Phase 2a clinical trial for Crohn disease using adrenomedulli
Phase 2
Completed
- Conditions
- Crohn disease
- Registration Number
- JPRN-jRCT2080223890
- Lead Sponsor
- niversity of Miyazaki
- Brief Summary
In this trial, we observed a long-lasting (24 weeks) decrease in CDAI in the adrenomedullin-treated groups. Adrenomedullin might be beneficial for biologic-resistant CD, but further research is needed.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- completed
- Sex
- All
- Target Recruitment
- 24
Inclusion Criteria
Biologics-resistant patients against maintenance therapy of biologics
Exclusion Criteria
Non-responder for biologics
Patients with small intestinal lesion and having risk of ileus
Patient with fulminant Crohn disease(CD)
Patient need early operation for CD
Patient with active infection
Patient with severe complication(s)
Patient with malignancy or past history of malignancy
Pregnant woman
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method efficacy<br>change of CDAI at week 8
- Secondary Outcome Measures
Name Time Method safety<br>efficacy<br>change of CDAIat week 4 and 6 <br>effective rate of CDAI at week 8<br>endoscopic evaluation (SESCD) at week 8<br>change of CRP at week 4 and 8<br>fecal immunochemical test and calprotectin at week 1