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 aged 18 to 70 years old at the time of signing the consent form, of any gender
• People who have been diagnosed with rheumatoid arthritis (RA) according to recognised medical classification systems
• People whose RA disease activity score (a measure of joint inflammation and symptoms) is above a certain level at the screening visit
• People whose blood test shows a raised level of C-reactive protein (a marker of inflammation) at the screening visit
• People who have already tried at least one standard RA medication (such as methotrexate, hydroxychloroquine, sulfasalazine, leflunomide, or similar drugs) without enough benefit or who could not tolerate it, and who agree to stop taking it during the study
• People who are able and willing to use effective contraception during the study and for 3 months after the last dose (this applies to both men and women who could potentially father or become pregnant); women who could become pregnant must have a negative pregnancy test before starting
• People who are willing and able to give written consent and follow all study requirements, including attending visits and completing questionnaires

Who may not be able to join:

• People who have a known allergy or sensitivity to the study drug or any of its ingredients
• People whose RA severely limits their ability to move or who are largely bedridden or wheelchair-bound
• People who have previously taken certain RA medications, including JAK inhibitors (such as tofacitinib, baricitinib, or upadacitinib) or biologic RA drugs, or who have taken part in a clinical trial of those drugs
• People who have taken standard RA medications (csDMARDs) within certain timeframes before joining — the specific timeframes vary by drug (confirm with trial site)
• People who have used strong immune-suppressing medications (such as cyclosporine, azathioprine, mycophenolate mofetil, or similar) within 4 weeks before joining
• People who have received steroid injections into a muscle, vein, or joint within 4 weeks before joining
• People who have received interferon treatment within 4 weeks before joining
• People who have taken oral traditional Chinese medicine for RA or other inflammatory conditions within 4 weeks before joining
• People who have used opioid pain medicines within 1 week (or longer, depending on the specific drug) before the first dose
• People who have received certain immune cell-targeting treatments within 3 months (or longer, depending on the specific drug) before the screening visit
• People who have other inflammatory joint or autoimmune diseases (such as lupus, psoriatic arthritis, gout, ankylosing spondylitis, or Crohn's disease), not including secondary Sjögren's syndrome
• People who have Felty's syndrome (a rare complication of RA)
• People who have a current or past history of any cancer
• People with a history of long-term or chronic pain that could affect study assessments
• People with active tuberculosis, untreated latent tuberculosis, or tuberculosis that has not fully resolved
• People with ongoing or repeated serious infections, or who have taken oral antibiotics within 14 days before the first dose (not including nail fungal infections); or who have had a deep tissue infection (such as a bone infection or abscess) within the past year
• People with poorly controlled serious health conditions such as diabetes, high blood pressure, kidney disease, liver disease, severe heart conditions, respiratory disease, or serious ongoing stomach or bowel conditions, where the treating doctor considers this a concern for study participation
• People who have had major surgery within 8 weeks before joining, or who expect to have major surgery during the study
• People whose blood tests at screening show certain abnormalities, including low haemoglobin, low white blood cell count, low neutrophils, low lymphocytes, or low platelets (confirm specific thresholds with trial site)
• People who test positive for hepatitis B surface antigen, or who have certain hepatitis B or C markers with detectable virus levels in the blood, or who test positive for HIV or syphilis
• People who have had a problem with drug or alcohol misuse or dependence at the time of screening, or within 6 months before joining
• People who have taken part in another clinical trial of a drug or medical device within 4 weeks (or longer, depending on the drug) before joining
• People who have donated 400 mL or more of blood, or received a blood transfusion, within 3 months before joining
• People where the trial doctor considers there to be any other reason that could affect the safety of the study or the reliability of the results

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