Evaluation of mucosal healing effects of intensive-granulocyte monocyte absorptive apheresis in patients with ulcerative colitis
- Conditions
- lcerative colitis
- Registration Number
- JPRN-UMIN000039958
- Lead Sponsor
- ational Defense Medical College
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 80
Not provided
1.Patients with granulocyte count 2,000/mm3 or less 2.Patients with serious infectious disease 3.Patients with proctitis 4.Patients who used of enema, suppository (mesalazine, sulfasalazine, steroids) within the last 2 weeks 5.Patients who started administration or increased the dosage of mesalazine, sulfasalazine within the last 4 weeks 6.Patients who started administration or increased the dosage of steroids (oral) within the last 2 weeks 7.Patients who received steroids (intravenous infusion) within the last 2 weeks 8.Patients who used of total parenteral nutrition within the last 4 weeks 9.Patients who received cyclosporine, tacrolimus within the last 4 weeks 10.Patients who started administration or increased the dosage of azathioprine, 6-mercaptopurine within the last 4 weeks 11.Patients who received infliximab within the last 6 weeks 12.Patients who used of GMA, LCAP within the last 8 weeks 13.Patients with history of colectomy 14.Patients with inappropriate for this study by doctor's judgement 15.Patients who refused to participate in this study
Study & Design
- Study Type
- Observational
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Mucosal healing rate (Endoscopic score of Mayo index)
- Secondary Outcome Measures
Name Time Method Remission rate (Mayo score) Efficacy (Mayo score) Changes in mRNA expression levels of inflammation associated molecules in colonic mucosa