UMIN-CTR Clinical Trial

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/icdr_e/ctr_view.cgi?recptno=R000026078