Unique ID issued by UMIN | UMIN000051508 |
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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 | 2024/07/03 10:10:57 |
Retrospective observational study of AJM300 CT3 trial investigating serum biomarkers, patient reported outcomes and maintenance medication
ASPECT study
Retrospective observational study of AJM300 CT3 trial investigating serum biomarkers, patient reported outcomes and maintenance medication
ASPECT study
Japan |
Ulcerative colitis
Gastroenterology |
Others
NO
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.
Efficacy
Others
Others
Not applicable
Correlation between the Mayo endoscopic score (MES) and biomarkers (LRG, anti-integrin alpha(v) beta(6) antibody titer) at the end of treatment
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
Observational
Not applicable |
Not applicable |
Male and Female
1. Patients who were enrolled in the CT3 Trial
2. Patients at sites that agreed to participate in the trial
1. Patients who have declined to participate in the trial
203
1st name | Katsuyoshi |
Middle name | |
Last name | Matsuoka |
Toho University Sakura Medical Center
Gastroenterology Chair of Internal Medicine
285-8741
564-1 Shimoshizu, Sakura-shi, Chiba
043-462-8811
katsuyoshi.matsuoka@med.toho-u.ac.jp
1st name | Saiko |
Middle name | |
Last name | Tamura |
Satt Co.,Ltd
Clinical Research Promotion Group
160-0022
5F ACN Shinjuku Building, 2-12-8 Shinjuku, Shinjuku-ku, Tokyo
03-5312-5026
ct3ret@sa-tt.co.jp
Toho University Sakura Medical Center
EA Pharma Co.,Ltd
KISSEI PHARMACEUTICAL CO., LTD.
Profit organization
EA Pharma Co.,Ltd
KISSEI PHARMACEUTICAL CO., LTD.
Ethics Committee of Toho University Sakura Medical Center
564-1 Shimoshizu, Sakura-shi, Chiba
043-462-8811(2616)
sakura.rinri@ext.toho-u.ac.jp
NO
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)
2023 | Year | 07 | Month | 03 | Day |
Unpublished
Enrolling by invitation
2023 | Year | 06 | Month | 21 | Day |
2023 | Year | 04 | Month | 12 | Day |
2023 | Year | 06 | Month | 21 | Day |
2024 | Year | 04 | Month | 10 | Day |
2024 | Year | 04 | Month | 10 | Day |
-
2023 | Year | 07 | Month | 03 | Day |
2024 | Year | 07 | Month | 03 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000057505
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