UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000006141
Receipt number R000007262
Scientific Title Comparative study of Infliximab monotherapy vs combined therapy with azathiopurine for inducing and maintaining clinical remission in steroid-dependent or -resistant ulcerative colitis
Date of disclosure of the study information 2011/08/12
Last modified on 2016/02/11 10:34:54

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Basic information

Public title

Comparative study of Infliximab monotherapy vs combined therapy with azathiopurine for inducing and maintaining clinical remission in steroid-dependent or -resistant ulcerative colitis

Acronym

Comparative study of Infliximab monotherapy vs combined therapy with azathiopurine for inducing and maintaining clinical remission in steroid-dependent or -resistant ulcerative colitis

Scientific Title

Comparative study of Infliximab monotherapy vs combined therapy with azathiopurine for inducing and maintaining clinical remission in steroid-dependent or -resistant ulcerative colitis

Scientific Title:Acronym

Comparative study of Infliximab monotherapy vs combined therapy with azathiopurine for inducing and maintaining clinical remission in steroid-dependent or -resistant ulcerative colitis

Region

Japan


Condition

Condition

ulcerative colitis

Classification by specialty

Gastroenterology

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

To evaluate the efficacy and safety of Infliximab monotherapy and combined therapy with azathiopurine for inducing and maintaining clinical remission in steroid-dependent or -resistant ulcerative colitis, in a multicenter, open labeled, randomized, controlled study

Basic objectives2

Safety,Efficacy

Basic objectives -Others


Trial characteristics_1

Confirmatory

Trial characteristics_2

Explanatory

Developmental phase

Not applicable


Assessment

Primary outcomes

Remission and clinical response rate at week 30

Key secondary outcomes

1) Remission rate (CAI 0-4) at week 8, 30, and 54
2) Clinical response (more than 50 percent reduction from baseline in their CAI) at week 8 and 54
3) Mucosal healing at week 8 and 54
4) Steroid sparing effect
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

Interventions/Control_1

Patients in Infliximab monotherapy receive intravenous infusion of IFX at week 0, 2, and 6, and then every 8 weeks (up to week 54).

Interventions/Control_2

Patients in the combination therapy of Infliximab and azathiopurine receive intravenous infusion of IFX (at week 0, 2, 6, and then every 8 weeks) and oral azathiopurine (up to week 54).

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

75 years-old >

Gender

Male and Female

Key inclusion criteria

1) Patients with moderately active ulcerative colitis (CAI; 7-11)
2) Patients treated with corticosteroid (PSL; less or equal to 30mg/day, within 2 weeks)
3) Immunomodulators (azathiopurine, methotrexate, tacrolimus, cyclosporine
) naive patients
4) Anti-TNF biologic agent naive patients

Key exclusion criteria

1) Patients who are required total colectomy or subtotal colectomy
2) Patients with severe active ulcerative colitis (CAI; more than 12)
3) Patients with malignancy
4) Patients with intestinal stenosis to cause intestinal obstruction
5) Patients with serious extraintestinal complication
6) Patients who are pregnant or desire pregnancy

Target sample size

50


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

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

京都大学医学部附属病院(京都府)
京都桂病院(京都府)
北野病院(大阪府)
大阪府済生会中津病院(大阪府)
日本赤十字社 大津赤十字病院(滋賀県)
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)
天理よろづ相談所病院(奈良県)
滋賀県立成人病センター(滋賀県)
日本赤十字社 和歌山医療センター(和歌山県)


Other administrative information

Date of disclosure of the study information

2011 Year 08 Month 12 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 07 Month 25 Day

Date of IRB


Anticipated trial start date

2011 Year 10 Month 01 Day

Last follow-up date

2014 Year 12 Month 01 Day

Date of closure to data entry


Date trial data considered complete

2015 Year 12 Month 31 Day

Date analysis concluded



Other

Other related information



Management information

Registered date

2011 Year 08 Month 09 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=R000007262


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name