14 results
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…
The primary objective is to compare PFS after treatment with tabalumab, bortezomib, anddexamethasone to that of placebo, bortezomib, and dexamethasone in patients with relapsed/refractory MM.Secondary objectives will include comparison of treatment…
To determine if orteronel plus prednisone improves radiographic progression-freesurvival (rPFS)To determine if orteronel plus prednisone improves overall survival (OS)
Given the medical need for improved treatment strategies for patients with previously treated and relapsed MM, the purpose of this phase III study is to compare treatment with bortezomib/dexamethasone + panobinostat to bortezomib/dexamethasone +…
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…
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), *…
The primary objective of this study is to determine if there is an improvement in progression-free survival(PFS) when siltuximab is added to VELCADE* (bortezomib) and dexamethasone in subjects with relapsedor refractory multiple myeloma.The…
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…
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)…
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:-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…
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…