NCT01788098

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
790

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Oct 2009

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

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

October 1, 2009

Completed
2.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2012

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2012

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

February 3, 2013

Completed
8 days until next milestone

First Posted

Study publicly available on registry

February 11, 2013

Completed
Last Updated

February 11, 2013

Status Verified

February 1, 2013

Enrollment Period

2.7 years

First QC Date

February 3, 2013

Last Update Submit

February 7, 2013

Conditions

Rheumatoid ArthritisLeukocytes, MononuclearGenetic Association Studies

Outcome Measures

Primary Outcomes (1)

  • Genetic association

    Association of selected single nucleotide polymorphisms with rheumatoid arthritis.

    1 day

Secondary Outcomes (1)

  • Peripheral blood mononuclear cells reactivity

    1 day

Study Arms (2)

Rheumatoid Arthritis

Patients with rheumatoid arthritis

Healthy controls

Healthy control subjects

Eligibility Criteria

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

Patients with rheumatoid arthritis and healthy controls from Slovakia and Austria

You may qualify if:

  • rheumatoid arthritis or healthy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Slovak Academy of Sciences, Center for Molecular Medicine

Bratislava, 83101, Slovakia

Location

Biospecimen

Retention: SAMPLES WITH DNA

frozen immune cells frozen serum frozen DNA

MeSH Terms

Conditions

Arthritis, Rheumatoid

Condition Hierarchy (Ancestors)

ArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic DiseasesConnective Tissue DiseasesSkin and Connective Tissue DiseasesAutoimmune DiseasesImmune System Diseases

Study Officials

  • Richard Imrich

    Slovak Academy of Sciences, Center for Molecular Medicine

    STUDY CHAIR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Head of Laboratory

Study Record Dates

First Submitted

February 3, 2013

First Posted

February 11, 2013

Study Start

October 1, 2009

Primary Completion

June 1, 2012

Study Completion

December 1, 2012

Last Updated

February 11, 2013

Record last verified: 2013-02

Locations

SL(1)