Ignite Creation Date:
2024-05-06 @ 8:24 PM
Last Modification Date:
2024-10-26 @ 3:26 PM
Study NCT ID:
NCT06360068
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-04-11
First Post:
2024-04-01
Brief Title:
A Prospective Single Arm Open Label Proof of Concept Clinical Study of Sulfasalazine in the Treatment of Active Systemic Lupus Erythematosus
Sponsor:
Qiong Fu
Organization:
RenJi Hospital
Study Overview
Official Title:
A Prospective Single Arm Open Label Proof of Concept Clinical Study of Sulfasalazine in the Treatment of Active Systemic Lupus Erythematosus
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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 750mgdose twice a day for 16 weeks The dosage will be increased to 1000mgdose within one month twice a day if the patient could tolerate
Visit the clinic once every 4 weeks for checkups and tests
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 750mgdose twice a day for 16 weeks The dosage will be increased to 1000mgdose within one month twice a day if the patient could tolerate
Visit the clinic once every 4 weeks for checkups and tests
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 82371767 | OTHER_GRANT | National Natural Science Foundation of China | None |