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

Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18-65
SponsorTasly Pharmaceutical Group Co., Ltd

About this trial

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

Qualifiers

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);

Disqualifiers

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;

Trial design

Treatments tested in this trial

  • Jitongning tablets
  • a simulated agent of Jitongning tablets

Treatment groups

408 Participants
are divided into 2 treatment groups