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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

Tracking Information
First Submitted Date September 9, 2005
First Posted Date September 12, 2005
Last Update Posted Date July 20, 2006
Study Start Date May 2004
Primary Completion Date Not Provided
Current Primary Outcome Measures Not Provided
Original Primary Outcome Measures Not Provided
Change History Complete list of historical versions of study NCT00154947 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Outcome Measures Not Provided
Original Other Outcome Measures Not Provided
 
Descriptive Information
Brief Title Develop Biomarkers for Assessing RA Joint Erosion
Official Title Develop Biomarkers for Assessing RA Joint Erosion
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.
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.
Study Type Observational
Study Design Observational Model: Case Control
Primary Purpose: Screening
Time Perspective: Longitudinal
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Not Provided
Study Population Not Provided
Condition Rheumatoid Arthritis
Intervention Not Provided
Study Groups/Cohorts Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Unknown status
Enrollment
 (submitted: September¬†9,¬†2005)
60
Original Enrollment Same as current
Study Completion Date May 2006
Primary Completion Date Not Provided
Eligibility Criteria

Inclusion Criteria:

  • rheumatoid arthritis

Exclusion Criteria:

Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Taiwan
Removed Location Countries  
 
Administrative Information
NCT Number NCT00154947
Other Study ID Numbers 9361700330
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Not Provided
Study Sponsor National Taiwan University Hospital
Collaborators Palo Alto Medical Foundation
Investigators
Principal Investigator: Liang-In Lin, PhD Department of Clinical Laboratory Sciences and Medical Biotechnology, National Taiwan University
PRS Account National Taiwan University Hospital
Verification Date July 2006