Phase 4 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 fully understand the trial, are willing to sign a consent form, and are able to complete all required visits and procedures
• Men aged 50 or older who do not wish to have children, or women who have gone through menopause, where all participants are under 70 years of age
• People who have been diagnosed with rheumatoid arthritis (RA) using recognised medical classification systems
• People whose RA fits a Traditional Chinese Medicine pattern called "Wind-Damp Bi obstruction," which involves symptoms such as joint pain and swelling that moves around or comes and goes, possibly with sensitivity to wind, spontaneous sweating, headaches, or heavy-feeling limbs, along with specific tongue and pulse findings assessed by a TCM practitioner
• People whose RA is moderately to severely active at the time of screening, shown by a certain number of painful and swollen joints and elevated levels of inflammation markers in blood tests
• People whose RA has not responded well enough to at least two different standard RA drug treatments (not including the specific combination of methotrexate, a JAK inhibitor, and Kunxian capsule), each taken for at least 12 weeks

Who may not be able to join:

• People with a known or suspected allergy to the study drug or similar medications, or any other serious allergic condition that the trial doctor considers a safety risk
• People who have another inflammatory joint or autoimmune condition in addition to RA, such as psoriatic arthritis, ankylosing spondylitis, or lupus
• People with serious, worsening, or poorly controlled conditions affecting the kidneys, liver, blood, digestive system, hormones, lungs, heart, nervous system, or mental health; or a history of blood clots in the veins, diverticulitis, or significantly abnormal cholesterol levels
• People with a history of lymphoma or any other cancer, past or present
• People with signs of tuberculosis (TB), including a history of active TB, recent close contact with someone who has active TB, symptoms suggesting active TB, a chest scan showing active TB within the past 3 months, or a positive TB blood test within the past 6 weeks
• People with a current or recent active infection, including those who received antibiotic or antiviral treatment within the past 4 weeks, or who had a sore throat, blocked nose, or any acute infection within the past 2 weeks
• People with a history of repeated or widespread shingles or herpes simplex infections, or any such infection within the past 2 months
• People who test positive at screening for hepatitis B (with detectable virus levels), hepatitis C, HIV, or syphilis
• People who have received, or are planning to receive, a live or weakened (attenuated) vaccine within 3 months before the trial starts, during the trial, or within 6 months after the last dose
• People who are pregnant, breastfeeding, planning a pregnancy, or planning to father a child during the trial or within 6 months after the last dose; or people of either sex who have plans to have children
• People with a clinically significant heart rhythm abnormality found on an ECG at screening, as judged by the trial doctor
• People with any other condition at screening that could interfere with trial assessments, as judged by the trial doctor
• People with certain abnormal blood test results at screening, including low levels of red blood cells, white blood cells, neutrophils, platelets, or lymphocytes, or abnormal liver or kidney function results
• People who have recently used strong opioid pain medicines, JAK inhibitor drugs, anti-inflammatory medicines (NSAIDs) with recent dose changes, or corticosteroids (steroids) above a certain dose or with recent dose changes, or who have received steroid injections into joints or muscles within the past 4 weeks
• People who are currently participating in another clinical drug trial
• People with any other clinical or laboratory finding that the trial doctor considers makes participation unsuitable

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