25 results
The objectives of this study are:* To determine the percentage of patients with recent-onset RA and UA who achieve and maintain clinical remission on treatment with a combination of methotrexate 25 mg/week and extended prednisone pulse (tapered high…
To improve response rate of primary treatment of extensive chronic GvHD with the addition of MPA to the reference treatment CsA+PDN (comparator)Primary ObjectiveTo improve remission rates with cyclosporine A+ prednisone + Myfortic® (CsA+PDN+MPA)…
Evaluate the efficacy and safety of treatment with CNTO 95 in combination with docetaxel and prednisone compared with docetaxel and prednisone without CNTO 95 in subjects with metastatic HRPC.
Primary Objective:• To determine if orteronel plus prednisone improves overall survival (OS)Key Secondary Objectives: • To determine if orteronel plus prednisone improves radiographic progression-free survival (rPFS)• To determine if orteronel plus…
Detection of breast carcinoma with an ICG enhanced optical imaging device in breast cancer patients.
Ergonomics and function of the imaging system - the NIRF imaging system should not interfere with the standard lumpectomy procedure and used safely by the surgeon while detection of ICG within the tumour takes place. Duration: 1,5 hour clinical…
The overall objective is to assess the effectiveness of treating patients with corticosteroids prior to surveillance in order to diminish the pitfall of active inflammation.
Feasibility study: The potential use of intraoperative, ICG based, fluorescence imaging of LN*s during CRC lymphadenectomy.
Prospective study: The potential use of intraoperative, ICG based, fluorescence imaging of LN's during CRC lymphadenectomy.
Assess the efficacy and safety of eculizumab in pediatric patients with aHUS to control TMA as characterized by thrombocytopenia, hemolysis and renal impairment.
Assess the efficacy of eculizumab in adult patients with aHUS to control TMA as characterized by thrombocytopenia, hemolysis and renal impairment.
The objective of the study is to evaluate the safety and efficacy of eculizumab to prevent AMR in sensitized recipients of living donor kidney transplants requiring desensitization therapy.
Primary Efficacy Objective:• To evaluate the efficacy of tocilizumab (TCZ) compared to placebo, in combination with a26-week prednisone taper regimen, in patients with giant cell arteritis (GCA), as measured by the proportion of patients in…
The primary objective is to assess safety and efficacy of abiraterone acetate plus prednisone and abiraterone acetate plus prednisone plus exemestane, each compared with exemestane alone, in postmenopausal women with ER+ metastatic breast cancer…
Main Objective:Assess the efficacy of eculizumab as compared with placebo in the treatment of refractory gMG based on the improvement in the MG specific Activities of Daily Living profile (MG-ADL).Secondary Objectives: - Safety and tolerability of…
Research Hypothesis: Treatment with nivolumab (BMS-936558) will lead to clinical benefit, as demonstrated by a clinically meaningful objective response rate, including durable responses with substantial magnitude of tumor burden reduction.Primary…
To determine if orteronel plus prednisone improves radiographic progression-freesurvival (rPFS)To determine if orteronel plus prednisone improves overall survival (OS)
Primary objective:* To determine whether orteronel 300 mg twice daily (BID) plus prednisone 5 mg BID more effectively reduces serum testosterone levels, compared to placebo plus prednisone 5 mg BID, when administered to patients in JapanSecondary…
Primary ObjectiveTo compare the objective response rate and overall surival of BMS-936558 versus docetaxel in subjects with squamous cell NSCLC after failure of prior platinum-based chemotherapySecondary ObjectivesTo compare the progression-free…
Primary Objective* To determine the DCR (disease control rate) at 12 weeks of nivolumab monotherapy in patients with progressive MPM.Secondary Objectives* To determine the safety of nivolumab monotherapy in patients with progressive MPM* To…
Phase 1Primary objective- To determine the maximum tolerated dose (MTD) and recommended phase 2 dose level (RDL) of lenalidomide administered during 21 days of a 4 week cycle, combined with continuous cyclophosphamide and prednisone. See paragraph…