A Clinical Study of TQH3821 Tablets in the Treatment of Treated Rheumatoid Arthritis

April 9, 2024 updated by: Chia Tai Tianqing Pharmaceutical Group Co., Ltd.

Randomized, Double-blind, Placebo-controlled, Multicenter Phase II Trial to Evaluate the Efficacy and Safety of TQH3821 Tablets in Patients With Treated Rheumatoid Arthritis

To evaluate the efficacy and safety of TQH3821 in treated patients with moderate-to-severe active rheumatoid arthritis.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

180

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Zhan-guo Li, Doctor
  • Phone Number: +86 13910713924
  • Email: li99@bjmu.edu.cn

Study Locations

  • China
    • Anhui
      • Bozhou, Anhui, China, 236804
        • Not yet recruiting
        • Bozhou People's Hospital
        • Contact:
    • Beijing
      • Beijing, Beijing, China, 100044
        • Recruiting
        • The Peking University People's Hospital
        • Contact:
      • Beijing, Beijing, China, 100041
        • Recruiting
        • Peking University Shougang Hospital
        • Contact:
        • Contact:
    • Chongqing
      • Chongqing, Chongqing, China, 400038
        • Recruiting
        • The Southwest Hospital of AMU
        • Contact:
    • Guangdong
      • Guangzhou, Guangdong, China, 510000
        • Recruiting
        • The Third Affiliated Hospital of Sun Yat-sen University
        • Contact:
    • Guangxi
      • Nanning, Guangxi, China, 530016
        • Recruiting
        • Guangxi Zhuang Autonomous Region People's Hospital
        • Contact:
    • Hebei
      • Shijiazhuang, Hebei, China, 050051
        • Recruiting
        • Hebei Provincial People's Hospital
        • Contact:
    • Heilongjiang
      • Ha'erbin, Heilongjiang, China, 150000
        • Not yet recruiting
        • The First Affiliated Hospital Of Harbin Medical University
        • Contact:
      • Qiqihar, Heilongjiang, China, 161005
        • Recruiting
        • The First Hospital of Qiqihar
        • Contact:
    • Henan
      • Anyang, Henan, China, 455000
        • Not yet recruiting
        • Anyang District Hospital of Puyang City
        • Contact:
      • Luoyang, Henan, China, 471003
        • Not yet recruiting
        • The First Affiliated Hospital of Henan University of Science and Technology
        • Contact:
      • Puyang, Henan, China, 457001
        • Recruiting
        • Puyang Oilfield General Hospital
        • Contact:
      • Zhengzhou, Henan, China, 450053
        • Recruiting
        • People's Hospital of Zhengzhou
        • Contact:
    • Hubei
      • Shiyan, Hubei, China, 442000
        • Recruiting
        • Shiyan Renmin Hospital
        • Contact:
    • Hunan
      • Changsha, Hunan, China, 410013
        • Recruiting
        • Xiangya Third Hospital of Central South University
        • Contact:
    • Jiangsu
      • Nanjing, Jiangsu, China, 211100
        • Recruiting
        • Nanjing Drum Tower Hospital
        • Contact:
      • Suzhou, Jiangsu, China, 215006
        • Recruiting
        • The First Affiliated Hospital Of Soochow University
        • Contact:
    • Jiangxi
      • Pingxiang, Jiangxi, China, 337000
        • Recruiting
        • Pingxiang People's Hospital
