Crohn'
Conditions
Interventions
Patients in the combination therapy of GMA with azathioprine receive intensive GMA (twice per week, total 10 sessions) and oral azathioprine.
Patients in the combination therapy of Infliximab and azat
Sponsors
Department of Gastroenterology and Hepatology, Kyoto University Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Patients with moderately to severely active Crohn's disease (CDAI 220-450) 2) Adequate peripheral venous access to allow for completion of GMA 3) Able to provide informed consent
Exclusion criteria
Exclusion criteria: 1) Patients with granulocyte count of equal to or less than 2,000/mm3 2) Patients with serious infectious disease 3) Patients with serious heart disease 4) Patients with serious kidney disease 5) Patients with hypotension (less than maximum blood pressure 80mmHg) 6) Patients who are pregnant or have the possibility of pregnancy 7) Patients with serious dehydration, hypercoagulability, serious anemia (under haemoglobin 8g/dl) 8) Patients with malignancy 9) Patients with Short-bowel syndrome 10) Patients with permanent ostomy 11) Patients with external fistula, including poor control of anal fistula 12) Patients with total colectomy and subtotal colectomy 13) Patients with intestinal stenosis to cause intestinal obstruction 14) Patients with serious extraintestinal complication 15) Patients who had undergone previous immunosuppressive therapies 16) Patients who had undergone previous biologic therapies 17) Patients who had introduced or increased the dosage of Steroids (intravenous Infusion, oral, enema, suppository) within the last 2 weeks 18) Patients who had introduced or increased the dosage of Metronidazole within the last 2 weeks 19) Patients who had introduced or increased the dosage of Mesalazine sulfasalazine (oral, enema, suppository) within the last 4 weeks 20) Patients who had introduced or increased the dosage of elemental diet within the last 4 weeks 21) Patients who had undergone the operation (except replace of Seton) for anal fistula within 4 weeks 22) Patients who had undergone total parental nutrition with in last 4 weeks 23) Patients who had undergone the operation, including strictureplasty, for bowel within the last 12 weeks
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Remission (CDAI<150) rate at the end of the study (intensive GMA plus azathioprine: at week 7, Infliximab plus azathioprine: at week 8) | — |
Secondary
| Measure | Time frame |
|---|---|
| 1) Clinical response (70 points reduction in their CDAI) 2) Reduction in CRP 3) Cytokine profile in CD4 positive T cell 4) Cumulative non-relapse rate 5) Safety assessment | — |
Countries
Japan
Contacts
Public ContactMinoru Matsuura
Kyoto University Hospital Department of Gastroenterology and Hepatology
Outcome results
None listed