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a Single-center Registered Clinical Research of Chinese Patients With Moderate to Severe Crohn's Disease

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02088944
Recruitment Status : Unknown
Verified March 2014 by Nanfang Hospital of Southern Medical University.
Recruitment status was:  Not yet recruiting
First Posted : March 17, 2014
Last Update Posted : March 17, 2014
Sponsor:
Information provided by (Responsible Party):
Nanfang Hospital of Southern Medical University

Tracking Information
First Submitted Date March 13, 2014
First Posted Date March 17, 2014
Last Update Posted Date March 17, 2014
Study Start Date March 2014
Estimated Primary Completion Date October 2015   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: March 13, 2014)
CD endoscopic index of severity(CDEIS)<4 [ Time Frame: 4 years ]
Original Primary Outcome Measures Same as current
Change History No Changes Posted
Current Secondary Outcome Measures
 (submitted: March 13, 2014)
no endoscopic ulcer [ Time Frame: 4 years ]
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title a Single-center Registered Clinical Research of Chinese Patients With Moderate to Severe Crohn's Disease
Official Title Not Provided
Brief Summary

Many studies reveal that infliximab (IFX, an immunoglobulin gamma-1 antibody)can response well to Crohn's Disease(CD) patients who are intolerant of corticosteroids and immunosuppressant,or steroids-dependent .More over,A complex fistula in CD is an indication for early IFX therapy in conjunction with surgical drainage.Some papers claim that IFX may prevent enterectomy CD patients from relapsing. Those with risk factors which at diagnosis associated with " disabling disease "include age < 40 years, initial need for steroid therapy, and the presence of perianal disease are recommended to use IFX early.

IFX is approved by State Food And Drug Administration(SFDA) in 2007 ,but the safety is still controversial by then.Some studies proclaim that the side effect may be infections,acute infusion reactions,anaphylactic reactions,autoimmunity,drug-induced lupus,congestive heart failure,abortion and demyelination,etc.

So some problems still need to be settled as follows:1)all the the infliximab dates are from other countries,there is rare date from the Chinese,especially the large quantity of random controlled studies and the CD patients with enterectomy.2)despite of the large number of databases from the international ,when to stop and the predictor of the response is still obscure.3)The high cost of IFX may hinder its applications,especially for the moderate to severe active CD patients who take mesalazine and/or immunosuppressant to maintain remission.In addition,the pathogenic age segments in the occurence of CD: from 15~ 50 years old ,so they suffer from the disability of self-improvements.

The main object of the clinical trial is to complete the database of Chinese CD patients ,especially the safety and efficacy of IFX and those with enterectomy.Then we can record the clinical manifestations of the moderate to severe CD patients with the use of IFX or conventional drugs,including the dose,course and Concomitant treatment.We can also study the predictor and the appropriate time to stop using IFX .We can make the mode of cost-benefit help the patients choose the best project.

Detailed Description Not Provided
Study Type Observational [Patient Registry]
Study Design Observational Model: Case-Control
Time Perspective: Prospective
Target Follow-Up Duration 8 Weeks
Biospecimen Not Provided
Sampling Method Probability Sample
Study Population moderate to severe CD patients
Condition Serological C Reactive Protein or Erythrocyte Sedimentation Rate
Intervention Drug: Infliximab
Study Groups/Cohorts exposed to IFX
Intervention: Drug: Infliximab
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Unknown status
Estimated Enrollment
 (submitted: March 13, 2014)
142
Original Estimated Enrollment Same as current
Study Completion Date Not Provided
Estimated Primary Completion Date October 2015   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion Criteria:

  • CD patients excluded from other diseases who are documented diagnosed with the tissue biopsy from colonoscopy or surgery,or those without tissue biopsy are followed over 6-12months finding that the clinical changs are in line with CD.
  • The moderate to severe CD patients (Best Crohn's disease activity index>220)

Exclusion Criteria:

  • Patients who are not willing to anticipate the trial
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years to 75 Years   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number NCT02088944
Other Study ID Numbers yimi-2
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Nanfang Hospital of Southern Medical University
Study Sponsor Nanfang Hospital of Southern Medical University
Collaborators Not Provided
Investigators Not Provided
PRS Account Nanfang Hospital of Southern Medical University
Verification Date March 2014