이 페이지는 자동 번역되었으며 번역의 정확성을 보장하지 않습니다. 참조하십시오 영문판 원본 텍스트의 경우.

BDMARD에 대한 반응이 부적절하거나 불내증인 RA 피험자를 대상으로 TLL-018과 토파시티닙을 비교하는 3상 연구 (TARA)

2026년 9월 22일 업데이트: Hangzhou Highlightll Pharmaceutical Co., Ltd

생물학적 DMARD(bDMARD)에 대한 반응이 부적절하거나 불내증인 활동성 류마티스 관절염 환자를 대상으로 TLL-018과 토파시티닙을 비교하는 무작위 배정, 이중 맹검, 양성 대조, 직접대조 단독요법 3상 연구

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.

연구 개요

상태

완전한

정황

개입 / 치료

상세 설명

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.

연구 유형

중재적

등록 (실제)

459

단계

  • 3단계

연락처 및 위치

이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.

연구 장소

  • 중국
    • Beijing Municipality
      • Beijing, Beijing Municipality, 중국
        • Peking Union Medical College Hospital

참여기준

연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.

자격 기준

공부할 수 있는 나이

18년 (성인, 고령자)

건강한 자원 봉사자를 받아들입니다

아니

연구 대상 성별

모두

설명

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;
  • 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;
  • 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);

공부 계획

이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.

연구는 어떻게 설계됩니까?

디자인 세부사항

  • 주 목적: 치료
  • 할당: 무작위
  • 중재 모델: 병렬 할당
  • 마스킹: 삼루타

무기와 개입

참가자 그룹 / 팔
개입 / 치료
실험적: sequence A

TLL018 tablets, 2piece,BID
의약품: TLL-018

Oral tablets administered 2pieces BID for 52 weeks.

다른 이름들:
  • TLL-018 정제
활성 비교기: sequence B

Tofacitinib tablets, 1piece,BID
의약품: Tofacitinib

Oral tablets administered 1pieces BID for 52 weeks.

다른 이름들:
  • 토파시티닙 정제

연구는 무엇을 측정합니까?

주요 결과 측정

결과 측정
측정값 설명
기간
Proportion of subjects achieving American College of Rheumatology 50% (ACR50) Response
기간: Week 24

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.
Week 24

2차 결과 측정

결과 측정
측정값 설명
기간
Proportion of subjects achieving DAS28-hsCRP <2.6
기간: Week 24

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.
Week 24
Proportion of subjects achieving American College of Rheumatology 20% (ACR20) and 70% (ACR70) Response
기간: Week 24

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.
Week 24
Change From Baseline in Disease Activity Score Based on 28-Joints Count-High-Sensitivity C-reactive Protein (DAS28-hsCRP)
기간: Week 24

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.
Week 24
Changes From Baseline in Health Assessment Questionnaire-Disability Index (HAQ-DI) Total Score
기간: Week 24

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.
Week 24
Changes From Baseline in SF-36 Score
기간: Week 24

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.
Week 24
Proportion of subjects achieving DAS28-hsCRP <＝3.2
기간: Week 24

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.
Week 24
Proportion of subjects achieving CDAI <＝10
기간: Week 24

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
Week 24

공동 작업자 및 조사자

여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.

스폰서

Hangzhou Highlightll Pharmaceutical Co., Ltd

연구 기록 날짜

이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.

연구 주요 날짜

연구 시작 (실제)

2023년 11월 15일

기본 완료 (실제)

2026년 1월 15일

연구 완료 (실제)

2026년 8월 20일

연구 등록 날짜

최초 제출

2023년 8월 25일

QC 기준을 충족하는 최초 제출

2023년 8월 25일

처음 게시됨 (실제)

2023년 8월 31일

연구 기록 업데이트

마지막 업데이트 게시됨 (실제)

2026년 9월 25일

QC 기준을 충족하는 마지막 업데이트 제출

2026년 9월 22일

마지막으로 확인됨

2026년 9월 1일

추가 정보

이 연구와 관련된 용어

추가 관련 MeSH 약관

기타 연구 ID 번호

  • TLL-018-301

개별 참가자 데이터(IPD) 계획

개별 참가자 데이터(IPD)를 공유할 계획입니까?

아니요

약물 및 장치 정보, 연구 문서

미국 FDA 규제 의약품 연구

아니

미국 FDA 규제 기기 제품 연구

아니

이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .

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