Phase 3 Rheumatoid Arthritis Trial, Completed

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 diagnosed with adult-onset Rheumatoid Arthritis (RA) according to the 2010 classification guidelines set by major rheumatology organisations
• People whose RA is moderately to severely active, meaning at least 6 out of 68 joints are tender and at least 6 out of 66 joints are swollen
• People whose blood test shows a raised level of a marker of inflammation called C-reactive protein (CRP or hsCRP), at or above the upper limit of the normal range
• People who have been treated with at least one biologic TNF-alpha inhibitor (a specific type of RA medication) at the approved dose for at least 3 months, and either found it did not work well enough, stopped working over time, or could not tolerate it
• People who have been regularly taking at least one conventional RA medication (called a cDMARD) for at least 12 weeks before joining the study, with the dose unchanged for at least the last 8 weeks

Who may not be able to join:

• People who have received a biologic RA treatment within 28 days before the planned start date, or who have received a medication called rituximab within 6 months before the planned start date
• People who are currently taking steroid medications (such as prednisone) at a dose above 10 mg per day, or whose steroid dose has been changed within the past 2 to 6 weeks
• People who have recently started taking anti-inflammatory pain medications (NSAIDs), or whose NSAID dose has been unstable within the past 2 to 6 weeks
• People who are currently taking three conventional RA medications together, specifically methotrexate, hydroxychloroquine, and sulfasalazine all at the same time, or any combination of three such medications
• People who have received steroid injections directly into a muscle or vein within 2 to 6 weeks before the planned start date, or who are expected to need this type of injection during the study
• People who have had 3 or more joints injected with steroids or hyaluronic acid within 2 to 6 weeks before the planned start date
• People who have active fibromyalgia that, in the investigator's opinion, would make it difficult to accurately measure RA disease activity during the study
• People who have been diagnosed with another inflammatory condition in addition to RA, such as Crohn's disease, ulcerative colitis, psoriatic arthritis, gout, or similar conditions (people with secondary Sjögren's syndrome are not excluded)
• People who have been diagnosed with Felty's syndrome (a rare complication of RA)
• People who have had major surgery within 8 weeks before joining the study, or who are expected to need major surgery during the study, if the investigator considers this to pose too great a risk
• People who have had a heart attack, unstable heart disease, or stroke within the 12 weeks before joining the study, or who have severe (stage IV) heart failure
• People who have a serious or unstable medical condition affecting the heart, lungs, liver, digestive system, hormonal system, blood, nervous system, or mental health, which in the investigator's opinion could make participation unsafe or affect the study results
• People who are largely or completely unable to care for themselves, such as those who are bedridden or confined to a wheelchair
• People whose kidneys are not functioning well enough, based on a specific blood test result falling below a set level (confirm with trial site)
• People who have a history of chronic liver disease and whose most recent liver blood test results are above a certain level (confirm with trial site)
• People who have a history of, or signs or symptoms suggesting, a disease affecting the lymph system, or who have an active cancer, or who have been in remission from a significant cancer for less than 5 years
• People who have received a live vaccine within 12 weeks before the planned start date, or who are expected to need a live vaccine during the study (herpes zoster vaccination is an exception)
• People who currently have or have recently had a serious infection caused by a virus, bacteria, fungus, or parasite
• People who have had a symptomatic shingles (herpes zoster) infection within 12 weeks before joining the study
• People who have a history of severe or widespread shingles, including cases that affected multiple areas of the body, the eyes, the brain or nervous system, or that caused long-lasting nerve pain
• People who have a weakened immune system that, in the investigator's opinion, makes participation too risky
• People who have a history of active hepatitis B, hepatitis C, or HIV infection
• People whose blood test results at the screening stage, including thyroid hormone levels, fall outside the normal range in a way that the investigator considers poses too great a risk
• People whose heart trace (ECG) at screening shows abnormalities that the investigator or study sponsor considers clinically significant and too risky for participation (confirm with trial site)
• People who have an active cold sore (herpes simplex) outbreak at the time of enrolment
• People who have evidence of active or latent tuberculosis (TB)

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