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

CTTQ

Status and phase: Terminated; Phase 2

Conditions: Rheumatoid Arthritis

Treatments: Drug: TQH3821 tablets 200 mg; Drug: TQH3821 tablets matching placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT05849727

TQH3821-II-01

Details and patient eligibility

About

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

Enrollment: 195 patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No 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;
• 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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195 participants in 2 patient groups, including a placebo group

TQH3821 tablets 200 mg

Experimental group

Description:

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

Treatment:

Drug: TQH3821 tablets 200 mg

TQH3821 tablets matching placebo

Placebo Comparator group

Description:

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

Treatment:

Drug: TQH3821 tablets matching placebo

Drug: TQH3821 tablets 200 mg