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

Primary Purpose

Rheumatoid Arthritis

Status
Recruiting
Phase
Phase 2
Locations
China
Study Type
Interventional
Intervention
TQH3821 tablets 200 mg
TQH3821 tablets 300 mg
TQH3821 tablets 400 mg
TQH3821 tablets 200 mg matching placebo
TQH3821 tablets 300 mg matching placebo
TQH3821 tablets 400 mg matching placebo
Sponsored by
Chia Tai Tianqing Pharmaceutical Group Co., Ltd.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Rheumatoid Arthritis

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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; Subject has active tuberculosis or a history of contact with an open tuberculosis subject within the last 6 months, and the laboratory T-spot test (or other tuberculosis diagnostic test) is positive; 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.

Sites / Locations

  • Bozhou People's Hospital
  • The Peking University People's HospitalRecruiting
  • Jieyang City People's HospitalRecruiting
  • Qingyuan People's Hospital
  • The First Hospital of Hebei Medical UniversityRecruiting
  • Hebei Provincial People's HospitalRecruiting
  • The First Affiliated Hospital of Harbin Medical University
  • Anyang District Hospital of Puyang City
  • The First Affiliated Hospital of Henan University of Science and Technology
  • Xiangya Hospital, Central South University
  • Huaihua First People's Hospital
  • China-japan Friendship Hospital of Jilin University
  • Jinzhou Central Hospital
  • Qilu Hospital of Shandong University
  • Shanghai Changhai Hospital
  • The First Affiliated Hospital of PLA Air Force Medical UniversityRecruiting
  • Tianjin First Central HospitalRecruiting
  • Xinjiang Uygur Autonomous Region People's Hospital
  • Dongyang People's Hospital
  • Wenling First People's Hospital

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm 6

Arm Type

Experimental

Experimental

Experimental

Placebo Comparator

Placebo Comparator

Placebo Comparator

Arm Label

TQH3821 tablets 200 mg

TQH3821 tablets 300 mg

TQH3821 tablets 400 mg

TQH3821 tablets 200 mg matching placebo

TQH3821 tablets 300 mg matching placebo

TQH3821 tablets 400 mg matching placebo

Arm Description

Oral administration of TQH3821 tablets 200 mg, twice a day for 24 weeks.

Oral administration of TQH3821 tablets 300 mg, twice a day for 24 weeks.

Oral administration of TQH3821 tablets 300 mg, twice a day for 24 weeks.

The 200 mg placebo group was taken orally until the end of week 12. Then, the 200 mg placebo group was switched to the oral administration of TQH3821 tablets 200 mg until the end of week 24.

The 300 mg placebo group was taken orally until the end of week 12. Then, the 300 mg placebo group was switched to the oral administration of TQH3821 tablets 300 mg until the end of week 24.

The 400 mg placebo group was taken orally until the end of week 12. Then, the 400 mg placebo group was switched to the oral administration of TQH3821 tablets 400 mg until the end of week 24.

Outcomes

Primary Outcome Measures

American College of Rheumatology 20 (ACR20) improvement
Proportion of patients with ACR20 at week 12.

Secondary Outcome Measures

American College of Rheumatology 20 (ACR20) improvement
Proportion of patients with ACR20.
American College of Rheumatology 50 (ACR50) improvement
Proportion of patients with ACR20.
C-reactive protein (CRP)
Changes in C-reactive protein (CRP) relative to baseline.
Erythrocyte sedimentation rate (ESR)
Changes in erythrocyte sedimentation rate (ESR) relative to baseline.
66 joint swelling counts (SJC)
Change in the number of 66 joint swelling relative to baseline.
68 joint tenderness counts (TJC)
Change in the number of 68 joint tenderness numbers (TJC) relative to baseline.
Disease activity score 28-C-reactive protein (DAS28-CRP)
Changes in disease activity score DAS28 -CRP relative to baseline.
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.
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.
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.
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.
Incidence of adverse events
Incidence of adverse events after administration.
Severity of adverse events
Severity of adverse events after administration.

Full Information

First Posted
April 24, 2023
Last Updated
September 5, 2023
Sponsor
Chia Tai Tianqing Pharmaceutical Group Co., Ltd.
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1. Study Identification

Unique Protocol Identification Number
NCT05849727
Brief Title
A Clinical Study of TQH3821 Tablets in the Treatment of Treated Rheumatoid Arthritis
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
Study Type
Interventional

2. Study Status

Record Verification Date
July 2023
Overall Recruitment Status
Recruiting
Study Start Date
August 30, 2023 (Actual)
Primary Completion Date
June 2024 (Anticipated)
Study Completion Date
December 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Chia Tai Tianqing Pharmaceutical Group Co., Ltd.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Rheumatoid Arthritis

