Pure Global
NCT06360068

A Prospective, Single Arm, Open Label, Proof of Concept Clinical Study of Sulfasalazine in the Treatment of Active Systemic Lupus Erythematosus

Qiong Fu·Phase 2·ClinicalTrials.gov·drugNot yet recruiting
View on ClinicalTrials.gov →
Study focus
Disease/Condition
Systemic Lupus Erythematosus
Drug/Device/Intervention
Sulfasalazine Tablets
Study type
Interventional
Intervention type
drug
Sponsor & location
Primary sponsor
Qiong Fu
Funder
RenJi Hospital
Timeline & enrollment
Phase
Phase 2
Start date
May 06, 2024
End date
May 01, 2025
Enrollment
20 participants
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
Systemic lupus erythematosusSystemic lupus erythematosus, unspecifiedLupus erythematosusSystemic lupus erythematosus with organ or system involvementOther forms of systemic lupus erythematosus
Data source
Registry
ClinicalTrials.gov
Trial ID
NCT06360068
Type
Non-Device Trial
About this record

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.

This page provides complete trial specifications, intervention details, outcomes, and location information. Pure Global AI offers free access to ClinicalTrials.gov data, helping medical device and pharmaceutical companies navigate clinical research efficiently.