Ulcerative colitis
Conditions
Interventions
Infliximab will be administered intravenously at the dose of 5 mg/kg at 0, 2, 6 weeks
GMA will be administrated 10 times
Sponsors
Hiroshima University Hospital, Department of Endoscopy
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: ?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
Exclusion criteria
Exclusion criteria: ?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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Response rate at week 10 | — |
Secondary
| Measure | Time frame |
|---|---|
| ?Remission rate at week 10 (DAI =< 2) ?Endoscopic remission rate ?Reduction in partial DAI score at week 2, week 6, week 10 ?The incidence of adverse events | — |
Countries
Japan
Outcome results
None listed