UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000029594 |
|---|---|
| Receipt number | R000033814 |
| Scientific Title | Assessment of bone related bio-markers in patients with rheumatoid arthritis treated with Certolizumab pegol |
| Date of disclosure of the study information | 2017/10/17 |
| Last modified on | 2021/10/29 17:21:37 |
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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
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
y.okita@imed3.med.osaka-u.ac.jp
Sponsor or person
Institute
Graduate School of Medicine, Osaka University
Department of Respiratory Medicine and Clinical Immunology
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000033814
