16 results
To determine the effect of lithium treatment (plasma levels between 0,4-0,8 mEq/liter) versus placebo - in addition to riluzole 2dd 50 mg - on reaching a clinical endpoint in patients with ALS.
Evaluate the efficacy and safety of treatment with CNTO 95 in combination with docetaxel and prednisone compared with docetaxel and prednisone without CNTO 95 in subjects with metastatic HRPC.
Primary objective:* To determine whether orteronel 300 mg twice daily (BID) plus prednisone 5 mg BID more effectively reduces serum testosterone levels, compared to placebo plus prednisone 5 mg BID, when administered to patients in JapanSecondary…
Primary Objective:• To determine if orteronel plus prednisone improves overall survival (OS)Key Secondary Objectives: • To determine if orteronel plus prednisone improves radiographic progression-free survival (rPFS)• To determine if orteronel plus…
To improve response rate of primary treatment of extensive chronic GvHD with the addition of MPA to the reference treatment CsA+PDN (comparator)Primary ObjectiveTo improve remission rates with cyclosporine A+ prednisone + Myfortic® (CsA+PDN+MPA)…
OBJECTIVE AND HYPOTHESISPrimary ObjectiveThe primary objective is to determine whether abiraterone acetate in combination with low-doseprednisone and androgen deprivation therapy (ADT) is superior to ADT alone in improving rPFS and OS insubjects…
Am2: Primary Objective* To compare the Overall Survival (OS) benefit of docetaxel and prednisone with and without lenalidomide as first-line combination therapy in chemo-naïve metastatic CRPC Secondary Objectives* Progression-Free Survival (PFS), *…
Primary Efficacy Objective:• To evaluate the efficacy of tocilizumab (TCZ) compared to placebo, in combination with a26-week prednisone taper regimen, in patients with giant cell arteritis (GCA), as measured by the proportion of patients in…
To determine if orteronel plus prednisone improves radiographic progression-freesurvival (rPFS)To determine if orteronel plus prednisone improves overall survival (OS)
Primary:-To evaluate the efficacy of KEVZARA (sarilumab) in patients with polymyalgia rheumatica (PMR) as assessed by the proportion of subjects with sustained remission for sarilumab with a shorter corticosteroid (CS) tapering regimen as compared…
Primary:The primary objective of the study is to evaluate the efficacy of KPL-301 versus placebo, coadministeredwith a 26 week steroid taper, for maintaining sustained remission for 26 weeks in subjects with newonsetor relapsing/refractory giant…
To investigate the efficacy and safety of drugs for patients with ALS.
Study AG348-C-018 is a Phase 3, double-blind, randomized, placebo-controlled, multicenter study designed to demonstrate the clinical efficacy and safety of mitapivat in subjects with α- or β-TDT. The primary objective of the study is to compare the…
The primary objective is to evaluate the efficacy of IFX-1 treatment as a replacement for glucocorticoids [GC] therapy in subjects with GPA and MPA.Secondary objectives:*To assess safety and tolerability of IFX-1*To compare GC-induced toxicity of…
Study AG348-C-017 is a Phase 3, double-blind, randomized, placebo-controlled, multicenter study designed to demonstrate the clinical efficacy and safety of mitapivat in subjects with α- or β NTDT. The primary objective of the study is to compare the…
To determine the efficacy of treatment with mitapivat compared with placebo, as assessed by the increase in Hb concentrations in pediatric subjects with PK deficiency who are not regularly transfused