6 results
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…
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…
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 ObjectivesThe primary objective is to explore the tolerability, safety and treatment response (maintained/improved efficacy), based on total Positive and Negative Syndrome Scale (PANSS) score, of a transition to flexibly dosed paliperidone…
To examine the effect of rituximab on endothelial activation, endothelial dysfunction, IMT and AGE accumulation in active RA.
Supported by the observation from the Phase I studies in healthy volunteers, doses within a range of 50 to 500 mg are safe and well tolerated. This Phase II trial will be performed to:a. obtain proof of concept of BI 44370 TAb. perform dose finding…