UMIN-CTR Clinical Trial

Public title

A comparative study of the efficacy of tacrolimus with infliximab in intractable ulcerative colitis

Acronym

A comparison of the efficacy of tacrolimus with infliximab in ulcerative colitis

Scientific Title

A comparative study of the efficacy of tacrolimus with infliximab in intractable ulcerative colitis

Scientific Title:Acronym

A comparison of the efficacy of tacrolimus with infliximab in ulcerative colitis

Region

Japan

Condition

Ulcerative colitis

Classification by specialty

Gastroenterology

Classification by malignancy

Others

Genomic information

NO

Narrative objectives1

To evaluate the efficacy of tacrolimus over infliximab in steroid-resistant or -dependent ulcerative colitis with moderate to severe activity.

Basic objectives2

Efficacy

Basic objectives -Others

Trial characteristics_1

Confirmatory

Trial characteristics_2

Pragmatic

Developmental phase

Phase IV

Primary outcomes

Clinical response rate at week 10 according to the DAI score.

Key secondary outcomes

Clinical remission rate at week 10
DAI score at week 10
Endoscopic remission rate at week 10

Study type

Interventional

Basic design

Parallel

Randomization

Randomized

Randomization unit

Individual

Blinding

Open -no one is blinded

Control

Active

Stratification

YES

Dynamic allocation

YES

Institution consideration

Institution is not considered as adjustment factor.

Blocking

NO

Concealment

Central registration

No. of arms

2

Purpose of intervention

Treatment

Type of intervention

Medicine

Interventions/Control_1

Tacrolimus will be administered orally for 10 weeks at the trough level of 10-15 ng/ml for the first 2 weeks following that of 5-10 ng/ml for the rest of the study period.

Interventions/Control_2

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

Interventions/Control_3

Interventions/Control_4

Interventions/Control_5

Interventions/Control_6

Interventions/Control_7

Interventions/Control_8

Interventions/Control_9

Interventions/Control_10

Age-lower limit

20

years-old

<=

Age-upper limit

Not applicable

Gender

Male and Female

Key inclusion criteria

Patients who have an established diagnosis of ulcerative colitis and fulfill the criteria as described below:
1. Patients with moderate to severe activity defined by a DAI score of more than or equal to 6, AND an endoscopic sub-score of more than or equal to 2.
2. Patients showing steroid-resistance or steroid-dependence defined as below.
1) Steroid-resistance: No symptomatic improvement despite administration of oral prednisolone >= 30 mg for 2 weeks or i ntravenous prednisolone >= 30 mg for 1 week.
2) Steroid-dependence: Symptomatic worsening during steroid tapering or following discontinuation of steroids within 12 months.

Key exclusion criteria

1. Patients with only proctitis.
2. Patients having contraindications to tacrolimus including current use of cyclosporine, bozentan, or potassium-sparing diuretics.
3. Patients having contraindications to infliximab including serious infection (sepsis), active tuberculosis infection, allergy to murine-derive proteins.
4. Patients who have been administered anti-TNF agents, tacrolimus, or cyclosporine.
5. Concomitant medication:
1) Changed the dose of oral 5-aminosalicylate (ASA) agents within 1 week.
2) Used topical 5-ASA agents or topical steroid agents within 1 week.
3) Underwent cytapheresis within 1 week.
4) Started an immunomodulator (azathioprine, mercaptopurine) within 12 weeks or changed the dose of the agent within 4 weeks.
5) Changed the dose of oral prednisolone within 1 week.
6) Changed the dose of intravenous prednisolone within 1 week.
6. Patients who have a serious infection or are suspected to have it.
7. Patients who have a serious cardiovascular disease.
8. Patients who have a serious renal disease (Serum Cr >= 2.0 mg/dl)
9. Patients who have a serious hepatic disease (Total bilirubin >= 3.0 mg/dl or AST or ALT >= 200 IU/ml)
10. Patients who are pregnant, possible to be pregnant, or want to be during the study period, or are breastfeeding.
11. Patients who have a neoplasm or had a neoplasm.
12. Patients who have a psychological disorder.
13. Patients who underwent resection of the colon (excluding appendectomy)
14. Patients who are judged to be exclusive by investigators for a certain reason.

