Printed from Voxsanity (voxsanity.com.au) — NCT06410833 — Data sourced from ClinicalTrials.gov. Verify directly with the trial site before attending. Not medical advice.
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Phase 4 Rheumatoid Arthritis Trial, Recruiting
NCT06410833
Who may be able to join
AI generated eligibility summary. Written by an AI model from the official source data and checked on a sample basis. It can contain mistakes, so confirm anything important against the original source. How we use AI
Who might be able to join this trial:
- Children and teenagers between 5 and 18 years old
- People who have been diagnosed with Sjögren's syndrome (SS) based on recognised medical diagnostic guidelines
- People whose Sjögren's syndrome has not responded well enough to treatment, meaning they have been on two or more immune-suppressing medications, or a combination of prednisone and an immune-suppressing medication, for more than 3 months, AND still have at least one of the following: ongoing joint, blood vessel, blood cell, skin, kidney, lung, nerve, or liver problems related to SS; certain abnormal blood test results linked to immune activity; or ongoing raised levels of inflammation markers in blood tests
- People who agree to receive the combination treatment of rituximab and belimumab as part of this trial
Who may not be able to join:
- People who have received rituximab in the past 6 months, or who have previously received certain other biological medicines, including belimumab or telitacicept
- People who have taken part in another clinical trial within the past 6 months
- People whose kidneys are not working well enough, based on a specific kidney function test result (confirm with trial site)
- People with certain active infections, including: a current or past hepatitis B or C infection based on blood test results; a previously positive HIV test or a positive HIV result at screening; or currently active tuberculosis
- People who are currently taking long-term medication to suppress a chronic infection (such as tuberculosis, certain fungal or viral infections); who were hospitalised for an infection within the 60 days before starting the trial; who received intravenous or injected antibiotics, antiviral, antifungal, or antiparasitic medicines within the 30 days before starting; who received a live vaccine within 3 months before starting; or who the treating doctor considers to be at high risk of infection for any reason
- People with a primary (inherited) immune system deficiency
- People with a history of cancer
- People with severe, worsening, or uncontrolled disease affecting the kidneys, liver, blood, digestive system, lungs, heart, or nervous system that is not related to Sjögren's syndrome, or other significant health conditions that the doctor considers would make participation unsafe
- People who need ongoing steroid treatment for a condition that is not related to Sjögren's syndrome
- People whose blood levels of certain immune proteins (IgG or IgA) are below specified levels within 10 days before starting belimumab (confirm with trial site)
- People whose white blood cell count or a specific type of white blood cell (neutrophils) falls below specified levels within 10 days before starting belimumab (confirm with trial site)
Important: Always verify eligibility with the trial site directly before applying.
Based on publicly available eligibility criteria from ClinicalTrials.gov. Verify directly with the trial site before acting. This is not medical advice.
This is a simplified plain English summary of the eligibility criteria. Full criteria are set by the trial investigators and may include additional requirements not shown here. Never self-exclude from a trial based on this summary. Contact the trial site directly to confirm your eligibility.
Phase 4 trials study a drug that has already been approved, monitoring long-term safety and effectiveness in real-world use.
Contact this trial
Phone: +86 01069156251
Contact details sourced from ClinicalTrials.gov. Verify directly with the trial site before attending.
GP referral letter
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Trial details
Status
Recruiting
Phase
Phase 4
Registry
ClinicalTrials.gov
Start date
9 March 2024
Est. completion
31 December 2025
Where this trial is recruiting
🇨🇳 China
Primary endpoints
Respondence rate
Can't join this trial?
Data last synced from ClinicalTrials.gov: 28 July 2026. Trial status can change. Always verify current status directly with the trial site before making any decision.
Trial recruitment status can change without notice between our nightly data updates. Always contact the trial site directly to confirm current recruitment status before making any decisions or travel arrangements.