A Phase 3 interventional study of TLL-018 and Tofacitinib in Rheumatoid Arthritis, sponsored by Hangzhou Highlightll Pharmaceutical Co., Ltd. Completed at 1 site in China. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2026-09-25.
Sponsored by Hangzhou Highlightll Pharmaceutical Co., Ltd · Phase 3, Interventional, and Treatment
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Among 249 studies in Arthritis, Rheumatoid with a site in China — 63 open to participants now, 72 under way, 3 of them phase 3. Arthritis, Rheumatoid · China.
Among the 249 studies in Arthritis, Rheumatoid with a site in China, this one is the 36th largest by enrollment of the 217 interventional ones that give a count, is one of 19 that started in 2023, is one of 44 in phase 3, and was the 168th registered.
3,334 studies on the registry are indexed under Arthritis, Rheumatoid; 444 are open to participants now.
Browse Arthritis, Rheumatoid studies →63 of the 249 studies in Arthritis, Rheumatoid with a site in China are open now. Recruiting first, the newest first:
Bristol-Myers Squibb · Sites in China, United States, Belgium and 8 more countries
Ages 18–65
Peking University People's Hospital · Sites in China
Ages 18+
Jacobio Pharmaceuticals Co., Ltd. · Sites in China
Ages 18–75
Peking Union Medical College Hospital · Sites in China
Ages 18–65
The First Affiliated Hospital with Nanjing Medical University · Sites in China
Ages 18–70
A study can be open while its sites in China have not opened yet or have stopped. Only those recruiting at a site in China →
Of the 293 Arthritis, Rheumatoid studies recruiting now, 150 (51%) set no upper age limit and 109 (37%) stop at 75 or younger; 15 take children under 18; 36 take healthy volunteers.
This study: 18 Years to 75 Years · all sexes · no healthy volunteers.
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249 studies; the count open now beside each. This study's row is marked.
A study in two phases is counted once above. Listed by phase, each with its combined phases: Phase 1 58 · Phase 2 46 · Phase 3 52 · Phase 4 28
First in 2003; this study’s year is marked. 19 started in 2023.
By drug class, each counting the studies that test any of its medicines:
This study's enrollment of 459 is above the median of 95 across 2,221 interventional studies indexed under Arthritis, Rheumatoid.
Median enrollment 134 across the 217 interventional studies, 287 across the 32 observational. Of the 115 that completed or were terminated, 28 (24%) have results posted.
This tab as a report to print or save as PDF → With an account.
129 of 249 have an industry lead sponsor. The 10 most frequent:
Hangzhou Highlightll Pharmaceutical Co., Ltd is the lead sponsor of 14 studies on the registry; 5 are open to participants now.
Hangzhou Highlightll Pharmaceutical Co., Ltd has 4 studies filed under Arthritis, Rheumatoid — fewer than ten, so there is no comparison to draw.
16 of the studies in Arthritis, Rheumatoid with a site in China that are under way reach primary completion within a year, 1 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT06887127Phase 3Hangzhou Highlightll Pharmaceutical Co., LtdA Long-term Extension Clinical Study of TLL-018 in Patients With Rheumatoid Arthritis | 2026-12-31 |
| NCT07408024Toll Biotech Co. Ltd. (Beijing)Safety and Efficacy of TollB-001 Tablets in Moderate to Severe Rheumatoid Arthritis | 2026-12 |
| NCT07045896Peking University People's HospitalFucoidan in the Treatment of Active Rheumatoid Arthritis | 2026-12 |
| NCT06945666Jie ChangA Study of Iguratimod in Combination With Tofacitinib in RA Patients | 2027-01-31 |
| NCT07491016Zhejiang Provincial People's HospitalEfficacy and Safety of Telitacicept Combined With Baricitinib for Refractory Rheumatoid Arthritis | 2027-03-30 |
Add all 16 to your calendar (.ics) → With an account.
Among the 249 studies in Arthritis, Rheumatoid with a site in China, from their registry updates:
This tab as a report to print or save as PDF → With an account.
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.
This is a randomized, double-blind, double-dummy, tofacitinib-parallel-group, 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.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.
Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.
Hepatitis C is a virus that infects the liver. An HCV antibody test can stay positive after an infection has cleared (and is occasionally positive without one); an HCV RNA test shows whether the virus is there now.
After treatment, hepatitis C counts as cured when HCV RNA is still undetectable 12 weeks or more after the treatment ended. Studies often accept people cured this way.
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.
Vaccines made with a weakened form of the germ, such as measles–mumps–rubella (MMR), chickenpox and yellow fever. They can be risky when the immune system is weakened. Flu injections are not live; the nasal flu spray is.
The other ingredients in a medicine besides the active drug, such as fillers, colours or preservatives.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
BMI (body mass index)
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Childbearing potential
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hepatitis B tests
Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.
Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hepatitis C tests
Hepatitis C is a virus that infects the liver. An HCV antibody test can stay positive after an infection has cleared (and is occasionally positive without one); an HCV RNA test shows whether the virus is there now.
After treatment, hepatitis C counts as cured when HCV RNA is still undetectable 12 weeks or more after the treatment ended. Studies often accept people cured this way.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
HIV
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Platelets
Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Live vaccines
Vaccines made with a weakened form of the germ, such as measles–mumps–rubella (MMR), chickenpox and yellow fever. They can be risky when the immune system is weakened. Flu injections are not live; the nasal flu spray is.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Excipients
The other ingredients in a medicine besides the active drug, such as fillers, colours or preservatives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
TLL018 tablets, 2piece,BID
Drug: TLL-018
Tofacitinib tablets, 1piece,BID
Drug: Tofacitinib
Oral tablets administered 2pieces BID for 52 weeks.
Also known as: TLL-018 tablets
Oral tablets administered 1pieces BID for 52 weeks.
Also known as: Tofacitinib tablets
Proportion of subjects achieving American College of Rheumatology 50% (ACR50) Response
ACR50 response: greater than or equal to (\>=) 50 percent (%) improvement in painful and tender joint count; \>= 50% improvement in swollen joint count; and \>= 50% improvement in at least 3 of 5 remaining ACR core measures: patient assessment of pain; patient global assessment of disease activity; physician global assessment of disease activity; self-assessed disability (disability index of the Health Assessment Questionnaire \[HAQ\]); and C-Reactive Protein (CRP)at each visit.
Time frame: Week 24
Proportion of subjects achieving DAS28-hsCRP <2.6
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 patient'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.
Time frame: Week 24
Proportion of subjects achieving American College of Rheumatology 20% (ACR20) and 70% (ACR70) Response
ACR20/70 response: greater than or equal to (\>=) 20/70 percent (%) improvement in painful and tender joint count; \>= 20%/70% improvement in swollen joint count; and \>= 20%/70% improvement in at least 3 of 5 remaining ACR core measures: patient assessment of pain; patient global assessment of disease activity; physician global assessment of disease activity; self-assessed disability (disability index of the Health Assessment Questionnaire \[HAQ\]); and C-Reactive Protein (CRP)at each visit.
Time frame: Week 24
Change From Baseline in Disease Activity Score Based on 28-Joints Count-High-Sensitivity C-reactive Protein (DAS28-hsCRP)
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 patient'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. Change = value at observation minus value at baseline.
Time frame: Week 24
Changes From Baseline in Health Assessment Questionnaire-Disability Index (HAQ-DI) Total Score
HAQ-DI score was an evaluation of the functional status for a participant. The 20-question instrument assessed the degree of difficulty a person had in accomplishing tasks in 8 functional areas (dressing, arising, eating, walking, hygiene, reaching, gripping, and activities of daily living). Responses in each functional area were scored from 0, indicated no difficulty, to 3, indicated inability to perform a task in that area. Overall score was computed as the sum of domain scores and divided by the number of domains answered. Total possible score range: 0-3 where 0 = least difficulty and 3 = extreme difficulty.
Time frame: Week 24
Changes From Baseline in SF-36 Score
SF-36 score was an evaluation of the functional status for a participant,taping eight health concepts: physical functioning, bodily pain, role limitations due to physical health problems, role limitations due to personal or emotional problems, emotional well-being, social functioning, energy/fatigue, and general health perceptions. Coded numeric values are recoded per the scoring key. All items are scored so that a high score defines a more favorable health state. Each item is scored on a o to 100 range. Items in the same scale are averaged together to create the 8 scale scores.
Time frame: Week 24
Proportion of subjects achieving DAS28-hsCRP <＝3.2
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 patient'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.
Time frame: Week 24
Proportion of subjects achieving CDAI <＝10
Clinical Disease Activity Index equals the sum of score of following variables：Tender joint count (TJC28), Swollen joint count (SJC28), Patient's Global Assessment of Arthritis, Physician's Global Assessment of Arthritis
Time frame: Week 24
Plan to share: No
No publications or documents are linked to this record.
Ran from Nov 2023 to primary completion in Jan 2026, 26 months.
Of 116 industry-sponsored phase 3 interventional studies under Arthritis, Rheumatoid, half reached primary completion within 24 months of starting (the median), counting those still running; a quarter within 16 and three quarters within 31. This study's 26 months is close to that.
Counting every sponsor, half of 148 studies reached it within 26 months; a quarter within 17 and three quarters within 40.
Completion moved once since we started tracking on Sep 25, 2026: Dec 2026 → Aug 2026, on Sep 25, 2026.
Earlier changes are on the record history on ClinicalTrials.gov ↗
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
This study is completed, as verified in Sep 2026. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: TLL-018
Hangzhou Highlightll Pharmaceutical Co., Ltd →