Actively Recruiting
Open-label Extension Study to Evaluate Long-term Safety, Tolerability, and Efficacy of TLL-018 in Adults With Rheumatoid Arthritis
Led by Hangzhou Highlightll Pharmaceutical Co., Ltd · Updated on 2026-05-20
350
Participants Needed
1
Research Sites
52 weeks
Total Duration
On this page
AI-Summary
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 ACR20/50/70 responses. The study evaluates participants over approximately 18 months to monitor long-term outcomes and treatment tolerability.
CONDITIONS
Brief Title
A Long-term Extension Clinical Study of TLL-018 in Patients With Rheumatoid Arthritis
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Completed the TLL-018-301 study within the past 3 months
- Aged between 18 and 75 years at the time of consent
- Female participants of childbearing potential must not be pregnant or breastfeeding and must have a negative pregnancy test
- Participants and their partners agree to use effective contraception for at least 90 days from the first to the last dose of the study drug
- Able to understand and voluntarily sign the informed consent form
You will not qualify if you...
- History of severe allergic reaction to TLL-018 during the previous TLL-018-301 study
- History of herpes zoster, major cardiovascular events, thromboembolism, or lymphoproliferative disorders since the previous study until screening
- Clinically significant cardiovascular, respiratory, or other serious unstable diseases posing risk for participation
- Abnormal and clinically significant laboratory test results at screening
- Use of traditional Chinese medicines, csDMARDs, immunosuppressive drugs, potent opioids, or other JAK inhibitors (except study drugs) within 1 week before starting this study
- Treatment with flunomide, any bDMARDs, interferon, or other injected immunosuppressants since the previous study until screening
- Receipt of any live vaccine within 2 months before starting the study drug or planned live vaccine during the study
- Active tuberculosis infection without clinical cure, suspected tuberculosis symptoms, or latent tuberculosis without completed preventive treatment within 3 years prior to screening
AI-Screening
AI-Powered Screening
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Your Study Journey
Duration - Up to 3 months
Participants are screened for eligibility to participate in the trial.
1 screening visit (in-person)
Duration - 78 weeks
Participants receive TLL-018 20 mg twice daily for 78 weeks to assess long-term safety, tolerability, and efficacy.
Visits at Weeks 6, 12, 24, 36, 48, 60, 72, and 78 for safety assessments; visits at Weeks 12, 24, 36, 48, 60, 72, and 78 for efficacy evaluations
Duration - Up to study completion
Participants are monitored after treatment for ongoing safety and efficacy assessments.
Follow-up visits coincide with the last treatment visit at Week 78
Trial Site Locations
Total: 1 location
1
Peking Union Hospital, Chinese Academy of Medical Sciences
Beijing, Beijing Municipality, China, 100022
Actively Recruiting
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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