UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000004201
Receipt number R000005048
Scientific Title The evaluation of efficacy for remission maintenance with immunomodulator following remission induction with tacrolimus in patients with moderate to severe active refractory ulcerative colitis.:mucosal healing for prognosis
Date of disclosure of the study information 2010/09/14
Last modified on 2024/03/10 22:28:06

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Basic information

Public title

The evaluation of efficacy for remission maintenance with immunomodulator following remission induction with tacrolimus in patients with moderate to severe active refractory ulcerative colitis.:mucosal healing for prognosis

Acronym

Hyogo College of Medicine, Osaka Medical College, Osaka City University Project 1, Tacrolimus-Ulcerative Colitis, 3 [Mucosal Healing for Prognosis]
: HOOP1 (TCL-UC)-3 [MHP]

Scientific Title

The evaluation of efficacy for remission maintenance with immunomodulator following remission induction with tacrolimus in patients with moderate to severe active refractory ulcerative colitis.:mucosal healing for prognosis

Scientific Title:Acronym

Hyogo College of Medicine, Osaka Medical College, Osaka City University Project 1, Tacrolimus-Ulcerative Colitis, 3 [Mucosal Healing for Prognosis]
: HOOP1 (TCL-UC)-3 [MHP]

Region

Japan


Condition

Condition

The patients with moderate to severe active refractory ulcerative colitis

Classification by specialty

Gastroenterology

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

The evaluation of efficacy for remission maintenance with immunomodulator following remission induction with tacrolimus in patients with moderate to severe active refractory ulcerative colitis.

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

Remission rate at 48 weeks after the administration of tacrolimus

Key secondary outcomes



Base

Study type

Interventional


Study design

Basic design

Parallel

Randomization

Randomized

Randomization unit

Individual

Blinding

Open -no one is blinded

Control

No treatment

Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms

2

Purpose of intervention

Treatment

Type of intervention

Medicine

Interventions/Control_1

Group of remission maintenance therapy for 48 weeks with immunomodulator at from 2 to 4 weeks following remission induction with tacrolimus,

Interventions/Control_2

Group of no remission maintenance therapy with immunomodulator following remission induction with tacrolimus,

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

16 years-old <=

Age-upper limit

65 years-old >

Gender

Male and Female

Key inclusion criteria

1)The patients with ulcerative colitis of left side colitis or pancolitis type
2)Moderate to severe active ulcerative colitis (more than 6 points for DAI)
3)Steroid refractory or dependent case

Key exclusion criteria

1)The treatment with immunomodulator or anti-TNF alpha agents within 12 weeks before administration of tacrolimus
2)The treatment with cytapheresis within 12 weeks before administration of tacrolimus
3)The patients who are not suitable for treatment of immunomodulator
4)The patients after colectomy
5)the patients with renal disorder

Target sample size

50


Research contact person

Name of lead principal investigator

1st name Kenji
Middle name
Last name Watanabe

Organization

Osaka City University, Graduate School of Medicine

Division name

Gastroenterology

Zip code

545-8585

Address

1-4-3, Asahi-machi, Abeno-ku, Osaka

TEL

0666453811

Email

kenjiw1779@gmail.com


Public contact

Name of contact person

1st name Kenji
Middle name
Last name Watanabe

Organization

Osaka City University, Graduate School of Medicine

Division name

Gastroenterology

Zip code

545-8585

Address

1-4-3, Asahi-machi, Abeno-ku, Osaka

TEL

0666453811

Homepage URL


Email

kenjiw1779@gmail.com


Sponsor or person

Institute

Osaka City University, Graduate School of Medicine,Department of Gastroenterology

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

Ethical Committee of Osaka City University, Graduate School of Medicine

Address

1-4-3, Asahi-machi, Abeno-ku, Osaka

Tel

06-6646-6125

Email

kenjiw1779@gmail.com


Secondary IDs

Secondary IDs

YES

Study ID_1

1772

Org. issuing International ID_1

Ethical Committee of Osaka City University, Graduate School of Medicine

Study ID_2


Org. issuing International ID_2


IND to MHLW



Institutions

Institutions

大阪市立大学病院(大阪府)、兵庫医科大学病院(兵庫県)、大阪医科大学病院(大阪府)


Other administrative information

Date of disclosure of the study information

2010 Year 09 Month 14 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

2013 Year 08 Month 29 Day

Date of IRB

2010 Year 06 Month 08 Day

Anticipated trial start date

2013 Year 12 Month 02 Day

Last follow-up date

2017 Year 03 Month 31 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information



Management information

Registered date

2010 Year 09 Month 14 Day

Last modified on

2024 Year 03 Month 10 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000005048


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name