Ignite Creation Date:
2024-05-05 @ 11:52 AM
Last Modification Date:
2024-10-26 @ 9:15 AM
Study NCT ID:
NCT00154947
Status:
UNKNOWN
Last Update Posted:
2006-07-20
First Post:
2005-09-09
Brief Title:
Develop Biomarkers for Assessing RA Joint Erosion
Sponsor:
National Taiwan University Hospital
Organization:
National Taiwan University Hospital
Study Overview
Official Title:
Develop Biomarkers for Assessing RA Joint Erosion
Status:
UNKNOWN
Status Verified Date:
2006-07
Last Known Status:
ACTIVE_NOT_RECRUITING
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:
None
Brief Summary:
With the current therapeutic focus in rheumatoid arthritis RA shifting from symptom control to actual disease modification there is a growing demand for more objective and sensitive ways to evaluate structural damage in the joints of these RA patients Conventional radiography of bone erosion and joint-space narrowing was the only imaging approach available for this Now significant advantages are offered in terms of speed precision and scope over conventional methods These advances include digital radiography and computer aided analysis as well as MRI which allow earlier identification of bone erosion and direct visualization of pre-erosive changes such as bone inflammation and synovitis Molecular markers of tissue turnover have been used for decades in clinical trials of osteoporosis but only recently in RA In contrast to serum C-reactive protein CRP which is only a nonspecific indicator of systemic inflammation and not directly reflective of structural damage to joints more recently developed molecular markers of synovial cartilage and bone turnover might provide a better indication of destructive activity of the disease Compared with radiography and MRI assessment molecular markers are particularly useful for patient selection and treatment but can be used in a variety of ways to accelerate clinical trials and reduce the uncertainty and cost of drug development In this project we will set up a panel of molecular markers which could show an association with the MRI results and have a quantitative correlation with the degree of joint damage sensitivity 90 - 95 specificity 80 - 90 The work in this project includes imaging markers evaluation and molecular markers analysis X-ray scoring MRI Bone degradation markers Bone formation Cartilage degradation Cartilage synthesis Synovial turnover and Others Nine molecular markers will be examined CartiLaps ELISACTX-II Urinary CrossLaps ELISACTX-I and Serum osteocalcin Serum COMP MMP-3 Serum PINP Serum PICP Urinary PIIINP and Serum YKL-40 The data will be managed to evaluate the significance of correlation to image and clinical reports so as to get a simple algorithm of parameters molecular markers which can reflect the structural damage of joint using mathematics and computer science
Detailed Description:
With the current therapeutic focus in rheumatoid arthritis RA shifting from symptom control to actual disease modification there is a growing demand for more objective and sensitive ways to evaluate structural damage in the joints of these RA patients Conventional radiography of bone erosion and joint-space narrowing was the only imaging approach available for this Now significant advantages are offered in terms of speed precision and scope over conventional methods These advances include digital radiography and computer aided analysis as well as MRI which allow earlier identification of bone erosion and direct visualization of pre-erosive changes such as bone inflammation and synovitis Molecular markers of tissue turnover have been used for decades in clinical trials of osteoporosis but only recently in RA In contrast to serum C-reactive protein CRP which is only a nonspecific indicator of systemic inflammation and not directly reflective of structural damage to joints more recently developed molecular markers of synovial cartilage and bone turnover might provide a better indication of destructive activity of the disease Compared with radiography and MRI assessment molecular markers are particularly useful for patient selection and treatment but can be used in a variety of ways to accelerate clinical trials and reduce the uncertainty and cost of drug development In this project we will set up a panel of molecular markers which could show an association with the MRI results and have a quantitative correlation with the degree of joint damage sensitivity 90 - 95 specificity 80 - 90 The work in this project includes imaging markers evaluation and molecular markers analysis X-ray scoring bone erosion and joint-space narrowing MRI bone erosion synovitis cartilage erosion tendonitis ligament rupture Bone degradation markers CTX-I NTX-I DPD Bone formation osteocalcin alkaline phosphatase PICP PINP Cartilage degradation CTX-II COMP Cartilage synthesis PIICP PIINP glycosaminoglycan Synovial turnover Glc-Gal-PYD and Others Hyaluronic acid YKL-40 MMP-1 MMP-3 MMP-13 TIMPs and type III collagen N-propeptide Nine molecular markers including bone formation and degradation cartilage synthesis and degradation will be examined CartiLaps ELISACTX-II Urinary CrossLaps ELISACTX-I and Serum osteocalcin Serum COMP MMP-3 Serum PINP Serum PICP Urinary PIIINP and Serum YKL-40 The data will be managed to evaluate the significance of correlation to image and clinical reports so as to get a simple algorithm of parameters molecular markers which can reflect the structural damage of joint using mathematics and computer science
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None