Phase ll Study of Postoperative Adalimumab Maintenance Therapy for Crohn's Disease Recurrence
- Conditions
- Crohn's disease
- Registration Number
- JPRN-UMIN000007514
- Lead Sponsor
- agoya University Gradeate School of Medicine Department of Gastroenterology
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up complete
- Sex
- All
- Target Recruitment
- 25
Not provided
(1)Uncontrolled infection (2)Confirmed opportunistic infection diseases within 6 months (3)Tuberculosis or a history of it (4)most positive tuberculin skin test (5)Active hepatitis B, C or a history of hepatitis C (6)Confirmed HIV infection (7)Demyelinating disease or a history of it (8)History of lymphoproliferative disorder, or suspicion of lymphoproliferative disorder or splenomegaly (9)Lupus syndrome, and positive anti-dsDNA antibody (10)malignant tumor (11)Clinically abnormal electrocardiogram or cardiovascular disease. (12)Severe pulmonary disease (13)Interstitial pneumonia or pulmonary fibrosis or a history of those (14)Severe hepatic disease (15)Severe renal failure (16)Severe drug allergies (17)Bowel obstraction or bowel paresis (18)Severe or uncontrollable complications (diabetes mellitus, hypertention, diarrhea, electrolyte abnormality, etc.) (19)Psychiatric disorder, central nervous system damage, cerebrovascular diseases (20)Pregnant women, possibly pregnant women, wishing to become pregnant, and nursing mothers. (21)Not appropriate for the study at the physician's assessment.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Endoscopic recurrence rete at the anastomotic site after 1 year.
- Secondary Outcome Measures
Name Time Method Endoscopic recurrence rete at the anastomotic site Clinical Recurrence rate Crohn's disease activity index point (CDAI) Recurrence-free survival time. Time to treatment failure. Rate of adverse event