Intestinal Behcet'
Conditions
Interventions
Subcutaneous injection of adalumumab with 160mg at 0 week, 80mg at 2 weeks and 40mg every other week after at 4 weeks continuously.
Oral administration of prednisolone with 0.6mg/kg/day during from 1
Sponsors
Castle Study Group
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: The patients with intestinal Behcet's disease who were refractory to conventional treatment and contained with typical punched-out ulce in the cecum.
Exclusion criteria
Exclusion criteria: 1) The patients with simple ulcer disease complicated without general Behcet's symptoms 2) Contraindication of adalimumab administration a: Severe infectious disease b: Active tuberculosis c: Past history for hypersensitivity of adalimumab contents d: Present or past history for demyelinating disorder e: Congestive heart failure 3) Contraindication for steroid administration a: Past history for hypersensitivity of prednisolone contents 4) Pregnant or breast feeding woman 5) Below the age of 15 years old 6) The patients who are unable to provide informed consent 7) The patients who are begun to administrate with more than 10mg/kg steroid within 2 weeks 8) The patients who are administrated with steroid more than 2 weeks 9) The patients who had been administrated with infliximab or adalimumab. However, the patients who were intolerant for infliximab within 2nd infusion (0 week or 2 weeks) can be enrolled. 10) The patients who are added or increased dosage of administration with as follows, 5-aminosalicylates or nutrition therapy within 2 weeks, colchicine or tacrolimus or ciclosporin or methotrexate within 4 weeks, azathioprine or 6-mercaptopurine within 8 weeks 11) Malignancy patient 12) The patients who are contained with untypical lesion for intestinal Behcet's disease 13) The patients who are indicated as insufficient by the physician
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Endoscopic efficacy at 12 weeks | — |
Countries
Japan
Contacts
Public ContactKenji Watanabe
Osaka City University Department of Gastroenterology
Outcome results
None listed