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

• Status: Not yet recruiting
• Trial end date: 2024-12-01
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Chia Tai Tianqing Pharmaceutical Group Co., Ltd.

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.