Genetics and Mechanisms of Rheumatoid Arthritis | NCT01788098

Studies
Genetics and Mechanisms of Rheumatoid Arthritis

NCT01788098

Sponsor

Slovak Academy of Sciences

Status

Completed

Last Update Posted

Feb 11, 2013Estimated

Enrollment

790Actual

Phase

Not provided

Conditions

Rheumatoid Arthritis
Leukocytes, Mononuclear
Genetic Association Studies

Interventions

Not provided

Countries

Slovakia

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

ID	Type	Description	Link
ATMOS N00024	Other Grant/Funding Number	Cross Border Cooperation Slovakia - Austria 2007 - 2013

Status Module

Record Verification Date

Feb 2013

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Oct 2009

Primary Completion Date

Jun 2012Actual

Completion Date

Dec 2012Actual

First Submitted Date

Feb 3, 2013

First Submission Date that Met QC Criteria

Feb 7, 2013

First Posted Date

Feb 11, 2013Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Feb 7, 2013

Last Update Posted Date

Feb 11, 2013Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

Retention

Enrollment

790Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Rheumatoid Arthritis		Patients with rheumatoid arthritis
Healthy controls		Healthy control subjects

Interventions

Not provided

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Genetic association	Association of selected single nucleotide polymorphisms with rheumatoid arthritis.	1 day

Secondary Outcomes

Measure	Description	Time Frame
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.	1 day

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

rheumatoid arthritis or healthy

Exclusion Criteria:

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Patients with rheumatoid arthritis and healthy controls from Slovakia and Austria

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Richard Imrich	Slovak Academy of Sciences, Center for Molecular Medicine	Study Chair

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Slovak Academy of Sciences, Center for Molecular Medicine		Bratislava		83101	Slovakia

Condition Browse Module

MeSH Terms

ID	Term
D001172	Arthritis, Rheumatoid

Ancestor Terms

ID	Term
D001168	Arthritis
D007592	Joint Diseases
D009140	Musculoskeletal Diseases
D012216	Rheumatic Diseases

Browse Leaves

Not provided

Browse Branches

Not provided