Long-term Study of TLL-018 Drug for Adults With Rheumatoid Arthritis Who Completed Previous TLL-018 Trial

What this Trial Is About

Researchers are evaluating the long-term safety, tolerability, and effectiveness of the drug TLL-018 in adults with rheumatoid arthritis RA who previously completed a related phase 3 randomized controlled trial. This open-label extension study aims to provide further information on how patients respond to continued treatment with TLL-018 over an extended period. The study is sponsored by Hangzhou Highlightll Pharmaceutical Co., Ltd and focuses on patients who have completed the earlier TLL-018-301 trial. Participants will receive TLL-018 at a dose of 20 mg twice daily for 78 weeks. The study includes a screening period, a treatment period where all participants receive TLL-018, and a follow-up period. During the previous trial, some participants were treated with tofacitinib and switched to TLL-018 if they did not achieve a certain response in this extension study, all participants receive TLL-018 20 mg twice daily as two tablets taken orally. Throughout the study, safety assessments including physical exams, vital signs, lab tests, and monitoring of adverse events will occur regularly at weeks 6, 12, 24, 36, 48, 60, 72, and 78. Effectiveness will be measured at multiple time points using joint assessments, patient and physician questionnaires, pain scales, and disease activity scores such as DAS28-hsCRP and ACR205070 responses. The study evaluates participants over approximately 18 months to monitor long-term outcomes and treatment tolerability.

A Long-term Extension Clinical Study of TLL-018 in Patients With Rheumatoid Arthritis