6 results
1. Overall survival (primary efficacy endpoint)2a. Efficacy: progression-free survival (PFS), overall response rate (ORR = CR + PR), and a clincal benefit rate (CBR) will be evaluated as CR + PR + SD for at least 3 months.2b. Safety: adverse events…
A proof-of-concept study in refractory SLE patients to assess the immunological consequences of a combination treatment with rituximab (anti-CD20) and belimumab (anti-BAFF) to achieve long-term B-cell depletion. The immunological and clinical…
To evaluate the safety and efficacy of subcutaneousbelimumab (GSK1550188) and intravenous rituximab coadministrationin subjects with primary Sjögren*s syndrome.
Primary objective:- To assess safety, efficacy, and potentially select the most active treatment regimen among 3 treatment arms to advance to the Phase 3 component of the study.Secondary objectives:- Ph1b: evaluate PK & assess immunogenicity…
The main aim of this project is to test the hypothesis that the presence or absence of specific synovial cellular and molecular signatures (B cells and B cell-associated signatures), assessed following a synovial tissue biopsy, will enrich for…
Primary Objectives- Determine the MTD of pixantrone, rituximab (only in CD20 positive tumors), etoposide, and bendamustine in *fit' patients with rel aNHL of B- or T-cell phenotype.- Evaluate the ORR and PFS using the combination of pixantrone…