UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000050907 |
|---|---|
| Receipt number | R000058017 |
| Scientific Title | Study for the relationship between blood C-reactive protein (CRP) levels and blood tofacitinib levels in ulcerative colitis |
| Date of disclosure of the study information | 2023/05/01 |
| Last modified on | 2023/04/22 19:27:50 |
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Basic information
Public title
Study for the relationship between blood C-reactive protein (CRP) levels and blood tofacitinib levels in ulcerative colitis
Acronym
the relationship between blood C-reactive protein (CRP) levels and blood tofacitinib levels in ulcerative colitis
Scientific Title
Study for the relationship between blood C-reactive protein (CRP) levels and blood tofacitinib levels in ulcerative colitis
Scientific Title:Acronym
the relationship between blood C-reactive protein (CRP) levels and blood tofacitinib levels in ulcerative colitis
Region
| Japan |
Condition
Condition
Ulcerative colitis
Classification by specialty
| Gastroenterology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The aim of this study is to clarify the individual differences in the efficacy of tofacitinib therapy in ulcerative colitis and the frequency of adverse drug reactions in relation to the variability of tofacitinib concentration in blood, in addition to the pathological score using inflammatory indices.
Basic objectives2
Pharmacokinetics
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Association between blood CRP concentration and tofacitinib concentration, association between blood IL-6 concentration and tofacitinib concentration, association between CYP3A4/5 gene polymorphism and tofacitinib concentration, association between duration of tofacitinib use and tofacitinib concentration, association between blood tofacitinib concentration and Lichtiger index, association between blood tofacitinib concentration and the frequency of side effects
Key secondary outcomes
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
| 18 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1. male or female, over 18 years old
2. diagnosed with ulcerative colitis at least 3 months prior to obtaining consent
3.The patient is taking Xeljanz.
4.Consent can be obtained from the individual.
Key exclusion criteria
1. Pregnant or lactating women.
2.Patients with a history of hypersensitivity to Xeljanz.
3.Patients who have previously undergone surgical treatment for ulcerative colitis.
4.Patients who are dependent on parenteral nutrition.
5.Patients with Child-pugh Class C hepatic impairment.
6.Patients with active tuberculosis or untreated latent tuberculosis.
7.Patients with a history of malignancy within the last 5 years.
8.Patients with a history of opportunistic infections or immunodeficiency syndromes. 9.Patients with mental illness.
10.Patients who are judged by the physician to be unsuitable for the safe conduct of the study.
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | Masaki |
| Middle name | |
| Last name | Takao |
Organization
Wakayama medical university
Division name
second department of internal medicine
Zip code
6410012
Address
811-1 Kimiidera, Wakayama city,Wakayama prefecture
TEL
0734472300
takao-ma@wakayama-med.ac.jp
Public contact
Name of contact person
| 1st name | Masaki |
| Middle name | |
| Last name | Takao |
Organization
Wakayama medical university
Division name
second department of internal medicine
Zip code
6410012
Address
811-1 Kimiidera, Wakayama city,Wakayama prefecture
TEL
0734472300
Homepage URL
takao-ma@wakayama-med.ac.jp
Sponsor or person
Institute
Wakayama medical university
Institute
Department
Personal name
Funding Source
Organization
Wakayama medical university
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Wakayama medical university
Address
811-1 Kimiidera, Wakayama city,Wakayama prefecture
Tel
0734472300
takao-ma@wakayama-med.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
Other administrative information
Date of disclosure of the study information
| 2023 | Year | 05 | Month | 01 | 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 | 10 | Month | 26 | Day |
Date of IRB
| 2023 | Year | 10 | Month | 26 | Day |
Anticipated trial start date
| 2023 | Year | 10 | Month | 26 | Day |
Last follow-up date
| 2025 | Year | 10 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Prospective Observational Study
Patients who visited the Department of Gastroenterology, Wakayama Medical University Hospital on or after October 26, 2023
Management information
Registered date
| 2023 | Year | 04 | Month | 22 | Day |
Last modified on
| 2023 | Year | 04 | Month | 22 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000058017
