Induced Adult Refractory Active Crohn's Disease Clinical Relieving by Using Thalidomide
Primary Purpose
Crohn Disease
Status
Unknown status
Phase
Early Phase 1
Locations
China
Study Type
Interventional
Intervention
Thalidomide
placebo(for thalidomide)
Sponsored by
About this trial
This is an interventional treatment trial for Crohn Disease
Eligibility 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
Sites / Locations
- Department of GastroenterologyRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
thalidomide
placebo
Arm Description
thalidomide 100mg tablet by mouth, every night for 8 weeks
placebo (for thalidomide) 100mg tablet by mouth, every night for 8 weeks
Outcomes
Primary Outcome Measures
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."
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.
Secondary Outcome Measures
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."
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.
Full Information
NCT ID
NCT02956538
First Posted
October 13, 2016
Last Updated
November 3, 2016
Sponsor
Sixth Affiliated Hospital, Sun Yat-sen University
1. Study Identification
Unique Protocol Identification Number
NCT02956538
Brief Title
Induced Adult Refractory Active Crohn's Disease Clinical Relieving by Using Thalidomide
Official Title
Induced Adult Refractory Active Crohn's Disease Clinical Relieving by Using Thalidomide: A Randomized, Double-blind, Placebo-controlled Multicenter Clinical Study
Study Type
Interventional
2. Study Status
Record Verification Date
November 2016
Overall Recruitment Status
Unknown status
Study Start Date
October 2016 (undefined)
Primary Completion Date
October 2018 (Anticipated)
Study Completion Date
October 2018 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Sixth Affiliated Hospital, Sun Yat-sen University
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Crohn Disease
7. Study Design
Primary Purpose
Treatment
Study Phase
Early Phase 1
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
72 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
thalidomide
Arm Type
Experimental
Arm Description
thalidomide 100mg tablet by mouth, every night for 8 weeks
Arm Title
placebo
Arm Type
Active Comparator
Arm Description
placebo (for thalidomide) 100mg tablet by mouth, every night for 8 weeks
Intervention Type
Drug
Intervention Name(s)
Thalidomide
Intervention Type
Drug
Intervention Name(s)
placebo(for thalidomide)
Intervention Description
sugar pill manufactured to mimic thalidomide 100mg tablet
Primary Outcome Measure Information:
Title
difference CDAI between thalidomide group and placebo group
Description
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."
Time Frame
8 weeks
Title
difference SES-CD score between thalidomide group and placebo group
Description
SES-CD means Simple endoscopic score for Crohn's disease ,which predicts long-term prognosis in Crohn's disease patients with clinical remission.
Time Frame
8weeks
Secondary Outcome Measure Information:
Title
difference CDAI between different thalidomide dosage group
Description
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."
Time Frame
1 year
Title
difference SES-CD score between different thalidomide dosage group
Description
SES-CD means Simple endoscopic score for Crohn's disease ,which predicts long-term prognosis in Crohn's disease patients with clinical remission.
Time Frame
1 year
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Xiang Peng, MM
Phone
18302076916
Email
stefaniepx@163.com
First Name & Middle Initial & Last Name or Official Title & Degree
Min Zhi, MD
Phone
13502076916
Email
merryzhi@163.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Xiang gao, MD
Organizational Affiliation
Sixth Affiliated Hospital, Sun Yat-sen University
Official's Role
Study Chair
Facility Information:
Facility Name
Department of Gastroenterology
City
Guangzhou
State/Province
Guangdong
ZIP/Postal Code
510000
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Xiang Peng, MM
Phone
18302076916
Email
stefaniepx@163.com
12. IPD Sharing Statement
Plan to Share IPD
Yes
Learn more about this trial
Induced Adult Refractory Active Crohn's Disease Clinical Relieving by Using Thalidomide
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