UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000007047
Receipt number R000008194
Scientific Title Effect of adacolumn and adalimumab combination therapy for the active stage Crohn's disease
Date of disclosure of the study information 2012/01/10
Last modified on 2020/07/18 12:17:59

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Basic information

Public title

Effect of adacolumn and adalimumab combination therapy for the active stage Crohn's disease

Acronym

Effect of adacolumn and adalimumab combination therapy for Crohn's disease

Scientific Title

Effect of adacolumn and adalimumab combination therapy for the active stage Crohn's disease

Scientific Title:Acronym

Effect of adacolumn and adalimumab combination therapy for Crohn's disease

Region

Japan


Condition

Condition

Crohn's disease

Classification by specialty

Gastroenterology

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

Effect of adacolumn and adalimumab combination therapy for the active stage Crohn's disease

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1

Exploratory

Trial characteristics_2

Pragmatic

Developmental phase

Not applicable


Assessment

Primary outcomes

Remission induction rate 11 weeks after the start of therapy.
Remission rate 104 weeks after the start of therapy.

Key secondary outcomes

Remission period
CT or CT enteroclysis/enterography
Change of the CRP
Safety


Base

Study type

Interventional


Study design

Basic design

Parallel

Randomization

Randomized

Randomization unit

Individual

Blinding

Open -no one is blinded

Control

Active

Stratification

NO

Dynamic allocation

NO

Institution consideration

Institution is not considered as adjustment factor.

Blocking

NO

Concealment

Numbered container method


Intervention

No. of arms

2

Purpose of intervention

Treatment

Type of intervention

Medicine

Interventions/Control_1

Adacolumn and adalimumab combination therapy for 10 weeks.
Adalimumab single therapy for remain 94 weeks.

Interventions/Control_2

Adacolumn single therapy for 104 weeks.

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

12 years-old <=

Age-upper limit

75 years-old >

Gender

Male and Female

Key inclusion criteria

The patient that it was judged that keeping blood access was possible.
The patient that agreed this study.

Key exclusion criteria

Below 2,000 / mm3 granulocyte count
Severe infection
Severe heart disease
Severe Renal disease
Systolic blood pressure less than 80mmHg
patient with suspected or currently pregnant
Increased intensity of extreme dehydration or coagulation system
Severe anemia
Malignant tumor
Short-bowel syndrome
Artificial anus
External fistula
Ileus or svere stenosis of the intestine
Extraintestinal complications
Recent use of steroid, 5-Aminosalicylic acid, immunomodulator, biologics, elemental diet
Recent operation

Target sample size

40


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Shinichi Hashimoto

Organization

Yamaguchi University Graduate School of Medicine

Division name

Department of Gastroenterology and Hepatology

Zip code


Address

1-1-1 Minami-Kogushi, Ube, Yamaguchi

TEL

0836-22-2241

Email



Public contact

Name of contact person

1st name
Middle name
Last name Shinichi Hashimoto

Organization

Yamaguchi University Graduate School of Medicine

Division name

Department of Gastroenterology and Hepatology

Zip code


Address

1-1-1 Minami-Kogushi, Ube, Yamaguchi

TEL

0836-22-2241

Homepage URL


Email

has-333@yamaguchi-u.ac.jp


Sponsor or person

Institute

Yamaguchi University Graduate School of Medicine Department of Gastroenterology and Hepatology

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


Address


Tel


Email



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

山口大学医学部付属病院 Yamaguchi University Hospital
セントヒル病院 Sainthill hospital


Other administrative information

Date of disclosure of the study information

2012 Year 01 Month 10 Day


Related information

URL releasing protocol


Publication of results

Unpublished


Result

URL related to results and publications


Number of participants that the trial has enrolled


Results


Results date posted


Results Delayed


Results Delay Reason


Date of the first journal publication of results


Baseline Characteristics


Participant flow


Adverse events


Outcome measures


Plan to share IPD


IPD sharing Plan description



Progress

Recruitment status

Terminated

Date of protocol fixation

2010 Year 10 Month 20 Day

Date of IRB

2011 Year 10 Month 26 Day

Anticipated trial start date

2011 Year 11 Month 01 Day

Last follow-up date

2015 Year 12 Month 01 Day

Date of closure to data entry

2015 Year 12 Month 10 Day

Date trial data considered complete

2015 Year 12 Month 10 Day

Date analysis concluded

2015 Year 12 Month 10 Day


Other

Other related information



Management information

Registered date

2012 Year 01 Month 10 Day

Last modified on

2020 Year 07 Month 18 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000008194


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name