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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000022831
Receipt No. 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

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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
Email 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
Email kazuhisa@med.uoeh-u.ac.jp

Sponsor
Institute University of Occupational and Environmental Health, Japan
Institute
Department

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
Email 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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000026078

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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