11 results
The primary objective is:1. To investigate whether high frequency low dosage IVIg treatment is more effective than low frequency high dosage as maintenance treatment for CIDP. Secondary objectives are:2. To investigate whether high frequency low…
Primary objective• To determine the optimal dose of IMU-838 to induce symptomatic remission (based on stool frequency [SF] and abdominal pain [AP], as assessed in the Crohn*s Disease Activity Index [CDAI] patient reported outcome [PRO]-2) in…
Primary Objective:- To demonstrate the superiority of palbociclib in combination with fulvestrant (with or without goserelin) over fulvestrant alone (with or without goserelin) in prolonging investigator-assessed PFS in women with HR+/HER2-negative…
To evaluate in a feasibility study whether low uptake on FES-PET at baseline is related to non-response to letrozole plus palbociclib treatment.
Primary Objective:To compare invasive disease-free survival (iDFS) for the combination of at least 5 years endocrine therapy and 2-year palbociclib treatment versus at least 5 years endocrine therapy alone in patients with histologically confirmed…
The primary objective of this trial is to study the effect of the moderate CYP3A4 inhibitor erythromycin on the pharmacokinetics of palbociclib, measured as AUC0-24h, Cmax and Cmin.The secondary objective of this trial is to compare the incidence…
The primary objective of the study is to evaluate if treatment with a non-steroidal aromatase inhibitor combined with CDK4/6 inhibition in first line followed at progression by fulvestrant in second line (strategy A) improves progression-free…
The primary objective of this study is to determine whether SAR439859 in combination with palbociclib improves progression free survival (PFS) compared to letrozole in combination with palbociclib in patients with ER +, HER2-advanced breast cancer…
The primary objective of this study is to assess the efficacy of IgPro20 0.5 g/kg weekly subcutaneous (SC) doses in comparison to placebo in adult subjects with DM, as measured by responder status based on the Total Improvement Score (TIS)…
To determine the optimal dose of IMU-838 to induce symptomatic remission and endoscopic healing in patients with moderate-to-severe ulcerative colitis (UC)
Primary: To compare the efficacy of palbociclib in combination with TMZ and IRN vs TMZ and IRN chemotherapy alone in the treatment of children, adolescents, and young adults with recurrent or refractory EWS.Secundary: To further compare the efficacy…