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

Induced Adult Refractory Active Crohn's Disease Clinical Relieving by Using Thalidomide: A Randomized, Double-blind, Placebo-controlled Multicenter Clinical Study

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.

Study Overview

• Status: Unknown
• Conditions: Crohn Disease
• Intervention / Treatment: Drug: Thalidomide; Drug: placebo(for thalidomide)

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.

• Study Type: Interventional
• Enrollment (Anticipated): 72
• Phase: Early Phase 1

Contacts and Locations

Study Locations

• China
  • Guangdong
    • Guangzhou, Guangdong, China, 510000
      • Recruiting
      • Department of Gastroenterology
      • Contact: Xiang Peng, MM; Phone Number: 18302076916; Email: stefaniepx@163.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 50 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Secondary Outcome Measures

Outcome Measure	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
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

Collaborators and Investigators

• Sponsor: Sixth Affiliated Hospital, Sun Yat-sen University
• Investigators: Study Chair: Xiang gao, MD, Sixth Affiliated Hospital, Sun Yat-sen University

Study record dates

Study Major Dates

• Study Start: October 1, 2016
• Primary Completion (Anticipated): October 1, 2018
• Study Completion (Anticipated): October 1, 2018

Study Registration Dates

• First Submitted: October 13, 2016
• First Submitted That Met QC Criteria: November 3, 2016
• First Posted (Estimate): November 6, 2016

Study Record Updates

• Last Update Posted (Estimate): November 6, 2016
• Last Update Submitted That Met QC Criteria: November 3, 2016
• Last Verified: November 1, 2016

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Gastrointestinal Diseases; Gastroenteritis; Intestinal Diseases; Inflammatory Bowel Diseases; Crohn Disease; Physiological Effects of Drugs; Anti-Infective Agents; Antineoplastic Agents; Immunosuppressive Agents; Immunologic Factors; Angiogenesis Inhibitors; Angiogenesis Modulating Agents; Growth Substances; Growth Inhibitors; Anti-Bacterial Agents; Leprostatic Agents; Thalidomide
• Other Study ID Numbers: E2016022

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES