Crohn'
Conditions
Interventions
Administration of Adalimumab 160 mg at baseline, 80 mg at 2 weeks and 40 mg every 2 weeks.
In addition to Adalimumab Therapy, co-administration of 25-100mg Azathioprine once a day.Fixed dosage of Azat
Sponsors
Department of Internal Medicine, School of Medicine, Keio University
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Moderate or severe (CDAI220-450) patients with CD who has not ever received anti-TNF antibodies or immunomodulators before.
Exclusion criteria
Exclusion criteria: (1)Adalimumab contraindication 1)Patients with severe infection (Sepsis, etc) 2)Patients with active tuberculosis 3)Patients with history of hypersensitivity to any of the other ingredients of Adalimumab 4)Patients with demyelinating disease (Multiple sclerosis, etc) or with history of demyelinating disease 5)Patients with congestive heart failure (2)Azathioprine contraindication 1)Patients with history of hypersensitivity to any of the other ingredients of Azathioprine 2)Patients with the number of leukocytes &#8804; 3000/mm3 3)Pregnant or likely to be pregnant women (3)Pregnant or lactating women (4)Patients < 20 years of age (5)Patients not approving the study consent (6)Patients who have ever received anti-TNF antibodies before (7)Patients who have received immunomodulators like Azathioprine, 6-mercaptopurine, Tacrolimus and Methotrexate (8)Patients with malignancy (9)Patients in 6 months after surgery (10)Patients with short bowel syndrome (11)Patients judged as inadequate at the discretion of physicians
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Remission(CDAI<150) rate at 26 weeks. | — |
Secondary
| Measure | Time frame |
|---|---|
| Remission rate at each observational period, Clinical Response70 (CR70) and Clinical Response100 (CR100). Mucosal healing rate at 26 weeks and 52 weeks. Deep remission rate at 26 weeks and 52 weeks Loss of response(Exacerbation) rate Adalimumab blood concentration and AAA Incidence rate at 26 weeks. Incidence of adverse events. Others. | — |
Countries
Japan
Contacts
Public ContactTakayuki Matsumoto
Iwate Medial University Division of Gastroenterology, Department of Medicine
Outcome results
None listed