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
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
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
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
