AzTrials
AzTrials

Rheumatoid ArthritisPhase 3TARANCT06020144

A Phase 3 Study Comparing TLL-018 to Tofacitinib in RA Subjects With Inadequate Response or Intolerance to bDMARDs

A Phase 3 study testing TLL-018 and Tofacitinib in people with Rheumatoid Arthritis, run by Hangzhou Highlightll Pharmaceutical Co., Ltd at 1 site in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 18 to 75 years
Conditions the study is for
Rheumatoid Arthritis
What is being tested?
TLL-018 and Tofacitinib
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
459 participants
Where
1 siteChina
Study dates
15 Nov 2023to 20 Aug 2026
Phase
Phase 3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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；
Show all 11Show fewer
  • 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;

Who cannot join

  • With other rheumatic diseases;
  • With other systemic inflammatory diseases;
  • With progressive or uncontrolled symptoms of renal, hepatic, hematologic, gastrointestinal, endocrine, pulmonary, cardiovascular, neurologic, psychiatric, or cerebral disease;
  • Previous history of severe hematologic diseases;
  • Previous history of malignancy within five years, with exception of cured basal cell carcinoma or cutaneous squamous cell carcinoma or cervical carcinoma in situ.
  • With active infection before randomization;
Show all 24Show fewer
  • Herpes zoster occurred within 1 year prior to randomization; disseminated or recurrent herpes zoster prior to randomization; disseminated herpes simplex before randomization;
  • Previous history of active tuberculosis (TB) and no evidence of clinical cure or imaging evidence of active TB; or T-spot or PPD positive at screening but have received TB preventive therapy less than one month;
  • HBsAg positive (or HBsAg negative but anti-HBc positive and HBV-DNA quantitative test positive), HCV antibody and HCV-RNA positive, or HIV antibody positive;
  • Previous history of thrombocytopenia, coagulopathy, or platelet dysfunction;
  • Previous history of cardiovascular and cerebrovascular accidents;
  • Previous history of thromboembolism or risk factors;
  • Previous history of gastrointestinal perforation;
  • Temporary usage of NSAIDs within 48 hours prior to the baseline visit;
  • Have received anti-rheumatic herb within 4 weeks before randomization;
  • Have received interferon therapy within 4 weeks before randomization;
  • Have donated blood more than 400 ml or received blood transfusion within 3 months prior to the study;
  • Have received any live vaccine within 2 months before randomization or plan to receive a live vaccine during the study;
  • Have experienced major surgery within 4 weeks before randomization, or expected to receive major surgical treatment after enrollment;
  • Laboratory test results are abnormal and may interfere the study judged by investigators;
  • Use of potent opioids within 4 weeks before the baseline visit;
  • Allergy to ingredients or excipients of tofacitinib or TLL-018;
  • Unable to accomplish evaluation in study;
  • Receiving any study drug within 4 weeks or less than 5 elimination of half-life period) before randomization (whichever is longer);

Trial locations and contacts

1 site in 1 country.

China1 site

  • Peking Union Medical College Hospital

    Beijing, Beijing Municipality

Other trials in China

About this study

Official title: A Phase 3, Randomized, Double-Blind, Positive-controlled, Head-to-Head Monotherapy Study Comparing TLL-018 to Tofacitinib in Subjects With Active Rheumatoid Arthritis With Inadequate Response or Intolerance to Biologic DMARDs (bDMARDs)

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.

Read the detailed description

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.

Being tested
TLL-018, Tofacitinib
Medical subject headings
Arthritis, Rheumatoid

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • TLL-018Drug

    Also called TLL-018 tablets

    Oral tablets administered 2pieces BID for 52 weeks.

  • TofacitinibDrug

    Also called Tofacitinib tablets

    Oral tablets administered 1pieces BID for 52 weeks.

Study groups in NCT06020144
Study groupRoleWhat they receive
sequence AExperimentalTLL018 tablets, 2piece,BID
Receives: Drug: TLL-018
sequence BActive comparatorTofacitinib tablets, 1piece,BID
Receives: Drug: Tofacitinib

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: Week 24

Secondary outcomes (7)

  1. 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.

    Measured: Week 24

  2. 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.

    Measured: Week 24

  3. 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.

    Measured: Week 24

  4. 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.

    Measured: Week 24

  5. 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.

    Measured: Week 24

  6. 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.

    Measured: Week 24

  7. 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

    Measured: Week 24

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted31 Aug 2023
  2. Study start15 Nov 2023
  3. Primary completion15 Jan 2026
  4. Study completion20 Aug 2026

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Triple blind
Who is masked
Participant, Care provider, Investigator
Enrolment
459 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06020144
Sponsor's protocol ID
TLL-018-301
Acronym
TARA
Status last verified
Sep 2026
First submitted
25 Aug 2023
Last updated
25 Sep 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing TLL-018 and Tofacitinib in people with Rheumatoid Arthritis, run by Hangzhou Highlightll Pharmaceutical Co., Ltd at 1 site in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 11 inclusion and 24 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 25 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Proportion of subjects achieving American College of Rheumatology 50% (ACR50) Response (time frame: Week 24). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06020144.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Sep 2026.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Keep searching with a free account

You’ve used your 3 free searches for this session. Log in or create a free AzTrials account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in
TARA Clinical Trial NCT06020144 | AzTrials