Withdrawal of immunomodulator in Crohn's disease treated with adalimumab and immnomodulator : a multicenter randomized trial(Diamond2 study).

UMIN ID: UMIN000009596

Registered date:21/12/2012

Basic Information

• Recruitment status: Complete: follow-up complete
• Health condition(s) or Problem(s) studied: Crohn`s disease
• Date of first enrollment: 2013/01/01
• Target sample size: 200
• Countries of recruitment: Japan
• Study type: Interventional

Intervention(s)

Withdrawal of the concomitant immunomodulator (azathioprine or 6-mercaptoprine) while under adalimumab 40 mg/every other week continued treatment.
Non-withdrawal of the concomitant immunomodulator (azathioprine or 6-mercaptoprine) while under adalimumab 40 mg/every other week continued treatment.

Outcome(s)

• Primary Outcome: 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: 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.

Key inclusion & exclusion criteria

• Age minimum: 15years-old
• Age maximum: Not applicable
• Gender: Male and Female
• Exclude 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.

Related Information

• Primary Sponsor: Department of Internal Medicine, School of Medicine, Keio University
• Source(s) of Monetary Support: Department of Internal Medicine(Gastroenterology), School of Medicine, Keio University and Self funding of each Institusions