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Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000017464
Receipt No. 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 2015/05/08

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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
Email 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
Email tamaim@nagasaki-u.ac.jp

Sponsor
Institute Nagasaki University Hospital
Institute
Department

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
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
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 Open public recruiting
Date of protocol fixation
2014 Year 10 Month 26 Day
Date of IRB
Anticipated trial start date
2015 Year 05 Month 18 Day
Last follow-up date
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, Kr&ouml;nke 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
2015 Year 05 Month 08 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000020242

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
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