Clinical trial NCT06000956: A Study of Comparing Overall Improvement of Patients With Spondyloarthritis Treated With Jitongning Tablets and Placebo
Official 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)
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE3
Conditions: Ankylosing Spondylitis
Lead sponsor: Tasly Pharmaceutical Group Co., Ltd
Sponsor class: INDUSTRY
First posted: 2023-08-21
Enrollment: 408
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility criteria: 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.

Primary outcomes:
measure: ASAS20
timeFrame: 8 weeks
Secondary outcomes:
measure: ASAS20
timeFrame: 4 weeks
measure: ASAS40
timeFrame: 8 weeks
measure: spinal pain scale
timeFrame: 8 weeks
measure: BASFI
timeFrame: 8 weeks
measure: PGA
timeFrame: 8 weeks
measure: BASDAI
timeFrame: 8 weeks
measure: Traditional Chinese medical Syndrome Points
timeFrame: 8 weeks
Other outcomes:
Locations:
city: Beijing
country: China
facility: Dongfang Hospital, Beijing University of Chinese Medicine
state: Beijing
city: Beijing
country: China
facility: Beijing Hospital of Traditional Chinese Medicine, Capital Medical University
state: Beijing
city: Lanzhou
country: China
facility: The First Hospital of Lanzhou University
state: Gansu
city: Shijiazhuang
country: China
facility: The First Hospital of Hebei Medical University
state: Hebei
city: Luoyang
country: China
facility: The First Affiliated Hospital of Henan University of Science and Technology
state: Henan
city: Wuhan
country: China
facility: Tongji Hospital of Tongji Medical College, Huazhong University of Science and Technology
state: Hubei
city: Suzhou
country: China
facility: Suzhou Hospital of Traditional Chinese Medicine
state: Jiangsu
city: Nanchong
country: China
facility: Affiliated Hospital of North Sichuan Medical College
state: Sichuan
city: Tianjin
country: China
facility: The First Affiliated Hospital of Tianjin University of Traditional Chinese Medicine
state: Tianjin
city: Kunming
country: China
facility: Yunnan Province Hospital of Traditional Chinese Medicine
state: Yunnan
Study officials:
References: