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NCT Number: NCT06000956

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

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.

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Key information

Conditions

Ankylosing Spondylitis Ankylosis Arthritis Axial Spondyloarthritis Bone Diseases Joint Diseases Musculoskeletal Diseases Spinal Diseases Spondylarthritis Spondylarthropathies Spondylitis Spondylitis, Ankylosing

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Beijing Hospital of Traditional Chinese Medicine, Capital Medical University, Beijing, Beijing Municipality, China

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

All of the following standards must be met:

  • Age range from 18 to 65 years old (including 18 and 65 years old), regardless of gender;
  • 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);
  • Conforming to the traditional Chinese medicine syndrome differentiation standards for kidney yang deficiency and blood stasis obstruction syndrome;
  • CT examination of sacroiliac arthritis grades I (A) to II (B) (both included);
  • Human leukocyte antigen B27 (HLA-B27) is positive;
  • Elevated C-reactive protein (CRP)/hypersensitive C-reactive protein (hsCRP) and/or erythrocyte sedimentation rate (ESR);
  • 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:

  • Received non-steroidal anti-inflammatory drugs within 2 weeks before enrollment;
  • 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;
  • Received spinal or joint surgery treatment within 8 weeks prior to enrollment;
  • Within 12 weeks prior to enrollment, biological agents with therapeutic effects on spinal arthritis have been used;
  • Within 6 months prior to enrollment, corticosteroid injections were received into the joint cavity or spine/paravertebral area;
  • CT indicates disappearance of sacroiliac joint space or complete spinal rigidity;
  • Subjects diagnosed with other rheumatic immune system diseases or immune deficiency syndrome, such as active ulcerative colitis, psoriasis, uveitis, etc;
  • Those who have fertility requirements within six months;
  • Pregnant or lactating women;
  • Suspected or actual drug, substance, or alcohol abuse;
  • Within 3 months prior to the trial or currently participating in clinical trials;
  • Serious heart, liver, kidney, brain, mental, and neurological disorders that affect informed consent and/or expression or observation of adverse events;
  • 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);
  • The researchers believe that it is not suitable to participate in this experiment.

Treatment and study plan

Jitongning tablets

Drug

The participants took orally three tablets of Jitongning tablets, twice a day, for 8 consecutive weeks.

a simulated agent of Jitongning tablets

Drug

The participants took orally three tablets of a simulated agent of Jitongning tablets, twice a day, for 8 consecutive weeks.

Primary outcomes

  1. 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:

    • Physical function, by BASFI (Bath Ankylosing Spondylitis Functional Index);
    • Spinal pain, by Spinal Pain Scale;
    • Overall assessment of the condition in the past week, by PGA (Patient Global Assessment)
    • 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.

Secondary outcomes

  1. 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:

    • Physical function, by BASFI (Bath Ankylosing Spondylitis Functional Index);
    • Spinal pain, by Spinal Pain Scale;
    • Overall assessment of the condition in the past week, by PGA (Patient Global Assessment)
    • 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.

  2. 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:

    • Physical function, by BASFI (Bath Ankylosing Spondylitis Functional Index);
    • Spinal pain, by Spinal Pain Scale;
    • Overall assessment of the condition in the past week, by PGA (Patient Global Assessment)
    • 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.

  3. 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.

  4. 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.

  5. 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.

  6. 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.

  7. 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Wei Liu

CONTACT

[email protected]

022-27432680

Sponsors and collaborators

Lead sponsor

Tasly Pharmaceutical Group Co., Ltd

Industry

Registry information

Official study title

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)

Important dates

Study start
2023
Primary completion
2026
Study completion
2026
First posted
Aug 21, 2023
Registry last updated
Nov 21, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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