Optimization of adalimumab switch therapy for loss of response with infliximab in Crohn's disease -OASISstudy
- Conditions
- Crohn's disease
- Registration Number
- JPRN-UMIN000010524
- Lead Sponsor
- Tokyo Medical & Dental University Gastroenterology
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up complete
- Sex
- All
- Target Recruitment
- 20
Not provided
(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 below 3000/mm3 3)Pregnant or likely to be pregnant women (3)Lactating women (4)Patients < 15 years of age (5)Patients not approving the study consent (6)Patients who have received immunomodulators like Azathioprine, 6-mercaptopurine, Tacrolimus and Methotrexate within 8 weeks. (7)Patients with malignancy (8)Patients in 3 months after gastrointestinal surgery (9)Patients with short bowel syndrome or an artificial anus (10)Patient has an imminent CD-related surgery (11)Patients judged as inadequate at the discretion of physicians
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method