A Phase 3 Study Comparing TLL-018 to Tofacitinib in RA Subjects With Inadequate Response or Intol… (NCT06020144) | Clinical Trial Compass
Active — Not RecruitingPhase 3
A Phase 3 Study Comparing TLL-018 to Tofacitinib in RA Subjects With Inadequate Response or Intolerance to bDMARDs
China459 participantsStarted 2023-11-15
Plain-language summary
A randomized, double-blind, double-dummy, positive-controlled, phase 3 study to assess the safety and efficacy of TLL-018 in active rheumatoid arthritis subjects who had an inadequate response or intolerance to Biologic DMARDs.
Who can participate
Age range
18 Years – 75 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Aged between 18 and 65;
* Meet the diagnostic criteria of rheumatoid arthritis of the American College of Rheumatology/European Alliance against Rheumatism (ACR/EULAR,2010) with duration of at least 3 months;
* Meet the criteria for active rheumatoid arthritis；
* Have received at least one kind of bDMARDs for three months or longer and show inadequate response or intolerance to at least one kind of bDMARDs；
* Meet the ACR (1991) grading criteria of grade I, II or III；
* Discontinuation of bDMARDs or JAK inhibitors for more than four weeks；
* To sustain a stable status, oral administration of stable doses of glucocorticoids (≤ prednisone 10 mg/day or equivalent corticosteroids) and stable doses of nonsteroidal anti-inflammatory drugs (NSAIDs) are allowed to use, provided that stable doses are maintained for at least one week prior to the study；
* BMI index is less than 35 kg/m2;
* Women of Child Bearing Potential (WOCBP) should not be pregnant or breastfeeding and the pregnancy test should be negative before randomization;
* Subjects (whether male or female) should have adequate barrier contraception during the whole treatment period and at least 90 days after treatment; subjects should avoid the sperm or ovum donation for at least six months after treatment；
* Subjects understand the informed consent form (ICF), volunteer for the study and sign the ICF;
Exclusion Criteria:
* With other rheumatic diseases;
* With other systemic inflammatory diseases;
*…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1This trial is comparing an investigational drug called TLL-018 directly against tofacitinib, which is already an approved medication — can you help me understand what that means for my treatment options, and whether starting tofacitinib on its own outside the trial might make more sense for me right now?
2Since the trial is no longer actively enrolling, is there any chance I could still be considered for participation, or is that door completely closed at this point?
3The trial is specifically for people who didn't respond well to or couldn't tolerate biologic DMARDs — given my own treatment history, do I fall into that category, and does that affect which options you'd recommend for me?
4The main thing this trial is measuring is whether at least half of my RA symptoms improve using the ACR50 scale — in your experience, how meaningful is that level of improvement in day-to-day life for someone with my level of disease activity?
5Since TLL-018 is still investigational even in a Phase 3 trial, what do we currently know about its safety profile compared to tofacitinib, which already has years of real-world safety data behind it?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Proportion of subjects achieving American College of Rheumatology 50% (ACR50) Response