Rheumatoid ArthritisRASGENASNCT01788098
Genetics and Mechanisms of Rheumatoid Arthritis
An observational study of Rheumatoid Arthritis and Leukocytes, Mononuclear, run by Slovak Academy of Sciences at 1 site in Slovakia.
Trial summary
The study is aimed at revealing genetic background in rheumatoid arthritis (RA). For that purpose samples of DNA will be collected from 500 RA patients and similar number of controls from whole Slovakia. Variations in several genes associated with RA will be evaluated. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Rheumatoid Arthritis, Leukocytes, Mononuclear, Genetic Association Studies
- How many people
- 790 participants
- Where
- 1 siteSlovakia
- Study dates
- Oct 2009to Dec 2012
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Patients with rheumatoid arthritis and healthy controls from Slovakia and Austria
Who may be able to join
- rheumatoid arthritis or healthy
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
Slovakia1 site
Slovak Academy of Sciences, Center for Molecular Medicine
Bratislava, 83101
About this study
Official title: Rheumatoid Arthritis Susceptibility Genes in Austrian and Slovak Population
The study is aimed at revealing genetic background in rheumatoid arthritis (RA). For that purpose samples of DNA will be collected from 500 RA patients and similar number of controls from whole Slovakia. Variations in several genes associated with RA will be evaluated. The second aim is to assess functional changes in immune cells from selected patients and their evaluation together with genetic background. The project has observational character without any intention to change the treatment of RA patients.
- Medical subject headings
- Arthritis, Rheumatoid
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 |
|---|---|---|
| Rheumatoid Arthritis | Patients with rheumatoid arthritis | |
| Healthy controls | Healthy control subjects |
What is being measured
The primary outcome is the main question the study is designed to answer.
Genetic association
Association of selected single nucleotide polymorphisms with rheumatoid arthritis.
Measured: 1 day
Secondary outcomes (1)
Peripheral blood mononuclear cells reactivity
Reactivity and functional changes of peripheral blood mononuclear cells obtained from patients with rheumatoid arthritis in comparison to healthy controls.
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Feb 2013 (estimated)
- Study startOct 2009
- Primary completionJun 2012
- Study completionDec 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Rheumatoid ArthritisStudies 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
- Time perspective
- Cross-sectional
- Enrolment
- 790 participants (actual)
Sponsor and investigators
- Lead sponsor
- Slovak Academy of Sciences
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Stefan Zorad, Slovak Academy of Sciences
- Investigators
- Richard Imrich, Study chair, Slovak Academy of Sciences, Center for Molecular Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01788098
- Sponsor's protocol ID
- RASGENAS
- Other IDs
- ATMOS N00024
- Acronym
- RASGENAS
- Status last verified
- Feb 2013
- First submitted
- 3 Feb 2013
- Last updated
- 11 Feb 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Feb 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Rheumatoid Arthritis Susceptibility Genes in Austrian and Slovak Population
- ClinicalTrials.gov ID
- NCT01788098
- Acronym / sponsor ID
- RASGENAS / RASGENAS
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 790 participants (actual)
- Lead sponsor
- Slovak Academy of SciencesOther government
- Study start
- Oct 2009
- Primary completion
- Jun 2012 (actual)
- Study completion
- Dec 2012 (actual)
- First posted
- 11 Feb 2013 (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.
The study is aimed at revealing genetic background in rheumatoid arthritis (RA). For that purpose samples of DNA will be collected from 500 RA patients and similar number of controls from whole Slovakia. Variations in several genes associated with RA will be evaluated. The second aim is to assess functional changes in immune cells from selected patients and their evaluation together with genetic background. The project has observational character without any intention to change the treatment of RA patients.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Rheumatoid Arthritis | – | –Patients with rheumatoid arthritis |
| Healthy controls | – | –Healthy control subjects |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with rheumatoid arthritis and healthy controls from Slovakia and Austria
Key inclusion criteria (1 listed)
- rheumatoid arthritis or healthy
Key exclusion criteria (0 listed)
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
Genetic association
Time frame: 1 day
Association of selected single nucleotide polymorphisms with rheumatoid arthritis.
1 secondary outcome
Peripheral blood mononuclear cells reactivity
Time frame: 1 day
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Feb 2013.
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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.
Richard Imrich study chair
Slovak Academy of Sciences, Center for Molecular Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Rheumatoid Arthritis and Leukocytes, Mononuclear, run by Slovak Academy of Sciences at 1 site in Slovakia.
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 1 inclusion and 0 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: finished, as of the sponsor's last update on 11 Feb 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Slovakia. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Genetic association (time frame: 1 day). 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 11 Feb 2013.