The primary objective of the study is to evaluate the long-term safety, tolerability, and efficacy of TLL-018 in patients with rheumatoid arthritis (RA) who have completed a preceding randomized controlled trial with TLL-018.
Subjects have completed TLL-018-301 study within 3 months;
Age (at the time of consent):>＝18 years of age, <＝75 years of age;
Female subjects of childbearing potential (WOCBP), who should not be pregnant or breastfeeding, should not enter the study until after pregnancy testing (e.g., HCG beta subunit-based monitoring);
All subjects and their partners voluntarily use contraception as deemed effective by the investigator for at least 90 days from the first dose of the investigational drug to the last dose of the investigational drug (Appendix I); no sperm or egg donation is planned by the subject for at least 6 months from the screening period to the last dose of the investigational drug.
Subjects have had severe allergic reaction related to the investigational drug during the TLL-018-301 study;
Subjects have had herpes zoster, a major cardiovascular event (MACE), thromboembolism, or lymphoproliferative disorders from the time of TLL-018-301 study to the screening of OLE study;
Subjects have a clinically significant cardiovascular, respiratory, or any other serious and/or non-stable disease, and there is security risk for subjects to participate in this study judged by the investigator;
Subjects have abnormal and clinically significant laboratory test values at screening;
Single group
TLL-018
DrugTLL-018 20 mg BID for 78 weeks
Number of occurrences and Percentage of Participants with AEs and SAEs
Evaluation includes vital signs, physical examination, ECG examination, laboratory tests, AE, SAE, etc.
Percentage of Participants With an American College of Rheumatology 50% (ACR50) Response Over Time
Participants who met the following 3 conditions for improvement from Baseline were classified as meeting the ACR20 response criteria: \>=50% improvement in 68-tender joint count; \>=50% improvement in 66-swollen joint count; \>=50% improvement in at least 3 of the 5 following parameters: Physician global assessment of disease activity Patient global assessment of disease activity Patient assessment of pain Health Assessment Questionnaire - Disability Index (HAQ-DI) High-sensitivity C-reactive protein (hsCRP).
Percentage of Participants With an American College of Rheumatology 20% (ACR20) Response Over Time
Participants who met the following 3 conditions for improvement from Baseline were classified as meeting the ACR20 response criteria: \>=20% improvement in 68-tender joint count; \>=20% improvement in 66-swollen joint count; \>=20% improvement in at least 3 of the 5 following parameters: Physician global assessment of disease activity Patient global assessment of disease activity Patient assessment of pain Health Assessment Questionnaire - Disability Index (HAQ-DI) High-sensitivity C-reactive protein (hsCRP).
Percentage of Participants With an American College of Rheumatology 70% (ACR70) Response Over Time
Participants who met the following 3 conditions for improvement from Baseline were classified as meeting the ACR70 response criteria: \>=70% improvement in 68-tender joint count; \>=70% improvement in 66-swollen joint count; \>=70% improvement in at least 3 of the 5 following parameters: Physician global assessment of disease activity Patient global assessment of disease activity Patient assessment of pain Health Assessment Questionnaire - Disability Index (HAQ-DI) High-sensitivity C-reactive protein (hsCRP).
Percentage of Participants Achieving Low Disease Activity (LDA) Based on Disease Activity Score-28 (DAS28[CRP]) Over Time
Disease Activity Score (DAS) based on a 28 joint count hsCRP consisted of composite numerical score of following variables: tender joint count (TJC28), swollen joint count (SJC28), hsCRP (mg/mL), and participant's global assessment of disease activity. DAS28-hsCRP was calculated using following formula: DAS28-hsCRP equals to (=) 0.56\*square root (sqrt) (TJC28) plus (+) 0.28\*sqrt (SJC28) + 0.36\*natural log(hsCRP+1) + 0.014\*participant's global assessment of disease activity + 0.96. Scores ranged 0-9.4, where lower scores indicated less disease activity.
Click on the lead sponsor to view all of their trials.
