UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000018483
Receipt number R000021398
Scientific Title Short-Term Outcomes of Adalimumab for Patients with Crohn's Disease and Associated Prognostic Factors: a Multicenter Retrospective Cohort Study in Japan (SAPPORO study)
Date of disclosure of the study information 2015/11/01
Last modified on 2022/10/03 13:36:51

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Basic information

Public title

Short-Term Outcomes of Adalimumab for Patients with Crohn's Disease and Associated Prognostic Factors: a Multicenter Retrospective Cohort Study in Japan (SAPPORO study)

Acronym

Evaluation of Adalimumab in Crohn's disease

Scientific Title

Short-Term Outcomes of Adalimumab for Patients with Crohn's Disease and Associated Prognostic Factors: a Multicenter Retrospective Cohort Study in Japan (SAPPORO study)

Scientific Title:Acronym

Evaluation of Adalimumab in 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 investigate retrospectively the short-term outcomes and related prognostic factors in patients with Crohn's disease treated by adalimumab.

Basic objectives2

Safety,Efficacy

Basic objectives -Others


Trial characteristics_1

Confirmatory

Trial characteristics_2

Pragmatic

Developmental phase

Not applicable


Assessment

Primary outcomes

Complete remission rate at 4 weeks following adalimumab administration.

Key secondary outcomes

Complete remission rates at 2, 8 and 12 weeks following adalimumab administration.
Remission rates at 2, 4, 8 and 12 weeks following adalimumab administration.
Change of HBI, CRP and alubumin value at 2, 4, 8 and 12 weeks following adalimumab administration.
Predictors for remission and complete remission rates at 2, 4, 8 and 12 weeks following adalimumab administration.
Bowel resection rate at 12 week following adalimumab administration.
Predictors for bowel resection rate at 12 week fllowing adalimumab administration.
Reasens of adalimumab discontinuation.
Adverse event.
etc.


Base

Study type

Observational


Study design

Basic design


Randomization


Randomization unit


Blinding


Control


Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms


Purpose of intervention


Type of intervention


Interventions/Control_1


Interventions/Control_2


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


Not applicable

Age-upper limit


Not applicable

Gender

Male and Female

Key inclusion criteria

Patients with Crohn's disease who received adalimumab induction therapy from October 2010 to March 2015.

Key exclusion criteria

1) The patient whom HBI before adalimumab administration was not able to measure.
2) The patients with HBI of <5 before adalimumab administration.
3) The patient that injection method within 4 weeks from adalimumab administraton is different from an package insert.
4) The patient with history of adalimumab treatment.
5) The patient with history of anti-TNF antibody agtents except infliximab.
6) The patient having a stoma
7) The patient who was administered adalimumab to prevent a postoperative recurrence.

Target sample size

200


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Hiroki Tanaka

Organization

Sapporo Kosei General Hospital

Division name

IBD Center

Zip code


Address

Kita-3, Higashi-8, Chuo-ku, Sapporo, HOKKAIDO, 060-0033, JAPAN

TEL

011-261-5331

Email

hirokit@mtc.biglobe.ne.jp


Public contact

Name of contact person

1st name
Middle name
Last name Hiroki Tanaka

Organization

Sapporo Kosei General Hospital

Division name

IBD Center

Zip code


Address

Kita-3, Higashi-8, Chuo-ku, Sapporo, HOKKAIDO, 060-0033, JAPAN

TEL

011-261-5331

Homepage URL


Email

hirokit@mtc.biglobe.ne.jp


Sponsor or person

Institute

IBD Center, Sapporo Kosei General 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

札幌厚生病院 IBDセンター(北海道),聖マリアンナ医科大学 消化器・肝臓内科(神奈川県),川崎医科大学 消化管内科学(岡山県),戸畑共立病院消化器病センター(福岡県),東京大学医科学研究所 TR・治験センター(東京都)


Other administrative information

Date of disclosure of the study information

2015 Year 11 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

Completed

Date of protocol fixation

2015 Year 07 Month 29 Day

Date of IRB

2015 Year 07 Month 29 Day

Anticipated trial start date

2015 Year 09 Month 01 Day

Last follow-up date

2019 Year 12 Month 31 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information

Obsevational study


Management information

Registered date

2015 Year 07 Month 29 Day

Last modified on

2022 Year 10 Month 03 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000021398


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name