NCT02956538

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
72

participants targeted

Target at P75+ for early_phase_1

Timeline
Completed

Started Oct 2016

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2016

Completed
12 days until next milestone

First Submitted

Initial submission to the registry

October 13, 2016

Completed
25 days until next milestone

First Posted

Study publicly available on registry

November 7, 2016

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2018

Completed
Last Updated

November 7, 2016

Status Verified

November 1, 2016

Enrollment Period

2 years

First QC Date

October 13, 2016

Last Update Submit

November 3, 2016

Conditions

Crohn Disease

Outcome Measures

Primary Outcomes (2)

  • 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 Outcomes (2)

  • difference CDAI between different thalidomide dosage group

    1 year

  • difference SES-CD score between different thalidomide dosage group

    1 year

Study Arms (2)

thalidomide

EXPERIMENTAL

thalidomide 100mg tablet by mouth, every night for 8 weeks

Drug: Thalidomide

placebo

ACTIVE COMPARATOR

placebo (for thalidomide) 100mg tablet by mouth, every night for 8 weeks

Drug: placebo(for thalidomide)

Interventions

ThalidomideDRUG
thalidomide
placebo(for thalidomide)DRUG

sugar pill manufactured to mimic thalidomide 100mg tablet

placebo

Eligibility Criteria

Age18 Years - 50 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Gastroenterology

Guangzhou, Guangdong, 510000, China

RECRUITING

MeSH Terms

Conditions

Crohn Disease

Interventions

Thalidomide

Condition Hierarchy (Ancestors)

Inflammatory Bowel DiseasesGastroenteritisGastrointestinal DiseasesDigestive System DiseasesIntestinal Diseases

Intervention Hierarchy (Ancestors)

PhthalimidesPhthalic AcidsAcids, CarbocyclicCarboxylic AcidsOrganic ChemicalsPiperidonesPiperidinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsIsoindolesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-Ring

Study Officials

  • Xiang gao, MD

    Sixth Affiliated Hospital, Sun Yat-sen University

    STUDY CHAIR

Central Study Contacts

Xiang Peng, MM

CONTACT

18302076916stefaniepx@163.com

Min Zhi, MD

CONTACT

13502076916merryzhi@163.com

Study Design

Study Type
interventional
Phase
early phase 1
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Clinical Professor

Study Record Dates

First Submitted

October 13, 2016

First Posted

November 7, 2016

Study Start

October 1, 2016

Primary Completion

October 1, 2018

Study Completion

October 1, 2018

Last Updated

November 7, 2016

Record last verified: 2016-11

Data Sharing

IPD Sharing
Will share

Locations

CN(1)