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Preliminary Study of Sonic Hedgehog Signaling Pathway in the Pathogenesis of Rheumatoid Arthritis

This study is not yet open for participant recruitment.
Verified November 2012 by Third Affiliated Hospital, Sun Yat-Sen University
Sponsor:
Collaborator:
National Natural Science Foundation of China
Information provided by (Responsible Party):
Shangling Zhu, Third Affiliated Hospital, Sun Yat-Sen University
ClinicalTrials.gov Identifier:
NCT01731262
First received: November 15, 2012
Last updated: November 20, 2012
Last verified: November 2012
History of Changes
  Purpose

Rheumatoid arthritis(RA) with a high incidence and high morbidity, the pathogenesis has not been fully elucidated. Fibroblast-like synovial cells excessive proliferation and synovial angiogenesis is the most important cause of RA synovitis and joint destruction. Our study was to find the role of Sonic Hedgehog(SHH) pathway in regulating proliferation of fibroblast-like synovial cells and modulating excess angiogenesis of synovial tissue.


Condition
Arthritis, Rheumatoid
Neovascularization, Pathologic
Synovitis

Study Type: Observational
Study Design: Observational Model: Case Control
Official Title: Preliminary Study of Sonic Hedgehog Signaling Pathway in the Pathogenesis of Rheumatoid Arthritis

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Third Affiliated Hospital, Sun Yat-Sen University:

Primary Outcome Measures:
  • mRNA expression [ Time Frame: 1 day (December 15, 2012) ] [ Designated as safety issue: No ]

Estimated Enrollment: 78
Study Start Date: November 2012
Estimated Study Completion Date: January 2013
Estimated Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)
Groups/Cohorts
RA group
expression of Shh pathway associated factors from peripheral blood mononuclear cells or synovial tissues will be detected
control group
expression of Shh pathway associated factors from peripheral blood mononuclear cells or synovial tissues will be detected

Detailed Description:

4ml blood from active RA patients(n=35) and healthy volunteers (n=35) will be collected

  • peripheral blood mononuclear cells will be detached
  • messenger ribonucleic acid expression of Sonic Hedgehog pathway associated factors in both groups will be detected

Synovial tissues from 4 RA patients and 4 patients with traumatic or meniscal injury who need to carry out knee joint replacement operation will be collected

  • inflammatory feature of synovial tissue will be observed
  • the expression of Shh, Ptch1, Gli1 and Smo in synovial tissue will be detected by immunohistochemistry assay
  • fibroblast-like synoviocytes will be cultured from synovial tissue of RA patients
  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population

residents of south China

Criteria

Inclusion Criteria:

  • definitely diagnosed
  • the disease is active (DAS28>3.2)

Exclusion Criteria:

  • combined with severe organ dysfunction
  • combined with other rheumatic diseases
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01731262

Contacts
Contact: Jianlin Huang, PhD 86 02085252194 jianlin_h@163.com
Contact: Guihua Chen, PhD 86 02085252205 zssyyuanzhangban@163.com

Sponsors and Collaborators
Third Affiliated Hospital, Sun Yat-Sen University
National Natural Science Foundation of China
Investigators
Principal Investigator: Jianlin Huang, PhD Third Affiliated Hospital, Sun Yat-Sen University
  More Information

No publications provided

Responsible Party: Shangling Zhu, Post-Graduate, Third Affiliated Hospital, Sun Yat-Sen University
ClinicalTrials.gov Identifier: NCT01731262     History of Changes
Other Study ID Numbers: 中大附三医伦[2012]2-75号
Study First Received: November 15, 2012
Last Updated: November 20, 2012
Health Authority: China: Ethics Committee

Keywords provided by Third Affiliated Hospital, Sun Yat-Sen University:
Arthritis, Rheumatoid
Sonic hedgehog protein, human
Neovascularization, Pathologic
Synovitis

Additional relevant MeSH terms:
Arthritis, Rheumatoid
Arthritis
Neovascularization, Pathologic
Synovitis
Joint Diseases
Musculoskeletal Diseases
 Rheumatic Diseases
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases
Metaplasia
Pathologic Processes

ClinicalTrials.gov processed this record on June 13, 2013