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

StatusRecruiting
PhasePhase 3
Started2023-09-11
View on ClinicalTrials.gov ↗

Amendment history

2024-11-18
Study Status, Outcome Measures v3
Primary completion date2025-08-15→2026-12-01
Completion date2026-08-15→2026-12-31
Secondary endpoints7 entries, revised
score of spinal pain scale
2024-09-03
Study Status, Outcome Measures v2
Start dateestimated 2023-09-15→confirmed 2023-09-11
Secondary endpoints+95 characters
ASAS20 ASAS40 score of spinal pain BASFI PGA BASDAI Traditional Chinese medical Syndrome Points
2023-09-03
Study Status v1
Start date2023-08-15→2023-09-15
2023-08-17
Original filing
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.
Trial Details
NCT Number NCT06000956
Lead Sponsor Tasly Pharmaceutical Group Co., Ltd
Conditions Ankylosing Spondylitis
Enrollment 408 participants
Start Date 2023-09-11
Primary Completion 2026-12-01 (estimated)
Study Completion 2026-12-31 (estimated)
Updated on ClinicalTrials.gov 2024-11-21