UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000015068
Receipt number R000015858
Scientific Title An open label randomized controlled trial of GMA and Infliximab in intractable ulcerative colitis
Date of disclosure of the study information 2014/09/05
Last modified on 2017/04/18 14:30:35

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Basic information

Public title

An open label randomized controlled trial of GMA and Infliximab in intractable ulcerative colitis

Acronym

An open label randomized controlled trial of GMA and Infliximab in intractable ulcerative colitis

Scientific Title

An open label randomized controlled trial of GMA and Infliximab in intractable ulcerative colitis

Scientific Title:Acronym

An open label randomized controlled trial of GMA and Infliximab in intractable ulcerative colitis

Region

Japan


Condition

Condition

Ulcerative colitis

Classification by specialty

Gastroenterology

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

To compare clinical remission rates, clinical response rates between patients with intractable ulcerative colitis treated with GMA or Infliximab.

Basic objectives2

Safety,Efficacy

Basic objectives -Others


Trial characteristics_1

Confirmatory

Trial characteristics_2

Pragmatic

Developmental phase

Not applicable


Assessment

Primary outcomes

Response rate at week 10

Key secondary outcomes

・Remission rate at week 10 (DAI =< 2)
・Endoscopic remission rate
・Reduction in partial DAI score at week 2, week 6, week 10
・The incidence of adverse events


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

Central registration


Intervention

No. of arms

2

Purpose of intervention

Treatment

Type of intervention

Medicine Device,equipment

Interventions/Control_1

Infliximab will be administered intravenously at the dose of 5 mg/kg at 0, 2, 6 weeks

Interventions/Control_2

GMA will be administrated 10 times

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

20 years-old <=

Age-upper limit


Not applicable

Gender

Male and Female

Key inclusion criteria

・Patients with moderate to severe activity defined by a DAI score of more than or equal to 6
・Patients with steroid-dependent or steroid-resistant
・Patiens relapse frequently or Chronic persistent type

Key exclusion criteria

・Granulocyte count is equal to or less than 2000/ mm3
・Serious infectious disease
・Active tuberculosis
・Patients who have a Hypersensitivity against Infliximab or Protein from mice
・Demyelinating disease
・Congestive heart failure
・Serious heart disease
・Serious kidney disease
・Hypotonicity (less than maximum blood pressure 80mmHg)
・Pregnancy or suspected
・Serious exsiccation / serious coagulation, serious anemia(under hemoglobin 8g/dl)
・Malignancy
・Introduce or increase the dosage of Steroids(intravenous infusion) within the last 1 week.
・Introduce or increase the dosage of Steroids(oral, enema, suppository) within the last 2 weeks.
・Introduce or increase the dosage of Mesalazine Sulfasalazine(oral, enema, suppository) within the last 4 weeks.
・Introduce or increase the dosage of Cyclosporine, Tacrolimus, Methotrexate within the last 8 weeks.
・Introduce or increase the dosage of Azathioprine, 6-mercaptopurine within the last 12 weeks.
・Introduce of Infliximab, Adalimumab, GMA, LCAP within the last 3 months.

Target sample size

150


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Shinji Tanaka

Organization

Hiroshima University Hospital

Division name

Department of Endoscopy

Zip code


Address

1-2-3 kasumi minami-ku Hiroshima city

TEL

082-257-5538

Email

colon@hiroshima-u.ac.jp


Public contact

Name of contact person

1st name
Middle name
Last name Yoshitaka Ueno

Organization

Hiroshima University Hospital

Division name

Department of Endoscopy

Zip code


Address

1-2-3 kasumi minami-ku Hiroshima city

TEL

082-257-5193

Homepage URL


Email

yueno@hiroshima-u.ac.jp


Sponsor or person

Institute

Hiroshima University Hospital, Department of Endoscopy

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

県立広島病院(広島県)、広島記念病院(広島県)、広島市民病院(広島県)、広島赤十字病院(広島県)、安佐市民病院(広島県)、済生会呉病院(広島県)、県立安芸津病院(広島県)、呉医療センター(広島県)、中国労災病院(広島県)、東広島医療センター(広島県)、JA広島総合病院(広島県)、広島西医療センター(広島県)、JA尾道総合病院(広島県)、呉共済病院(広島県)、木村胃腸科病院(広島県)


Other administrative information

Date of disclosure of the study information

2014 Year 09 Month 05 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

Completed

Date of protocol fixation

2014 Year 07 Month 03 Day

Date of IRB


Anticipated trial start date

2014 Year 09 Month 05 Day

Last follow-up date


Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information



Management information

Registered date

2014 Year 09 Month 05 Day

Last modified on

2017 Year 04 Month 18 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000015858


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name