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:

• People who have signed and dated a consent form before any trial procedures begin.
• People who have been officially diagnosed with rheumatoid arthritis (RA) according to recognised international classification standards.
• People whose RA diagnosis was made no more than 6 months ago, and whose RA symptoms have been present for no more than 18 months in total.
• People who have never taken any disease-modifying anti-rheumatic drugs (medications used to slow RA progression).
• People who have at least 6 tender joints and 6 swollen joints at the screening and baseline visits.
• People whose RA is considered highly active, based on specific scoring measures taken at screening and baseline.
• People with a blood inflammation marker (hsCRP) at or above a certain level at screening.
• People who test positive for specific RA-related antibodies in their blood (rheumatoid factor and/or anti-CCP antibodies), or, if these tests are negative, people whose inflammation marker (hsCRP) is at a higher specified level.
• People who are able and willing to attend all scheduled visits and follow all study procedures.
• People who can become pregnant must have a negative pregnancy test at both screening and baseline.
• People who are sexually active and could become pregnant, or male participants with partners who could become pregnant, must agree to use two forms of contraception during the study and for 90 days after the last dose, or must agree to remain abstinent during the same period.

Who may not be able to join:

• People whose RA has left them unable to perform most self-care activities (classified as the most severe functional level under recognised RA standards).
• People who have another autoimmune or rheumatic disease in addition to RA, such as lupus, scleroderma, or polymyositis, or who have significant body-wide complications from RA.
• People who have another type of inflammatory joint disease alongside RA.
• People who have a non-inflammatory muscle or joint condition that, in the investigator's opinion, is significant enough to interfere with assessing RA or the study treatment.
• People with known digestive system diseases that could affect how medications are absorbed or processed by the body.
• People with severe, worsening, or uncontrolled conditions affecting the kidneys, liver, blood, digestive system, metabolism, hormones, lungs, heart, or nervous system.
• People who have had an active cancer at any point in the 12 months before the screening visit.
• People with acute or chronic hepatitis, unexplained significant liver enzyme elevations (confirmed on at least two occasions in the 6 months before screening), or HIV infection.
• People with a history of alcohol or drug misuse in the 12 months before the screening visit.
• People who received a live vaccine in the 6 weeks before the screening visit.
• People whose blood test results at screening fall outside acceptable ranges for haemoglobin, haematocrit, white blood cells, neutrophils, or platelets (confirm specific values with trial site).
• People whose liver-related blood test results at screening are significantly above the normal upper limit for certain enzymes or bilirubin (confirm specific values with trial site).
• People whose kidney function, as measured by a specific calculation, falls below a certain level at screening (confirm with trial site).
• People whose heart tracing (ECG) shows clinically significant abnormal findings, as determined by the investigator.
• People who test positive for a tuberculosis screening test (QuantiFERON-in-Tube).
• People who have taken hydroxychloroquine in the 30 weeks before the screening visit.
• People who have received steroid medications (taken by mouth, injection, or into a joint) within 6 weeks before the screening visit.
• People who use anti-inflammatory pain medications (NSAIDs) irregularly — regular use at a stable dose for at least 4 weeks before screening is acceptable.
• People who have taken part in another clinical trial or used an experimental treatment in the 6 months before the screening visit.
• People who have any other condition that, in the investigator's opinion, could affect the safety or accuracy of the trial results.

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