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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000024535
Receipt No. R000027992
Scientific Title Longitudinal analysis of the joint microstructure changes assesed by HR-pQCT in rheumatoid arthritis who are treated with CTLA4-Ig.
Date of disclosure of the study information 2016/11/01
Last modified on 2018/04/30

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Basic information
Public title Longitudinal analysis of the joint microstructure changes assesed by HR-pQCT in rheumatoid arthritis who are treated with CTLA4-Ig.
Acronym Analysis of joint change using HR-pQCT in rheumatoid arthritis treated by CTLA4-Ig.
Scientific Title Longitudinal analysis of the joint microstructure changes assesed by HR-pQCT in rheumatoid arthritis who are treated with CTLA4-Ig.
Scientific Title:Acronym Analysis of joint change using HR-pQCT in rheumatoid arthritis treated by CTLA4-Ig.
Region
Japan

Condition
Condition Rheumatoid Arthritis
Classification by specialty
Clinical immunology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To investigate the difference of effect to bone microarchitecture in rheumatoid arthritis during treatment of CTLA4-Ig and other disease-modifying antirheumatic drugs (DMARDs).
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2 Pragmatic
Developmental phase Not applicable

Assessment
Primary outcomes Volume changes after 12 months of bone erosion that is detected by High Resolution peripheral Quantitative CT (HR-pQCT) in the evaluation joint during CTLA4-Ig treamtne.
Key secondary outcomes -Changes of bone microstructure compared with baseline
-Correlation of Bone microstructure changes and joint ultrasound findings,biomarker
-Correlation of bone microstructure changes and bone mineral density
-Correlation of bone microstructure changes and joint MRI,joint XP.

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 Patients with rheumatoid arthritis who attend or are in hospital at Department of immunology and Rheumatology or Department of Orthopaedic Surgery, Nagasaki University Hospital
Inclusion criteria
Patients who meet either of the following [2] and [3] as well as all of [1], [4], and [5] are included.

[1] Patients with rheumatoid arthritis who are diagnosed based on the American College of Rheumatology (ACR) classification criteria for rheumatoid arthritis (revised in 1987) or the 2010 ACR-European League Against Rheumatism (EULAR) classification criteria for rheumatoid arthritis
[2] Patients who are scheduled to newly start administration of abatacept against RA
[3] Patients who receive a new antirheumatic drug other than abatacept and molecular target drugs (TNF inhibitor, IL-6 inhibitor, tofacitinib) against RA (control group)
[4] Any sex
[5] Patients at the age of 20 or more from whom consent is obtained in written form by the patient's own will after they are sufficiently explained for participating in the study and understand well
Key exclusion criteria [1] A patient who is pregnant or may be pregnant
[2] A patient who has following disease that may change the bone structure: A patients who has paralysis due to cerebral stroke, a patient who receives hemodialysis, a patient undergoing treatment for malignant tumor, a patient who takes a drug for osteoporosis or steroid orally
[3] A patient who has been administered with a molecular target drug (TNF inhibitor, IL-6 inhibitor, tofacitinib) including abatacept
[4] A patient who cannot keep his/her extremities still
[5] A patient who is determined as inappropriate as a subject for other reasons by a principle investigator
Target sample size 40

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Naoki Iwamoto
Organization Graduate School of Biomedical Sciences, Nagasaki University
Division name Department of Immunology and Rheumatology, Advanced Preventive Medical Sciences.
Zip code
Address 1-7-1 Sakamoto, Nagasaki 852-8501, Japan
TEL 095-819-7200
Email naoki-iwa@nagasaki-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Naoki Iwamoto
Organization Graduate School of Biomedical Sciences, Nagasaki University
Division name Department of Immunology and Rheumatology, Advanced Preventive Medical Sciences.
Zip code
Address 1-7-1 Sakamoto, Nagasaki 852-8501, Japan
TEL 095-819-7200
Homepage URL
Email naoki-iwa@nagasaki-u.ac.jp

Sponsor
Institute Department of Immunology and Rheumatology, Unit of Advanced Preventive Medical Sciences, Nagasaki University Graduate School of Biomedical Sciences, Nagasaki, Japan.
Institute
Department

Funding Source
Organization Ono pharmaceutical Co., Ltd. and Bristol-Myers Squibb
Organization
Division
Category of Funding Organization Profit organization
Nationality of Funding Organization

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

IRB Contact (For public release)
Organization
Address
Tel
Email

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
2016 Year 11 Month 01 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 Preinitiation
Date of protocol fixation
2016 Year 10 Month 21 Day
Date of IRB
Anticipated trial start date
2016 Year 12 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information preinitiation

Management information
Registered date
2016 Year 10 Month 24 Day
Last modified on
2018 Year 04 Month 30 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000027992

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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