        • Contact:
    • Jilin
      • Changchun, Jilin, China, 130021
        • Recruiting
        • Jilin Provincial People's Hospital
        • Contact:
      • Changchun, Jilin, China, 130033
        • Not yet recruiting
        • China-Japan friendship Hospital of Jilin university
        • Contact:
    • Liaoning
      • Jinzhou, Liaoning, China, 121000
    • Shandong
      • Heze, Shandong, China, 274000
        • Recruiting
        • Heze Municipal Hospital
        • Contact:
      • Yantai, Shandong, China, 264003
        • Recruiting
        • Yantaishan Hospital of Yantai
        • Contact:
      • Zaozhuang, Shandong, China, 277100
        • Recruiting
        • Zaozhuang Municipal Hospital
        • Contact:
    • Shanghai
      • Shanghai, Shanghai, China, 200000
        • Recruiting
        • Tongji Hospital
        • Contact:
    • Shanxi
      • Changzhi, Shanxi, China, 046000
        • Recruiting
        • Heping Hospital Affiliated to Changzhi Medical College
        • Contact:
      • Taiyuan, Shanxi, China, 030001
        • Recruiting
        • First Hospital of Shanxi Medical University
        • Contact:
      • Xi'an, Shanxi, China, 710000
        • Recruiting
        • The First Affiliated Hospital of PLA Air Force Medical University
        • Contact:
    • Sichuan
      • Chengdu, Sichuan, China, 611130
        • Recruiting
        • Chengdu Fifth People's Hospital
        • Contact:
    • Tianjin
      • Tianjin, Tianjin, China, 300211
        • Recruiting
        • Second Hospital of Tianjin Medical University
        • Contact:
    • Yunnan
      • Kunming, Yunnan, China, 650032
        • Recruiting
        • First Affiliated Hospital of Kunming Medical University
        • Contact:
    • Zhejiang
      • Taizhou, Zhejiang, China, 317500
        • Not yet recruiting
        • Wenling First People's Hospital
        • Contact:
      • Taizhou, Zhejiang, China, 318000
        • Recruiting
        • Taizhou Central Hospital Taizhou University Hospitai
        • Contact:
      • Yuyao, Zhejiang, China, 315400
        • Recruiting
        • Yuyao People's hospital
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Subjects voluntarily participate in this study and sign informed consent;
  • Male and female, ≥18 years old and ≤70 years old (subject to the date of signing the informed consent);
  • The diagnosis meets the rheumatoid arthritis (RA) classification criteria jointly established by the American College of Rheumatology (ACR) and the European Alliance against Rheumatism (EULAR) in 2010, for at least 3 months ;
  • Moderate to severe active RA was defined by the following criteria: joint swelling ≥6 (based on 66 joints), joint tenderness ≥6 (based on 68 joints), Disease activity score 28-C-reactive protein (DAS28-CRP) ≥3.2, and CRP>10mg/L or erythrocyte sedimentation rate (ESR) >28mm/h;
  • At least 12 weeks of treatment with methotrexate (dose 7.5 to 25 mg/ week) and stable dose (7.5 to 25 mg/ week) ≥4 weeks prior to initial administration of the study drug (oral stable dose methotrexate will be continued as background therapy during the trial);
  • The subjects can attend the study visit on time and complete the visit;

