Early 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:

• You are between 18 and 70 years old (any gender)
• You have been diagnosed with rheumatoid arthritis (RA) for at least 24 weeks, based on recognized medical guidelines
• You have tried at least one standard RA medication (called a csDMARD) in the past, and then also tried at least one biological or targeted medication for 12 weeks without enough improvement in your joint swelling, pain, or overall disease activity
• Your RA is currently moderately to severely active, shown by specific disease activity scores or ongoing joint symptoms and inflammation in blood tests or imaging
• At your screening and starting appointments, you have at least 6 joints that are tender and at least 4 joints that are swollen
• If you are taking steroid tablets (such as prednisone), your dose is no more than 7.5 mg per day and has been stable for at least 2 weeks before starting the trial
• You are willing to sign a consent form, communicate with the research team, and attend all required appointments

Who may not be able to join:

• You have another autoimmune disease that the trial team believes would not benefit from this treatment, or that makes it hard to assess your joint symptoms
• You have recently taken certain RA or immune-related medications within specific time windows before starting the trial (for example, some medications within 2 to 6 weeks beforehand — confirm exact medications and timeframes with the trial site)
• You have received a B-cell depleting therapy such as rituximab within the past 3 months, or your relevant blood cell counts have not recovered sufficiently
• You have or have had an infection around a joint implant (such as a hip or knee replacement)
• You have a weakened immune system based on low levels of a specific immune protein in your blood (immunoglobulin G)
• You have a history of nerve-related diseases affecting the protective covering of nerves, such as multiple sclerosis or Guillain-Barré syndrome
• Your blood test results show certain abnormalities, such as low red blood cells, low white blood cells, low platelets, reduced kidney function, high levels of protein in urine, or raised liver markers (confirm specific values with trial site)
• You have received a live vaccine within 30 days before starting the trial
• You have active hepatitis, or certain positive test results for hepatitis B, hepatitis C, HIV, or syphilis during the screening period
• You have had a significant infection requiring antibiotic, antiviral, antifungal, or antiparasitic treatment within 2 weeks before screening, or a skin infection requiring treatment within 1 week before screening
• You have had a major surgery (such as on the brain, chest, or abdomen) within 4 weeks before starting, have wounds or fractures that have not healed, or are planning major surgery during the trial
• You have a serious medical history — such as heart disease, lung disease, blood disorders, or psychiatric conditions — that the trial team believes could put you at risk or affect the trial results (for example, a heart attack or severe heart rhythm problems within the past 6 months)
• You may have an active tuberculosis (TB) infection, based on recent test results or chest imaging
• You have been diagnosed with cancer in the past 5 years (some very specific, fully treated cancers may be exceptions — confirm with the trial site)
• You have had a major organ transplant (such as heart, lung, kidney, or liver) or a bone marrow/stem cell transplant
• You have taken part in another clinical trial within 4 weeks before starting this trial (or longer, depending on the previous trial drug)
• You are currently being treated for depression and have had thoughts of suicide within the past 6 months
• You are pregnant, breastfeeding, planning to become pregnant, or your male partner's female partner plans to become pregnant during the study period
• The trial team has any other reason to believe you should not participate

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