UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000024535 |
|---|---|
| Receipt number | 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 | 2024/10/30 09:28:06 |
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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
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
naoki-iwa@nagasaki-u.ac.jp
Sponsor or person
Institute
Department of Immunology and Rheumatology, Unit of Advanced Preventive Medical Sciences, Nagasaki University Graduate School of Biomedical Sciences, Nagasaki, Japan.
Institute
Department
Personal name
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
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
Completed
Date of protocol fixation
| 2016 | Year | 10 | Month | 21 | Day |
Date of IRB
| 2016 | Year | 11 | Month | 01 | Day |
Anticipated trial start date
| 2016 | Year | 12 | Month | 01 | Day |
Last follow-up date
| 2022 | Year | 01 | Month | 31 | Day |
Date of closure to data entry
| 2022 | Year | 04 | Month | 01 | Day |
Date trial data considered complete
| 2022 | Year | 05 | Month | 02 | Day |
Date analysis concluded
| 2024 | Year | 04 | Month | 01 | Day |
Other
Other related information
FInishing data nalyzing. Published the results.
Management information
Registered date
| 2016 | Year | 10 | Month | 24 | Day |
Last modified on
| 2024 | Year | 10 | Month | 30 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000027992
