An open label randomized controlled trial of GMA and Infliximab in intractable ulcerative colitis
- Conditions
- lcerative colitis
- Registration Number
- JPRN-UMIN000015068
- Lead Sponsor
- Hiroshima University Hospital, Department of Endoscopy
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Enrolling by invitation
- Sex
- All
- Target Recruitment
- 150
?Patients with moderate to severe activity defined by a DAI score of more than or equal to 6
?Patients with steroid-dependent or steroid-resistant
?Patiens relapse frequently or Chronic persistent type
?Granulocyte count is equal to or less than 2000/ mm3
?Serious infectious disease
?Active tuberculosis
?Patients who have a Hypersensitivity against Infliximab or Protein from mice
?Demyelinating disease
?Congestive heart failure
?Serious heart disease
?Serious kidney disease
?Hypotonicity (less than maximum blood pressure 80mmHg)
?Pregnancy or suspected
?Serious exsiccation / serious coagulation, serious anemia(under hemoglobin 8g/dl)
?Malignancy
?Introduce or increase the dosage of Steroids(intravenous infusion) within the last 1 week.
?Introduce or increase the dosage of Steroids(oral, enema, suppository) within the last 2 weeks.
?Introduce or increase the dosage of Mesalazine Sulfasalazine(oral, enema, suppository) within the last 4 weeks.
?Introduce or increase the dosage of Cyclosporine, Tacrolimus, Methotrexate within the last 8 weeks.
?Introduce or increase the dosage of Azathioprine, 6-mercaptopurine within the last 12 weeks.
?Introduce of Infliximab, Adalimumab, GMA, LCAP within the last 3 months.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Response rate at week 10
- Secondary Outcome Measures
Name Time Method ?Remission rate at week 10 (DAI =< 2)<br>?Endoscopic remission rate<br>?Reduction in partial DAI score at week 2, week 6, week 10<br>?The incidence of adverse events