The A3BC will recruit three groups of patients:
- Biologic group: any Australian patients with inflammatory arthritis or autoimmune disease (e.g. RA, PsA, AS/SpA, JIA, Vasculitis, IIMs, SS) who have been prescribed a bDMARD.
- Arthritis and autoimmune disease controls: any Australian patients with inflammatory arthritis or autoimmune disease who have not been exposed to a bDMARD. These patients may enter group A if they are prescribed a bDMARD in the future.
- Non-arthritic/non-autoimmune controls: the A3BC intends to collect healthy controls on a project-specific basis, possibly from first-degree relatives, friends and family accompanying A3BC participants to the clinic or the general community or through the Australian Red Cross Blood Service. Population control samples or data may also be sourced from the Garvan Institute’s Medical Genome Reference Bank, The 45 & Up Study, the North West Adelaide Health Study (NWAHS), UK Biobank or the CLARITY JIA Biobank at the researcher’s responsibility.
Initially, control participants will only be recruited on a project-specific basis. Inclusion and exclusion criteria will be defined within the accessing project’s protocol through an A3BC-linked Low or Negligible Risk HREC application within the A3BC Access Process. Contact and referral processes of control participants for A3BC recruitment and sample collection will also be specified in the accessing study protocol according to the following process:
- A3BC investigator or external researcher determines that control samples/data will be required to answer a comparative research question with existing A3BC disease-specific samples/data.
- The A3BC investigator or external researcher submits their research question and study methodology to the A3BC Consortium Committee for preliminary review. This includes control inclusion/exclusion criteria and any additional screening that might be required to confirm ‘true control’ status.
- If there are no known alternative sources for the required control samples (e.g. other biobanks) and the Consortium Committee deems the research question and control recruitment feasible, the researcher will be advised to obtain HREC approval of project-specific methodology, advertising materials (e.g. flyers and brochures) to be provided to potential controls with the more generic A3BC brochure and control identification and referral methods.
- Once ethics-approved and Access Committee-approved the potential control participants would be recruited according to the type of control described in the A3BC protocol.
- Family and friends accompanying A3BC participants to their routine clinic visits: An A3BC investigator will discuss the relevant project and provide an A3BC brochure and project-specific brochure to the potential control participant (family member, friend) to read. If they agree, a PTC form can be filled in by the investigator and potential participant and the A3BC Control PISCF will be emailed to the potential control or completed on paper in clinic with the investigator.
- First-degree relatives of A3BC disease-positive participants: may be referred to the A3BC website and/or project team by their participating relative for referral and recruitment as comparative controls via PTC and PISCF completion in person or remotely.
- General members of the community: may hear about the A3BC via the website, current participants or other media formats. Phone and email contact details for the A3BC project team will be available across these formats so volunteers can discuss participation in the A3BC as a control. If they are agreeable a PTC form would be completed in-person or over the phone and the A3BC Control PISCF would be emailed or completed in person to enrol them in the A3BC.