UMIN-CTR Clinical Trial

Basic information
Public title	Assessment of bone related bio-markers in patients with rheumatoid arthritis treated with Certolizumab pegol
Acronym	Bone related bio-markers in rheumatoid arthritis
Scientific Title	Assessment of bone related bio-markers in patients with rheumatoid arthritis treated with Certolizumab pegol
Scientific Title:Acronym	Bone related bio-markers in rheumatoid arthritis
Region	Japan

Condition
Condition	rheumatoid arthritis
Classification by specialty	Clinical immunology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To assess association between bone related bio-markers and clinical disease activity during clinical course treated with certolizumab pegol, an anti-TNF monoclonal antibody and one of the most effective anti-rheumatic treatment.(Observational research, approved treatment)
Basic objectives2	Others
Basic objectives -Others	no
Trial characteristics_1	Others
Trial characteristics_2	Others
Developmental phase	Not applicable

Assessment
Primary outcomes	Clinical standardized assessments and measurement of bio-markers as below; Semaphorines 3A/3E/4A/4D/7A, Osteocarcin, Bone alkaline phosphatase (BAP), type I collagen cross-linked N-telopeptide(NTX), type I collagen cross-linked C-telopeptide(CTX),tartrate-resistant acid phosphatase(TRACP)-5b, rheumatoid factor(RF), anti-CCP antibody(ACPA), Interleukin(IL)-6, TNF arufa, IL-17
Key secondary outcomes	None (Observational study)

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	20 years-old <=
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	Diagnosed as Rheumatoid arthritis Over 20 years old Newly administrated with Certolizumab pegol
Key exclusion criteria	None
Target sample size	40

Research contact person
Name of lead principal investigator	1st name Yasutaka Middle name Last name Okita
Organization	Graduate School of Medicine, Osaka University
Division name	Department of Respiratory Medicine and Clinical Immunology
Zip code	565-0871
Address	2-2 Yamada-oka, Suita city, Osaka, Japan
TEL	06-6879-3833
Email	y.okita@imed3.med.osaka-u.ac.jp

Public contact
Name of contact person	1st name Yasutaka Middle name Last name Okita
Organization	Graduate School of Medicine, Osaka University
Division name	Department of Respiratory Medicine and Clinical Immunology
Zip code	565-0871
Address	2-2 Yamada-oka, Suita city, Osaka, Japan
TEL	06-6879-3833
Homepage URL	http://www.med.osaka-u.ac.jp/pub/imed3/lab_2/page6/clinical_research2.html
Email	y.okita@imed3.med.osaka-u.ac.jp

Sponsor
Institute	Graduate School of Medicine, Osaka University Department of Respiratory Medicine and Clinical Immunology
Institute
Department

Funding Source
Organization	Medical affairs Astellas Pharma Inc.
Organization
Division
Category of Funding Organization	Profit organization
Nationality of Funding Organization	Japan

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization	Osaka University Hospital
Address	2-15 Yamadaoka, Suita, Osaka, Japan
Tel	06-6879-5111
Email	rinri@hp-crc.med.osaka-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

Other administrative information
Date of disclosure of the study information	2017 Year 10 Month 17 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	Completed
Date of protocol fixation	2017 Year 10 Month 16 Day
Date of IRB	2017 Year 07 Month 20 Day
Anticipated trial start date	2017 Year 10 Month 17 Day
Last follow-up date	2021 Year 10 Month 31 Day
Date of closure to data entry	2021 Year 10 Month 31 Day
Date trial data considered complete	2021 Year 10 Month 31 Day
Date analysis concluded	2021 Year 10 Month 31 Day

Other
Other related information	Observational research Assessment of clinical course and bone related bio-markers during 104 weeks (2 years) after administraion of Certolizumab pegol, an anti-TNF monoclonal antibody agent which is now approved.

Management information
Registered date	2017 Year 10 Month 17 Day
Last modified on	2021 Year 10 Month 29 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000033814