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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000020785
Receipt No. R000023972
Scientific Title Evaluation of Adalimumab therapy in Mesalazine refractory or intolerant Ulcerative colitis: An observational study
Date of disclosure of the study information 2016/01/28
Last modified on 2020/02/02

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Basic information
Public title Evaluation of Adalimumab therapy in Mesalazine refractory or intolerant Ulcerative colitis:
An observational study
Acronym EARLY trial
Scientific Title Evaluation of Adalimumab therapy in Mesalazine refractory or intolerant Ulcerative colitis:
An observational study
Scientific Title:Acronym EARLY trial
Region
Japan

Condition
Condition Ulcerative colitis
Classification by specialty
Gastroenterology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 Efficacy and safety of Adalimumab(ADA) will be identified among ulcerative colitis patients including steroid naive who are intractable with or intolerant to mesalazine (5-ASA).
The discontinuation of ADA will be considered for patients demonstrate efficacy.
The inflation rate and the efficacy and safety of ADA re-administration will also be evaluated.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes remission rate
Key secondary outcomes

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
15 years-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria Mesalazine refractory or intolerant Ulcerative colitis
Key exclusion criteria 1) Less than 15 years old
2) Patients that may be pregnant or pregnant
3) Patients with malignant tumor
4) Patients with serious infections
5) Patients with a treatment history of adalimumab
6) Contraindication of adalimumab
7) Patients consent can not be obtained on the clinical research participation
8) Patients who are otherwise classified as unfit by the attending physicians for the research.
Target sample size 30

Research contact person
Name of lead principal investigator
1st name Toshiharu
Middle name
Last name Sakurai
Organization KINKI University Faculty of Medicine
Division name Department of Gastroenterology and Hepatology
Zip code 589-8511
Address 377-2 Ohno-higashi, Osaka-sayama, Osaka
TEL 072-366-0221
Email sakurai@med.kindai.ac.jp

Public contact
Name of contact person
1st name Toshiharu
Middle name
Last name Sakurai
Organization KINKI University Faculty of Medicine
Division name Department of Gastroenterology and Hepatology
Zip code 589-8511
Address 377-2 Ohno-higashi, Osaka-sayama, Osaka
TEL 072-366-0221
Homepage URL
Email sakurai@med.kindai.ac.jp

Sponsor
Institute Department of Gastroenterology and Hepatology, KINKI University Faculty of Medicine
Institute
Department

Funding Source
Organization none
Organization
Division
Category of Funding Organization Other
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization Kindai University IRB
Address 377-2 Ohno-Higashi Osaka-Sayama
Tel 072-366-0221
Email zizen@med.kindai.ac.jp

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 近畿大学医学部附属病院(大阪府)
近畿大学医学部堺病院(大阪府)
近畿大学医学部奈良病院(奈良県)
ベルランド総合病院(大阪府)
鳳胃腸病院(大阪府)

Other administrative information
Date of disclosure of the study information
2016 Year 01 Month 28 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 Open public recruiting
Date of protocol fixation
2016 Year 01 Month 01 Day
Date of IRB
2016 Year 01 Month 10 Day
Anticipated trial start date
2016 Year 01 Month 14 Day
Last follow-up date
2020 Year 12 Month 01 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information The presence of relapse is assessed.
Patients who come from January 2016 to December 2018 and qualify the inclusion criteria are enrolled.

Management information
Registered date
2016 Year 01 Month 28 Day
Last modified on
2020 Year 02 Month 02 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000023972

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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