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 are willing and able to give written consent to participate in the study
• People aged 18 to 65 years old (inclusive) at the time of signing the consent form
• People who have been diagnosed with rheumatoid arthritis (RA) for at least 3 months, using recognised international diagnostic standards
• People who have recurring swelling and pain in at least one knee, with a pain score of 4 or higher on a standard scale, inflammation confirmed by ultrasound, and whose knee symptoms have not improved significantly after 3 months of RA treatment
• People who have been taking a type of RA medication called a csDMARD for at least 3 months, with the dose unchanged for at least 4 weeks before the screening visit
• People whose background RA treatment includes certain approved medications (such as methotrexate, sulfasalazine, hydroxychloroquine, or leflunomide) at stable doses for at least 4 weeks before screening — either alone or in combination
• People taking anti-inflammatory pain medications (NSAIDs) at a stable dose for at least 2 weeks before screening may also be eligible
• Women who could become pregnant must have a negative blood pregnancy test within 7 days before starting treatment and must not be breastfeeding; all participants regardless of gender must use at least one highly effective form of contraception throughout the study
• People who are generally in good health and able to walk independently without a wheelchair, walker, or crutches
• People who are willing and able to attend scheduled visits, follow the treatment plan, and complete all required tests and study procedures

Who may not be able to join:

• People who have other immune system conditions at the start of the study that could affect how the treatment works or is evaluated
• People with a history of, or currently significant, heart, psychiatric, kidney, liver, immune, or hormonal conditions (including uncontrolled diabetes or thyroid disease), or conditions that require medications not permitted by the study
• People who test positive for HIV, hepatitis B, hepatitis C, or syphilis
• People with active tuberculosis (TB), or a history of TB that was not properly treated and documented
• People with a bleeding or clotting disorder that the trial doctor believes could affect safety or the assessment of the knee
• People who had a serious infection within 1 month before screening (requiring hospitalisation and at least 3 days of IV antibiotics, antivirals, or antifungals), or who are being treated for an active infection during screening
• People who have had an infection in the target knee within 3 months before the start of the study
• People who have had a steroid injection or other drug injection into the target knee within 3 months before the start of the study
• People who have had a knee injury or knee surgery in the target knee within 1 year before the start of the study
• People whose liver enzyme levels (ALT or AST) are 2 or more times above the normal range during screening
• People whose kidney function (measured by creatinine clearance) falls below a certain threshold during screening (confirm with trial site)
• People with certain blood count abnormalities during screening, including low red blood cell levels, low white blood cell or neutrophil counts, or a low platelet count
• People with abnormal heart rhythm or electrical activity on an ECG (heart tracing) that the trial doctor believes could increase safety risks
• People with uncontrolled high blood pressure (systolic at or above 160 mmHg and/or diastolic at or above 90 mmHg) at screening or at the start of the study
• People with a body mass index (BMI) over 30 kg/m² at screening
• People who cannot have an MRI scan, for example due to having a pacemaker, certain stents, or an artificial heart valve
• People with a current or past psychiatric condition such as anxiety or depression, if the trial doctor considers this makes participation unsuitable
• People with a history of cancer, except for certain types of treated skin cancers that have not spread
• Women who are pregnant, breastfeeding, or planning to become pregnant during the study, and men who plan to donate sperm during the study
• People who have received high-dose steroid treatment (by injection or oral prednisone equivalent above 10 mg per day) or who have been on an unstable steroid dose in the 28 days before the start of the study
• People with a known allergy or sensitivity to any ingredient in the study treatment or similar medications
• People who have taken part in another clinical trial within 4 weeks before the start of the study, or within 5 half-lives of their last dose of any trial drug
• People with a history of alcohol or drug misuse within 6 months before starting the study, if the trial doctor believes this would affect participation
• People who have received a live virus vaccine within 8 weeks before the start of the study
• People classified as legally disabled under a specific Chinese law (April 2008 version) (confirm with trial site)
• People with health, mental, or social circumstances that the trial doctor believes would prevent them from following the study requirements
• People with nerve or muscle conditions (such as fibromyalgia, significant back pain, hip pain, sciatica, or spinal disc problems) that could interfere with the assessment of knee pain and function
• People with any other condition that the trial doctor considers makes participation unsuitable

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