10 results
Primary:To identify the recommended dose of sorafenib and of sirolimus for combination therapy in subsequent phase II trials Secondary:1. to determine the safety profile of the combination therapy of sorafenib with sirolimus.2. to determine, if…
The primary objective of the trial is to study the efficacccy of sirolimus in paraneoplastisch neurological syndromes associated with anti-Hu antibodies (Hu-PNS)Secondary objectives are to correlate clinical improvement with anti-Hu antibody titers…
To investigate the safety and efficacy of a programmed introduction of a sirolimus based calcineurin inhibitor free maintenance immunosuppressive regime three months after renal transplantation in recipients of a non-heart-beating donor kidney graft…
Primary: to evaluate and compare the efficacy of:1) PDL treatment followed by topical sirolimus application after Er:Yag laser ablation of the stratum corneum in PWS 2) PDL treatment followed by topical sirolimus application without Er:Yag laser…
To assess the efficacy and safety of treatment with tocilizumab versus adalimumab, both in combination with methotrexate, in patients with moderate to severe active rheumatoid arthritis who have had an inadequate efficacy response to treatment with…
The primary objective is to study changes in synovial inflammation in serial biopsy samples following the administration of tocilizumab in patients with active RA.The secondary objectives of this study are to:I. Assess clinical response at week 16;…
Primary objective: to compare the effect two immunosupressive therapy regimens on GFR estimated by iohexol clearance at week 52 post kidney transplantationSecundary objective: to compare the safety and efficacy profiles of the two immunosupressive…
Primary ObjectiveThe primary objective of this study is to compare prospectively in patients treated with TCZ or etanercept (ETA), the time to first occurrence of any component of a composite of major adverse cardiovascular events (MACE) consisting…
To evaluate the safety and tolerability of SC TCZ monotherapy and/or in combination with MTX or other non-biologic DMARDs comprising AEs, physical examination, vital signs, and clinical laboratory assessments, including immunogenicity, in patients…
EFFICACY OBJECTIVESThe primary efficacy objective for this study is as follows:* To evaluate the efficacy of TCZ compared with placebo on skin sclerosis, as measured by mRSS at Week 48The secondary efficacy objectives for this study are as follows…