UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000062396 |
|---|---|
| Receipt number | R000071410 |
| Scientific Title | Clinical Impact of Discontinuing Oral 5-Aminosalicylic Acid in Patients with Ulcerative Colitis Who Have Achieved Endoscopic Mucosal Healing with Advanced Therapy: A Randomized Controlled Trial |
| Date of disclosure of the study information | 2026/07/29 |
| Last modified on | 2026/07/30 00:30:41 |
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Basic information
Public title
Study of Oral 5-ASA Discontinuation in Patients with Ulcerative Colitis Who Have Achieved Mucosal Healing
Acronym
Advanced Therapy-guided Long-term oral 5-AminoSalicylic acid Discontinuation Trial (ATLAS-D Trial)
Scientific Title
Clinical Impact of Discontinuing Oral 5-Aminosalicylic Acid in Patients with Ulcerative Colitis Who Have Achieved Endoscopic Mucosal Healing with Advanced Therapy: A Randomized Controlled Trial
Scientific Title:Acronym
Advanced Therapy-guided Long-term oral 5-AminoSalicylic acid Discontinuation Trial (ATLAS-D Trial)
Region
| Japan |
Condition
Condition
Ulcerative Colitis
Classification by specialty
| Gastroenterology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the efficacy and safety of discontinuing oral 5-aminosalicylic acid (5-ASA) compared with continuing oral 5-ASA in patients with ulcerative colitis who have achieved endoscopic mucosal healing with Advanced Therapy.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Cumulative clinical relapse rate through Week 52 after randomization.
Key secondary outcomes
Cumulative clinical relapse rates through Weeks 12, 24, and 104
Changes in the Partial Mayo Score at Weeks 12, 24, 52, and 104
Changes in inflammatory and disease activity biomarkers at Weeks 12, 24, 52, and 104
Changes in endoscopic disease activity (Mayo Endoscopic Subscore)
Re-initiation rate of oral 5-aminosalicylic acid (5-ASA) in the discontinuation group
Incidence of adverse events
Medication adherence at baseline and at Weeks 12, 24, 52, and 104
Pill burden at baseline and at Weeks 12, 24, 52, and 104
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Active
Stratification
NO
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Continue oral 5-aminosalicylic acid while maintaining Advanced Therapy.
Interventions/Control_2
Discontinue oral 5-aminosalicylic acid while maintaining Advanced Therapy.
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
| 16 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1) Patients aged 16 years or older with a diagnosis of ulcerative colitis.
2) Receiving oral 5-aminosalicylic acid.
3) Receiving maintenance therapy with an advanced therapy approved for ulcerative colitis in Japan.
4) No systemic or topical corticosteroid use for at least 8 weeks before enrollment.
5) No changes in the type, dose, or dosing interval of oral 5-ASA or advanced therapy for at least 8 weeks before enrollment.
6) Clinical remission maintained for at least 8 weeks before enrollment (Partial Mayo Score of 1 or less and Rectal Bleeding Subscore =0).
7) Endoscopic mucosal healing (Mayo Endoscopic Subscore of 1 or less) confirmed within 8 weeks before enrollment.
8) Written informed consent obtained.
Key exclusion criteria
1) Refusal or inability to provide written informed consent.
2) Age younger than 16 years.
3) Pregnant or breastfeeding women.
4) History of total or subtotal colectomy.
5) Patients considered unsuitable for participation by the investigator.
Target sample size
60
Research contact person
Name of lead principal investigator
| 1st name | Shogo |
| Middle name | |
| Last name | Kitahata |
Organization
Ehime Prefectural Central Hospital
Division name
Department of Gastroenterology
Zip code
790-0024
Address
83 Kasugamachi, Matsuyama, Ehime 790-0024, Japan
TEL
089-947-1111
c-skitahata@eph.pref.ehime.jp
Public contact
Name of contact person
| 1st name | Shogo |
| Middle name | |
| Last name | Kitahata |
Organization
Ehime Prefectural Central Hospital
Division name
Department of Gastroenterology
Zip code
790-0024
Address
83 Kasugamachi, Matsuyama, Ehime 790-0024, Japan
TEL
089-947-1111
Homepage URL
c-skitahata@eph.pref.ehime.jp
Sponsor or person
Institute
Ehime Prefectural Central Hospital
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
Institutional Review Board, Ehime Prefectural Central Hospital
Address
83 Kasugamachi, Matsuyama, Ehime 790-0024, Japan
Tel
089-947-1111
c-skitahata@eph.pref.ehime.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
Other administrative information
Date of disclosure of the study information
| 2026 | Year | 07 | Month | 29 | 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
| 2026 | Year | 06 | Month | 15 | Day |
Date of IRB
| 2026 | Year | 07 | Month | 29 | Day |
Anticipated trial start date
| 2026 | Year | 07 | Month | 30 | Day |
Last follow-up date
| 2031 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2026 | Year | 07 | Month | 29 | Day |
Last modified on
| 2026 | Year | 07 | Month | 30 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000071410
