Clinical trial NCT05849727: A Clinical Study of TQH3821 Tablets in the Treatment of Treated Rheumatoid Arthritis
Official title: Randomized, Double-blind, Placebo-controlled, Multicenter Phase II Trial to Evaluate the Efficacy and Safety of TQH3821 Tablets in Patients With Treated Rheumatoid Arthritis
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Rheumatoid Arthritis
Lead sponsor: Chia Tai Tianqing Pharmaceutical Group Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2023-05-09
Enrollment: 195
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: To evaluate the efficacy and safety of TQH3821 in treated patients with moderate-to-severe active 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;
* 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.

Primary outcomes:
measure: American College of Rheumatology 20 (ACR20) improvement
timeFrame: Evaluated at week 12.
Secondary outcomes:
measure: American College of Rheumatology 20 (ACR20) improvement
timeFrame: Evaluated at week 4, 8, 18, and 24.
measure: American College of Rheumatology 50 (ACR50) improvement
timeFrame: Evaluated at week 4, 8, 12, 18, and 24.
measure: C-reactive protein (CRP)
timeFrame: Evaluated at week 4, 8, 12, 18, and 24.
measure: Erythrocyte sedimentation rate (ESR)
timeFrame: Evaluated at week 4, 8, 12, 18, and 24.
measure: 66 joint swelling counts (SJC)
timeFrame: Evaluated at week 4, 8, 12, 18, and 24.
measure: 68 joint tenderness counts (TJC)
timeFrame: Evaluated at week 4, 8, 12, 18, and 24.
measure: Disease activity score 28-C-reactive protein (DAS28-CRP)
timeFrame: Evaluated at week 4, 8, 12, 18, and 24.
measure: Patient's visual analogue score (PVAS)
timeFrame: Evaluated at week 4, 8, 12, 18, and 24.
measure: Patient's global assessment (PtGA)
timeFrame: Evaluated at week 4, 8, 12, 18, and 24.
measure: Physician's global assessment (PhGA)
timeFrame: Evaluated at week 4, 8, 12, 18, and 24.
measure: Health Assessment questionnaire-Disability Index (HAQ-DI)
timeFrame: Evaluated at week 4, 8, 12, 18, and 24.
measure: Incidence of adverse events
timeFrame: Baseline up to 28 weeks.
measure: Severity of adverse events
timeFrame: Baseline up to 28 weeks.
Other outcomes:
Locations:
city: Bozhou
country: China
facility: Bozhou People's Hospital
state: Anhui
city: Beijing
country: China
facility: Peking University Shougang Hospital
state: Beijing
city: Beijing
country: China
facility: The Peking University People's Hospital
state: Beijing
city: Chongqing
country: China
facility: The Southwest Hospital of AMU
state: Chongqing
city: Guangzhou
country: China
facility: The Third Affiliated Hospital of Sun Yat-sen University
state: Guangdong
city: Nanning
country: China
facility: Guangxi Zhuang Autonomous Region People's Hospital
state: Guangxi
city: Shijiazhuang
country: China
facility: Hebei Provincial People's Hospital
state: Hebei
city: Ha'erbin
country: China
facility: The First Affiliated Hospital of Harbin Medical University
state: Heilongjiang
city: Qiqihar
country: China
facility: The First Hospital of Qiqihar
state: Heilongjiang
city: Anyang
country: China
facility: Anyang District Hospital of Puyang City
state: Henan
city: Luoyang
country: China
facility: The First Affiliated Hospital of Henan University of Science and Technology
state: Henan
city: Puyang
country: China
facility: Puyang Oilfield General Hospital
state: Henan
city: Zhengzhou
country: China
facility: People's Hospital of Zhengzhou
state: Henan
city: Shiyan
country: China
facility: Shiyan Renmin Hospital
state: Hubei
city: Changsha
country: China
facility: Xiangya Third Hospital of Central South University
state: Hunan
city: Nanjing
country: China
facility: Nanjing Drum Tower Hospital
state: Jiangsu
city: Suzhou
country: China
facility: The First Affiliated Hospital of Soochow University
state: Jiangsu
city: Pingxiang
country: China
facility: Pingxiang People's Hospital
state: Jiangxi
city: Changchun
country: China
facility: Jilin Provincial People's Hospital
state: Jilin
city: Changchun
country: China
facility: China-japan Friendship Hospital of Jilin University
state: Jilin
city: Jinzhou
country: China
facility: Central Hospital of Jinzhou
state: Liaoning
city: Heze
country: China
facility: Heze Municipal Hospital
state: Shandong
city: Yantai
country: China
facility: Yantaishan Hospital of Yantai
state: Shandong
city: Zaozhuang
country: China
facility: Zaozhuang Municipal Hospital
state: Shandong
city: Shanghai
country: China
facility: Tongji Hospital
state: Shanghai
city: Changzhi
country: China
facility: Heping Hospital Affiliated to Changzhi Medical College
state: Shanxi
city: Taiyuan
country: China
facility: First Hospital of Shanxi Medical University
state: Shanxi
city: Xi'an
country: China
facility: The First Affiliated Hospital of PLA Air Force Medical University
state: Shanxi
city: Chengdu
country: China
facility: Chengdu Fifth People's Hospital
state: Sichuan
city: Tianjin
country: China
facility: Second Hospital of Tianjin Medical University
state: Tianjin
city: Kunming
country: China
facility: First Affiliated Hospital of Kunming Medical University
state: Yunnan
city: Taizhou
country: China
facility: Wenling First People's Hospital
state: Zhejiang
city: Taizhou
country: China
facility: Taizhou Central Hospital Taizhou University Hospitai
state: Zhejiang
city: Yuyao
country: China
facility: Yuyao People's Hospital
state: Zhejiang
Study officials:
References: