Effects of Telitacicept vs Cyclophosphamide on Lupus Related Interstitial Lung Disease
Trial statusRecruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age18-80
SponsorTongji Hospital
About this trial
Recent data indicate that Telitacicept is beneficial for lupus nephritis. Our goal is to determine whether Telitacicept is an effective and safe treatment, compared to standard-of-care Cyclophosphamide, for subclinical and clinical ILD in patients with early lupus.
Eligibility criteria
Qualifiers
Meet the 2019 EULAR/ACR classification criteria for systemic lupus erythematosus;
Male or non-pregnant female aged ≥ 18 years;
Diagnosis by high-resolution lung CT (HRCT) is clearly consistent with interstitial lung disease (ILD);
FEV1/FVC%≥60% and diffusion function DLCO (measured value/estimated value) ≥40%;
Disqualifiers
Alanine aminotransferase and/or aspartate aminotransferase (ALT/AST) > 5 times the upper limit of normal;
severe chronic kidney disease (stage IV) or need for dialysis (estimated glomerular filtration rate (eGFR) < 30ml/min/1.73m2);
Hemoglobin < 80 g/L;
WBC < 2.0×10^9;
Trial design
Treatments tested in this trial
- Methylprednisolone (Corticosteroid)
- Immunosuppressant other than CYC
- Telitacicept Freeze-dried powder Injection 80mg
- Cyclophosphamide (CYC)
Treatment groups
100 Participants
are divided into 2 treatment groupsSponsors and collaborators
Tongji Hospital
Lead sponsor
Wuhan Central Hospital
Collaborator
Wuhan Hospital of Traditional Chinese Medicine
Collaborator
Rongchang Biopharmaceutical
Collaborator
Johns Hopkins Bloomberg School of Public Health
Collaborator
Source ClinicalTrials.gov