UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000005689
Receipt number R000006728
Scientific Title GMA (Granulocyte and Monocyte Adsorption) early combined with azathioprine vs Infliximab plus azathioprine for induction of remission in active Crohn's disease : an open randomized trial
Date of disclosure of the study information 2011/05/31
Last modified on 2016/02/11 10:36:51

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Basic information

Public title

GMA (Granulocyte and Monocyte Adsorption) early combined with azathioprine vs Infliximab plus azathioprine for induction of remission in active Crohn's disease : an open randomized trial

Acronym

Effect of GMA early combined with azathioprine on induction of remission in active Crohn's disease

Scientific Title

GMA (Granulocyte and Monocyte Adsorption) early combined with azathioprine vs Infliximab plus azathioprine for induction of remission in active Crohn's disease : an open randomized trial

Scientific Title:Acronym

Effect of GMA early combined with azathioprine on induction of remission in active Crohn's disease

Region

Japan


Condition

Condition

Crohn's disease

Classification by specialty

Gastroenterology

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

To evaluate the efficacy and safety of GMA (Granulocyte and Monocyte Adsorption) early combined with azathioprine in comparison with Infliximab plus azathioprine, for induction of remission in active Crohn's disease, in a multicenter, prospective, randomized, controlled, non-blinded study

Basic objectives2

Safety,Efficacy

Basic objectives -Others


Trial characteristics_1

Confirmatory

Trial characteristics_2

Explanatory

Developmental phase

Not applicable


Assessment

Primary outcomes

Remission (CDAI<150) rate at the end of the study (intensive GMA plus azathioprine: at week 7, Infliximab plus azathioprine: at week 8)

Key secondary outcomes

1) Clinical response (70 points reduction in their CDAI)
2) Reduction in CRP
3) Cytokine profile in CD4 positive T cell
4) Cumulative non-relapse rate
5) Safety assessment


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

YES

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

Patients in the combination therapy of GMA with azathioprine receive intensive GMA (twice per week, total 10 sessions) and oral azathioprine.

Interventions/Control_2

Patients in the combination therapy of Infliximab and azathioprine receive infusion of IFX (at week 0, 2, 6) and oral azathioprine.

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

1) Patients with moderately to severely active Crohn's disease (CDAI 220-450)
2) Adequate peripheral venous access to allow for completion of GMA
3) Able to provide informed consent

Key exclusion criteria

1) Patients with granulocyte count of equal to or less than 2,000/mm3
2) Patients with serious infectious disease
3) Patients with serious heart disease
4) Patients with serious kidney disease
5) Patients with hypotension (less than maximum blood pressure 80mmHg)
6) Patients who are pregnant or have the possibility of pregnancy
7) Patients with serious dehydration, hypercoagulability, serious anemia (under haemoglobin 8g/dl)
8) Patients with malignancy
9) Patients with Short-bowel syndrome
10) Patients with permanent ostomy
11) Patients with external fistula, including poor control of anal fistula
12) Patients with total colectomy and subtotal colectomy
13) Patients with intestinal stenosis to cause intestinal obstruction
14) Patients with serious extraintestinal complication
15) Patients who had undergone previous immunosuppressive therapies
16) Patients who had undergone previous biologic therapies
17) Patients who had introduced or increased the dosage of Steroids (intravenous Infusion, oral, enema, suppository) within the last 2 weeks
18) Patients who had introduced or increased the dosage of Metronidazole within the last 2 weeks
19) Patients who had introduced or increased the dosage of Mesalazine sulfasalazine (oral, enema, suppository) within the last 4 weeks
20) Patients who had introduced or increased the dosage of elemental diet within the last 4 weeks
21) Patients who had undergone the operation (except replace of Seton) for anal fistula within 4 weeks
22) Patients who had undergone total parental nutrition with in last 4 weeks
23) Patients who had undergone the operation, including strictureplasty, for bowel within the last 12 weeks

Target sample size

60


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Hiroshi Nakase

Organization

Kyoto University Hospital

Division name

Division of Endoscopic Medicine

Zip code


Address

54 Kawahara-cho, Shogoin, Sakyo-ku, Kyoto, 606-8507, Japan

TEL

075-751-4319

Email

hiropy_n@kuhp.kyoto-u.ac.jp


Public contact

Name of contact person

1st name
Middle name
Last name Minoru Matsuura

Organization

Kyoto University Hospital

Division name

Department of Gastroenterology and Hepatology

Zip code


Address

54 Kawahara-cho, Shogoin, Sakyo-ku, Kyoto, 606-8507, Japan

TEL

075-751-4319

Homepage URL


Email

minomats@kuhp.kyoto-u.ac.jp


Sponsor or person

Institute

Department of Gastroenterology and Hepatology, Kyoto University Hospital

Institute

Department

Personal name



Funding Source

Organization

JIMRO Co.,Ltd.

Organization

Division

Category of Funding Organization

Profit organization

Nationality of Funding Organization

JAPAN


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

京都大学医学部附属病院(京都府)
大阪府済生会中津病院(大阪府)
大津日本赤十字病院(滋賀県)
北野病院(大阪府)
神戸市立医療センター中央市民病院(兵庫県)
神戸市立医療センター西市民病院(兵庫県)
西神戸医療センター(兵庫県)


Other administrative information

Date of disclosure of the study information

2011 Year 05 Month 31 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

2011 Year 03 Month 17 Day

Date of IRB


Anticipated trial start date

2011 Year 09 Month 01 Day

Last follow-up date

2013 Year 05 Month 31 Day

Date of closure to data entry


Date trial data considered complete

2014 Year 05 Month 01 Day

Date analysis concluded

2014 Year 05 Month 01 Day


Other

Other related information



Management information

Registered date

2011 Year 05 Month 31 Day

Last modified on

2016 Year 02 Month 11 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000006728


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name