Status:
UNKNOWN
Sequential Belimumab and T-cell Based Therapy in SLE
Lead Sponsor:
National University Hospital, Singapore
Collaborating Sponsors:
GlaxoSmithKline
Conditions:
Systemic Lupus Erythematosus
Eligibility:
All Genders
21-70 years
Phase:
PHASE4
Brief Summary
Systemic lupus erythematosus (SLE) is a disease in which the immune system (the bodily system that fights infection) attacks the body's own cells and tissues, causing inflammation and organ damage if ...
Eligibility Criteria
Inclusion
- Age ≥ 21
- Able to understand the details of the trial and willing to give written informed consent and comply with the requirements of the study protocol.
- Patients who fulfill the classification criteria (SLICC 2012 or ACR 1997) for SLE and have active disease (SELENA-SLEDAI ≥ 6).
- Patients whose sera are positive for ANA (titre ≥ 1:80) or anti-dsDNA (\>100U/L based on NUH standard laboratory cut-off).
- Patients who are on stable dose of prednisolone (0-40mg/day) and/or non-steroidal anti-inflammatory, antimalarial or immunosuppressive drugs for at least 30 days before first study dose.
- Females of child-bearing potential and non-sterilized males with female partners of child-bearing potential may participate this trial only if they use a reliable means of contraception.
- Females of child-bearing potential must have a negative serum pregnancy test within three weeks prior to baseline.
Exclusion
- They have severe active nephritis and/or active CNS lupus and/or other autoimmune diseases e.g. RA, mixed connective tissue disease, scleroderma, dermatomyositis and polymyositis.
- They are pregnant.
- They have had previous treatment with any B-cell and T-cell targeted biologic therapy, intravenous (IV) cyclophosphamide within 6 months of enrolment, intravenous immunoglobulins or prednisolone (\>100mg/day) within 3 months.
Key Trial Info
Start Date :
November 8 2021
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
May 20 2025
Estimated Enrollment :
80 Patients enrolled
Trial Details
Trial ID
NCT04447053
Start Date
November 8 2021
End Date
May 20 2025
Last Update
June 22 2023
Active Locations (1)
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1
National University Hospital
Singapore, Singapore