20 results
The primary objective of the study is to evaluate the effect of denosumab 60mg every 6 months (Q6M) compared with Actonel 150mg monthly (QM) on total hip Bone Mineral Density (BMD) at 12 months in postmenopausal women transitioning from previous…
· To determine the efficacy of several doses of Viaskin® Peanut to significantlydesensitize peanut-allergic subjects to peanut after 12 months of EPIT treatment .· To evaluate the safety of a long-term EPIT with Viaskin® Peanut.
The primary objective in the glucocorticoid-continuing subpopulation of men and women treated with chronic glucocorticoid therapy (>= 7.5 mg daily prednisone or its equivalent for >= 3 months and are planning to continue treatment for…
To determine if denosumab is non-inferior to zoledronic acid (Zometa) with respect to the first on-study occurrence of a skeletal-related event (SRE) in men with hormone-refractory prostate cancer and bone metastases.
To determine if denosumab is non-inferior to zoledronic acid (Zometa) with respect to the first on-study occurrence of a skeletal-related event (SRE) in subjects with advanced breast cancer and bone metastases.
To determine if denosumab is non-inferior to zoledronic acid with respect to the first on-study occurrence of a skeletal related event (SRE) in subjects with advanced cancers and bone metastases (or lytic bone lesions from multiple myeloma).SRE is…
To describe the safety and tolerability of up to 5 years denosumab administration as measured by adverse event monitoring, immunogenicity, and safety laboratory parameters in subjects who previously received denosumab.
Primary objective• Determine the change in intratumoral T-cell (CD4, CD8 and Treg) and Myeloid cell (M1/M2 Macrophage, MDSC, DC) numbers and function between the baseline biopsy and the surgical specimen.Secondary objectives• PBMC before start…
To study the long term safety (up to 5 years) of denosumab in subjects undergoing androgen-deprivation therapy for non-metastatic prostate cancer.
Primary objective: To demonstrate a clinically significant improvement in morning FEV1 in moderate to severe allergic asthmatics inadequately controlled by ICS therapy treated with QAW039 for 12 weeks compared to placebo.Secondary objectives:…
Primary:Subjects with salvageable giant cell rich tumors:- To evaluate subjects who do not require surgery during the study- To evaluate subjects who are able to undergo a less morbid surgical procedure compared with the planned surgical procedure…
The primary objective of the trial is to evaluate the risk versus benefit of denosumab in maintenance setting in patients requiring long-use (>1 year) of denosumab. For that purpose, the treatment schedule with reduced dose density (120mg SC…
The primary objective is to evaluate the pharmacokinetic (PK) parameters of JNJ-63623872 in combination with oseltamivir in elderly subjects (aged 65 to *85 years) compared to adults (aged 18 to *64 years) with influenza A infection.
The purpose of this research study is to evaluate how safe and effective Denosumab is, compared with placebo, in delaying the time it takes for cancer to spread to the bones in subjects with early-stage breast cancer at high risk of recurrence.The…
The objective of the study is to evaluate the safety profile of denosumab in subjects with Giant Cell Tumor of bone.
This study will be carried out to gain more knowledge about denosumab in patientes with NSCLC. The effect of denosumab in combination with platinum-doublet chemotherapy in patients with NSCLC and the relation with the presence of biomarkers in…
Primary Objective:The primary objective of this study is:• To evaluate the efficacy of namilumab in subjects with chronic pulmonary sarcoidosis (CPS).Key Secondary Objective:• To evaluate the effect of namilumab on proportion of subjects on OCS…
Does single subcutaneous injection with denosumab or placebo (NACL 0.9%) induces a shorter Total contact cast treatment duration and faster bonefracture healing (days) and does it prevent deformation of the foot in patients with Charcot foot
Primary Objectives:To determine the efficacy of brigatinib, as evidenced by confirmed objective response rate (ORR), in patients with ALK+ locally advanced or metastatic NSCLC whose disease has progressed on therapy with alectinib or ceritinib.…
To investigate whether 3 monthly Dmab will improve the clinical, radiological and biochemical manifestations of FD bone lesions.