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New treatment option for Autoimmune Rheumatic Diseases
Official title Influence of Methotrexate Discontinuation on Immunogenicity After PCV-20 Vaccine in Patients ARDs
ClinicalTrials.gov ID: NCT07242092
What this study is testing
What is Pneumococcal Vaccine?
Pneumococcal Vaccine is an investigational medicine, given as an injection into a muscle, being studied as a potential treatment for autoimmune rheumatic diseases.
Also referred to as 20-valent Pneumococcal Conjugate Vaccine (PCV20).
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- This clinical trial aims to evaluate the effect of temporary methotrexate (MTX) discontinuation on the humoral immunogenicity of the 20-valent pneumococcal conjugate vaccine (PCV20) in adult patients with autoimmune rheumatic diseases (ARDs). Key questions: Does suspending MTX for 2 weeks after PCV20 enhance humoral immunogenicity?
- Phase 4: studies an already-approved treatment
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 100
You may be able to join if
- 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).
You likely can't join if
- 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).
See the full eligibility 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).
- 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.
The study team makes the final eligibility decision.
Where it's taking place
- São Paulo, São Paulo, Brazil
Compensation & support
A stipend or compensation may be offered.
Compensation mentioned.
ClinicalTrials.gov doesn't provide a reliable structured field for payment or travel support - confirm details with the study team.
Questions & answers
Do participants get paid in this trial?
This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team - confirm the details with them.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 100 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include São Paulo, São Paulo, Brazil. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.