31 results
PRIMARY OBJECTIVESThe primary objective of MAKEI V is to assess in a randomized comparison whether the efficacy of Carboplatin (600 mg/m² per cycle) (AUC 7.9 mg/ml/min.) is not inferior to Cisplatin (100 mg/m² per cycle) in malignant GCT (MGCT) of…
Primary ObjectiveTo evaluate whether lenvatinib in combination with ifosfamide and etoposide (Arm A) is superior to ifosfamide and etoposide (Arm B) in improving progression-free survival (PFS) by independent imaging review [IIR] using Response…
(Protocol v1.0 25Jul2014 p.18) The primary objective of the study is to compare the efficacy of certolizumab pegol (CZP) administered subcutaneously at the doses of CZP 400mg every two weeks and CZP 200mg every two weeks after a loading dose of CZP…
Objectives: The primary objectives of the study are to assess whether 80 mg LY2439821 every 2 weeks (Q2W) or every 4 weeks (Q4W) is:* Superior to placebo at Week 12 in the treatment of patients with moderate-to-severe plaque Ps as measured by: o…
Co-Primary- to assess whether ixekizumab Q4W is superior to placebo at Week 12 (Visit 7) in the treatment of pediatric subjects(children and adolescents) with moderate-to-severe plaque psoriasis as measured by PASI 75 and by sPGA (0,1)Gated…
Primary objective:Determine the short- and long-term safety and tolerability of single and multiple doses of NI006 in subjects with ATTR-CM by evaluating adverse events (AE) and serious adverse events (SAE) and changes in laboratory parameters (…
Primary ObjectivesThe primary objective of this study is to evaluate the efficacy and safety of guselkumab in pediatric participants aged >=6 through <18 years with chronic plaque psoriasis.Secondary ObjectivesThe secondary objectives…
PRIMARY OBJECTIVES*Phase 1 Dose Finding Studies:-To determine the recommended phase II dose (RP2D) of new systemic therapy regimens. *Frontline chemotherapy questions:-To compare systemic therapy regimens for patients with VHR disease at diagnosis (…
Primary objectives Part A:To test the non-inferiority, as evaluated by OS, of three courses of HDCT compared to focal RT plus conventional chemotherapy as consolidation therapy following conventional chemotherapy in children with ATRT aged 12 - 35…
To study whether polytherapy (methotrexate plus sulfasalazine plus hydroxychloroquine) results in more patients with inactive disease and therefore less patients who need treatment with a TNF inhibitor after 6 months of treatment compared to primary…
Primary objective:Identify pre-treatment profiles with integrated clinical, transcriptomic, metabolomic, proteomic, flow cytometric, and imaging data that predict response to treatment with tofacitinib, in DMARD-naïve and DMARD non-responsive PsA…