A Prospective, Single Arm, Open Label, Proof of Concept Clinical Study of Sulfasalazine in the Treatment of Active Systemic Lupus Erythematosus - Trial NCT06360068
Access comprehensive clinical trial information for NCT06360068 through Pure Global AI's free database. This Phase 2 trial is sponsored by Qiong Fu and is currently Not yet recruiting. The study focuses on Systemic Lupus Erythematosus. Target enrollment is 20 participants.
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Study Focus
Sponsor & Location
Qiong Fu
RenJi Hospital
Timeline & Enrollment
Phase 2
May 06, 2024
May 01, 2025
Primary Outcome
the change of disease activity (SLEDAI score)
Summary
The goal of this clinical trial is to learn if sulfasalazine is safe and feasible in the
 treatment of active lupus erythematosus (SLE). The main questions it aims to answer are:
 
 Does drug sulfasalazine with stable background treatment help lower the disease activity
 (SLEDAI) at week 16? How many patients can reach SRI-4 at week 16? Can this regimen help
 lower the prednisone dosage the patients need at week 16? What about the change of the type I
 interferon related genes expression at week 16?
 
 Participants will:
 
 Take sulfasalazine 750mg/dose, twice a day for 16 weeks. The dosage will be increased to
 1000mg/dose within one month, twice a day if the patient could tolerate.
 
 Visit the clinic once every 4 weeks for checkups and tests.
ICD-10 Classifications
Data Source
ClinicalTrials.gov
NCT06360068
Non-Device Trial