Investigation and prevention of Rheumatoid Arthritis before symptom onset

Prospective observational cohort of unaffected first-degree relatives (FDR) of probands with Rheumatoid Arthritis (RA) and healthy controls followed for five years with the simultaneous collection of tissue samples; designed to examine the role of genetic and environmental factors influencing the development and progression of RA-related autoimmunity and to identify and explore immunological alterations prior to the onset of disease, to establish the proportion of FDRs who develop RA defined by the ACR 2010 classification criteria at 5 years and to identify biomarkers in FDRs prior to and at onset of disease for disease prediction, diagnosis and prognosis of RA and to direct and guide treatment.

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

ANZCTR

Registry ID

ACTRN12615000124538

Enrollment

268

Registered

2015-02-11

Start date

2015-01-20

Completion date

2016-12-13

Last updated

2020-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief summary

This trial will establish a large multi-centre prospective cohort and tissue bio-bank of unaffected first-degree relatives (FDR) of probands with RA designed to examine the role of genetic, environmental and microbial factors influencing the development and progression of RA-related autoimmunity. FDRs will be followed annually with an expected 15% likely to develop asymptomatic autoimmunity and to progress to RA within 5 years. This population cohort with accompanying genetic, environmental and immunological data will characterise more precisely people at risk of RA, allowing detection and risk stratification prior to symptoms becoming apparent.

Interventions

Observational Study - To follow prospectively a cohort of unaffected first-degree relatives (FDR) of people with rheumatoid arthritis (RA) annually for five years. FDR will be evaluated and data obtained including demographic information, medical history, environmental exposures questionnaire, connective tissue disease screening questionnaire, physical examination, joint counts and tissue samples collected including blood, mouth and faecal swabs.

Eligibility

Sex/Gender

All

Age

18 Years to 85 Years

Healthy volunteers

Yes

Inclusion criteria

Participant is willing and able to give informed consent for participation in the study. Male or Female, aged 18 years or above. Be a first-degree relative (parent, full-sibling or offspring) of a person with RA (FDR), have been diagnosed with RA (of any disease duration and severity (Proband), or a healthy volunteer without a family history of RA and are in good health (Healthy Control). Able (in the Investigators opinion) and willing to comply with all study requirements. Willing to allow his or her General Practitioner and consultant, if appropriate, to be notified of participation in the study.

Exclusion criteria

Any significant disease or disorder which, in the opinion of the Investigator, may either put the participants at risk because of participation in the study, or may influence the result of the study, or the participant’s ability to participate in the study. Participants who have participated in another research study involving an investigational product in the past 12 weeks

Outcome results