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:

Healthy participants:

• People aged 18 to 55 years old
• People with a body mass index (a measure of body weight relative to height) between 18 and 32
• People who a doctor determines to be in generally good health based on a physical check-up, medical history, vital signs, and blood test results

People with rheumatoid arthritis (RA):

• Adults aged 18 to 75 years old
• People with a body mass index between 18 and 35
• People who have had rheumatoid arthritis for at least 6 months
• People whose blood tests show a positive result for rheumatoid factor (RF) or a related antibody called ACPA
• People whose blood shows elevated levels of a marker of inflammation called hsCRP at the screening visit
• People whose RA is currently active, meaning a doctor has measured significant joint disease activity (a score above 3.2 on a standard RA scale) and who have at least 4 swollen and 4 tender joints at both the screening and baseline visits
• People who have been taking the medication methotrexate (MTX) by mouth or injection for at least 12 weeks before screening, at a stable dose of 15–25 mg per week (or 10–15 mg per week if there is a documented reason they cannot tolerate the higher dose), with plans to continue at the same dose throughout the study

Who may not be able to join:

Healthy participants:

• People who have, or have had, any illness that a doctor believes could affect the study results or create unacceptable health risks
• People who have had a recent serious infection or have an ongoing infection
• People with a known or suspected condition that causes the immune system not to work properly (primary immunodeficiency)
• People who have received steroid injections or taken systemic steroid medications within 6 weeks before screening
• People taking certain medications that are not allowed in this trial (confirm with trial site for the specific list)
• People whose blood test results fall outside acceptable ranges, including: low white blood cell count, low neutrophil count (a type of white blood cell), low haemoglobin (indicating anaemia), low platelet count, elevated liver enzymes (ALT) or bilirubin (unless a specific benign liver condition called Gilbert's disease is the cause), reduced kidney function, abnormal blood clotting measure (INR), blood sugar control measure (HbA1c) above 6%, a positive test for nicotine or alcohol or certain drugs of abuse (a positive result for cannabis/THC is not disqualifying), thyroid hormone levels outside the normal range, or a low morning cortisol level

RA participants:

• People with significant unstable or uncontrolled serious health conditions such as heart disease (including heart failure or history of heart attack), lung disease, blood disorders, gastrointestinal, liver, kidney, neurological, psychiatric, skin, or other infectious diseases that a doctor considers an unacceptable risk for the trial
• People with another autoimmune or autoinflammatory condition that a doctor considers an unacceptable risk for the trial
• People with a recent serious infection, an ongoing infection, or a condition that puts them at high risk of serious infection
• People known to be HIV-positive or who have a parasitic infection called strongyloides (particularly if they have travelled to or live in areas where this is common)
• People with active or latent (inactive but present) tuberculosis (TB), as indicated by a positive chest X-ray or positive TB blood test within 12 weeks before screening, or a positive screening chest X-ray or TB test
• People with a clinically significant abnormal heart tracing (ECG), including a heart rate below 40 or above 100 beats per minute, or certain abnormal electrical intervals measured on the ECG that fall outside acceptable ranges (confirm with trial site for specific values)
• People using certain medications within specified timeframes, including: unstable use of herbal medicines or supplements within 4 weeks before screening; steroid medications (systemic or local) within 6 weeks before the start of the study; joint injections within 4 weeks before screening; certain immune-suppressing medications within 6 to 8 weeks before screening; the medication rituximab or similar cell-depleting therapies within 1 year before screening; other injectable biologic medications within 12 weeks (or 5 half-lives, whichever is longer) before screening; other oral disease-modifying medications (including JAK inhibitors) within 12 weeks before screening (methotrexate and hydroxychloroquine are permitted as outlined in the inclusion criteria); prior use of more than one biologic therapy for RA, or use of one biologic therapy that was not stopped at least 12 weeks (or 5 half-lives, whichever is longer) before screening; participation in another drug or device trial within 30 days or 5 half-lives before screening; or unstable or excessive use of anti-inflammatory pain medications (NSAIDs) in the 2 weeks before screening
• People whose blood test results at screening fall outside acceptable ranges, including: low white blood cell count, low neutrophil count, low haemoglobin, low platelet count, elevated liver enzymes (ALT) or bilirubin (unless Gilbert's disease is the cause), significantly reduced kidney function, abnormal clotting measure (INR), blood sugar control measure (HbA1c) above 8%, a positive alcohol breath test or drug screen for substances of abuse (a positive cannabis/THC result or a positive result explained by prescribed medications for a known condition are not disqualifying), thyroid hormone levels outside the normal range, or a low morning cortisol level at the baseline visit

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