UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000037953 |
|---|---|
| Receipt number | R000043263 |
| Scientific Title | Correlation between anti-infliximab trough level and clinical markers in ulcerative colitis patients treated with infliximab |
| Date of disclosure of the study information | 2019/09/09 |
| Last modified on | 2023/03/10 18:32:03 |
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Basic information
Public title
Correlation between anti-infliximab trough level and clinical markers in ulcerative colitis patients treated with infliximab
Acronym
IFX trough level in UC patients
Scientific Title
Correlation between anti-infliximab trough level and clinical markers in ulcerative colitis patients treated with infliximab
Scientific Title:Acronym
IFX trough level in UC patients
Region
| Japan |
Condition
Condition
ulcerative colitis
Classification by specialty
| Gastroenterology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To determine the efficacy of measuring anti-infliximab trough levels.
Basic objectives2
Pharmacodynamics
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
time for clinical and endoscopic recurrence
Key secondary outcomes
factors associated with anti-infliximab trough levels
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
ulcerative colitis patients treated with infliximab
Key exclusion criteria
patients with allergy to infliximab
patients with severe cardiovascular disease treated with anticoagulant medications
patients suspected colonic cancer
patinent with severe infectious disease through blood
Target sample size
22
Research contact person
Name of lead principal investigator
| 1st name | Hiroki |
| Middle name | |
| Last name | Tanabe |
Organization
Asahikawa general Kousei hospital
Division name
Department of gastroenterology
Zip code
078-8211
Address
1-Jo 24-chome, Asahikawa, Hokkaido, Japan
TEL
+81-166-33-7171
tant@asahikawa-med.ac.jp
Public contact
Name of contact person
| 1st name | Hiroki |
| Middle name | |
| Last name | Tanabe |
Organization
Asahikawa Medical University
Division name
Department of Medicine
Zip code
078-8510
Address
Midorigaoka-Higashi 2-1-1-1, Asahikawa, Hokkaido
TEL
+81-166-68-2462
Homepage URL
tant@asahikawa-med.ac.jp
Sponsor or person
Institute
Asahikawa Medical University
Institute
Department
Personal name
Funding Source
Organization
Asahikawa Medical University
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
Asahikawa Kouse General Hospital ethical committee
Address
1-jo 24-chome, Asahikawa
Tel
+81-166-68-2297
kotomi.hashimoto at ja-hokkaidoukouseiren.or.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
| 2019 | Year | 09 | Month | 09 | 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
18
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
Completed
Date of protocol fixation
| 2016 | Year | 08 | Month | 16 | Day |
Date of IRB
| 2017 | Year | 02 | Month | 07 | Day |
Anticipated trial start date
| 2017 | Year | 02 | Month | 07 | Day |
Last follow-up date
| 2022 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
| 2022 | Year | 03 | Month | 31 | Day |
Date trial data considered complete
| 2022 | Year | 03 | Month | 31 | Day |
Date analysis concluded
| 2023 | Year | 03 | Month | 31 | Day |
Other
Other related information
Anti-TNF trough levels were measured from eligible patients and they were treated for 3 years, observed in clinical and endoscopic remission
Management information
Registered date
| 2019 | Year | 09 | Month | 06 | Day |
Last modified on
| 2023 | Year | 03 | Month | 10 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000043263