Target sample size

130

Name of lead principal investigator

1st name
Middle name
Last name	Toshifumi Hibi

Organization

Kitasato University Kitasato Institute Hospital

Division name

Center for Advanced IBD Research and Treatment

Zip code

Address

5-9-1 Shirogane, Minato Tokyo

TEL

03-5791-6487

Email

thibi@insti.kitasato-u.ac.jp

Name of contact person

1st name
Middle name
Last name	Toshifumi Hibi

Organization

Kitasato University Kitasato Institute Hospital

Division name

Center for Advanced IBD Research and Treatment

Zip code

Address

5-9-1 Shirogane, Minato Tokyo

TEL

03-5791-6487

Homepage URL

Email

thibi@insti.kitasato-u.ac.jp

Institute

Department of Internal Medicine, Division of Gastroenterology and Hepatology, Keio University School of Medicine

Institute

Department

Personal name

Organization

Research group of intractable inflammatory bowel disease subsidized by the Ministry of Health, Labour and Welfare of Japan

Organization

Division

Category of Funding Organization

Nationality of Funding Organization

Co-sponsor

Name of secondary funder(s)

Organization

Address

Tel

Email

Secondary IDs

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

愛知医科大学 (愛知県)、秋田赤十字病院 (秋田県)、旭川医科大学 (北海道)、大船中央病院 (神奈川県)、大阪市立十三市民病院 (大阪府)、大阪市立大学 (大阪府)、鹿児島大学 (鹿児島県)、金沢大学 (石川県)、関西医科大学 (大阪府)、京都大学 (京都府)、京都府立大学 (京都府)、九州大学 (福岡県)、慶應義塾大学 (東京都)、滋賀医科大学 (滋賀県)、札幌厚生病院 (北海道)、島根大学 (島根県)、社会保険中央総合病院 (東京都)、昭和大学横浜市北部病院 (神奈川県)、東京医科歯科大学 (東京都)、東京慈恵会医科大学 (東京都)、東京女子医科大学・消化器内科 (東京都)、東京女子医科大学・第二外科 (東京都)、東京大学・腫瘍外科 (東京都)、東邦大学医療センター佐倉病院 (千葉県)、東北大学 (宮城県)、名古屋大学 (愛知県)、名古屋市立大学 (愛知県)、浜松南病院 (静岡県)、兵庫医科大学 (兵庫県)、弘前病院 (青森県)、弘前大学医学部 (青森県)、広島大学 (広島県)、福岡大学筑紫病院 (福岡県)、藤田保健衛生大学 (愛知県)、防衛医科大学校 (埼玉県)、横浜市立大学市民医療センター (神奈川県)、琉球大学 (沖縄県)、和歌山県立医科大学 (和歌山県)、群馬大学 (群馬県)、北里大学北里研究所病院 (東京都)、東海大学八王子病院 (東京都)、横浜市立大学 (神奈川県)、埼玉医科大学 (埼玉県)、横浜市民病院 (神奈川県)、大阪府済生会中津病院 (大阪府)、岡山大学 (岡山県)、新潟大学 (新潟県)、埼玉メディカルセンター (埼玉県)

Date of disclosure of the study information

2013

Year

05

Month

01

Day

URL releasing protocol

Publication of results

Unpublished

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

Recruitment status

Completed

Date of protocol fixation

2013

Year

02

Month

25

Day

Date of IRB

Anticipated trial start date

2013

Year

05

Month

01

Day

Last follow-up date

Date of closure to data entry

Date trial data considered complete

Date analysis concluded

Other related information

Registered date

2013

Year

04

Month

29

Day

Last modified on

2016

Year

10

Month

31

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000012376