Crohn'
Conditions
Interventions
Combination treatment with 10mg/kg IFX (evry 8 weeks) and elemental dietary therapy (900 or1200kcal/day)
Treatment with 10mg/kg IFX (evry 8 weeks)
Sponsors
Japanese Society of Inflammatory Bowel Disease
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Patients with Crohn's disease that was intractable to 5-mg/kg Infliximab maintenance treatment 2) Patients with two consecutive CDAI values of 175 or more at the time of 5-mg/kg IFX maintenance therapy 3) Patients aged between 16 and under 70 years at the time of giving informed consent 4) Patients accepted regardless of gender or being treated on an inpatient or outpatient basis 5) Patients who were able to give their informed consent in writing were enrolled. For patients aged under 20 years, the written consent should be obtained from a person with parental authority (essential guardians) in addition to the patient's informed consent 6) Patients who showed good compliance (>80%) to Elental therapy during a 1-week receptivity test or patients who a doctor in attendance can judge to have been able to take 3 or more packs of Elental in the past
Exclusion criteria
Exclusion criteria: 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The cumulative rate for successful completion of the scheduled maintenance treatment with IFX infusion at 10 mg/kg every 8 weeks. | — |
Secondary
| Measure | Time frame |
|---|---|
| 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) | — |
Countries
Japan
Contacts
Public ContactAkiko Ikeda
Japanese Society of Inflammatory Bowel Disease a secretariat
Outcome results
None listed