UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000020785 |
|---|---|
| Receipt number | 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 07:58:20 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
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
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
sakurai@med.kindai.ac.jp
Sponsor or person
Institute
Department of Gastroenterology and Hepatology, KINKI University Faculty of Medicine
Institute
Department
Personal name
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
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
Value
https://center6.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 |
