A Study of Comparing Overall Improvement of Patients With Spondyloarthritis Treated With Jitongning Tablets and Placebo

November 18, 2024 updated by: Tasly Pharmaceutical Group Co., Ltd

A Multicenter, Randomized, Double-blind, Placebo-controlled Phase III Clinical Trial Protocol of the Efficacy and Safety of Jitongning Tablets for Treating Spondyloarthritis (Kidney Yang Deficiency and Blood Stasis Obstruction)

The goal of this clinical trial is evaluating the efficacy and safety of Jitongning tablets in participant population. The main questions it aims to answer are:

  • Based on the proportion of participants who achieved improvement in ASAS20, evaluate whether the efficacy of Jitongning tablets is superior to placebo in active ax-SpA adult participants.
  • Evaluate the efficacy of Jitongning tablets in improving other key functions and symptom outcomes.

  • Evaluating the safety of Jitongning tablets in adult ax-SpA participants. Participants will

    1. take orally Jitongning tablets or a simulated agent of Jitongning tablets.
    2. Receive examinations and follow-up visits.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

408

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • China
    • Beijing
      • Beijing, Beijing, China, 100078
        • Recruiting
        • Dongfang Hospital, Beijing University of Chinese Medicine
        • Contact:
      • Beijing, Beijing, China
        • Recruiting
        • Beijing Hospital of Traditional Chinese Medicine, Capital Medical University
        • Contact:
    • Gansu
      • Lanzhou, Gansu, China
        • Recruiting
        • The First Hospital of Lanzhou University
        • Contact:
    • Hebei
      • Shijiazhuang, Hebei, China
        • Recruiting
        • The First Hospital of Hebei Medical University
        • Contact:
    • Henan
      • Luoyang, Henan, China
        • Recruiting
        • The First Affiliated Hospital of Henan University of Science and Technology
        • Contact:
    • Hubei
      • Wuhan, Hubei, China
        • Recruiting
        • Tongji Hospital of Tongji Medical College, Huazhong University of Science and Technology
        • Contact:
    • Jiangsu
      • Suzhou, Jiangsu, China
        • Recruiting
        • Suzhou Hospital of Traditional Chinese Medicine
        • Contact:
    • Sichuan
      • Nanchong, Sichuan, China
        • Recruiting
        • Affiliated Hospital of North Sichuan Medical College
        • Contact:
    • Tianjin
      • Tianjin, Tianjin, China
        • Recruiting
        • The First Affiliated Hospital of Tianjin University of Traditional Chinese Medicine
        • Contact:
    • Yunnan
      • Kunming, Yunnan, China
        • Recruiting
        • Yunnan Province Hospital of Traditional Chinese Medicine
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

All of the following standards must be met:

  1. Age range from 18 to 65 years old (including 18 and 65 years old), regardless of gender;
  2. Meets the diagnostic criteria for axial osteoarthritis recommended by ASAS in 2009, and the condition is in an active phase. The criteria for determining disease activity are to meet two criteria: Bass ankylosing spondylitis disease activity index (BASDAI) ≥ 40mm (0-100mm, evaluated using VAS); Spinal pain score ≥ 40mm (0-100mm, evaluated using VAS);
  3. Conforming to the traditional Chinese medicine syndrome differentiation standards for kidney yang deficiency and blood stasis obstruction syndrome;
  4. CT examination of sacroiliac arthritis grades I (A) to II (B) (both included);
  5. Human leukocyte antigen B27 (HLA-B27) is positive;
  6. Elevated C-reactive protein (CRP)/hypersensitive C-reactive protein (hsCRP) and/or erythrocyte sedimentation rate (ESR);
  7. Voluntarily participate in this clinical trial and sign an informed consent form.

Exclusion Criteria:

Those who meet any of the following criteria cannot be included in this experiment:

  1. Received non-steroidal anti-inflammatory drugs within 2 weeks before enrollment;
  2. Within 4 weeks before enrollment, he received traditional Chinese patent medicines and simple preparations or traditional Chinese medicine decoction, chemical drugs (such as sulfasalazine, methotrexate, leflunomide, hydroxychloroquine, cyclophosphamide, azathioprine, etc.), opioid analgesics (such as methadone, morphine, etc.), JAK inhibitor drugs (such as tofatib, etc.), and systemic glucocorticoid treatment;
  3. Received spinal or joint surgery treatment within 8 weeks prior to enrollment;
  4. Within 12 weeks prior to enrollment, biological agents with therapeutic effects on spinal arthritis have been used;
  5. Within 6 months prior to enrollment, corticosteroid injections were received into the joint cavity or spine/paravertebral area;
  6. CT indicates disappearance of sacroiliac joint space or complete spinal rigidity;
  7. Subjects diagnosed with other rheumatic immune system diseases or immune deficiency syndrome, such as active ulcerative colitis, psoriasis, uveitis, etc;
  8. Those who have fertility requirements within six months;
  9. Pregnant or lactating women;
  10. Suspected or actual drug, substance, or alcohol abuse;
  11. Within 3 months prior to the trial or currently participating in clinical trials;
  12. Serious heart, liver, kidney, brain, mental, and neurological disorders that affect informed consent and/or expression or observation of adverse events;
  13. Abnormal liver function (elevated levels of alanine or alanine aminotransferase above the upper limit of normal values); Abnormal renal function (serum creatinine levels above the upper limit of normal values);
  14. The researchers believe that it is not suitable to participate in this experiment.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Jitongning tablets
Drug: Jitongning tablets
The participants took orally three tablets of Jitongning tablets, twice a day, for 8 consecutive weeks.
Placebo Comparator: a simulated agent of Jitongning tablets
Drug: a simulated agent of Jitongning tablets
The participants took orally three tablets of a simulated agent of Jitongning tablets, twice a day, for 8 consecutive weeks.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
ASAS20
Time Frame: 8 weeks

