Withdrawal of immunomodulator in Crohn's disease treated with adalimumab and immnomodulator : a multicenter randomized trial(Diamond2 study).
Not Applicable
- Conditions
- Crohn`s disease
- Registration Number
- JPRN-UMIN000009596
- 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
Inclusion Criteria
Not provided
Exclusion Criteria
1. The patient is below 15 years of age 2. The patient is pregnant or lactating 3. The patient has an artificial anus 4. The period after the patient underwent gastrointestinal surgery is within 6 months 5. The patient has short-bowel syndrome 6. The patient has an imminent CD-related surgery 7. The patient has malignant tumor 8. The patient was judged not eligible by the investigator.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Remission maintenance rate (nonclinical relapse rate) following a steroid-free period of 52 weeks. *Clinical relapse: The condition where CDAI increased at least 70%, and is at least 150.
- Secondary Outcome Measures
Name Time Method Endoscopic relapse rate *Endoscopic relapse: ulcer findings present CRP negative rate *CRP positive: CRP is at least 0.3 mg/dL Steroid-free remission maintenance rate by factor (duration of illness, IFX treatment history, CRP, endoscopic findings etc.) Incidence of adverse events etc.