The study of the effectiveness of anti-TNF antibody maintenance treatment combined with elemental diet for Crohn's disease patients
- Conditions
- Crohn's disease
- Registration Number
- JPRN-UMIN000007343
- Lead Sponsor
- Tohoku University Graduate School of Medicine (Tohoku University Hospital)
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up complete
- Sex
- All
- Target Recruitment
- 90
Not provided
(1) anti-TNF antibody contraindication 1) Patients with severe infection (Sepsis, etc) 2) Patients with active tuberculosis 3) Patients with history of hypersensitivity to the ingredient of anti-TNF antibody, or the protein of mouse origin 4) Patients with demyelinating disease (Multiple sclerosis, etc) or with history of demyelinating disease 5) Patients with congestive heart failure (2) 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 severe obstructive strictures or abdominal abscess assessed by X-ray, abdominal computed tomography, or endoscopy (7) Patients with active hepatitis B or C (8) Patients with human immunodeficiency virus (9) Patients with malignancy (10) Patients judged as inadequate at the discretion of physicians
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method The occurrence of relapse (Relapse was defined as either the increase of CDAI score of more than 70 points compared with the score at week 8, or the need for therapy to induce remission.)
- Secondary Outcome Measures
Name Time Method 1) The rate of clinical response (CDAI score of less than 220) at week 8 2) The rate of mucosal healing at week 24 and 48 3) Safety assessment etc.