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NCT01731262 Clinical Trial

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

Arthritis, Rheumatoid Clinical Trial

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data
NCT number NCT01731262
Other study ID # ??????[2012]2-75?
Secondary ID
Status Not yet recruiting
Phase N/A
First received November 15, 2012
Last updated November 20, 2012
Start date November 2012
Est. completion date January 2013

Study information
Verified date November 2012
Source Third Affiliated Hospital, Sun Yat-Sen University
Contact Jianlin Huang, PhD
Phone 86 02085252194
Email jianlin_h@163.com
Is FDA regulated No
Health authority China: Ethics Committee
Study type Observational

Clinical Trial Summary

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.

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

Recruitment information / eligibility
Status Not yet recruiting
Enrollment 78
Est. completion date January 2013
Est. primary completion date December 2012
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group 18 Years to 65 Years
Eligibility Inclusion Criteria:

- definitely diagnosed

- the disease is active (DAS28>3.2)

Exclusion Criteria:

- combined with severe organ dysfunction

- combined with other rheumatic diseases

Study Design

Observational Model: Case Control

Related Conditions & MeSH terms

Locations
Country Name City State
n/a

Sponsors (2)
Lead Sponsor Collaborator
Third Affiliated Hospital, Sun Yat-Sen University National Natural Science Foundation of China

Outcome
Type Measure Description Time frame Safety issue
Primary mRNA expression 1 day (December 15, 2012) No
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