Proportion of subjects who achieved improvement in ASAS20（Assessment of Spondylarthritis International Society） at week 8 of treatment.

The ASAS Improvement Criteria contains the following 4 assessment domains:

  1. Physical function, by BASFI (Bath Ankylosing Spondylitis Functional Index);
  2. Spinal pain, by Spinal Pain Scale;
  3. Overall assessment of the condition in the past week, by PGA (Patient Global Assessment)
  4. Inflammatory activity, by the last 2 items of BASDAI (Bath Ankylosing Spondylitis Disease Activity Index) were averaged.

ASAS 20% response criteria (ASAS 20): 1. 3 of the above 4 items have at least ≥20% improvement and improved ≥ 10 mm in 0-100mm score; 2. Moreover, there was no deterioration in 1 item that did not achieve a 20% improvement from baseline.
8 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
ASAS20
Time Frame: 4 weeks

Proportion of subjects who achieved improvement in ASAS20 at week 4 of treatment.The ASAS Improvement Criteria contains the following 4 assessment domains:

  1. Physical function, by BASFI (Bath Ankylosing Spondylitis Functional Index);
  2. Spinal pain, by Spinal Pain Scale;
  3. Overall assessment of the condition in the past week, by PGA (Patient Global Assessment)
  4. Inflammatory activity, by the last 2 items of BASDAI (Bath Ankylosing Spondylitis Disease Activity Index) were averaged.

ASAS 20% response criteria (ASAS 20): 1. 3 of the above 4 items have at least ≥20% improvement and improved ≥ 10 mm in 0-100mm score; 2. Moreover, there was no deterioration in 1 item that did not achieve a 20% improvement from baseline.
4 weeks
ASAS40
Time Frame: 8 weeks

Proportion of subjects who achieved improvement in ASAS40 at week 8 of treatment.The ASAS Improvement Criteria contains the following 4 assessment domains:

  1. Physical function, by BASFI (Bath Ankylosing Spondylitis Functional Index);
  2. Spinal pain, by Spinal Pain Scale;
  3. Overall assessment of the condition in the past week, by PGA (Patient Global Assessment)
  4. Inflammatory activity, by the last 2 items of BASDAI (Bath Ankylosing Spondylitis Disease Activity Index) were averaged.

ASAS 40% response standard (ASAS 40): 1. 3 of the above 4 items have at least ≥20% improvement and improved ≥ 20 mm in 0-100mm score; 2. Moreover, there was no deterioration in 1 item that did not achieve a 40% improvement from baseline.
8 weeks
spinal pain scale
Time Frame: 8 weeks
Change from baseline in score of spinal pain at week 8 of treatment.The highest score on the scale is 100mm and the lowest is 0mm, and the higher the score, the more severe the condition.
8 weeks
BASFI
Time Frame: 8 weeks
Change from baseline in score of BASFI（Bath Ankylosing Spondylitis Functional Index） at week 8 of treatment.The highest score on the scale is 100mm and the lowest is 0mm, and the higher the score, the more severe the condition.
8 weeks
PGA
Time Frame: 8 weeks
Change from baseline in score of PGA（Patient Global Assessment） at week 8 of treatment.The highest score on the scale is 100mm and the lowest is 0mm, and the higher the score, the more severe the condition.
8 weeks
BASDAI
Time Frame: 8 weeks
Change from baseline in score of BASDAI（Bath Ankylosing Spondylitis Disease Activity Index） at week 8 of treatment.The highest score on the scale is 100mm and the lowest is 0mm, and the higher the score, the more severe the condition.
8 weeks
Traditional Chinese medical Syndrome Points
Time Frame: 8 weeks
Change from baseline in score of traditional Chinese medical Syndrome at week 8 of treatment.The scale has a maximum score of 36 points and a minimum score of 0 points, with lower scores indicating milder TCM symptoms.
8 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Tasly Pharmaceutical Group Co., Ltd

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 11, 2023

Primary Completion (Estimated)

December 1, 2026

Study Completion (Estimated)

December 31, 2026

Study Registration Dates

First Submitted

August 9, 2023

First Submitted That Met QC Criteria

August 17, 2023

First Posted (Actual)

August 21, 2023

Study Record Updates

Last Update Posted (Estimated)

November 21, 2024

Last Update Submitted That Met QC Criteria

November 18, 2024

Last Verified

November 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • TSL-TCM-JTNP-Ⅲ

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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