UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000030988
Receipt number R000035381
Scientific Title Open-label, randomized, two-parallel-arm, single center study to designed to evaluate azathioprine versus adalimumab after induction of tacrolimus in refractory ulcerative colitis therapy
Date of disclosure of the study information 2018/02/01
Last modified on 2018/01/25 12:59:22

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Basic information

Public title

Open-label, randomized, two-parallel-arm, single center study to designed to evaluate azathioprine versus adalimumab after induction of tacrolimus in refractory ulcerative colitis therapy

Acronym

Comparison of maintenance treatment between azathioprine and adalimumab after induction of tacrolimus in ulcerative colitis therapy (CAT study)

Scientific Title

Open-label, randomized, two-parallel-arm, single center study to designed to evaluate azathioprine versus adalimumab after induction of tacrolimus in refractory ulcerative colitis therapy

Scientific Title:Acronym

Comparison of maintenance treatment between azathioprine and adalimumab after induction of tacrolimus in ulcerative colitis therapy (CAT study)

Region

Japan


Condition

Condition

Ulcerative Colitis

Classification by specialty

Gastroenterology

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

To compare the efficacy and safety of maintenance therapy by azathioprine versus adalimumab after induction of tacrolimus

Basic objectives2

Safety,Efficacy

Basic objectives -Others


Trial characteristics_1

Confirmatory

Trial characteristics_2

Pragmatic

Developmental phase

Not applicable


Assessment

Primary outcomes

Comparison of non-relapse rates (1 year) between azathioprine group and adalimumab group

Key secondary outcomes

Comparison of side-effect rates (1 year) between azathioprine group and adalimumab group
Comparison of clinical remission rates (1 year) between azathioprine group and adalimumab group
Comparison of endoscopic remission rates (1 year) between azathioprine group and adalimumab group


Base

Study type

Interventional


Study design

Basic design

Parallel

Randomization

Randomized

Randomization unit

Individual

Blinding

Open -no one is blinded

Control

Active

Stratification

YES

Dynamic allocation

NO

Institution consideration

Institution is considered as a block.

Blocking

YES

Concealment

Pseudo-randomization


Intervention

No. of arms

2

Purpose of intervention

Treatment

Type of intervention

Medicine

Interventions/Control_1

Induce azathioprine and continue maintenance therapy by azathioprine

Interventions/Control_2

Induce adalimumab and continue maintenance therapy by adalimumab

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

15 years-old <=

Age-upper limit


Not applicable

Gender

Male and Female

Key inclusion criteria

Moderate to severe ulcerative colitis patients who are refractory to steroid therapy
No history of immunomodulator, anti-TNF drug or calcineurin inhibitor within 1 year

Key exclusion criteria

Patients who are contraindicated of tacrolimus, azathioprine or adalimumab
Female patients who are in lactation or desire to bear children
Patients less than 15 years old
Patients who do not consent to the trial
Patients who had malignancy
Patients who had intestinal resection within 6 months
Patients who are short-bowel syndrome
Patients who are not appropriate to participate to the trial

Target sample size

53


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Yasuo Suzuki

Organization

Sakura Medical Center, Toho university

Division name

Inflammatory bowel disease (IBD) center

Zip code


Address

564-1, Shimoshizu, Sakura, Chica

TEL

043-462-8811

Email

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


Public contact

Name of contact person

1st name
Middle name
Last name Yasuo Suzuki

Organization

Sakura Medical Center, Toho university

Division name

Inflammatory bowel disease (IBD) center

Zip code


Address

564-1, Shimoshizu, Sakura, Chica

TEL

043-462-8811

Homepage URL


Email

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


Sponsor or person

Institute

Sakura Medical Center, Toho university

Institute

Department

Personal name



Funding Source

Organization

Sakura Medical Center, Toho university

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



Other administrative information

Date of disclosure of the study information

2018 Year 02 Month 01 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

Preinitiation

Date of protocol fixation

2018 Year 01 Month 26 Day

Date of IRB


Anticipated trial start date

2018 Year 02 Month 01 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

2018 Year 01 Month 25 Day

Last modified on

2018 Year 01 Month 25 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000035381


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name