Rheumatoid Arthritis
Conditions
Brief summary
To evaluate the efficacy and safety of TQH3821 in treated patients with moderate-to-severe active rheumatoid arthritis.
Interventions
DRUGTQH3821 tablets 200 mg
TQH3821 is a Interleukin-1 Receptor-Associated Kinase 4 (IRAK4) inhibitor.
DRUGTQH3821 tablets matching placebo
TQH3821 tablets matching placebo without active substance.
Sponsors
Chia Tai Tianqing Pharmaceutical Group Co., Ltd.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| American College of Rheumatology 20 (ACR20) improvement | Evaluated at week 12. | Proportion of patients with ACR20 at week 12. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| American College of Rheumatology 50 (ACR50) improvement | Evaluated at week 4, 8, 12, 18, and 24. | Proportion of patients with ACR20. |
| C-reactive protein (CRP) | Evaluated at week 4, 8, 12, 18, and 24. | Changes in C-reactive protein (CRP) relative to baseline. |
| Erythrocyte sedimentation rate (ESR) | Evaluated at week 4, 8, 12, 18, and 24. | Changes in erythrocyte sedimentation rate (ESR) relative to baseline. |
| 66 joint swelling counts (SJC) | Evaluated at week 4, 8, 12, 18, and 24. | Change in the number of 66 joint swelling relative to baseline. |
| 68 joint tenderness counts (TJC) | Evaluated at week 4, 8, 12, 18, and 24. | Change in the number of 68 joint tenderness numbers (TJC) relative to baseline. |
| Disease activity score 28-C-reactive protein (DAS28-CRP) | Evaluated at week 4, 8, 12, 18, and 24. | Changes in disease activity score DAS28 -CRP relative to baseline. |
| American College of Rheumatology 20 (ACR20) improvement | Evaluated at week 4, 8, 18, and 24. | Proportion of patients with ACR20. |
| Patient's global assessment (PtGA) | 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. |
| Physician's global assessment (PhGA) | 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. |
| Health Assessment questionnaire-Disability Index (HAQ-DI) | 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. |
| Incidence of adverse events | Baseline up to 28 weeks. | Incidence of adverse events after administration. |
| Severity of adverse events | Baseline up to 28 weeks. | Severity of adverse events after administration. |
| Patient's visual analogue score (PVAS) | 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. |
Countries
China
Outcome results
None listed