Phase
Condition
Systemic Lupus Erythematosus
Lupus
Bone Diseases
Treatment
N/AClinical Study ID
Ages 18-65 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
Age range: 18 - 65 years old;
Meets the revised SLE classification criteria of the American College ofRheumatology in 1997 or the SLE diagnostic classification criteria issued byEULAR/ACR in 2019;
The SELENA-SLEDAI score is at least 8 points (clinical symptoms are no less than 6points, excluding positive anti-double-stranded DNA (anti-dsDNA) and lowcomplement);
Has not responded well to hormone and/or immunosuppressant treatment, is intolerantor has recurrence, and is willing to accept tixocortinib/belimumab as a therapeuticdrug.
Exclusion
Exclusion Criteria:
Any of the following conditions exists: active central nervous system disease,severe active lupus nephritis, HIV infection, hepatitis B or C virus infection, lowgamma globulinemia, liver dysfunction;
eGFR < 30 mL/min/1.73m², or undergoing hemodialysis or kidney transplantation;
Pregnant women, or women who are about to become pregnant in the near future, orlactating women;
Participants who are simultaneously participating in other clinical studies;
Within 1 year before randomization, received B-cell targeted therapy (includingbelimumab);
During treatment, used traditional Chinese medicine with immunosuppressive effects (such as Tripterygium wilfordii, White Peony Root, etc.) in combination.
Study Design
Connect with a study center
Qianfoshan Hospital
Jinan, Shandong 250000
ChinaSite Not Available

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