UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000017464 |
|---|---|
| Receipt number | R000020242 |
| Scientific Title | Investigation of articular cartilage injury (joint space narrowing) using 3T Gd-DTPA enhanced MRI of wrist and finger joints in rheumatoid arthritis |
| Date of disclosure of the study information | 2015/05/18 |
| Last modified on | 2021/10/22 11:28:13 |
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Basic information
Public title
Investigation of articular cartilage injury (joint space narrowing) using 3T Gd-DTPA enhanced MRI of wrist and finger joints in rheumatoid arthritis
Acronym
Articular cartilage injury(joint space narrowing) using 3T Gd-enhanced MRI of wrist and finger joints in rheumatoid arthritis
Scientific Title
Investigation of articular cartilage injury (joint space narrowing) using 3T Gd-DTPA enhanced MRI of wrist and finger joints in rheumatoid arthritis
Scientific Title:Acronym
Articular cartilage injury(joint space narrowing) using 3T Gd-enhanced MRI of wrist and finger joints 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 examine the predictive factors toward articular cartilage injury evaluating joint space narrowing by 3T Gd-DTPA enhanced MRI, clinical disease activity and serologic variables.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Change in MRI (joint space narrowing, synovitis, bone edema, bone erosion), plain radiographic findings (erosion, joint space narrowing, Genant-modified Sharp score) and HAQ (total score, each variables) during 1 year follow-up
Key secondary outcomes
Change in the following variables during the observational period:
1.Progression of cartilage injury (joint space narrowing) is parallel with the inflammation of the synovial tissues?
2.MRI joint space narrowing is correlated with MRI synovitis, bone edema, and bone erosion?
3.What biomarkers of serum and plasma are related to cartilage injury (joint space narrowing)?
4.MRI is better to evaluate the cartilage injury?
5.There are any differences with cartilage injury according to treatment regimen?
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
1.Patients 20 years old and over
2.Patients who can receive imaging examination, especially, Gd-DTPA MRI without contraindication
3.Patients who can well understand and obtain informed consent.
Key exclusion criteria
1.Patients under 20 years old
2.Patients who have any contraindication with MRI(for example, pacemaker implantation, claustrophobia, allergy for Gd-DTPA, metal in body, etc.).
3.Patients who are considered inappropriate by physician (for example, lack the ability to understand, less or non-cooporative, etc.)
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Mami Tamai |
Organization
Nagasaki University Hospital
Division name
Department of Immunology and Rheumatology Nagasaki University Graduate School of Biomedical Sciences
Zip code
Address
1-7-1 Sakamoto,Nagasaki
TEL
095-819-7262
tamaim@nagasaki-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Mami Tamai |
Organization
Nagasaki University Hospital
Division name
Department of Immunology and Rheumatology Nagasaki University Graduate School of Biomedical Sciences
Zip code
Address
1-7-1 Sakamoto,Nagasaki
TEL
095-819-7262
Homepage URL
tamaim@nagasaki-u.ac.jp
Sponsor or person
Institute
Nagasaki University Hospital
Institute
Department
Personal name
Funding Source
Organization
JSPS KAKENHI Grant
Organization
Division
Category of Funding 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
| 2015 | Year | 05 | Month | 18 | 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
| 2014 | Year | 10 | Month | 26 | Day |
Date of IRB
| 2014 | Year | 10 | Month | 28 | Day |
Anticipated trial start date
| 2015 | Year | 05 | Month | 18 | Day |
Last follow-up date
| 2019 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
1.Development and preliminary validation of a magnetic resonance imaging joint space narrowing score for use in rheumatoid arthritis potential adjunct to the OMERACT RA MRI Scoring System.
(Oslash-stergaard M, Boyesen P, Eshed I, Gandjbakhich F, Lillegraven S, Bird P, Foltz V, Boonen A, Lassere M, Hermann K, Anandarajah A, Dohn U, Freeston J, Peterfy C, Genant H, Haavardsholm E, McQueen F, Conaghan P. J Rheumatol 2011-38-2045-2050)
2.Osteitis and synovitis, but not bone erosion, is associated with proteoglycan loss and microstructure damage in the cartilage of patients with rheumatoid arthritis.
(Herz B, Albrecht A, Englbrecht M, Welsch GH, Uder M, Renner N, Schlechtweg P, Paul D, Lauer L, Engelke K, Janka K, Rech J, Schett G, Finzel S. Ann Rheum Dis 2014;73:1101 8211;1106.)
3.MRI osteitis predicts cartilage damage at the wrist in RA: a three-year prospective 3T MRI study examining cartilage damage.
4.ACPA positivity correlates with cartilage damage and proteoglycan levels in patients with rheumatoid arthritis in the hand joints.
(McQueen F, McHaffie A, Clarke A, Lee A, Reeves Q, Curteis B, Dalbeth N. Arthritis Res Ther 2014, 16:R33.
Renner N, Krönke G, Rech J, Uder M, Janka R, Lauer L, Paul D, Herz B, Schlechtweg P, Hennig F, Schett G, Welsch G. Arthritis Rheumatol doi 10.1002 art.3886)
Management information
Registered date
| 2015 | Year | 05 | Month | 08 | Day |
Last modified on
| 2021 | Year | 10 | Month | 22 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000020242
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