Study of Combination Therapy of Adalimumab and an Immunomodulator for Crohn's Disease(Diamond study)
- Conditions
- Crohn's disease
- Registration Number
- JPRN-UMIN000005146
- Lead Sponsor
- Department of Internal Medicine, School of Medicine, Keio University
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up complete
- Sex
- All
- Target Recruitment
- 200
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 ≤ 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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Remission(CDAI<150) rate at 26 weeks.
- Secondary Outcome Measures
Name Time Method 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.