This is the official website of the South African Rheumatism and Arthritis Association, home of the rheumatology community of South Africa. Our aim is to promote, maintain and protect the honour and interest of the discipline of rheumatology as a medical specialty for the benefit of all.

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Biologics Registry

The SARAA Biologics Registry

The SARAA Biologics Registry is a national database, capturing data of all patients with a rheumatic disease on biologic disease modifying anti-rheumatic drugs (bDMARDs). The main purpose of the registry is to ensure the rational use of biologics in the treatment of rheumatic conditions; in-line with established local and international standards of care. This is primarily to ensure the safety of our patients. Furthermore, the registry system allows SARAA to assist with patient access to these very expensive specialised medications through a peer-reviewed panel approval system, that assists with medical funder claims.

Beyond this

The registry also allows us to capture important clinical and epidemiological information on the effects of bDMARDs in our subgroup of patients. It allows us to monitor important aspects of pharmacovigilance, with regards to safety and efficacy, particularly in the context of South Africa, where tuberculosis and other opportunistic infections are an important concern. The registry is also an important tool for clinical and marketing research, with many opportunities for study. The value of observational data is widely accepted in rheumatology practice globally, and we are fortunate to have the support and commitment of our rheumatologists and sponsors, in ensuring the continued success of this system. Ultimately this allows for improvement in the management of patients with rheumatic diseases in our country.

The registry was initiated in 2008

The registry has since been updated in 2013. This year sees the launch of the latest version of the database. The new fully-automated online system hopes to improve application processing times and data-entry accuracy, and as such improve patient access and increase research interest. The registry has been ethically approved by Pharmaethics.

Self Register
Registry documents and resources
Terms & Conditions of use
  • Registry access is limited to rheumatologists who are full SARAA members.
  • Any rheumatologist who would like to contribute to the registry will be expected to complete the doctor consent form.
  • Any new patient starting on a bDMARD will be entered onto the database for initial approval.
  • All existing patients will require the entry of regular follow up data at 6 months, 12 months and then annually, to ensure patient safety and secure approval.
  • Patient informed consent must be obtained by the treating rheumatologist prior to data entry. Patient information leaflets and consent forms are available here.
  • Members will only have access to their own patient information.
  • Access to the full database for research purposes can be applied for through the SARAA biologics steering committee, with appropriate SARAA and ethics approval.
  • Any access will exclude patient and physician identifying information.
  • Data entered should be true, and not falsified to obtain access to medications.
  • SARAA is the owner of the biologics registry and data that emerges from the registry and is managed by the biologics steering committee.
  • The Chairperson of the steering committee, as appointed by SARAA, will be responsible for reporting to pharma-ethics and other regulatory authorities as appropriate.
  • The pharmaceutical industry and Discovery Health provides sponsorship to SARAA for the maintenance of the Registry and the database. They do not have any direct involvement in the register, and will not have access to individual identifiable patient or clinician data.
  • Overall data relating to product may be shared with industry, for market research and to improve patient access, through contractual arrangements with SARAA that ensure the ethical and appropriate dissemination of information.
Data collected includes:
  • Demographics- Age, Gender, Race, Medical aid and plan, address, employment status
  • Disease: Diagnosis (classification criteria), Duration of disease (from symptom onset), disease activity measures and functional assessments.
  • Comorbid diseases
  • Smoking status – never smoked, exsmoker, current smoker – duration of smoking
  • Previous DMARD history – start date, stop date, maximum dose and reason for discontinuation
  • Current DMARD – start date and dose.
  • Steroid use – start date and dose.
  • TB risk: past history of TB, previous treatment for TB or LTBI, current TB exposure
  • Assessment of LBTI (CXR; PPD/TB quantiferon) and TB prophylaxis drug/s and duration of prophylaxis
  • Adverse events
  • Changes in therapies, acticity, function