9 results
To examine the effect of rituximab on endothelial activation, endothelial dysfunction, IMT and AGE accumulation in active RA.
Primary objectives:The primary objectives of this trial are:• To show PK similarity of BI 695500 to MabThera® and Rituxan® and of Rituxan® to MabThera® (three-way PK similarity).• To establish statistical equivalence of efficacy of BI 695500 and…
Primary objective;Confirm superiority of IgG antibody levels against pertussis toxin (Ptx), present in the acellular vaccines, in infants at the age of 3 months of mothers having received a pertussis vaccine during pregnancy versus infants of…
PRINCIPAL OBJECTIVE To evaluate whether sequential therapy with tacrolimus for 9 months (6 months of full therapy and 3 months of tapering doses) followed by a dose of RTX leads to a greater increase in the proportion of primary MN patients with…
The primary objective:To demonstrate that CT-P10 is similar to Rituxan in terms of pharmacokinetics as determined by AUCtau and CmaxSS at Cycle 4 and maximum serum concentration at steady state The secondary objective:Efficacy: the primary endpoints…
The primary objective of this study is to identify if reduced number of BCG instillations are not inferior to standard number and dose intravesical BCG treatment in patients with high grade NMIBC. The primary endpoint for inferiority analysis is…
Primary objective:To investigate Pertussis Toxin (PT) specific antibody responses 1 month following the second aP vaccine given at 5 months of age to infants whose mothers have (Arm 1) or have not (Arm 2) received a pertussis booster vaccine during…
Part A (Single Ascending Dose):Primary: To assess the safety and tolerability of single oral doses of PRAX-628 Secondary: To evaluate the pharmacokinetics (PK) of single oral doses of PRAX-628 Part B (Multiple Ascending Dose):Primary: To assess the…
Primary Safety Objective: To describe the safety profile of 20vPnC