Comparing Jitongning tablets to placebo for treating spondyloarthritis

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)

This study is testing if Jitongning tablets can help people with active ankylosing spondylitis feel better compared to a placebo.

Quick facts

• Phase: Phase 3
• Study type: Interventional
• Enrollment: 408 (estimated)
• Ages: 18 Years to 65 Years
• Sex: All
• Sponsor: Tasly Pharmaceutical Group Co., Ltd (Industry-sponsored)
• Drugs / interventions: methotrexate, cyclophosphamide
• Locations: 10 sites (Beijing, Beijing Municipality and 9 other locations)
• Trial ID: NCT06000956 on ClinicalTrials.gov

What this trial studies

This clinical trial evaluates the efficacy and safety of Jitongning tablets in patients with active ankylosing spondylitis. Participants will be randomly assigned to receive either Jitongning tablets or a placebo, and their improvement will be assessed using the ASAS20 criteria. The study will also monitor other key symptoms and functions, alongside safety evaluations through regular examinations and follow-up visits. The trial aims to determine if Jitongning tablets provide superior benefits compared to a placebo.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 to 65 with active ankylosing spondylitis meeting specific diagnostic criteria.

Not a fit: Patients with non-active ankylosing spondylitis or those not meeting the inclusion criteria may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could offer a new effective option for managing symptoms of ankylosing spondylitis.

How similar studies have performed: Other studies have shown promise in using traditional Chinese medicine approaches for similar conditions, but the specific use of Jitongning tablets is novel.

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.

Where this trial is running

Beijing, Beijing Municipality and 9 other locations

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

Study contacts

• Study coordinator: Wei Liu

Conditions Ankylosing Spondylitis