Ignite Creation Date:
2024-05-06 @ 11:05 AM
Last Modification Date:
2024-10-26 @ 12:40 PM
Study NCT ID:
NCT03429426
Status:
ENROLLING_BY_INVITATION
Last Update Posted:
2021-01-13
First Post:
2018-01-24
Brief Title:
Progression of Bone Erosions in Rheumatoid Arthritis Assessed by HR-pQCT and Conventional X-ray
Sponsor:
Aarhus University Hospital
Organization:
Aarhus University Hospital
Study Overview
Official Title:
An Observational Study of Bone Erosion Determination and Progression in Rheumatoid Arthritis Assessed by HR-pQCT and Conventional X-ray
Status:
ENROLLING_BY_INVITATION
Status Verified Date:
2021-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
RACTX
Brief Summary:
Today regular X-ray examination is not sufficiently sensitive for detecting progression of bone destruction in rheumatoid arthritis but a new type of high-resolution CT scanner the High-Resolution peripheral Quantitative Computed Tomography HR-pQCT can detect very early and minor joint injuries
The purpose of this study is to use HR-pQCT techniques to look at the damage and disease activity progression in the hand and wrist joints of patients with rheumatoid arthritis
The purpose of this study is to use HR-pQCT techniques to look at the damage and disease activity progression in the hand and wrist joints of patients with rheumatoid arthritis
Detailed Description:
The design of the trial is an observational study with three distinct groups At the start of the trial period and at one-year of follow-up the trial subject will have their hand X-rayed by conventional radiography and their metacarpophalangeal MCP joint and wrist scanned by HR-pQCT-Imaging The 28-joint Disease Activity ScoreDAS28-CRP Health Assessment Questionnaire HAQ Visual analogue scaleVAS-score for pain fatigue and quality of life are performed to investigate the correlation between radiographic changes and disease activity Blood samples are collected to investigate serological markers of bone metabolism and inflammation and the radiographic changes The following groups are investigated
Rheumatoid ArthritisRA Patients with RA 5 years according to the ACREULAR 2010 classification criteria or the American Rheumatism Association 1987 revised criteria are recruited from the outpatient clinic at the Department of Rheumatology Aarhus University Hospital Treatment will be adjusted according to the patients need and according to national guidelines n450
Pre-RA patients Patients with pre-RA joint pain but no swelling and Anti-CCP 3 times above the upper limit are recruited from the outpatient clinic at the Department of Rheumatology Aarhus University Hospital n75
Healthy subjects Healthy age- and sex-matched Individuals are recruited as a control group by posting at libraries in Aarhus Aarhus University Aarhus University Hospital and postings on the websites wwwforsøgspersondk and wwwSundheddk N100
Rheumatoid ArthritisRA Patients with RA 5 years according to the ACREULAR 2010 classification criteria or the American Rheumatism Association 1987 revised criteria are recruited from the outpatient clinic at the Department of Rheumatology Aarhus University Hospital Treatment will be adjusted according to the patients need and according to national guidelines n450
Pre-RA patients Patients with pre-RA joint pain but no swelling and Anti-CCP 3 times above the upper limit are recruited from the outpatient clinic at the Department of Rheumatology Aarhus University Hospital n75
Healthy subjects Healthy age- and sex-matched Individuals are recruited as a control group by posting at libraries in Aarhus Aarhus University Aarhus University Hospital and postings on the websites wwwforsøgspersondk and wwwSundheddk N100
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None