Crohn'
Conditions
Interventions
Adalimubab is administered 160 mg at week 0, 80 mg at week 2, 40 mg every other week from week 4.
Sponsors
Department of Gastroenterology and Hepatology, Kyoto University Hospital
Departments of Molecular Gastroenterology and Hepatology, Kyoto Prefectural University of Medicine, Graduate School of Medical Science
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Active Crohn's disease patients who have inadequate efficacy of adalimumab therapy after 6 weeks (1) More than 150 points of CDAI (2) Patients who had changed dosage and administration of other medication for Crhon's disease just before 3 months of obtained the informed concent
Exclusion criteria
Exclusion criteria: (1) Patients < 15 years of age (2) Patients who are pregnant or likely to be pregnant women (3) Patients with severe infection (4) Patients who underwent surgery within 3 months (5) Patients with severe intestinal structures (6) Patients with malignancy (7) Patients not approving the study consent (8) Patients judged as inappropriate for enrollment by physician
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Remission rate at week 12 (Remission: CDAI<150) | — |
Secondary
| Measure | Time frame |
|---|---|
| (1) Serial change of CDAI (Remission rate, Decreasing ratio from baseline, Clinical response 50,70,100) (2) Serial change of CRP level (3) Antibody against adalimumab (4) Level of adalimumab concentration (5) Mucosal healing rate at week 26 (6) Adverse event | — |
Countries
Japan
Contacts
Public ContactMinoru Matsuura
Kyoto University Hospital Department of Gastroenterology & Hepatology
Outcome results
None listed