To evaluate the efficacy and safety of TQH3821 in treated patients with moderate-to-severe active rheumatoid arthritis.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
195
TQH3821 is a Interleukin-1 Receptor-Associated Kinase 4 (IRAK4) inhibitor.
TQH3821 tablets matching placebo without active substance.
American College of Rheumatology 20 (ACR20) improvement
Proportion of patients with ACR20 at week 12.
Time frame: Evaluated at week 12.
American College of Rheumatology 20 (ACR20) improvement
Proportion of patients with ACR20.
Time frame: Evaluated at week 4, 8, 18, and 24.
American College of Rheumatology 50 (ACR50) improvement
Proportion of patients with ACR20.
Time frame: Evaluated at week 4, 8, 12, 18, and 24.
C-reactive protein (CRP)
Changes in C-reactive protein (CRP) relative to baseline.
Time frame: Evaluated at week 4, 8, 12, 18, and 24.
Erythrocyte sedimentation rate (ESR)
Changes in erythrocyte sedimentation rate (ESR) relative to baseline.
Time frame: Evaluated at week 4, 8, 12, 18, and 24.
66 joint swelling counts (SJC)
Change in the number of 66 joint swelling relative to baseline.
Time frame: Evaluated at week 4, 8, 12, 18, and 24.
68 joint tenderness counts (TJC)
Change in the number of 68 joint tenderness numbers (TJC) relative to baseline.
Time frame: Evaluated at week 4, 8, 12, 18, and 24.
Disease activity score 28-C-reactive protein (DAS28-CRP)
Changes in disease activity score DAS28 -CRP relative to baseline.
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Bozhou People's Hospital
Bozhou, Anhui, China
Peking University Shougang Hospital
Beijing, Beijing Municipality, China
The Peking University People's Hospital
Beijing, Beijing Municipality, China
The Southwest Hospital of AMU
Chongqing, Chongqing Municipality, China
The Third Affiliated Hospital of Sun Yat-sen University
Guangzhou, Guangdong, China
Guangxi Zhuang Autonomous Region People's Hospital
Nanning, Guangxi, China
Hebei Provincial People's Hospital
Shijiazhuang, Hebei, China
The First Affiliated Hospital of Harbin Medical University
Harbin, Heilongjiang, China
The First Hospital of Qiqihar
Qiqihar, Heilongjiang, China
Anyang District Hospital of Puyang City
Anyang, Henan, China
...and 24 more locations
Time frame: Evaluated at week 4, 8, 12, 18, and 24.
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.
Time frame: Evaluated at week 4, 8, 12, 18, and 24.
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.
Time frame: Evaluated at week 4, 8, 12, 18, and 24.
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.
Time frame: Evaluated at week 4, 8, 12, 18, and 24.
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.
Time frame: Evaluated at week 4, 8, 12, 18, and 24.
Incidence of adverse events
Incidence of adverse events after administration.
Time frame: Baseline up to 28 weeks.
Severity of adverse events
Severity of adverse events after administration.
Time frame: Baseline up to 28 weeks.