The Effect of Elemental Dietary Therapy Combined with Infliximab in Patients with Crohn's Disease Intractable to Infliximab Remission Maintenance Therapy (CERISIER-Trail) - CERISIER-Trial;Combination of Elemental Dietary Therapy and Infliximab for Secondary Failure to Infliximab in Patients with Crohn's Disease

Japanese Society of Inflammatory Bowel Disease0 sites135 target enrollmentFebruary 18, 2013

ConditionsCrohn&#39 s disease

Overview

Phase: 未知
Intervention: Not specified
Conditions: Crohn&#39
Sponsor: Japanese Society of Inflammatory Bowel Disease
Enrollment: 135
Status: Completed
Last Updated: 2 years ago

Overview Investigators Eligibility Criteria Outcomes Similar Trials

Overview

Brief Summary

No summary available.

Registry

who.int

Start Date

February 18, 2013

End Date

TBD

Last Updated

2 years ago

Study Type

Interventional

Sex

All

Investigators

Sponsor

Japanese Society of Inflammatory Bowel Disease

Eligibility Criteria

Inclusion Criteria

Not provided

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