UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000022831 |
|---|---|
| Receipt number | R000026078 |
| Scientific Title | Anti-TNF-Study Utilizing Biomarker Assay to Monitor Early Response to Certolizumab Pegol |
| Date of disclosure of the study information | 2016/08/02 |
| Last modified on | 2021/04/12 19:21:34 |
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Basic information
Public title
Anti-TNF-Study Utilizing Biomarker Assay to Monitor Early Response to Certolizumab Pegol
Acronym
TSUBAME Study
Scientific Title
Anti-TNF-Study Utilizing Biomarker Assay to Monitor Early Response to Certolizumab Pegol
Scientific Title:Acronym
TSUBAME Study
Region
| Japan |
Condition
Condition
Rheumatoid Arthritis
Classification by specialty
| Clinical immunology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To examine the efficacy and safety in clinical use of CZP from 24 hours after treatment
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Others
Developmental phase
Not applicable
Assessment
Primary outcomes
Change of DAS28-ESR at 12weeks
Key secondary outcomes
(1) Change of DAS28-ESR at 24 hours, 48hours and 24weeks
(2) Remission rate of DAS28 and CDAI at 24 hours, 48hours, 12 weeks and 24weeks
(3) Adverse event
(4) The factors for each 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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Eligible patients were diagnosed with RA, as defined by the ACR 1987 criteria or ACR/EULAR 2010 criteria.
Key exclusion criteria
Patients were excluded if they had history of demyelinating or convulsive disease of the central nervous system (e.g., multiple sclerosis and epilepsy), New York Heart Association Class III or IV congestive heart failure, infectious disease, hepatitis B or hepatitis C, malignant tumor or lymphoproliferative disorder, including lymphoma or signs and symptoms suggestive of lymphoproliferative disease. Patients with any indication of current or past tuberculosis as shown by clinical history, chest X-ray and/or positive tuberculin reaction test were also excluded unless preventive therapy by isoniazid was first taken.
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | Yoshiya |
| Middle name | |
| Last name | Tanaka |
Organization
University of Occupational and Environmental Health, Japan
Division name
The First Department of Internal Medicine, School of Medicine
Zip code
807-8555
Address
1-1, Iseigaoka, Yahata-nishi-ku, Kitakyushu, Japan
TEL
093-603-1611
tanaka@med.uoeh-u.ac.jp
Public contact
Name of contact person
| 1st name | Kazuhisa |
| Middle name | |
| Last name | Nakano |
Organization
University of Occupational and Environmental Health, Japan
Division name
The First Department of Internal Medicine, School of Medicine
Zip code
807-8555
Address
1-1, Iseigaoka, Yahata-nishi-ku, Kitakyushu, Japan
TEL
093-603-1611
Homepage URL
kazuhisa@med.uoeh-u.ac.jp
Sponsor or person
Institute
University of Occupational and Environmental Health, Japan
Institute
Department
Personal name
Funding Source
Organization
Astellas Pharma Inc
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
Ethics Committee of Medical Research,University of Occupational and Environmental Health,Japan
Address
1-1, Iseigaoka, Yahata-nishi-ku, Kitakyushu, Japan
Tel
093-691-7205
daigakukanri@mbox.pub.uoeh-u.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
産業医科大学病院
Other administrative information
Date of disclosure of the study information
| 2016 | Year | 08 | Month | 02 | 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
100
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 | 05 | Month | 16 | Day |
Date of IRB
| 2017 | Year | 03 | Month | 06 | Day |
Anticipated trial start date
| 2016 | Year | 06 | Month | 13 | Day |
Last follow-up date
| 2019 | Year | 12 | Month | 28 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
prospective study
Management information
Registered date
| 2016 | Year | 06 | Month | 21 | Day |
Last modified on
| 2021 | Year | 04 | Month | 12 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000026078
