Rapid LeukocyAPheresis InDuction for Ulcerative Colitis
Phase 2
- Conditions
- ulcerative colitis
- Registration Number
- JPRN-UMIN000005358
- Lead Sponsor
- ower Gastroenterology, Hyogo College of Medicine
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up complete
- Sex
- All
- Target Recruitment
- 40
Inclusion Criteria
Not provided
Exclusion Criteria
1) Patients with proctitis 2) Patients with chronic persistent UC 3) Patients having consecutively received corticosteroids therapy of 5mg/day or more, for more than 3 months 4) Patients having consecutively received corticosteroids enema therapy for more than 3 months 5) Patients with either white blood cell count of less than 3,000/mm3, or hemoglobin level of less than 10g/dL, or platelet count of less than 100,000/mm3 6) Patients who are younger than 12 years old or who are older than 80 years old. 7) Patients determined to be inappropriate for this study by the investigators
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method The primary outcome is the improvement of Mayo score obtained after 6th LCAP. Mayo score is taken before (within 2 weeks of starting LCAP) and after 6th LCAP. Partial-Mayo score is taken at every visit and/or whenever the score has to be taken without endoscopic evaluation.
- Secondary Outcome Measures
Name Time Method The secondary outcome is the Lichtiger's clinical activity index taken before (within 2 weeks of starting LCAP) and after 6th LCAP.