Multi-omics Studies on the Efficacy of Telitacicept in Chinese SLE Patients
NCT ID: NCT05666336
Last Updated: 2024-01-17
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE4
30 participants
INTERVENTIONAL
2022-12-31
2024-06-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Experimental Group
The treatment regimen consists of four drugs, a glucocorticoid plus Telitacicept plus hydroxychloroquine plus an immunosuppressor.
Prednisone(30mg, Qd) or Methylprednisolone(24mg, Qd) plus Telitacicept(160mg, Qw) plus Hydroxychloroquine (0.2g, Qd) plus cyclophosphamide(0.8g, Qm) or Mycophenolate Mofetil (0.5g, Bid) or Tacrolimus (1mg, Bid) The above treatment will continue for 24 weeks.
Telitacicept
It is necessary and will be given by subcutaneous injection of 160mg/week for 24 weeks.
Hydroxychloroquine
It is necessary and will be given by oral administration of 0.2g/day for 24 weeks.
Prednisone
It is permitted which can be interchangeable with methylprednisolone. It will be given by oral administration of 30mg/day from beginning and be lowed dosage during the treatment of 24 weeks.
Methylprednisolone
It is permitted which can be interchangeable with prednisone. It will be given by oral administration of 24mg/day from beginning and be lowed dosage during the treatment of 24 weeks.
Cyclophosphamide
It is permitted which can be interchangeable with mycophenolate mofetil or tacrolimus. It will be given by oral administration of 0.8g/month for 24 weeks.
Mycophenolate Mofetil
It is permitted which can be interchangeable with cyclophosphamide or tacrolimus. It will be given by oral administration of 0.5g twice a day for 24 weeks.
Tacrolimus
It is permitted which can be interchangeable with cyclophosphamide or mycophenolate mofetil. It will be given by oral administration of 1mg twice a day for 24 weeks.
Interventions
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Telitacicept
It is necessary and will be given by subcutaneous injection of 160mg/week for 24 weeks.
Hydroxychloroquine
It is necessary and will be given by oral administration of 0.2g/day for 24 weeks.
Prednisone
It is permitted which can be interchangeable with methylprednisolone. It will be given by oral administration of 30mg/day from beginning and be lowed dosage during the treatment of 24 weeks.
Methylprednisolone
It is permitted which can be interchangeable with prednisone. It will be given by oral administration of 24mg/day from beginning and be lowed dosage during the treatment of 24 weeks.
Cyclophosphamide
It is permitted which can be interchangeable with mycophenolate mofetil or tacrolimus. It will be given by oral administration of 0.8g/month for 24 weeks.
Mycophenolate Mofetil
It is permitted which can be interchangeable with cyclophosphamide or tacrolimus. It will be given by oral administration of 0.5g twice a day for 24 weeks.
Tacrolimus
It is permitted which can be interchangeable with cyclophosphamide or mycophenolate mofetil. It will be given by oral administration of 1mg twice a day for 24 weeks.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
2. Patients with good compliance, will sign the informed consent before the test.
3. Patients who have received conventional treatment for SLE, and the type and dose of treatment drugs have been stable for at least 30 days.
4. Patients who have a positive anti-nuclear antibody test result and SELENA-SLEDAI score ≥8 at screening. If there is a low complement and/or positive anti-dsDNA antibody, the SELENA-SLEDAI score can be defined as ≥ 6 points.
Exclusion Criteria
2. Patients with SLE-caused or non-SLE-caused central nervous system disease within the last 2 months.
3. Patients with severe condition in blood, important organs including heart, liver, gastrointestinal tract and endocrine system which are not related with SLE.
4. Patients who use prednisone ≥100mg/d over 14 days or receive plasma replacement and suffer from active infection within the last 1 month.
5. Patients who received any other targeted agents over the past 12 months.
18 Years
75 Years
ALL
Yes
Sponsors
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Fen Li
OTHER
Responsible Party
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Fen Li
chief physician
Principal Investigators
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Fen Li, doctor
Role: PRINCIPAL_INVESTIGATOR
Central South University
Locations
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Department of Rheumatology and Immunology, Xiangya Second Hospital, Central South University
Changsha, Hunan, China
Countries
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Central Contacts
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Facility Contacts
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References
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Other Identifiers
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LYF2022151
Identifier Type: -
Identifier Source: org_study_id
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