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Genetics and Mechanisms of Rheumatoid Arthritis (RASGENAS)

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ClinicalTrials.gov Identifier: NCT01788098
Recruitment Status : Completed
First Posted : February 11, 2013
Last Update Posted : February 11, 2013
Sponsor:
Information provided by (Responsible Party):
Stefan Zorad, Slovak Academy of Sciences

Tracking Information
First Submitted Date February 3, 2013
First Posted Date February 11, 2013
Last Update Posted Date February 11, 2013
Study Start Date October 2009
Actual Primary Completion Date June 2012   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: February 7, 2013)
Genetic association [ Time Frame: 1 day ]
Association of selected single nucleotide polymorphisms with rheumatoid arthritis.
Original Primary Outcome Measures Same as current
Change History No Changes Posted
Current Secondary Outcome Measures
 (submitted: February 7, 2013)
Peripheral blood mononuclear cells reactivity [ Time Frame: 1 day ]
Reactivity and functional changes of peripheral blood mononuclear cells obtained from patients with rheumatoid arthritis in comparison to healthy controls.
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Genetics and Mechanisms of Rheumatoid Arthritis
Official Title Rheumatoid Arthritis Susceptibility Genes in Austrian and Slovak Population
Brief 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. 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.
Detailed Description Not Provided
Study Type Observational
Study Design Observational Model: Case Control
Time Perspective: Cross-Sectional
Target Follow-Up Duration Not Provided
Biospecimen Retention:   Samples With DNA
Description:
frozen immune cells frozen serum frozen DNA
Sampling Method Probability Sample
Study Population Patients with rheumatoid arthritis and healthy controls from Slovakia and Austria
Condition
  • Rheumatoid Arthritis
  • Leukocytes, Mononuclear
  • Genetic Association Studies
Intervention Not Provided
Study Groups/Cohorts
  • Rheumatoid Arthritis
    Patients with rheumatoid arthritis
  • Healthy controls
    Healthy control subjects
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: February 7, 2013)
790
Original Actual Enrollment Same as current
Actual Study Completion Date December 2012
Actual Primary Completion Date June 2012   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion Criteria:

  • rheumatoid arthritis or healthy

Exclusion Criteria:

Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers Yes
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Slovakia
Removed Location Countries  
 
Administrative Information
NCT Number NCT01788098
Other Study ID Numbers RASGENAS
ATMOS N00024 ( Other Grant/Funding Number: Cross Border Cooperation Slovakia - Austria 2007 - 2013 )
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Stefan Zorad, Slovak Academy of Sciences
Study Sponsor Slovak Academy of Sciences
Collaborators Not Provided
Investigators
Study Chair: Richard Imrich Slovak Academy of Sciences, Center for Molecular Medicine
PRS Account Slovak Academy of Sciences
Verification Date February 2013