UMIN-CTR Clinical Trial

Public title

Improvement of efficacy in Crohn's disease by early use of infliximab

Acronym

Early use of infliximab in Crohn's disease

Scientific Title

Improvement of efficacy in Crohn's disease by early use of infliximab

Scientific Title:Acronym

Early use of infliximab in Crohn's disease

Region

Japan

Condition

Crohn's disease

Classification by specialty

Gastroenterology

Classification by malignancy

Others

Genomic information

NO

Narrative objectives1

Improvement of efficacy

Basic objectives2

Efficacy

Basic objectives -Others

Trial characteristics_1

Trial characteristics_2

Developmental phase

Primary outcomes

Improvement of long-term relapse-free rate (At 5 years after induction of remission)

Key secondary outcomes

Remission rate at 6 weeks after the initiation of treatment

Study type

Observational

Basic design

Randomization

Randomization unit

Blinding

Control

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

No. of arms

Purpose of intervention

Type of intervention

Interventions/Control_1

Interventions/Control_2

Interventions/Control_3

Interventions/Control_4

Interventions/Control_5

Interventions/Control_6

Interventions/Control_7

Interventions/Control_8

Interventions/Control_9

Interventions/Control_10

Age-lower limit

10

years-old

<=

Age-upper limit

85

years-old

>

Gender

Male and Female

Key inclusion criteria

Newly diagnosed or relapsed Crohn's disease who is naive to biologics

Key exclusion criteria

Patient who was initially treated by steroid or immunosuppressants

Target sample size

100

Name of lead principal investigator

1st name	Mitsuro
Middle name
Last name	Chiba

Organization

Akita City Hospital

Division name

Gatroenterology

Zip code

010-0933

Address

Akita

TEL

0188234171

Email

mchiba@m2.gyao.ne.jp

Name of contact person

1st name	Tsuyoshi
Middle name
Last name	Kudo

Organization

Akita city Hospital

Division name

General Administration Division

Zip code

010-0933

Address

Akita

TEL

0188234171

Homepage URL

Email

ro-homn@city.akita.akita.jp

Institute

IBD Relapse Prevention Team

Institute

Department

Personal name

Organization

None

Organization

Division

Category of Funding Organization

Self funding

Nationality of Funding Organization

Co-sponsor

Name of secondary funder(s)

Organization

Akita city Hospital

Address

Akita

Tel

0188234171

Email

ro-homn@city.akita.akita.jp

Secondary IDs

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

Date of disclosure of the study information

2015

Year

12

Month

30

Day

URL releasing protocol

Publication of results

Partially published

URL related to results and publications

Number of participants that the trial has enrolled

Results

1) Chiba M et al. Induction with infliximab and a plant-based diet as first-line (IPF) therapy for Crohn disease: A Single-group trial. Perm J 2017;21:17-009
2) Chiba M et al. How to avoid primary non-responders to infliximab in Crohn's disease. Inflamm Bowel Dis 2017;23:E55-E56
3) Chiba M et al. Relapse-free course in nearly half of Crohn's disease patients with infliximab and plant-based diet as first-line (IPF) therapy: Single-group trial. Perm J 2022;26:21.073

Results date posted

2020

Year

01

Month

13

Day

Results Delayed

Results Delay Reason

Date of the first journal publication of results

2017

Year

10

Month

06

Day

Baseline Characteristics

Participant flow

Adverse events

Outcome measures

Plan to share IPD

IPD sharing Plan description

Recruitment status

Enrolling by invitation

Date of protocol fixation

2003

Year

04

Month

01

Day

Date of IRB

2013

Year

10

Month

21

Day

Anticipated trial start date

2003

Year

04

Month

01

Day

Last follow-up date

2025

Year

12

Month

27

Day

Date of closure to data entry

Date trial data considered complete

Date analysis concluded

Other related information

Background & aims: Around 30% of patients with Crohn's disease (CD) are reported to be unresponsive to biologics. The aim of this study was to investigate the remission rate of infliximab combined with a plant-based diet (PBD) as the first-line therapy for CD.
Methods: Subjects: consecutive newly diagnosed adults (n = 22 (male 14); mean age 31 years), newly diagnosed children (11 (male 9); 16 years) and relapsed CD (9 (male 5); 33 years), altogether 42 cases, all were naive to biologics. Mean disease duration for newly diagnosed was 9 months and relapsed cases was 6 years. Induction therapy: Patients were admitted and followed a standard induction therapy of infliximab (5 mg/kg of body weight, 3 infusions at 0, 2, and 6 weeks). Immunosuppressive agents were not used. A semi-vegetarian diet (SVD), a PBD one, was initiated by at least the first infusion of infliximab. Evaluation of treatment: Clinical remission was defined as the disappearance of active symptoms of CD at week 6. Crohn Disease Activity Index (CDAI) and C-reactive protein (CRP) and morphology were also evaluated.
Results: All 42 cases achieved clinical remission. Mean CDAI 300 on admission decreased to 72 at week 6 (P<0.0001). Mean CRP 5.54 mg/dl decreased to 0.14 (P<0.0001). Mucosal healing was achieved in 19 of 39 patients. No adverse reaction to infliximab or SVD was observed.
Conclusions: The combined infliximab and PBD therapy as the first-line therapy brought remission in all patients with CD irrespective of newly diagnosed adults and children or relapsed patients.

Registered date

2015

Year

12

Month

25

Day

Last modified on

2023

Year

02

Month

09

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000023488