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
204 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
TQH3821 tablets 200 mg
Arm Type
Experimental
Arm Description
Oral administration of TQH3821 tablets 200 mg, twice a day for 24 weeks.
Arm Title
TQH3821 tablets 300 mg
Arm Type
Experimental
Arm Description
Oral administration of TQH3821 tablets 300 mg, twice a day for 24 weeks.
Arm Title
TQH3821 tablets 400 mg
Arm Type
Experimental
Arm Description
Oral administration of TQH3821 tablets 300 mg, twice a day for 24 weeks.
Arm Title
TQH3821 tablets 200 mg matching placebo
Arm Type
Placebo Comparator
Arm Description
The 200 mg placebo group was taken orally until the end of week 12. Then, the 200 mg placebo group was switched to the oral administration of TQH3821 tablets 200 mg until the end of week 24.
Arm Title
TQH3821 tablets 300 mg matching placebo
Arm Type
Placebo Comparator
Arm Description
The 300 mg placebo group was taken orally until the end of week 12. Then, the 300 mg placebo group was switched to the oral administration of TQH3821 tablets 300 mg until the end of week 24.
Arm Title
TQH3821 tablets 400 mg matching placebo
Arm Type
Placebo Comparator
Arm Description
The 400 mg placebo group was taken orally until the end of week 12. Then, the 400 mg placebo group was switched to the oral administration of TQH3821 tablets 400 mg until the end of week 24.
Intervention Type
Drug
Intervention Name(s)
TQH3821 tablets 200 mg
Intervention Description
TQH3821 is a Interleukin-1 Receptor-Associated Kinase 4 (IRAK4) inhibitor.
Intervention Type
Drug
Intervention Name(s)
TQH3821 tablets 300 mg
Intervention Description
TQH3821 is a Interleukin-1 Receptor-Associated Kinase 4 (IRAK4) inhibitor.
Intervention Type
Drug
Intervention Name(s)
TQH3821 tablets 400 mg
Intervention Description
TQH3821 is a Interleukin-1 Receptor-Associated Kinase 4 (IRAK4) inhibitor.
Intervention Type
Drug
Intervention Name(s)
TQH3821 tablets 200 mg matching placebo
Intervention Description
TQH3821 tablets 200 mg matching placebo without active substance.
Intervention Type
Drug
Intervention Name(s)
TQH3821 tablets 300 mg matching placebo
Intervention Description
TQH3821 tablets 300 mg matching placebo without active substance.
Intervention Type
Drug
Intervention Name(s)
TQH3821 tablets 400 mg matching placebo
Intervention Description
TQH3821 tablets 400 mg matching placebo without active substance.
Primary Outcome Measure Information:
Title
American College of Rheumatology 20 (ACR20) improvement
Description
Proportion of patients with ACR20 at week 12.
Time Frame
Evaluated at week 12.
Secondary Outcome Measure Information:
Title
American College of Rheumatology 20 (ACR20) improvement
Description
Proportion of patients with ACR20.
Time Frame
Evaluated at week 4, 8, 18, and 24.
Title
American College of Rheumatology 50 (ACR50) improvement
Description
Proportion of patients with ACR20.
Time Frame
Evaluated at week 4, 8, 12, 18, and 24.
Title
C-reactive protein (CRP)
Description
Changes in C-reactive protein (CRP) relative to baseline.
Time Frame
Evaluated at week 4, 8, 12, 18, and 24.
Title
Erythrocyte sedimentation rate (ESR)
Description
Changes in erythrocyte sedimentation rate (ESR) relative to baseline.
Time Frame
Evaluated at week 4, 8, 12, 18, and 24.
Title
66 joint swelling counts (SJC)
Description
Change in the number of 66 joint swelling relative to baseline.
Time Frame
Evaluated at week 4, 8, 12, 18, and 24.
Title
68 joint tenderness counts (TJC)
Description
Change in the number of 68 joint tenderness numbers (TJC) relative to baseline.
Time Frame
Evaluated at week 4, 8, 12, 18, and 24.
Title
Disease activity score 28-C-reactive protein (DAS28-CRP)
Description
Changes in disease activity score DAS28 -CRP relative to baseline.
Time Frame
Evaluated at week 4, 8, 12, 18, and 24.
Title
Patient's visual analogue score (PVAS)
Description
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.
Time Frame
Evaluated at week 4, 8, 12, 18, and 24.
Title
Patient's global assessment (PtGA)
Description
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.
Time Frame
Evaluated at week 4, 8, 12, 18, and 24.
Title
Physician's global assessment (PhGA)
Description
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.
Time Frame
Evaluated at week 4, 8, 12, 18, and 24.
Title
Health Assessment questionnaire-Disability Index (HAQ-DI)
Description
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.
Time Frame
Evaluated at week 4, 8, 12, 18, and 24.
Title
Incidence of adverse events
Description
Incidence of adverse events after administration.
Time Frame
Baseline up to 28 weeks.
Title
Severity of adverse events
Description
Severity of adverse events after administration.
Time Frame
Baseline up to 28 weeks.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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; Subject has active tuberculosis or a history of contact with an open tuberculosis subject within the last 6 months, and the laboratory T-spot test (or other tuberculosis diagnostic test) is positive; 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Zhan-guo Li, Doctor
