Crohn`s disease
Conditions
Interventions
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 (az
Sponsors
Department of Internal Medicine, School of Medicine, Keio University
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: CD patient on concomitant treatment of adalimumab and an immunomodulator (azathioprine;25 mg/day or 6-mercaptoprine;15 mg/day) for at least 6 month, and the steroid-free remission (CDAI is below 150 without the use of steroids) period has continued for at least 6 months.
Exclusion criteria
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| 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. | — |
Countries
Japan
Contacts
Public ContactTadakazu Hisamatsu
School of Medicine, Keio University Gastroenterology
Outcome results
None listed