A Study of Comparing Overall Improvement of Patients With Spondyloarthritis Treated With Jitongning Tablets and Placebo
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)
1 other identifier
interventional
408
1 country
10
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
- take orally Jitongning tablets or a simulated agent of Jitongning tablets.
- Receive examinations and follow-up visits.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_3
Started Sep 2023
Typical duration for phase_3
10 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 9, 2023
CompletedFirst Posted
Study publicly available on registry
August 21, 2023
CompletedStudy Start
First participant enrolled
September 11, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
December 31, 2026
November 21, 2024
November 1, 2024
3.2 years
August 9, 2023
November 18, 2024
Conditions
Outcome Measures
Primary Outcomes (1)
ASAS20
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 Outcomes (7)
ASAS20
4 weeks
ASAS40
8 weeks
spinal pain scale
8 weeks
BASFI
8 weeks
PGA
8 weeks
- +2 more secondary outcomes
Study Arms (2)
Jitongning tablets
EXPERIMENTALa simulated agent of Jitongning tablets
PLACEBO COMPARATORInterventions
The participants took orally three tablets of Jitongning tablets, twice a day, for 8 consecutive weeks.
The participants took orally three tablets of a simulated agent of Jitongning tablets, twice a day, for 8 consecutive weeks.
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (10)
Dongfang Hospital, Beijing University of Chinese Medicine
Beijing, Beijing Municipality, 100078, China
Beijing Hospital of Traditional Chinese Medicine, Capital Medical University
Beijing, Beijing Municipality, China
The First Hospital of Lanzhou University
Lanzhou, Gansu, China
The First Hospital of Hebei Medical University
Shijiazhuang, Hebei, China
The First Affiliated Hospital of Henan University of Science and Technology
Luoyang, Henan, China
Tongji Hospital of Tongji Medical College, Huazhong University of Science and Technology
Wuhan, Hubei, China
Suzhou Hospital of Traditional Chinese Medicine
Suzhou, Jiangsu, China
Affiliated Hospital of North Sichuan Medical College
Nanchong, Sichuan, China
The First Affiliated Hospital of Tianjin University of Traditional Chinese Medicine
Tianjin, Tianjin Municipality, China
Yunnan Province Hospital of Traditional Chinese Medicine
Kunming, Yunnan, China
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 9, 2023
First Posted
August 21, 2023
Study Start
September 11, 2023
Primary Completion (Estimated)
December 1, 2026
Study Completion (Estimated)
December 31, 2026
Last Updated
November 21, 2024
Record last verified: 2024-11
Data Sharing
- IPD Sharing
- Will not share