Ankylosing SpondylitisPhase 3NCT06000956
A Study of Comparing Overall Improvement of Patients With Spondyloarthritis Treated With Jitongning Tablets and Placebo
A Phase 3 study testing Jitongning tablets and a simulated agent of Jitongning tablets in people with Ankylosing Spondylitis, run by Tasly Pharmaceutical Group Co., Ltd at 10 sites in China.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Ankylosing Spondylitis
- What is being tested?
- Jitongning tablets and a simulated agent of Jitongning tablets
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 408 participants
- Where
- 10 sitesChina
- Study dates
- 11 Sep 2023to 31 Dec 2026
- Phase
- Phase 3
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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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;
Show all 15Show fewer
- 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.
Trial locations and contacts
10 sites in 1 country. Contact the study team or a site near you to ask about taking part.
10 sites in 1 country
China10 sites, 10 recruiting
- Recruiting
Dongfang Hospital, Beijing University of Chinese Medicine
Beijing, Beijing Municipality, 100078
Wenna Liu, 010-67689923, dfjgb2019@126.com
- Recruiting
Beijing Hospital of Traditional Chinese Medicine, Capital Medical University
Beijing, Beijing Municipality
Xueqi Zhu, 010-52176813, bjzyyygcp@sina.com
- Recruiting
Yunnan Province Hospital of Traditional Chinese Medicine
Kunming, Yunnan
An Wang, 0871-63623713, ynzygcp1@163.com
- Recruiting
The First Hospital of Lanzhou University
Lanzhou, Gansu
Ting Wang, 0931-8356748, ting_w6710@163.com
- Recruiting
The First Affiliated Hospital of Henan University of Science and Technology
Luoyang, Henan
Yuntong Zhai, 0379-64830815, 1652065260@qq.com
- Recruiting
Affiliated Hospital of North Sichuan Medical College
Nanchong, Sichuan
Yan Zeng, 0817-2608120, 393241992@qq.com
- Recruiting
The First Hospital of Hebei Medical University
Shijiazhuang, Hebei
Wenxiu Si, 0311-87156671, swxlbc@163.com
- Recruiting
Suzhou Hospital of Traditional Chinese Medicine
Suzhou, Jiangsu
Xiaofeng Zhu, 0512-67872186, szszyyyll@163.com
- Recruiting
The First Affiliated Hospital of Tianjin University of Traditional Chinese Medicine
Tianjin, Tianjin Municipality
Hui Wang, 022-27986257, yfyjdb@163.com
- Recruiting
Tongji Hospital of Tongji Medical College, Huazhong University of Science and Technology
Wuhan, Hubei
Chang Shu, 027-83663940, tongjigcp@163.com
About this study
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)
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.
- Conditions
- Ankylosing Spondylitis
- Being tested
- Jitongning tablets, a simulated agent of Jitongning tablets
- Medical subject headings
- Spondylitis, Ankylosing
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Jitongning tabletsDrug
The participants took orally three tablets of Jitongning tablets, twice a day, for 8 consecutive weeks.
a simulated agent of Jitongning tabletsDrug
The participants took orally three tablets of a simulated agent of Jitongning tablets, twice a day, for 8 consecutive weeks.
| Study group | Role | What they receive |
|---|---|---|
| Jitongning tablets | Experimental | Not described Receives: Drug: Jitongning tablets |
| a simulated agent of Jitongning tablets | Placebo comparator | Not described Receives: Drug: a simulated agent of Jitongning tablets |
What is being measured
The primary outcome is the main question the study is designed to answer.
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:
- 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.
Measured: 8 weeks
Secondary outcomes (7)
ASAS20
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.
Measured: 4 weeks
ASAS40
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.
Measured: 8 weeks
spinal pain scale
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.
Measured: 8 weeks
BASFI
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.
Measured: 8 weeks
PGA
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.
Measured: 8 weeks
BASDAI
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.
Measured: 8 weeks
Traditional Chinese medical Syndrome Points
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.
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Aug 2023
- Study start11 Sep 2023
- Primary completion1 Dec 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ankylosing SpondylitisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 408 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Tasly Pharmaceutical Group Co., Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06000956
- Sponsor's protocol ID
- TSL-TCM-JTNP-Ⅲ
- Status last verified
- Nov 2024
- First submitted
- 9 Aug 2023
- Last updated
- 21 Nov 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No