NCT07242092 Influence of Methotrexate Discontinuation on Immunogenicity After PCV-20 Vaccine in Patients ARDs
| NCT ID | NCT07242092 |
| Status | Recruiting |
| Phase | Phase 4 |
| Sponsor | University of Sao Paulo General Hospital |
| Condition | Autoimmune Rheumatic Diseases |
| Study Type | INTERVENTIONAL |
| Enrollment | 192 participants |
| Start Date | 2026-06-22 |
| Primary Completion | 2027-12-30 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 4 studies follow an already-approved treatment in real-world conditions to monitor long-term safety and effectiveness.
This trial targets 192 participants in total. It began in 2026-06-22 with a primary completion date of 2027-12-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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? * What is the impact of MTX discontinuation on functional opsonophagocytic activity (OPA) and cellular immunity? * What is the risk of disease flaring with MTX withdrawal?
Eligibility Criteria
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.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT07242092 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 100 Years, studying Autoimmune Rheumatic Diseases. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT07242092 trial and what does that mean for participants?
Phase 4 studies are conducted after a treatment has been approved. They monitor long-term safety and real-world effectiveness in a broader patient population.
Is NCT07242092 currently recruiting?
Yes, NCT07242092 is actively recruiting participants. Contact the research team at vacina.reumatousp@gmail.com for enrollment information.
Where is the NCT07242092 trial being conducted?
This trial is being conducted at São Paulo, Brazil.
Who is sponsoring the NCT07242092 clinical trial?
NCT07242092 is sponsored by University of Sao Paulo General Hospital. The trial plans to enroll 192 participants.