UMIN-CTR Clinical Trial

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
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Blinding
Control
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Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
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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
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IRB Contact (For public release)
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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
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Results
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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
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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	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
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Research case data
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