New pill shows promise for arthritis patients who fail standard treatments

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: 1. Aged between 18 and 75 years (inclusive) at the time of signing the informed consent form, regardless of gender; 2. Meeting the diagnostic criteria for rheumatoid arthritis (RA) as defined in the 2010 American College of Rheumatology (ACR)/European League Against Rheumatism (EULAR) criteria for RA; 3. Having moderate to severe active RA, defined as having a tender joint count (TJC) ≥ 6 or a swollen joint count (SJC) ≥ 6 based on a 68/66-joint count at screening, or a Disease Activity Score in 28 joints with erythrocyte sedimentation rate (DAS28 ESR)/C-reactive protein (CRP) ≥ 3.2, and having an ESR \> 28 mm/h or CRP/high-sensitivity CRP (hsCRP) \> 5 mg/L at screening; 4. Having an inadequate response to or intolerance of at least one or more conventional synthetic disease-modifying antirheumatic drugs (csDMARDs). Subjects must have received regular csDMARD therapy for at least 3 months and have been on a stable dose for at least 4 weeks prior to initiating study drug treatment. Allowable csDMARDs include methotrexate (MTX), sulfasalazine, hydroxychloroquine, chloroquine, and leflunomide, among others. Exclusion Criteria: 1. Requiring continued combination therapy with methotrexate (MTX), hydroxychloroquine, and sulfasalazine, or any combination of three csDMARDs; 2. Subjects who have previously received a standard course of JAK inhibitors (e.g., tofacitinib, upadacitinib, baricitinib, filgotinib, deucravacitinib, etc., including topical formulations) and have primary failure to biologic DMARDs (bDMARDs) treatment; 3. Subjects judged by the investigator to have active symptoms of primary fibromyalgia or other conditions that may interfere with the assessment of RA symptoms; 4. Lactating or pregnant women, or fertile subjects unwilling to take effective contraceptive measures throughout the trial period and for 1 month after the last administration of emmacitinib tablets; 5. Subjects with uncontrolled infections, such as hepatitis B carriers with liver dysfunction (aspartate aminotransferase or alanine aminotransferase ≥ 3 times the upper limit of the laboratory normal range, or bilirubin ≥ 1.5 times the upper limit of the laboratory normal range); subjects with a history of latent or active tuberculosis who have not completed an adequate course of anti-tuberculosis treatment; subjects with symptomatic herpes zoster infection; 6. Subjects with an estimated glomerular filtration rate (eGFR) \< 60 mL/min/1.73 m² calculated by the Modified Diet in Renal Disease (MDRD) formula or other methods; 7. Subjects with moderate to severe congestive heart failure (New York Heart Association Class III or IV), or those who have experienced a cardiovascular or cerebrovascular event requiring hospitalization within 6 months prior to enrollment, including but not limited to percutaneous transluminal coronary angioplasty, coronary artery bypass grafting, cerebral hemorrhage, or subarachnoid hemorrhage; 8. Subjects with a current or history of malignancy (except for adequately treated or excised non-metastatic basal cell carcinoma or squamous cell carcinoma of the skin, or cervical carcinoma in situ); 9. Subjects who have received a live/attenuated vaccine within the previous 3 months or are expected to receive a live/attenuated vaccine during the study period or within 28 days after the end of the study; 10. Subjects who have participated in another clinical trial within 30 days prior to the screening period; 11. Subjects who refuse to sign the informed consent form or are unwilling or unable to cooperate with the collection of medical history and clinical photographs; 12. Subjects considered by the investigator to have any other conditions that make them unsuitable for participation in this study.