16 results
To compare overall survival between RAD001+BSC and placebo+BSC in patients with advanced gastric cancer after progression on prior systemic chemotherapy.
The primary objective of this study is to demonstrate that the efficacy of rivaroxaban, a direct FXa inhibitor, is non-inferior to that of dose-adjusted warfarin for the prevention of thromboembolic events in subjects with non-valvular atrial…
To determine whether treatment with RAD001 10 mg/d plus Sandostatin LAR® prolongs the progression free survival (PFS) compared to treatment with Sandostatin LAR® alone in patients with advanced carcinoid tumor.
Primary objective: to demonstrate equivalence of the efficacy of TL011 in comparison with the reference product MabThera(rituximab) in subjects with severe, active RA treated with MTX.• Secondary objective: To assess the pharmacodynamics (PD),…
Primary objective:* To assess the safety and tolerability of combined treatment with atacicept and rituximab insubjects with active rheumatoid arthritis receiving re-treatment with rituximab.Secondary objectives:* To evaluate the effect of combined…
Phase I- To characterize the safety and tolerability and determine the maximum tolerated dose of daily RAD001 in combination with daily sorafenibPhase II- To estimate the hazard ratio of the treatment effect as measure of anti-tumor activity of the…
To assess indacaterol (300 and 600 ug once daily via SDDPI) superiority in patients with COPD as compared to placebo with respect to 24 h post dose (through) FEV1 after 12 weeks of treatment.
The primary objective of this study is to demonstrate the efficacy of the combination therapy of aliskiren (150 mg and 300 mg) and HCTZ 25 mg in hypertensive patients who do not show sufficient blood pressure response to a 4-week treatment of HCTZ…
To determine the effect of rituximab, when added to standard immunsuppressive therapy, on the incidence and severity of biopsy-confirmed acute rejection within the first six months after transplantation.
The primary objective of this trial is to demonstrate that aliskiren 300 mg, in addition to standard therapy, has superior efficacy compared to placebo in reducing the primary index of adverse cardiac remodeling (defined as the change in LVESV from…
Primary objective:* Evaluate long-term effect of tolvaptan in ADPKD through rate of renal volume change(%) for tolvaptan-treated compared to placebo-treated subjects.Secondary objectives:* Evaluate long-term efficacy of tolvaptan in ADPKD through a…
To assess the difference in efficacy between two ultra-low doses (1 x 500 mg and 1 x 200 mg) and standard low dose (1 x 1000 mg) of RTX retreatment on the change in DAS28-CRP, compared to a pre-specified non-inferiority margin of 0.6, at 3 and 6…
*To demonstrate comparability of the ORR in patients with previously untreated, advanced stage FL who receive GP2013-CVP combination treatment to patients who receive MabThera®-CVP treatment. ORR will be determined during the combination treatment…
This study will evaluate the efficacy of brentuximab vedotin in combination with lenalidomide and rituximab among subjects with relapsed or refractory CD30-positive (CD30 expression >=1%) or CD30 <1% (CD30 expression <1%) DLBCL.
Primary:To evaluate the efficacy of belimumab and a single cycle of rituximab administered in a combination regimen to adult participants with SLE. Secondary:Other aspects of efficacy. Safety and tolerability. Questionnaires.
Primary ObjectiveThe primary objective of this study is to evaluate whether the addition of ibrutinib to bendamustine and rituximab will result in prolongation of PFS in subjects with newly diagnosed MCL who are 65 years of age or older.Secondary…