Exclusion Criteria:

  • 8 weeks before baseline examination, subjects underwent joint surgery or received intraarticular glucocorticoid therapy at the joint sites evaluated in this study;
  • Patients with rheumatoid arthritis with joint functional activity grade Ⅳ or confined to a wheelchair or bed;
  • Current or previous inflammatory joint diseases other than RA and other autoimmune venereal diseases;
  • Patients with lung diseases deemed unsuitable for the study by the investigator;
  • Cardiovascular and cerebrovascular abnormalities;
  • Abnormal thyroid function;
  • Subjects with a history or suspected demyelinating disease of the central nervous system;
  • Have any type of active malignant tumor or have a history of malignant tumor;
  • Presence of active Mycobacterium tuberculosis (TB) infection or latent TB infection without appropriate treatment;
  • Have any acute or chronic active infectious disease;
  • There are serious poorly controlled diseases;
  • People with active hepatitis, or hepatitis B surface antigen (HBsAg) positive, hepatitis B core antibody (HBcAb) positive + hepatitis B virus (HBV) DNA positive, or hepatitis C virus (HCV) antibody-positive;
  • History of human immunodeficiency virus (HIV) infection, or positive HIV serological results at screening, and positive antibodies to treponema pallidum during screening;
  • Subjects who had suffered a severe trauma, fracture, or surgical procedure within 8 weeks prior to screening, or who were expected to require major surgical procedures during the study period;
  • Female subjects who are pregnant or lactating;
  • Those who received live attenuated vaccine within 28 days before the start of treatment, inactivated vaccine within 7 days, or planned vaccination during the study period;
  • The subject has any medical condition that may affect oral drug absorption, gastrectomy or gastrointestinal disease of clinical significance.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: TQH3821 tablets 200 mg
Oral administration of TQH3821 tablets 200 mg, twice a day for 24 weeks.
Drug: TQH3821 tablets 200 mg
TQH3821 is a Interleukin-1 Receptor-Associated Kinase 4 (IRAK4) inhibitor.
Placebo Comparator: TQH3821 tablets matching placebo
The placebo group was taken orally until the end of week 12. At the end of week 12, the placebo group was switched to the oral administration of TQH3821 tablets 200 mg until the end of week 24.
Drug: TQH3821 tablets 200 mg
TQH3821 is a Interleukin-1 Receptor-Associated Kinase 4 (IRAK4) inhibitor.
Drug: TQH3821 tablets matching placebo
TQH3821 tablets matching placebo without active substance.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
American College of Rheumatology 20 (ACR20) improvement
Time Frame: Evaluated at week 12.
Proportion of patients with ACR20 at week 12.
Evaluated at week 12.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
American College of Rheumatology 20 (ACR20) improvement
Time Frame: Evaluated at week 4, 8, 18, and 24.
Proportion of patients with ACR20.
Evaluated at week 4, 8, 18, and 24.
American College of Rheumatology 50 (ACR50) improvement
Time Frame: Evaluated at week 4, 8, 12, 18, and 24.
Proportion of patients with ACR20.
Evaluated at week 4, 8, 12, 18, and 24.
C-reactive protein (CRP)
Time Frame: Evaluated at week 4, 8, 12, 18, and 24.
Changes in C-reactive protein (CRP) relative to baseline.
Evaluated at week 4, 8, 12, 18, and 24.
Erythrocyte sedimentation rate (ESR)
Time Frame: Evaluated at week 4, 8, 12, 18, and 24.
Changes in erythrocyte sedimentation rate (ESR) relative to baseline.
Evaluated at week 4, 8, 12, 18, and 24.
66 joint swelling counts (SJC)
Time Frame: Evaluated at week 4, 8, 12, 18, and 24.
Change in the number of 66 joint swelling relative to baseline.
Evaluated at week 4, 8, 12, 18, and 24.
68 joint tenderness counts (TJC)
Time Frame: Evaluated at week 4, 8, 12, 18, and 24.
Change in the number of 68 joint tenderness numbers (TJC) relative to baseline.
Evaluated at week 4, 8, 12, 18, and 24.
Disease activity score 28-C-reactive protein (DAS28-CRP)
Time Frame: Evaluated at week 4, 8, 12, 18, and 24.
Changes in disease activity score DAS28 -CRP relative to baseline.
Evaluated at week 4, 8, 12, 18, and 24.
Patient's visual analogue score (PVAS)
Time Frame: Evaluated at week 4, 8, 12, 18, and 24.
PVAS is a questionnaire to evaluate joint pain in subjects with scores from 0 to 10, where 0 means no pain and 10 means the worst pain.
Evaluated at week 4, 8, 12, 18, and 24.
Patient's global assessment (PtGA)
Time Frame: Evaluated at week 4, 8, 12, 18, and 24.
PtGA is a questionnaire to evaluate arthritis score by patient's overall assessment, with scores from 0 to 10, where 0 means very good and 10 means very poor.
Evaluated at week 4, 8, 12, 18, and 24.
Physician's global assessment (PhGA)
Time Frame: Evaluated at week 4, 8, 12, 18, and 24.
PhGA is a questionnaire to evaluate arthritis score by physician's overall assessment, with scores from 0 to 10, where 0 means very good and 10 means very poor.
Evaluated at week 4, 8, 12, 18, and 24.
Health Assessment questionnaire-Disability Index (HAQ-DI)
Time Frame: Evaluated at week 4, 8, 12, 18, and 24.
HAQ-DI is a questionnaire to evaluate quality of life of subjects with scores from 0 to 3, 0 means easy and 3 means very difficult.
Evaluated at week 4, 8, 12, 18, and 24.
Incidence of adverse events
Time Frame: Baseline up to 28 weeks.
Incidence of adverse events after administration.
Baseline up to 28 weeks.
Severity of adverse events
Time Frame: Baseline up to 28 weeks.
Severity of adverse events after administration.
Baseline up to 28 weeks.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Chia Tai Tianqing Pharmaceutical Group Co., Ltd.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 30, 2023

Primary Completion (Estimated)

June 1, 2024

Study Completion (Estimated)

December 1, 2024

Study Registration Dates

First Submitted

April 24, 2023

First Submitted That Met QC Criteria

May 5, 2023

First Posted (Actual)

May 9, 2023

Study Record Updates

Last Update Posted (Actual)

April 11, 2024

Last Update Submitted That Met QC Criteria

April 9, 2024

Last Verified

April 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • TQH3821-II-01

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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