The Effect of Elemental Dietary Therapy Combined with Infliximab in Patients with Crohn's Disease Intractable to Infliximab Remission Maintenance Therapy (CERISIER-Trail)
- Conditions
- Crohn's disease
- Registration Number
- JPRN-UMIN000010058
- Lead Sponsor
- Japanese Society of Inflammatory Bowel Disease
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up complete
- Sex
- All
- Target Recruitment
- 135
Not provided
1) Patients who have received the treatments stated below during the following treatment periods as indicated by the number of weeks in parentheses * Biological agents other than infliximab (0-16 weeks) * Cyclosporine or tacrolimus (0-8 weeks) * Methotrexate (0-12 weeks) * Surgery for Crohn's disease (0-16 weeks) * Total parenteral nutrition (TPN) (0-16 weeks) * Enteral nutrition at more than 300 kcal/day (0-8 weeks) * Corticosteroids at doses equivalent to or exceeding 20-mg/day prednisolone (0-4 weeks) 2) Patients who started one of the following therapies or changed the dosage of the drugs * Corticosteroids (0-4 weeks) * Azathioprine or mercaptopurine (0-16 weeks) * Metronidazole or ciprofloxacin (0-4 weeks) * 5-ASA reagents, including salazosulfapyridine (0-4 weeks) * Enteral nutrition (0-8 weeks), except the Elental receptivity test period 3) Patients with colorectal or ilecolonic Crohn's disease only with an anastomotic ulcer after enterocolostomy 4) Patients with severe stenosis in the ileum, colon, and rectum 5) Patients who underwent a colostomy 6) Patients with short bowel syndrome 7) Patients who are scheduled to have surgery for Crohn's disease during this trial 8) Patients with severe infectious disease or complications due to infection within 1 year prior to the trial 9) Patients with intra-abdominal abscess 10) Patients with a serum creatinine level of >2.0 mg/dL 11) Patients with a total bilirubin of >3.0 mg/dL or AST or ALT of >100 IU/L 12) Patients with a history of severe drug allergy 13) Patients with malignancy 14) Patients with mental manifestation 15) Patients with a history or complications of drug or alcohol dependency 16) Patients who are pregnant or likely to be pregnant 17) Patients who participated in another clinical trial within 12 weeks prior to the trial 18) Patients who are considered to be unsuitable by the trial investigators
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method The cumulative rate for successful completion of the scheduled maintenance treatment with IFX infusion at 10 mg/kg every 8 weeks.
- Secondary Outcome Measures
Name Time Method i) The percentage of patients who successfully completed the scheduled maintenance treatment with IFX infusion at 10 mg/kg every 8 weeks at the time of the 56th week of treatment ii) The percentage of patients with CDAI decreased by 50 points or more at the 16th week of treatment iii) The percentage of patients with CDAI decreased by 100 points or more between the 8th to the 56th week of treatment iv) The percentage of patients who achieved remission, as indicated by a CDAI below 150 points, during the 8th to 56th week of treatment v) Changes in CRP values from baseline between the 8th and 56th week of treatment vi) Changes in IBDQ scores from baseline at the 16th and 56th weeks of treatment vii) Changes in SES-CD scores from baseline at the 56th week of treatment (or at the time of treatment discontinuation) viii) Patient compliance to elemental diet therapy from baseline to the 56th week of treatment (only in the IFX/ED combination therapy group)