Phone
+86 13910713924
Email
li99@bjmu.edu.cn
Facility Information:
Facility Name
Bozhou People's Hospital
City
Bozhou
State/Province
Anhui
ZIP/Postal Code
236804
Country
China
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yuhui Zhang, Doctor
Phone
+86 18905688161
Email
clearhui1118@126.com
Facility Name
The Peking University People's Hospital
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100044
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Zhan-guo Li, Doctor
Phone
+86 13910713924
Email
li99@bjmu.edu.cn
Facility Name
Jieyang City People's Hospital
City
Jieyang
State/Province
Guangdong
ZIP/Postal Code
522000
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Baijie Xu, Bachelor
Phone
+86 15915658899
Email
1207076298@qq.com
Facility Name
Qingyuan People's Hospital
City
Qingyuan
State/Province
Guangdong
ZIP/Postal Code
511500
Country
China
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Xiang Peng, Doctor
Phone
+86 13926684791
Email
1342501184@qq.com
Facility Name
The First Hospital of Hebei Medical University
City
Shijiazhuang
State/Province
Hebei
ZIP/Postal Code
050000
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Zhanqing Gu, Master
Phone
+86 18633889366
Email
gzhq1964@163.com
Facility Name
Hebei Provincial People's Hospital
City
Shijiazhuang
State/Province
Hebei
ZIP/Postal Code
050051
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Fang Li, Master
Phone
+86 13831198761
Email
lifanghbsrm@163.com
Facility Name
The First Affiliated Hospital of Harbin Medical University
City
Ha'erbin
State/Province
Heilongjiang
ZIP/Postal Code
150000
Country
China
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Zhiyi Zhang, Doctor
Phone
+86 13303608999
Email
zhangzhiyi2014@163.com
Facility Name
Anyang District Hospital of Puyang City
City
Anyang
State/Province
Henan
ZIP/Postal Code
455000
Country
China
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Xiaohan Wang, Bachelor
Phone
+86 13569009795
Email
wangxiaohan11@hotmail.com
Facility Name
The First Affiliated Hospital of Henan University of Science and Technology
City
Luoyang
State/Province
Henan
ZIP/Postal Code
471003
Country
China
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Xiaofei Shi, Master
Phone
+86 13663884080
Email
13663884080@163.com
Facility Name
Xiangya Hospital, Central South University
City
Changsha
State/Province
Hunan
ZIP/Postal Code
410008
Country
China
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Hui Luo, Doctor
Phone
+86 13974871326
Email
luohuihn@sina.com
Facility Name
Huaihua First People's Hospital
City
Huaihua
State/Province
Hunan
ZIP/Postal Code
418000
Country
China
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Liang Song, Bachelor
Phone
+86 18674558206
Email
18674558206@163.com
Facility Name
China-japan Friendship Hospital of Jilin University
City
Changchun
State/Province
Jilin
ZIP/Postal Code
130033
Country
China
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Liqi Bi, Doctor
Phone
+86 13578879099
Email
biliqi66@126.com
Facility Name
Jinzhou Central Hospital
City
Jinzhou
State/Province
Liaoning
ZIP/Postal Code
121000
Country
China
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Liying Zhang, Bachelor
Phone
+86 13840644524
Email
zhangliying777@126.com
Facility Name
Qilu Hospital of Shandong University
City
Jinan
State/Province
Shandong
ZIP/Postal Code
250063
Country
China
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Huaxiang Liu, Doctor
Phone
+86 18566081680
Email
lzzlhx63@163.com
Facility Name
Shanghai Changhai Hospital
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
200433
Country
China
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jie Gao, Doctor
Phone
+86 13585561861
Email
4872530759195@qq.com
Facility Name
The First Affiliated Hospital of PLA Air Force Medical University
City
Xi'an
State/Province
Shanxi
ZIP/Postal Code
710000
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Zhaohui Zheng, Doctor
Phone
+86 13571924267
Email
zhengzh@fmmu.edu.cn
Facility Name
Tianjin First Central Hospital
City
Tianjin
State/Province
Tianjin
ZIP/Postal Code
300190
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Wufang Qi, Doctor
Phone
+86 13702061222
Email
13702061222@163.com
Facility Name
Xinjiang Uygur Autonomous Region People's Hospital
City
Ürümqi
State/Province
Xinjiang
ZIP/Postal Code
830002
Country
China
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Wu Lijun, Bachelor
Phone
+86 13999265917
Email
Wwlj330@126.com
Facility Name
Dongyang People's Hospital
City
Jinhua
State/Province
Zhejiang
ZIP/Postal Code
322100
Country
China
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jian Wang, Bachelor
Phone
+86 13505892618
Email
13505892618@163.com
Facility Name
Wenling First People's Hospital
City
Taizhou
State/Province
Zhejiang
ZIP/Postal Code
317500
Country
China
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yongjun Cheng, Bachelor
Phone
+86 13958633696
Email
chengyj677@126.com

12. IPD Sharing Statement

Learn more about this trial

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

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