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UMIN-CTR Clinical Trial |
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Name: | UMIN ID: |
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 |
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 |
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Condition | ||
Condition | Rheumatoid arthritis | |
Classification by specialty |
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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 | |
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Randomization | |
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Stratification | |
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Blocking | |
Concealment |
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Eligibility | ||||
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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. |
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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.) |
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Target sample size | 100 |
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Name of lead principal investigator |
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Organization | Nagasaki University Hospital
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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 |
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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 | |
Institute | Nagasaki University Hospital |
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Funding Source | |
Organization | JSPS KAKENHI Grant |
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Secondary IDs | |
Secondary IDs | NO |
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IND to MHLW |
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Date of disclosure of the study information |
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URL releasing protocol | |
Publication of results | Unpublished |
Result | |
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Recruitment status | Open public recruiting | ||||||
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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) |
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Link to view the page | |
URL(English) | https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000020242 |
Research Plan | |
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