Crohn'
Conditions
Interventions
Adalimumab therapy (40 mg/dose, every other week) combined with Granulocyte/ Monocyte Apheresis (GMA), once weekly for 5 comsecutive weeks. If responses are noted, GMA is applied for another 5 session
Sponsors
Department of Lower Gastroenterology, Hyogo College of Medicine
Hyogo College of Medicine (Hyogo, Japan), Osaka City Univ. (Osaka, Japan), Osaka Medical College (Osaka, Japan), Kyoto Univ. (Kyoto, Japan), Shiga University of Medical Science (Shiga, Japan)
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Patients with Crohn's disease having large bowel lesions showing temporary clinical remission (CDAI less than 150) in response to uncombined adalimumab therapy but poorly responding (CDAI over 150) to subsequent maintenance adalimumab therapy (40 mg/dose, every other week)
Exclusion criteria
Exclusion criteria: (1) Cases that are contraindicated for GMA Granulocyte count below 2000/mm3 Complication by infection present or suspected (2) Patients with small intestine type Crohn's disease (no large bowel lesion) (3) Patients with colostomy (4) Patients younger than 15 (5) Patients who do not submit informed consent (6) Patients with malignant tumor (7) Patients within 3 months of post intestinal surgery (8) Patients with short bowel syndrome (9) Other patients judged as inappropriate by the physician
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Remission rate in week12 (remission:CDAI<150) | — |
Secondary
| Measure | Time frame |
|---|---|
| Time course of CDAI during each observation period Time course of CRP during each observation period Mucosal healing rate at 12 weeks Incidence of adverse events etc. | — |
Countries
Japan
Contacts
Public ContactFukunaga, Ken
Hyogo College of Medicine Department of Lower Gastroenterology
Outcome results
None listed