Arthritis, RheumatoidNCT01731262
Preliminary Study of Sonic Hedgehog Signaling Pathway in the Pathogenesis of Rheumatoid Arthritis
An observational study of Arthritis, Rheumatoid and Neovascularization, Pathologic, run by Third Affiliated Hospital, Sun Yat-Sen University.
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. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Arthritis, Rheumatoid, Neovascularization, Pathologic, Synovitis
- How many people
- 78 participants
- Where
- No sites listed yet
- Study dates
- Nov 2012to Jan 2013
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: residents of south China
Who may be able to join
- definitely diagnosed
- the disease is active (DAS28>3.2)
Who cannot join
- combined with severe organ dysfunction
- combined with other rheumatic diseases
Trial locations and contacts
No sites are listed yet.
About this study
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.
Read the 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
- Keywords
- Arthritis, Rheumatoid, Sonic hedgehog protein, human, Neovascularization, Pathologic, Synovitis
- Medical subject headings
- Arthritis, Rheumatoid, Neovascularization, Pathologic, Synovitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
mRNA expression
Measured: 1 day (December 15, 2012)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Nov 2012 (estimated)
- Study startNov 2012
- Primary completionDec 2012 (estimated)
- Study completionJan 2013 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Arthritis, RheumatoidStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Enrolment
- 78 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Third Affiliated Hospital, Sun Yat-Sen University
- Sponsor type
- University, hospital or other
- Collaborators
- National Natural Science Foundation of China
- Responsible party
- Principal investigator, Shangling Zhu, Third Affiliated Hospital, Sun Yat-Sen University
- Investigators
- Jianlin Huang, PhD, Principal investigator, Third Affiliated Hospital, Sun Yat-Sen University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01731262
- Sponsor's protocol ID
- 中大附三医伦[2012]2-75号
- Status last verified
- Nov 2012
- First submitted
- 15 Nov 2012
- Last updated
- 21 Nov 2012
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 21 Nov 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Preliminary Study of Sonic Hedgehog Signaling Pathway in the Pathogenesis of Rheumatoid Arthritis
- ClinicalTrials.gov ID
- NCT01731262
- Acronym / sponsor ID
- 中大附三医伦[2012]2-75号
- Keywords
- Arthritis, Rheumatoid, Sonic hedgehog protein, human, Neovascularization, Pathologic, Synovitis
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 78 participants (estimated)
- Lead sponsor
- Third Affiliated Hospital, Sun Yat-Sen UniversityUniversity, hospital or other
- Collaborators
- National Natural Science Foundation of China
- Study start
- Nov 2012
- Primary completion
- Dec 2012 (estimated)
- Study completion
- Jan 2013 (estimated)
- First posted
- 21 Nov 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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
Study design
- Observational model
- Case-control
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- residents of south China
Key inclusion criteria (2 listed)
- definitely diagnosed
- the disease is active (DAS28>3.2)
Key exclusion criteria (2 listed)
- combined with severe organ dysfunction
- combined with other rheumatic diseases
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
mRNA expression
Time frame: 1 day (December 15, 2012)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Nov 2012.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jianlin Huang, PhD principal investigator
Third Affiliated Hospital, Sun Yat-Sen University
Questions about this trial
What is this clinical trial studying?
An observational study of Arthritis, Rheumatoid and Neovascularization, Pathologic, run by Third Affiliated Hospital, Sun Yat-Sen University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 21 Nov 2012. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Jianlin Huang, PhD (86 02085252194, jianlin_h@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
mRNA expression (time frame: 1 day (December 15, 2012)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Nov 2012.