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Yearly TB check may shield vulnerable patients from a hidden threat

NCT ID NCT07731672

Prevention Sponsor: University of Sao Paulo General Hospital Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting This study
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jul 28, 2026 · Last updated Aug 19, 2026 · Updated 4 times

Summary

This trial investigates whether annual re-screening for tuberculosis infection using a blood test (IGRA) can prevent active TB in people with autoimmune rheumatic diseases who are taking biologic or immunosuppressive medications. Participants who initially test negative for TB are randomly assigned to either yearly re-screening or standard care without routine re-screening. Those who convert to a positive test receive preventive treatment. The study aims to see if this approach lowers the number of active TB cases in this higher-risk group.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
annual tuberculosis re-screening using IGRA blood test
What this could lead to
If effective, annual TB re-screening could become a standard preventive practice for patients with autoimmune rheumatic diseases on immunosuppressive therapy, reducing cases of active tuberculosis.
What could go wrong
This is a single-center study, and results may not apply to all populations. The benefit of annual screening may be small if TB conversion rates are low, and false positives could lead to unnecessary treatment.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

About 1,660 people

The number the study aims to enrol. It can still change while the study runs.

Expected to start

Aug 2026

An estimate. Start dates often move.

Expected to finish

Jul 2031

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

Children (under 18), adults (18 to 64) and older adults (65 and over)

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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

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Conditions

The condition(s) this trial relates to.

autoimmune disease latent tuberculosis infection rheumatic disorder tuberculosis prevention target

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Autoimmune rheumatic diseases Prevention

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Rheumatology Division, Faculdade de Medicina da USP, São Paulo, SP

    São Paulo, São Paulo, 01246-903, Brazil

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