The study of the effectiveness of anti-TNF antibody maintenance treatment combined with elemental diet for Crohn's disease patients

• Register: JPRN
• Last refreshed on: 17 October 2023
• Main ID: JPRN-UMIN000007343
• Date of registration: 21/02/2012
• Prospective Registration: No
• Primary sponsor: Tohoku University Graduate School of Medicine (Tohoku University Hospital)
• Public title: The study of the effectiveness of anti-TNF antibody maintenance treatment combined with elemental diet for Crohn's disease patients
• Scientific title: The study of the effectiveness of anti-TNF antibody maintenance treatment combined with elemental diet for Crohn's disease patients - The study of the effectiveness of anti-TNF antibody maintenance treatment combined with elemental diet for Crohn's disease patients
• Date of first enrolment: 2012/02/01
• Target sample size: 90
• Recruitment status: Complete: follow-up complete
• URL: https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000008656
• Study type: Interventional
• Study design: Parallel Randomized
• Phase: Not applicable

Countries of recruitment

Japan

Contacts

• Name: Hisashi Shiga
• Affiliation: Tohoku University Graduate School of Medicine (Tohoku University Hospital) Division of Gastroenterology

• Name: Katsuya Endo
• Affiliation: Tohoku University Graduate School of Medicine (Tohoku University Hospital) Division of Gastroenterology

Key inclusion & exclusion criteria

Inclusion criteria:
Exclusion criteria: (1) anti-TNF antibody contraindication 1) Patients with severe infection (Sepsis, etc) 2) Patients with active tuberculosis 3) Patients with history of hypersensitivity to the ingredient of anti-TNF antibody, or the protein of mouse origin 4) Patients with demyelinating disease (Multiple sclerosis, etc) or with history of demyelinating disease 5) Patients with congestive heart failure (2) Pregnant or likely to be pregnant women (3) Pregnant or lactating women (4) Patients < 20 years of age (5) Patients not approving the study consent (6) Patients who have severe obstructive strictures or abdominal abscess assessed by X-ray, abdominal computed tomography, or endoscopy (7) Patients with active hepatitis B or C (8) Patients with human immunodeficiency virus (9) Patients with malignancy (10) Patients judged as inadequate at the discretion of physicians

Age minimum: 20years-old
Age maximum: Not applicable
Gender: Male and Female

Health Condition(s) or Problem(s) studied

Crohn's disease

Intervention(s)

Patients in monotherapy group receive; 1) intravenous infusion of infliximab (10mg/kg) at every 8 weeks (dose escalation of anti-TNF antibody), or 2) intravenous infusion of infliximab (5mg/kg) at week 0, 2, and 6 and then every 8 weeks, or subcutaneous injection of adalimumab at week 0 (160mg), 2 (80mg) and then every 2 weeks (40mg) (first time or switch of anti-TNF antibody).
Patients in combination therapy group take half the amount of their daily allowance of calories (900-1,200kcal) by elemental diet and the remaining half by usual unrestricted meals, in addition to above anti-TNF antibody therapy.

Primary Outcome(s)

The occurrence of relapse (Relapse was defined as either the increase of CDAI score of more than 70 points compared with the score at week 8, or the need for therapy to induce remission.)

Secondary Outcome(s)

1) The rate of clinical response (CDAI score of less than 220) at week 8 2) The rate of mucosal healing at week 24 and 48 3) Safety assessment etc.

Source(s) of Monetary Support

none

Ethics review

Status: YES
Approval date: 18/11/2011
Contact:

Results

• Results available: Yes
• Date Completed: 30/11/2016