2592 results
PrimaryThe primary objective is to compare both ixekizumab regimens (80 mg every 2 weeks [Q2W] or 80 mg every 4 weeks [Q4W]) versus placebo in patients with active radiographic axial spondyloarthritis (rad-axSpA) at Week 16.SecondaryThe major…
Primary Objective To evaluate long term safety and tolerability of LAI (590 mg) administered once daily (QD) for up to 12 months in subjects who were refractory to standard multi-drug treatment and failed to convert in Study INS-212. Secondary…
Primary Objective The primary objective of this study is to compare the change from baseline in HbA1c after 24 weeks of double blinded treatment with dapagliflozin 5 mg or 10 mg plus adjustable insulin versus placebo plus adjustable insulin.…
Primary objective of this trial is to generate open-label, long-term (up to 12 months) safety and tolerability data for ZS in subjects with hyperkalaemia (S-K * 5.1 mmol/L)Secondary objectives:* To evaluate the portion of ZS-treated subjects in whom…
Period 1: The first objective, of period 1, is to compare the safety and efficacy of ABT-494 30 mg (QD) and 15 mg QD versus placebo on a background of csDMARD(s) for the treatment of signs and symptoms of rheumatoid arthritis (RA) in bDMARD-…
The main purpose of this study is to determine the side effects of trastuzumab when it is given by each of these subcutaneous injection methods. The study will also gather information about whether and when the cancer comes back after taking…
Period 1: The first objective, of period 1, is to compare the safety and efficacy of ABT-494 15 mg QD monotherapy, and 30 mg QD monotherapy versus weekly methotrexate (MTX) monotherapy for the treatment of signs and symptoms of rheumatoid arthritis…
Primary Objective• To compare the anti-tumor efficacy of oral single-agent rociletinib, as measured by investigator assessment of the progression-free survival (PFS), with that of single-agent cytotoxic chemotherapy in patients with EGFR mutated,…
The purpose of this study is to assess the safety, tolerability and efficacy of long term drisapersen in subjects with DMD.
The primary objective of this study is to assess whether the efficacy of ocrelizumab given as two dose regimens of 600 mg (given as 300 mg infusions on days 1 and 15 and 600 mg infusion in the following cycles) or 400 mg (given as 200 mg infusions…
The primary objective of the study is to evaluate the efficacy of 2 dose regimens of dupilumab compared to placebo, administered with concomitant topical corticosteroids (TCS), in adult patients with severe AD who are not adequately controlled with…
The objective of this study is to investigate whether Levosimendan is able to lower creatinine levels as a measure of kidney failure and if urinary output can be increased.
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…
This is a follow-up (FU) study for subjects who completed Study ALX0681-C301 (HERCULES) according to the protocol (i.e., completed the Final [28 day] FU visit). Subjects who completed Study ALX0681-C301 will be given the option to participate in…
The primary goal is to increase the quality of recovery, as measured by the QoR-15-scale.Secundary goals are to decrease the use of systemic opiates, less bladderspasms and pain, reduce the side-effects op opiates, increase the patient-satisfaction…
The hypothesis of this study is that patient barriers regarding pain management can be diminished by individual nurse-led education (the Pain Education Program), resulting in lower pain intensity and better quality of life of patients.
Primary objective:To determine the response to a 144-hour (6 day) continuous intravenous infusion of SAGE-547 compared to placebo administered to support the weaning of all third-line agents in subjects with SRSE, and for the response to endure at…
To determine the best treatment for anaplastich oligodendroglial tumors with combined 1p/19q loss, and to determine the optimal treatment with respect to the maintenance of a maximal neurological and cognitive functioning.
The purpose of this study is to assess the safety and device success of the Edwards CENTERA Transcatheter Heart Valve (THV) System in patients with symptomatic, severe aortic stenosis who are indicated for aortic valve replacement.
The objective of this protocol is to provide a mechanism to supply mepolizumab on an individual subject basis to eligible asthma subjects who previously participated in a GSK-sponsored mepolizumab study. During the execution of the protocol SAEs…