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Develop Biomarkers for Assessing RA Joint Erosion

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ClinicalTrials.gov Identifier: NCT00154947
Recruitment Status : Unknown
Verified July 2006 by National Taiwan University Hospital.
Recruitment status was:  Active, not recruiting
First Posted : September 12, 2005
Last Update Posted : July 20, 2006
Sponsor:
Collaborator:
Palo Alto Medical Foundation
Information provided by:
National Taiwan University Hospital

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 ELISA/CTX-II, Urinary CrossLaps ELISA/CTX-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.

Condition or disease
Rheumatoid Arthritis

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 ELISA/CTX-II, Urinary CrossLaps ELISA/CTX-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.

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Study Type : Observational
Enrollment : 60 participants
Observational Model: Case Control
Primary Purpose: Screening
Time Perspective: Longitudinal
Time Perspective: Prospective
Official Title: Develop Biomarkers for Assessing RA Joint Erosion
Study Start Date : May 2004
Study Completion Date : May 2006

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Arthritis





Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • rheumatoid arthritis

Exclusion Criteria:


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00154947


Locations
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Taiwan
Liang-In Lin
Taipei, Taiwan
Sponsors and Collaborators
National Taiwan University Hospital
Palo Alto Medical Foundation
Investigators
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Principal Investigator: Liang-In Lin, PhD Department of Clinical Laboratory Sciences and Medical Biotechnology, National Taiwan University

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ClinicalTrials.gov Identifier: NCT00154947     History of Changes
Other Study ID Numbers: 9361700330
First Posted: September 12, 2005    Key Record Dates
Last Update Posted: July 20, 2006
Last Verified: July 2006

Additional relevant MeSH terms:
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Arthritis, Rheumatoid
Arthritis
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases