Phase 2 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:

• You must be 18 years old or older when you sign the consent form
• Your vaccinations must be up to date, and you must not be planning to have any vaccines in the 3 months after your infusion
• Your blood counts, liver, and kidneys must be working well enough (as confirmed by tests)
• You must be willing to have a flu vaccine every year
• You must be willing to be followed up for 15 years as part of the study
• You must be well enough to carry out some self-care, but not completely disabled (confirm with trial site)
• You must be willing and able to use a reliable form of contraception
• If you are taking steroids, your dose must have been stable before the screening stage

If you have difficult-to-treat rheumatoid arthritis, you also need to:

• Have been formally diagnosed with rheumatoid arthritis using recognised medical guidelines
• Meet the criteria for "difficult-to-treat" rheumatoid arthritis as defined by 2021 guidelines
• Have signs that your rheumatoid arthritis is currently active, shown by clinical or lab results
• Have visible inflammation in the joints used to measure your disease activity

If you have a skin-affecting condition called diffuse cutaneous systemic sclerosis, you also need to:

• Have been formally diagnosed using recognised medical guidelines
• Have a specific marker in your blood (antinuclear antibodies) that shows up in tests
• Have not responded well enough to standard disease-modifying treatments
• Have a skin involvement score of at least 15 on a recognised scale (confirm with trial site)
• Have evidence of lung scarring shown on a scan or breathing test
• Show signs that your condition is currently active based on a recognised assessment tool

Who may not be able to join:

• You have another serious medical condition or significantly abnormal test results
• You have a history of, or concerns about, autoimmune diseases other than the one being studied
• You have an active infection, or repeated infections that need ongoing treatment
• You have a weakened immune system or receive regular immunoglobulin (antibody) infusions
• You have ever had, or currently have, hepatitis B or C, tuberculosis, syphilis, or HIV
• You have a significant heart condition or severely reduced lung function
• You have taken part in another experimental drug trial recently (confirm exact timeframe with trial site)
• You have previously received any type of cell therapy treatment
• You have received certain experimental treatments targeting B cells in a clinical trial within the past year
• You have had a transplant of a solid organ, bone marrow, or stem cells
• You have been diagnosed with cancer in the past 5 years
• You are taking certain medications that cannot be stopped before the study begins

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