UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000039958 |
|---|---|
| Receipt number | R000045279 |
| Scientific Title | Evaluation of mucosal healing effects of intensive-granulocyte monocyte absorptive apheresis in patients with ulcerative colitis |
| Date of disclosure of the study information | 2020/03/26 |
| Last modified on | 2024/04/03 19:53:49 |
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Basic information
Public title
Evaluation of mucosal healing effects of intensive-granulocyte monocyte absorptive apheresis in patients with ulcerative colitis
Acronym
Evaluation of mucosal healing effects of intensive-GMA in ulcerative colitis patients
Scientific Title
Evaluation of mucosal healing effects of intensive-granulocyte monocyte absorptive apheresis in patients with ulcerative colitis
Scientific Title:Acronym
Evaluation of mucosal healing effects of intensive-GMA in ulcerative colitis patients
Region
| Japan |
Condition
Condition
Ulcerative colitis
Classification by specialty
| Gastroenterology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Clarify the effects of intensive-GMA on mucosal healing in patients with ulcerative colitis
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Mucosal healing rate (Endoscopic score of Mayo index)
Key secondary outcomes
Remission rate (Mayo score)
Efficacy (Mayo score)
Changes in mRNA expression levels of inflammation associated molecules in colonic mucosa
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
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Patients with active ulcerative colitis who satisfy all below requirements and over 20 years old.
1. Mayo score =>5
2. Mayo endoscopic subscore =>2
3. Patients who understood information of this study and voluntarily consented for this study
Key exclusion criteria
1. Patients with granulocyte count 2,000/mm3 or less
2. Patients with serious infectious disease
3. Patients with proctitis
4. Patients who used of enema, suppository (mesalazine, sulfasalazine, steroids) within the last 2 weeks
5. Patients who started administration or increased the dosage of mesalazine, sulfasalazine within the last 4 weeks
6. Patients who started administration or increased the dosage of steroids (oral) within the last 2 weeks
7. Patients who received steroids (intravenous infusion) within the last 2 weeks
8. Patients who used of total parenteral nutrition within the last 4 weeks
9. Patients who received cyclosporine, tacrolimus within the last 4 weeks
10. Patients who started administration or increased the dosage of azathioprine, 6-mercaptopurine within the last 4 weeks
11. Patients who received infliximab within the last 6 weeks
12. Patients who used of GMA, LCAP within the last 8 weeks
13. Patients with history of colectomy
14. Patients with inappropriate for this study by doctor's judgement
15. Patients who refused to participate in this study
Target sample size
80
Research contact person
Name of lead principal investigator
| 1st name | Ryota |
| Middle name | |
| Last name | Hokari |
Organization
National Defense Medical College
Division name
Second Department of Internal Medicine
Zip code
359-8513
Address
Namiki 3-2, Tokorozawa, Saitama
TEL
04-2995-1211
ryota@ndmc.ac.jp
Public contact
Name of contact person
| 1st name | Ryota |
| Middle name | |
| Last name | Hokari |
Organization
National Defense Medical College
Division name
Second Department of Internal Medicine
Zip code
359-8513
Address
Namiki 3-2, Tokorozawa, Saitama
TEL
04-2995-1221
Homepage URL
ryota@ndmc.ac.jp
Sponsor or person
Institute
National Defense Medical College
Institute
Department
Personal name
Funding Source
Organization
National Defense Medical College
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Other related organizations
Co-sponsor
Ohmori Toshihide Gastro-intestinal Clinic
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Ethics committee of National Defense Medical College
Address
Namiki 3-2, Tokorozawa, Saitama
Tel
04-2995-1211
ckurihara-ndm@umin.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
防衛医科大学校（埼玉県）
大森敏秀胃腸科クリニック（埼玉県）
Other administrative information
Date of disclosure of the study information
| 2020 | Year | 03 | Month | 26 | Day |
Related information
URL releasing protocol
Publication of results
Partially published
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
| 2019 | Year | 12 | Month | 24 | Day |
Date of IRB
| 2019 | Year | 12 | Month | 24 | Day |
Anticipated trial start date
| 2020 | Year | 01 | Month | 06 | Day |
Last follow-up date
| 2027 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Clarify the efficacy of intensive-GMA on mucosal healing in patients with ulcerative colitis. Subjects are patients with ulcerative colitis who received intensive-GMA in the related organizations.
Management information
Registered date
| 2020 | Year | 03 | Month | 26 | Day |
Last modified on
| 2024 | Year | 04 | Month | 03 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000045279
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| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
