NCT01731262

Brief 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.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
78

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Nov 2012

Shorter than P25 for all trials

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2012

Completed
14 days until next milestone

First Submitted

Initial submission to the registry

November 15, 2012

Completed
6 days until next milestone

First Posted

Study publicly available on registry

November 21, 2012

Completed
10 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2012

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2013

Completed
Last Updated

November 21, 2012

Status Verified

November 1, 2012

Enrollment Period

1 month

First QC Date

November 15, 2012

Last Update Submit

November 20, 2012

Conditions

Arthritis, RheumatoidNeovascularization, PathologicSynovitis

Keywords

Arthritis, RheumatoidSonic hedgehog protein, humanNeovascularization, PathologicSynovitis

Outcome Measures

Primary Outcomes (1)

  • mRNA expression

    1 day (December 15, 2012)

Study Arms (2)

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

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

residents of south China

You may qualify if:

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

You may not qualify if:

  • combined with severe organ dysfunction
  • combined with other rheumatic diseases

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Arthritis, RheumatoidNeovascularization, PathologicSynovitis

Condition Hierarchy (Ancestors)

ArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic DiseasesConnective Tissue DiseasesSkin and Connective Tissue DiseasesAutoimmune DiseasesImmune System DiseasesMetaplasiaPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Jianlin Huang, PhD

    Third Affiliated Hospital, Sun Yat-Sen University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Jianlin Huang, PhD

CONTACT

86 02085252194jianlin_h@163.com

Guihua Chen, PhD

CONTACT

86 02085252205zssyyuanzhangban@163.com

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Post-Graduate

Study Record Dates

First Submitted

November 15, 2012

First Posted

November 21, 2012

Study Start

November 1, 2012

Primary Completion

December 1, 2012

Study Completion

January 1, 2013

Last Updated

November 21, 2012

Record last verified: 2012-11