UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000051508 |
|---|---|
| Receipt number | R000057505 |
| Scientific Title | Retrospective observational study of AJM300 CT3 trial investigating serum biomarkers, patient reported outcomes and maintenance medication |
| Date of disclosure of the study information | 2023/07/03 |
| Last modified on | 2023/07/27 19:14:18 |
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Basic information
Public title
Retrospective observational study of AJM300 CT3 trial investigating serum biomarkers, patient reported outcomes and maintenance medication
Acronym
ASPECT study
Scientific Title
Retrospective observational study of AJM300 CT3 trial investigating serum biomarkers, patient reported outcomes and maintenance medication
Scientific Title:Acronym
ASPECT study
Region
| Japan |
Condition
Condition
Ulcerative colitis
Classification by specialty
| Gastroenterology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The remaining blood samples (cryopreserved serum) collected in the AJM300 (nonproprietary name: carotegrast methyl) trial (CT3 Trial) will be used to assay biomarkers (LRG, anti-integrin alpha(v) beta(6) antibody titer) that had not been assayed in the trial, in order to assess efficacy-related biomarkers.
Patient symptom diaries (occurrence of bloody stool, bowel movement frequency) will be collected to study the time points at which AJM300 had an effect on the occurrence of bloody stool and bowel movement frequency.
Maintenance medication (medication, dose, duration of dosing) will be studied in patients who achieved remission as a result of AJM300 treatment.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Others
Trial characteristics_2
Others
Developmental phase
Not applicable
Assessment
Primary outcomes
Correlation between the Mayo endoscopic score (MES) and biomarkers (LRG, anti-integrin alpha(v) beta(6) antibody titer) at the end of treatment
Key secondary outcomes
1) MES-biomarker correlation at each time point
2) Comparison of change over time in biomarkers between patients who did and did not achieve remission
3) Use of Biomarkers for Predicting Response and Exploring End-of-Treatment Criteria
4) Comparison of change in course of recovery from bloody stool and normalization of bowel movement frequency between placebo group and active drug group
5) Assessment of bloody stool/bowel movement status after 1, 2, 3, 4, 5, and 6 weeks of treatment, and effect on mucosal score at Week 8
6) Correlation between laboratory values (e.g., FCP, CRP) and biomarkers
7) Correlation between biomarkers and duration of remission
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
1. Patients who were enrolled in the CT3 Trial
2. Patients at sites that agreed to participate in the trial
Key exclusion criteria
1. Patients who have declined to participate in the trial
Target sample size
203
Research contact person
Name of lead principal investigator
| 1st name | Katsuyoshi |
| Middle name | |
| Last name | Matsuoka |
Organization
Toho University Sakura Medical Center
Division name
Gastroenterology Chair of Internal Medicine
Zip code
285-8741
Address
564-1 Shimoshizu, Sakura-shi, Chiba
TEL
043-462-8811
katsuyoshi.matsuoka@med.toho-u.ac.jp
Public contact
Name of contact person
| 1st name | Saiko |
| Middle name | |
| Last name | Tamura |
Organization
Satt Co.,Ltd
Division name
Clinical Research Promotion Group
Zip code
160-0022
Address
5F ACN Shinjuku Building, 2-12-8 Shinjuku, Shinjuku-ku, Tokyo
TEL
03-5312-5026
Homepage URL
ct3ret@sa-tt.co.jp
Sponsor or person
Institute
Toho University Sakura Medical Center
Institute
Department
Personal name
Funding Source
Organization
EA Pharma Co.,Ltd
KISSEI PHARMACEUTICAL CO., LTD.
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
EA Pharma Co.,Ltd
KISSEI PHARMACEUTICAL CO., LTD.
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Ethics Committee of Toho University Sakura Medical Center
Address
564-1 Shimoshizu, Sakura-shi, Chiba
Tel
043-462-8811(2616)
sakura.rinri@ext.toho-u.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
札幌厚生病院(北海道),旭川厚生病院(北海道),弘前大学医学部附属病院(青森県),弘前総合医療センター(青森県),東北大学病院(宮城県),仙台医療センター(宮城県),イムス明理会仙台総合病院(宮城県),かんけ胃腸クリニック(栃木県),大森敏秀胃腸科クリニック(埼玉県),防衛医科大学校病院(埼玉県),辻仲病院柏の葉(千葉県),千葉大学医学部附属病院(千葉県),東京慈恵会医科大学附属柏病院(千葉県),順天堂大学医学部附属浦安病院(千葉県),順天堂大学医学部附属順天堂医院(東京都),東京山手メディカルセンター(東京都),東海大学医学部付属八王子病院(東京都),北里大学北里研究所病院(東京都),三井記念病院(東京都),東京医科歯科大学医学部附属病院(東京都),杏林大学医学部付属病院(東京都),北里大学病院(神奈川県),山梨県立中央病院(山梨県),松田病院(静岡県),よこやまIBDクリニック(愛知県),だいどうクリニック(愛知県),小畑内科クリニック(京都府),大阪公立大学医学部附属病院(大阪府),藤田胃腸科病院(大阪府),若草第一病院(大阪府),神戸市立医療センター中央市民病院(兵庫県),兵庫医科大学病院(兵庫県),チクバ外科・胃腸科・肛門科病院(岡山県),岡山大学病院(岡山県),倉敷中央病院(岡山県),福山医療センター(広島県),広島市立広島市民病院(広島県),徳山中央病院(山口県),福岡大学筑紫病院 (福岡県),福岡大学病院(福岡県),福岡県済生会福岡総合病院(福岡県),佐賀大学医学部附属病院(佐賀県),長崎大学病院(長崎県)
Other administrative information
Date of disclosure of the study information
| 2023 | Year | 07 | Month | 03 | 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
Enrolling by invitation
Date of protocol fixation
| 2023 | Year | 06 | Month | 21 | Day |
Date of IRB
| 2023 | Year | 04 | Month | 12 | Day |
Anticipated trial start date
| 2023 | Year | 06 | Month | 21 | Day |
Last follow-up date
| 2024 | Year | 09 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
-
Management information
Registered date
| 2023 | Year | 07 | Month | 03 | Day |
Last modified on
| 2023 | Year | 07 | Month | 27 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000057505
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