sen University
ClinicalTrials.gov Identifier: NCT02956538     History of Changes
Other Study ID Numbers: E2016022
First Posted: November 7, 2016    Key Record Dates
Last Update Posted: November 7, 2016
Last Verified: November 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Additional relevant MeSH terms:
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Crohn Disease
Inflammatory Bowel Diseases
Gastroenteritis
Gastrointestinal Diseases
Digestive System Diseases
Intestinal Diseases
Thalidomide
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Leprostatic Agents
Anti-Bacterial Agents
Anti-Infective Agents
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Growth Inhibitors
Antineoplastic Agents