Phase 1 Rheumatoid Arthritis Trial, Recruiting

Written by an AI model from ClinicalTrials.gov eligibility criteria and checked on a sample basis. Please confirm against the original criteria.

Who might be able to join this trial:

• People who have been formally diagnosed with rheumatoid arthritis (RA) for at least 12 weeks before the screening visit, based on recognised international criteria.
• People whose RA appears to be driven by a part of the immune system called B-cells, shown either by certain proteins in the blood (called RF or AMPA antibodies) or by a joint tissue sample showing B-cell activity.
• People whose RA is currently active, shown by a specific disease activity score and at least one visibly swollen joint at the time of screening.
• People who have already tried at least two different targeted RA treatments (from different treatment types) without adequate benefit, after also trying conventional RA medicines (unless those were not suitable for them).
• People whose blood test results at screening fall within the following ranges: sufficient levels of certain white blood cells (lymphocytes, B-cells, and neutrophils), adequate haemoglobin (a measure of red blood cells), sufficient platelet count, kidneys functioning at an adequate level, and liver enzyme and bilirubin levels within acceptable limits (confirm with trial site for exact values).
• People taking low-dose steroid tablets (no more than 10 mg per day of prednisone or equivalent) for at least two weeks before starting the study treatment may still be considered, as may those taking hydroxychloroquine or chloroquine within specified doses.

Who may not be able to join:

• People who have had another active inflammatory disease (other than RA) in the 12 months before or during screening — though thyroid inflammation or a secondary dry eye/mouth condition (secondary Sjögren's syndrome) are generally allowed.
• People with another significant unstable or poorly controlled medical condition that, in the treating doctor's judgement, could put them at unnecessary risk or affect study results.
• People who have previously received cellular therapies such as CAR-T cell therapy, or any gene therapy.
• People who have taken part in another clinical trial or received an experimental treatment within 30 days before the study start date (or longer, depending on the drug involved).
• People who have received certain B-cell targeting treatments (such as rituximab, ocrelizumab, obinutuzumab, blinatumomab, or ofatumumab) within three months before the study start date.
• People who have taken certain conventional RA medicines within 14 days before the study start date, or immune-suppressing biologics or cyclophosphamide within two months before the study start date.
• People who have received a live vaccine within four weeks before or during the screening period.
• People with active or latent tuberculosis (TB) shown by a positive or unclear TB blood test, unless they have documented proof of completing TB treatment and have no current signs of TB.

Important: Always verify eligibility with the trial site directly before applying.