A Clinical Study of TQH3821 Tablets in the Treatment of Treated Rheumatoid Arthritis
Rheumatoid Arthritis
About this trial
This is an interventional treatment trial for Rheumatoid Arthritis
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.
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
Experimental
Experimental
Experimental
Placebo Comparator
Placebo Comparator
Placebo Comparator
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
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.