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

Rheumatoid Arthritis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05849727
• Other study ID #: TQH3821-II-01
• Status: Recruiting
• Phase: Phase 2
• Start date: August 30, 2023
• Est. completion date: December 2024

Study information

• Verified date: April 2024
• Source: Chia Tai Tianqing Pharmaceutical Group Co., Ltd.
• Contact: Zhan-guo Li, Doctor
• Phone: +86 13910713924
• Email: li99[@]bjmu.edu.cn
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 180
• Est. completion date: December 2024
• Est. primary completion date: June 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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 ? 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.

Related Conditions & MeSH terms

• Arthritis
• Arthritis, Rheumatoid
• Rheumatoid Arthritis

Intervention

Drug:
• TQH3821 tablets 200 mg
TQH3821 is a Interleukin-1 Receptor-Associated Kinase 4 (IRAK4) inhibitor.
• TQH3821 tablets matching placebo
TQH3821 tablets matching placebo without active substance.

Locations

Country	Name	City	State
China	Anyang District Hospital of Puyang City	Anyang	Henan
China	Peking University Shougang Hospital	Beijing	Beijing
China	The Peking University People's Hospital	Beijing	Beijing
China	Bozhou People's Hospital	Bozhou	Anhui
China	China-japan Friendship Hospital of Jilin University	Changchun	Jilin
China	Jilin Provincial People's Hospital	Changchun	Jilin
China	Xiangya Third Hospital of Central South University	Changsha	Hunan
China	Heping Hospital Affiliated to Changzhi Medical College	Changzhi	Shanxi
China	Chengdu Fifth People's Hospital	Chengdu	Sichuan
China	The Southwest Hospital of AMU	Chongqing	Chongqing
China	The Third Affiliated Hospital of Sun Yat-sen University	Guangzhou	Guangdong
China	The First Affiliated Hospital of Harbin Medical University	Ha'erbin	Heilongjiang
China	Heze Municipal Hospital	Heze	Shandong
China	Central Hospital of Jinzhou	Jinzhou	Liaoning
China	First Affiliated Hospital of Kunming Medical University	Kunming	Yunnan
China	The First Affiliated Hospital of Henan University of Science and Technology	Luoyang	Henan
China	Nanjing Drum Tower Hospital	Nanjing	Jiangsu
China	Guangxi Zhuang Autonomous Region People's Hospital	Nanning	Guangxi
China	Pingxiang People's Hospital	Pingxiang	Jiangxi
China	Puyang Oilfield General Hospital	Puyang	Henan
China	The First Hospital of Qiqihar	Qiqihar	Heilongjiang
China	Tongji Hospital	Shanghai	Shanghai
China	Hebei Provincial People's Hospital	Shijiazhuang	Hebei
China	Shiyan Renmin Hospital	Shiyan	Hubei
China	The First Affiliated Hospital of Soochow University	Suzhou	Jiangsu
China	First Hospital of Shanxi Medical University	Taiyuan	Shanxi
China	Taizhou Central Hospital Taizhou University Hospitai	Taizhou	Zhejiang
China	Wenling First People's Hospital	Taizhou	Zhejiang
China	Second Hospital of Tianjin Medical University	Tianjin	Tianjin
China	The First Affiliated Hospital of PLA Air Force Medical University	Xi'an	Shanxi
China	Yantaishan Hospital of Yantai	Yantai	Shandong
China	Yuyao People's Hospital	Yuyao	Zhejiang
China	Zaozhuang Municipal Hospital	Zaozhuang	Shandong
China	People's Hospital of Zhengzhou	Zhengzhou	Henan

Sponsors (1)

Lead Sponsor	Collaborator
Chia Tai Tianqing Pharmaceutical Group Co., Ltd.

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	American College of Rheumatology 20 (ACR20) improvement	Proportion of patients with ACR20 at week 12.	Evaluated at week 12.
Secondary	American College of Rheumatology 20 (ACR20) improvement	Proportion of patients with ACR20.	Evaluated at week 4, 8, 18, and 24.
Secondary	American College of Rheumatology 50 (ACR50) improvement	Proportion of patients with ACR20.	Evaluated at week 4, 8, 12, 18, and 24.
Secondary	C-reactive protein (CRP)	Changes in C-reactive protein (CRP) relative to baseline.	Evaluated at week 4, 8, 12, 18, and 24.
Secondary	Erythrocyte sedimentation rate (ESR)	Changes in erythrocyte sedimentation rate (ESR) relative to baseline.	Evaluated at week 4, 8, 12, 18, and 24.
Secondary	66 joint swelling counts (SJC)	Change in the number of 66 joint swelling relative to baseline.	Evaluated at week 4, 8, 12, 18, and 24.
Secondary	68 joint tenderness counts (TJC)	Change in the number of 68 joint tenderness numbers (TJC) relative to baseline.	Evaluated at week 4, 8, 12, 18, and 24.
Secondary	Disease activity score 28-C-reactive protein (DAS28-CRP)	Changes in disease activity score DAS28 -CRP relative to baseline.	Evaluated at week 4, 8, 12, 18, and 24.
Secondary	Patient's visual analogue score (PVAS)	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.
Secondary	Patient's global assessment (PtGA)	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.
Secondary	Physician's global assessment (PhGA)	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.
Secondary	Health Assessment questionnaire-Disability Index (HAQ-DI)	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.
Secondary	Incidence of adverse events	Incidence of adverse events after administration.	Baseline up to 28 weeks.
Secondary	Severity of adverse events	Severity of adverse events after administration.	Baseline up to 28 weeks.