Reumatoidalne zapalenie stawów: badanie fazy I leku CLN-978

Kryteria włączenia kto może wziąć udział (14)

1. Documented diagnosis of RA which fulfills the 2010 American College of Rheumatology (ACR)/European League Against Rheumatism (EULAR) Classification Criteria ≥12 weeks prior to screening.
2. Evidence of B-cell-driven disease at Screening or previous medical documentation, defined as either (i) seropositivity for RF and/or any AMPA and/or (ii) a synovial biopsy showing B-cell infiltration
3. Active RA disease, as demonstrated by a DAS28 - ESR ≥3.2 and at least one swollen joint at screening.
4. Inadequate response to at least 2 targeted treatments with different mechanisms. These can include tsDMARD and/or bDMARD, after failing conventional synthetic DMARD (unless contraindicated).
5. Local laboratory assessments must meet the following criteria:
6. Absolute lymphocyte count (ALC) ≥0.5 x 10^9/L
7. Peripheral CD19+ B cell count ≥25 cells/μL
8. Absolute neutrophil count (ANC) ≥1.0 x 10^9/L
9. Hemoglobin (Hgb) ≥8 g/dL
10. Platelet count ≥75 x 10^9/L
11. Estimated glomerular filtration rate (eGFR) (based on the Chronic Kidney Disease Epidemiology Collaboration [CKD-EPI] formula) ≥30 mL/min/1.73m^2
12. Total bilirubin ≤1.5 × ULN, except patients with confirmed Gilbert's Syndrome
13. Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤2.5 × ULN
14. Concurrent corticosteroids is permitted if the dose is ≤10 mg/day prednisone equivalent in the 2 weeks prior to initiation of study treatment. Hydroxychloroquine ≤400 mg/d or chloroquine ≤ 250 mg/d is allowed.