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Rheumatoid ArthritisPhase 2NCT05849727

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

A Phase 2 study testing TQH3821 tablets 200 mg in people with Rheumatoid Arthritis, run by Chia Tai Tianqing Pharmaceutical Group Co., Ltd. at 34 sites in China.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial summary

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

Who is it for?
Ages 18 to 70 years
Conditions the study is for
Rheumatoid Arthritis
What is being tested?
TQH3821 tablets 200 mg
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
195 participants
Where
34 sitesChina
Study dates
30 Aug 2023to 15 Jan 2025
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 70 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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;

Who cannot join

  • 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;
Show all 17Show fewer
  • 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 locations and contacts

34 sites in 1 country.

34 sites in 1 country

China34 sites

  • Anyang District Hospital of Puyang City

    Anyang, Henan, 455000

  • Peking University Shougang Hospital

    Beijing, Beijing Municipality, 100041

  • The Peking University People's Hospital

    Beijing, Beijing Municipality, 100044

  • Bozhou People's Hospital

    Bozhou, Anhui, 236804

  • Jilin Provincial People's Hospital

    Changchun, Jilin, 130021

  • China-japan Friendship Hospital of Jilin University

    Changchun, Jilin, 130033

  • Xiangya Third Hospital of Central South University

    Changsha, Hunan, 410013

  • Heping Hospital Affiliated to Changzhi Medical College

    Changzhi, Shanxi, 046000

  • Chengdu Fifth People's Hospital

    Chengdu, Sichuan, 611130

  • The Southwest Hospital of AMU

    Chongqing, Chongqing Municipality, 400038

  • The Third Affiliated Hospital of Sun Yat-sen University

    Guangzhou, Guangdong, 510000

  • The First Affiliated Hospital of Harbin Medical University

    Harbin, Heilongjiang, 150000

  • Heze Municipal Hospital

    Heze, Shandong, 274000

  • Central Hospital of Jinzhou

    Jinzhou, Liaoning, 121000

  • First Affiliated Hospital of Kunming Medical University

    Kunming, Yunnan, 650032

  • The First Affiliated Hospital of Henan University of Science and Technology

    Luoyang, Henan, 471003

  • Nanjing Drum Tower Hospital

    Nanjing, Jiangsu, 211100

  • Guangxi Zhuang Autonomous Region People's Hospital

    Nanning, Guangxi, 530016

  • Pingxiang People's Hospital

    Pingxiang, Jiangxi, 337000

  • Puyang Oilfield General Hospital

    Puyang, Henan, 457001

  • The First Hospital of Qiqihar

    Qiqihar, Heilongjiang, 161005

  • Tongji Hospital

    Shanghai, Shanghai Municipality, 200000

  • Hebei Provincial People's Hospital

    Shijiazhuang, Hebei, 050051

  • Shiyan Renmin Hospital

    Shiyan, Hubei, 442000

  • The First Affiliated Hospital of Soochow University

    Suzhou, Jiangsu, 215006

  • First Hospital of Shanxi Medical University

    Taiyuan, Shanxi, 030001

  • Wenling First People's Hospital

    Taizhou, Zhejiang, 317500

  • Taizhou Central Hospital Taizhou University Hospitai

    Taizhou, Zhejiang, 318000

  • Second Hospital of Tianjin Medical University

    Tianjin, Tianjin Municipality, 300211

  • The First Affiliated Hospital of PLA Air Force Medical University

    Xi’an, Shanxi, 710000

  • Yantaishan Hospital of Yantai

    Yantai, Shandong, 264003

  • Yuyao People's Hospital

    Yuyao, Zhejiang, 315400

  • Zaozhuang Municipal Hospital

    Zaozhuang, Shandong, 277100

  • People's Hospital of Zhengzhou

    Zhengzhou, Henan, 450053

Other trials in China

About this study

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

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

Being tested
TQH3821 tablets 200 mg, TQH3821 tablets matching placebo
Medical subject headings
Arthritis, Rheumatoid

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • TQH3821 tablets 200 mgDrug

    TQH3821 is a Interleukin-1 Receptor-Associated Kinase 4 (IRAK4) inhibitor.

  • TQH3821 tablets matching placeboDrug

    TQH3821 tablets matching placebo without active substance.

Study groups in NCT05849727
Study groupRoleWhat they receive
TQH3821 tablets 200 mgExperimentalOral administration of TQH3821 tablets 200 mg, twice a day for 24 weeks.
Receives: Drug: TQH3821 tablets 200 mg
TQH3821 tablets matching placeboPlacebo comparatorThe 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.
Receives: Drug: TQH3821 tablets 200 mg; Drug: TQH3821 tablets matching placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. American College of Rheumatology 20 (ACR20) improvement

    Proportion of patients with ACR20 at week 12.

    Measured: Evaluated at week 12.

Secondary outcomes (13)

  1. American College of Rheumatology 20 (ACR20) improvement

    Proportion of patients with ACR20.

    Measured: Evaluated at week 4, 8, 18, and 24.

  2. American College of Rheumatology 50 (ACR50) improvement

    Proportion of patients with ACR20.

    Measured: Evaluated at week 4, 8, 12, 18, and 24.

  3. C-reactive protein (CRP)

    Changes in C-reactive protein (CRP) relative to baseline.

    Measured: Evaluated at week 4, 8, 12, 18, and 24.

  4. Erythrocyte sedimentation rate (ESR)

    Changes in erythrocyte sedimentation rate (ESR) relative to baseline.

    Measured: Evaluated at week 4, 8, 12, 18, and 24.

  5. 66 joint swelling counts (SJC)

    Change in the number of 66 joint swelling relative to baseline.

    Measured: Evaluated at week 4, 8, 12, 18, and 24.

  6. 68 joint tenderness counts (TJC)

    Change in the number of 68 joint tenderness numbers (TJC) relative to baseline.

    Measured: Evaluated at week 4, 8, 12, 18, and 24.

  7. Disease activity score 28-C-reactive protein (DAS28-CRP)

    Changes in disease activity score DAS28 -CRP relative to baseline.

    Measured: Evaluated at week 4, 8, 12, 18, and 24.

  8. Patient's visual analogue score (PVAS)

    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.

    Measured: Evaluated at week 4, 8, 12, 18, and 24.

  9. Patient's global assessment (PtGA)

    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.

    Measured: Evaluated at week 4, 8, 12, 18, and 24.

  10. Physician's global assessment (PhGA)

    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.

    Measured: Evaluated at week 4, 8, 12, 18, and 24.

  11. Health Assessment questionnaire-Disability Index (HAQ-DI)

    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.

    Measured: Evaluated at week 4, 8, 12, 18, and 24.

  12. Incidence of adverse events

    Incidence of adverse events after administration.

    Measured: Baseline up to 28 weeks.

  13. Severity of adverse events

    Severity of adverse events after administration.

    Measured: Baseline up to 28 weeks.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted9 May 2023
  2. Study start30 Aug 2023
  3. Primary completion15 Jan 2025
  4. Study completion15 Jan 2025

Why it stopped: Per sponsor request.

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
195 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05849727
Sponsor's protocol ID
TQH3821-II-01
Status last verified
Apr 2024
First submitted
24 Apr 2023
Last updated
20 Feb 2025
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing TQH3821 tablets 200 mg in people with Rheumatoid Arthritis, run by Chia Tai Tianqing Pharmaceutical Group Co., Ltd. at 34 sites in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 20 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 34 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study was stopped early (reason given: Per sponsor request.). Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

American College of Rheumatology 20 (ACR20) improvement (time frame: Evaluated at week 12.). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05849727.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Feb 2025.

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