UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000009284
Receipt number R000010904
Scientific Title The Study for Efficacy of Adalimumab Maintenance Therapy Initiated Following Resection of Active Lesions in Crohn's Disease Patients
Date of disclosure of the study information 2012/11/20
Last modified on 2019/05/14 11:28:28

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Basic information

Public title

The Study for Efficacy of Adalimumab Maintenance Therapy Initiated Following Resection of Active Lesions in Crohn's Disease Patients

Acronym

The Efficacy of Adalimumab Maintenance Therapy for Post-Operative Crohn's Disease

Scientific Title

The Study for Efficacy of Adalimumab Maintenance Therapy Initiated Following Resection of Active Lesions in Crohn's Disease Patients

Scientific Title:Acronym

The Efficacy of Adalimumab Maintenance Therapy for Post-Operative Crohn's Disease

Region

Japan


Condition

Condition

Crohn's disease Patients who has been treated with following surgical removal of active lesions(intestinal resection)

Classification by specialty

Medicine in general Gastroenterology Gastrointestinal surgery
Adult

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

The aim of this study is to evaluated the efficacy of adalimumab maintenance therapy for post-operative Crohn's disease.

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase

Phase II


Assessment

Primary outcomes

remission maintenance rate of adalimumab maintenance therapy ,evaluated by CDAI score 12months after intestinal resection.

Key secondary outcomes

remission maintenance rate 6months and 12months after intestinal resection, evaluated by CDAI score and C-reactive protein. remission maintenae rate 6months and 12months after intestinal resection, evaluated by endoscopic score(Rutgeerts score)


Base

Study type

Interventional


Study design

Basic design

Single arm

Randomization

Non-randomized

Randomization unit


Blinding

Open -no one is blinded

Control

Self control

Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms

1

Purpose of intervention

Treatment

Type of intervention

Medicine

Interventions/Control_1

adalimumab injected immediately(within 3months) after surgical removal Crohn's disease lesions(intestinal resection). Inject SC 160mg,80mg,40mg in every other week.

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



Eligibility

Age-lower limit

18 years-old <=

Age-upper limit

65 years-old >=

Gender

Male and Female

Key inclusion criteria

patients after surgical removal of Crohn's disease lesions(intestinal resection)
patients enrolled endoscopy 6months and 12months after surgery

Key exclusion criteria

1the patient of contraindication for adalimumab
2pregnancy
3the patient who is short bowel syndrome
4the patient who is not able to calculate CDAI
5the patient with stoma
6the case which is hard to get the patient's consent
7the patient who was judged for insuitable by responsibility doctor

Target sample size

20


Research contact person

Name of lead principal investigator

1st name Yasuo
Middle name
Last name Suzuki

Organization

Sakura Medical center,Toho University

Division name

IBD center

Zip code

2858741

Address

564-1,Shimoshizu,Sakura-city,Chiba

TEL

043-462-8811

Email

yasuo-suzuki@sakura.med.toho-u.ac.jp


Public contact

Name of contact person

1st name Akihiro
Middle name
Last name Yamada

Organization

Sakura Medical Center,Toho University

Division name

Internal medicine

Zip code

2858741

Address

564-1,Shimoshizu,Sakura-city,Chiba

TEL

043-462-8811

Homepage URL


Email

taro-dog@sakura.med.toho-u.ac.jp


Sponsor or person

Institute

Sakura Medical Center,Toho university

Institute

Department

Personal name



Funding Source

Organization

none

Organization

Division

Category of Funding Organization

Self funding

Nationality of Funding Organization



Other related organizations

Co-sponsor


Name of secondary funder(s)



IRB Contact (For public release)

Organization

Ethics committee, Sakura Medical Center,Toho university

Address

564-1,shimoshizu,sakura

Tel

0434628811

Email

taro-dog@sakura.med.toho-u.ac.jp


Secondary IDs

Secondary IDs

NO

Study ID_1


Org. issuing International ID_1


Study ID_2


Org. issuing International ID_2


IND to MHLW



Institutions

Institutions



Other administrative information

Date of disclosure of the study information

2012 Year 11 Month 20 Day


Related information

URL releasing protocol

Waiting for enforcement

Publication of results

Partially published


Result

URL related to results and publications

Waiting for enforcement

Number of participants that the trial has enrolled


Results

clinical remission rate at 12months was 70.0%
endoscopic remission rate at 12months was 62.5%

Results date posted

2019 Year 05 Month 14 Day

Results Delayed


Results Delay Reason


Date of the first journal publication of results


Baseline Characteristics

post-operative Crohn's disease patients

Participant flow

Hospitalization at the relevant facility, operation example

Adverse events

Severe adverse events of hemorrhage, white blood cell count decrease and sepsis were seen

Outcome measures

The endoscopic remission was assessed by Rutgeerts score, clinical remission assessed by Crohn's disease activity index (CDAI).

Plan to share IPD


IPD sharing Plan description



Progress

Recruitment status

Completed

Date of protocol fixation

2012 Year 11 Month 01 Day

Date of IRB

2012 Year 10 Month 10 Day

Anticipated trial start date

2012 Year 11 Month 20 Day

Last follow-up date

2014 Year 11 Month 19 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information



Management information

Registered date

2012 Year 11 Month 07 Day

Last modified on

2019 Year 05 Month 14 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000010904


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name