Autoimmune Rheumatic Diseases, Prevention
Conditions
Keywords
Tuberculosis, Tuberculosis disease, Tuberculosis infection, Autoimmune Rheumatic Diseases, Biologic Therapy, Screening, IGRA, Rheumatology, Prevention, Prospective Study
Brief summary
This is a prospective, randomized, controlled study designed to evaluate the effectiveness of annual re-screening for tuberculosis infection (TBI) (previous) in patients with autoimmune rheumatic diseases (ARDs) receiving biologic and/or immunosuppressive therapy. Patients with negative baseline TBI screening will be randomized to undergo annual re-screening using interferon-gamma release assay (IGRA) or to a control group without routine re-screening. Patients with newly detected TBI will receive preventive treatment. The primary objective is to assess whether annual re-screening combined with TBI treatment reduces the incidence of active tuberculosis. Secondary objectives include determining TBI conversion rates and identifying risk factors for infection.
Detailed description
Tuberculosis remains highly prevalent in endemic countries such as Brazil. Patients with autoimmune rheumatic diseases (ARDs) receiving immunosuppressive therapies, particularly biologic agents, are at increased risk of progression from tuberculosis infection (TBI) to tuberculosis disease.
Interventions
OTHERre-screening
Routine annual TB re-screening after negative (IGRA)
OTHERNo Rescreening
Standard clinical follow-up without routine annual TB re-screening
Sponsors
University of Sao Paulo General Hospital
Fundação de Amparo à Pesquisa do Estado de São Paulo
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
Inclusion criteria
* Patients (adults and children) diagnosed with autoimmune rheumatic diseases according to established international classification criteria * negative baseline screening for tuberculosis infection.
Exclusion criteria
* History of tuberculosis infection or disease * Radiographic evidence suggestive of prior TB * Previous treatment for TBD or TBI * Positive baseline TB screening; * Follow-up shorter than 12 months
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of Tuberculosis Disease | Up to 48 months | Incidence of confirmed TBD cases during the follow-up period among patients with autoimmune rheumatic diseases using biologic and/or Immunosuppressive therapy in both arms: "annual IGRA rescreening" (intervention arm) and "no rescreening" (standard clinical follow-up). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Risk Factors for TBD Development | Up to 48 months | Identification of demographic, clinical, nutritional, and therapeutic predictors (e.g., type of biologic, corticosteroid use) for TBD development. |
| Rate of TBI Conversion | Up to 36 months | Proportion of patients converting from negative to positive IGRA during follow-up in the "annual IGRA rescreening group" (interventional arm). |
| Risk Factors for TBI Conversion | Up to 36 months | Identification of demographic, clinical, nutritional, and therapeutic predictors (e.g., type of biologic, corticosteroid use) in the "annual IGRA rescreening group" (interventional arm). |
| Adverse Events Related to TBI Treatment | Up to 48 months | Frequency of drug-related adverse events (e.g., hepatotoxicity) |
Countries
Brazil
Contacts
CONTACTEloisa SDO Bonfa, Full Professor
Outcome results
None listed