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Pausing arthritis drug may boost pneumonia Shot's power

NCT ID NCT07242092

Disease control 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 study
This trial is taking on new participants right now.
Not yet recruiting
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jun 27, 2026 · Last updated Jul 21, 2026 · Updated 2 times

Summary

This study tests whether temporarily stopping methotrexate for 2 weeks after receiving a pneumonia vaccine (PCV20) helps the vaccine work better in adults with autoimmune rheumatic diseases like rheumatoid arthritis or lupus. About 192 participants with stable, low disease activity will be randomly assigned to either pause methotrexate or continue it as usual. The main goal is to see if more people develop protective antibodies after vaccination.

What this could mean

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

Active substance
20-valent pneumococcal conjugate vaccine (PCV20)
What this could lead to
If it works, this could show that a short break from methotrexate helps the pneumonia vaccine work better in people with rheumatic diseases, potentially improving protection against serious infections.
What could go wrong
This is a small, early-phase trial (192 people) looking at immune markers, not actual infection rates. Pausing methotrexate may cause disease flares in some participants.

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

Phase 4

Runs after approval, following long-term safety and how well the treatment works in everyday use.

Participants

About 192 people

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

Started

Jun 2026

Expected to finish

Dec 2028

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

18 to 100 years

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: * Adults (\>=18 years ) with confirmed ARD diagnosis (e.g., RA, PsA, axial SpA, primary Sjögren's, SLE, IIM, SSc, MCTD). * Stable MTX dose ≥12 weeks. * Prednisone ≤5 mg/day. * Low disease activity/remission according to specific disease activity criteria. * Eligible for PCV20 vaccination (no prior PCV20). Exclusion Criteria: * Anaphylaxis to vaccine components. * Acute febrile illness. * Guillain-Barré, decompensated CHF (NYHA III-IV), demyelinating disease. * Live virus vaccine ≤4 weeks or inactivated vaccine ≤2 weeks before. * Blood products in last 6 months. * Severe infection in last month (including pneumococcal). * Hospitalization at enrollment. * Refusal to participate or inability to complete study procedures.

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Conditions

The condition(s) this trial relates to.

autoimmune disease idiopathic inflammatory myopathy mixed connective tissue disease psoriatic arthritis rheumatic disorder rheumatoid arthritis Sjogren syndrome spondyloarthropathy systemic lupus erythematosus systemic sclerosis

As listed by the trial registrant

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

Autoimmune rheumatic diseases

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

  • Reumatology division of Hospital das Clinicas da Faculdade de Medicina da Universidade de Sao Paulo

    RECRUITING

    São Paulo, São Paulo, 05403-000, Brazil

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