Crohn'
Conditions
Interventions
Repeat 3 sets of the concomitant therapy with IFX and GMA. Each set is consisted from a single 5mg/kg/dose of infliximab infusion plus 3 times of weekly GMA at 5, 6, and 7 weeks after IFX infusion.
Re
Sponsors
Department of Lower Gastroenterology, Hyogo College of Medicine
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: (1) Patient of ileo-colitis or colitis type Crohn's disease (2) Patients with Crohn's disease showing temporary clinical remission (CDAI less than 150) in response to 5mg/kg/dose infliximab therapy but poorly responding (CDAI over 175 and increase more than 50 points during the recent 4 weeks) to subsequent maintenance infliximab therapy (5mg/kg/dose, every 8 weeks). (3) Patients age from 16 to 74. (4) Patients considered being capable for venous catheter insertion
Exclusion criteria
Exclusion criteria: (1) Cases that granulocyte count below 2000/mm3 (2) Cases that complication by infection present or suspected (3) Patients with severe heart disease (4) Patients with severe kidney disease (5) Patients with hypotension (Systolic blood pressure less than 80mmHg) (6) Patients willing or being pregnant (or lactation). (7) Patient with severe dehydration and/or hyper-viscosity. Patients with severe anemia (Hb <8g/dL) (8) Patients with malignant tumor (9) Patients with colostomy (10) Patients with uncontrollable external-fistulas. (11) Patients with intestinal stenosis. (12) Patients with severe extra-intestinal complications. (13) Patients with short bowel syndrome. (14) Patients after total colectomy. (15) Patients who have been treated with corticosteroids (iv, po, or topical) within 2 weeks. (16) Patients who have treated with intravenous hyperalimentation (IVH) within 4 weeks. (17) Patients who have been given more than 1,200kcal of elemental nutrition within 4 weeks. (18) Patients who have episode of starting or increasing dosage of thioprine within 8 weeks. (19) Patients who do not submit informed consent (20) Patients who have been treating with non-approval therapy and/or enrolling other clinical trials. (21) Other patients judged as inappropriate by the physician
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change in CDAI at 24 weeks relative to the base-line | — |
Secondary
| Measure | Time frame |
|---|---|
| (1) CDAI scores at each observation period (2) The CDAI 50 points improvement ratio (CR50) at each observation period (3) Remission (CDAI<150) induction rate at each observation period (4) Change in CDAI at each observation period relative to the base-line. (5) The CRP values at each observation period (6) Change in CRP and ESR at each observation period relative to the base-line. (7) Change in secretions of the various peripheral cytokine at each observation period relative to the base-line. (8) Endoscopic and/or barium enema evaluation comparing between pre- (-8 to 0 week) and post- (24 to 28 weeks) allocation (9) Incidence of adverse events etc. | — |
Countries
Japan
Contacts
Public ContactKen Fukunaga
Hyogo College of Medicine Department of Lower Gastroenterology
Outcome results
None listed