Actively Recruiting
A Long-term Extension Clinical Study of TLL-018 in Patients With Rheumatoid Arthritis
Led by Hangzhou Highlightll Pharmaceutical Co., Ltd · Updated on 2025-03-25
350
Participants Needed
1
Research Sites
146 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official 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...
- Subjects have completed TLL-018-301 study within 3 months
- Age at consent between 18 and 75 years
- Female subjects of childbearing potential must not be pregnant or breastfeeding and require pregnancy testing before entering
- Subjects and their partners must use effective contraception from first to last dose of the investigational drug
- Subjects must understand and voluntarily sign the informed consent form
You will not qualify if you...
- Severe allergic reaction to investigational drug during TLL-018-301 study
- History of herpes zoster, major cardiovascular event, thromboembolism, or lymphoproliferative disorders since TLL-018-301 study
- Clinically significant cardiovascular, respiratory, or other serious unstable diseases posing security risk
- Abnormal and clinically significant lab test values at screening
- Use of traditional Chinese medicines, csDMARDs, immunosuppressive drugs, potent opioids, or other JAK inhibitors (except in TLL-018-301) within 1 week before first dose in this study
- Treatment with flunomide, any bDMARDs, interferon, or other injected immunosuppressive drugs since TLL-018-301 study
- Receipt of live vaccine within 2 months before first dose or planned during study
- Active tuberculosis infection without clinical cure, suspected tuberculosis symptoms, or latent tuberculosis infection without completed preventive treatment within 3 years prior to screening
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
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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