Serological C Reactive Protein or Erythrocyte Sedimentation Rate Clinical Trial
| NCT number | NCT02088944 |
| Other study ID # | yimi-2 |
| Secondary ID | |
| Status | Not yet recruiting |
| Phase | N/A |
| First received | March 13, 2014 |
| Last updated | March 13, 2014 |
| Start date | March 2014 |
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.
| Status | Not yet recruiting |
| Enrollment | 142 |
| Est. completion date | |
| Est. primary completion date | October 2015 |
| Accepts healthy volunteers | No |
| Gender | Both |
| Age group | 18 Years to 75 Years |
| Eligibility |
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 |
Observational Model: Case Control, Time Perspective: Prospective
| Country | Name | City | State |
|---|---|---|---|
| n/a | |||
| Lead Sponsor | Collaborator |
|---|---|
| Nanfang Hospital of Southern Medical University |
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | CD endoscopic index of severity(CDEIS)<4 | 4 years | Yes | |
| Secondary | no endoscopic ulcer | 4 years | Yes |