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Personalised Risk Assessment and Infection Surveillance with Disease Modifying Therapies (PRISM) - A prospective registry and biorepository

Personalised Risk Assessment and Infection Surveillance with Disease Modifying Therapies (PRISM) - A prospective registry and biorepository for patients with infection and auto-immunity.

Status
Not yet recruiting
Phases
Unknown
Study type
Observational
Source
ANZCTR
Registry ID
ACTRN12625001160426
Acronym
PRISM
Enrollment
2500
Registered
2025-10-23
Start date
2025-11-03
Completion date
2035-11-03
Last updated
2025-10-27

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

Conditions

None listed

Brief summary

PRISM is a prospective registry and biorepository, established to facilitate the collection of clinical data and biospecimens with the aim of improving infection prevention, infection surveillance and infection management in patients receiving disease modifying therapies for autoimmune conditions. Research questions which may be address relate to the real-world epidemiology of infections in patients receiving disease modifying therapies, impact of disease modifying therapies on vaccine response, and the effect of sequential immunological therapies on the immune system.

Interventions

Patients with auto-immune diseases receiving, or planning to receive, disease modifying therapies, will be included prospectively in the registry under an opt-out consent. Demographic, medical history, treatment history, vaccination history and infection events will be included. Participants may also be invited, with written informed consent, to participate actively by donating research samples including serology, blood cultures, and infection diagnostics at baseline, and at any pertinent event

Patients with auto-immune diseases receiving, or planning to receive, disease modifying therapies, will be included prospectively in the registry under an opt-out consent. Demographic, medical history, treatment history, vaccination history and infection events will be included. Participants may also be invited, with written informed consent, to participate actively by donating research samples including serology, blood cultures, and infection diagnostics at baseline, and at any pertinent event post enrolment, including infection on therapy, vaccination on therapy, augmentation to therapy or hospitalisation. Any pre-existing infection or treatment data from the medical-record will be reviewed and may be collected retrospectively.

Sponsors

The University of Melbourne
Lead SponsorUniversity

Eligibility

Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

Patient receiving a disease modifying therapy for an auto-immune, or suspected auto-immune condition.

Exclusion criteria

Nil

Outcome results

None listed

Source: ANZCTR · Data processed: Feb 4, 2026