30 results
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…
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…
To determine if orteronel plus prednisone improves radiographic progression-freesurvival (rPFS)To determine if orteronel plus prednisone improves overall survival (OS)
Determine the diagnostic accuracy of the E.G.Scan 2.0* compared to conventional upper endoscopy in patients referred for diagnostic upper endoscopy to evaluate esophageal disorders.
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…
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…
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…
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.
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)…
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…
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: • Investigate the effectiveness and tolerability of methotrexate as first-line therapy in patients with pulmonary sarcoidosis compared with prednisone.Secondary: • Examine (immunological) biomarkers of disease progression and chronicity.•…
Main objective of the trial is to determine the effect of individualizing the immunosuppressive therapy based on baseline immune-risk stratification according to 2 new biomarkers (d-sp ELISPOT IFN-γ and donor/recipient HLA Eplet Mismatch), in a…
Primary:The primary objective of the study is to evaluate the efficacy of KPL-301 versus placebo, coadministeredwith a 26 week steroid taper, for maintaining sustained remission for 26 weeks in subjects with newonsetor relapsing/refractory giant…
Primary Objective:The primary objective is to compare the radiographic progression-free survival (rPFS) ofapalutamide in combination with abiraterone acetate (AA) plus prednisone or prednisolone(AAP) and AAP in subjects with chemotherapy-naïve mCRPC…
This study aims to test the hypothesis that zandelisib in combination with rituximab has better clinical activity and risk/benefit profile compared to standard 2nd line immunochemotherapy (R-CHOP/R-B) in subjects with relapsed FL or MZL. Primary…
In this study we therefore investigate the influence of prednisone on docetaxel exposure in metastatic prostate cancer patients.
The primary objective is to evaluate the efficacy of daratumumab in addition to standard chemotherapy in relapsed/refractory B-cell acute lymphoblastic leukemia (ALL) and T-cell ALL as measured by the complete response (CR) rate.The secondary…
Primary Objective:To compare the progression-free survival (PFS) of transplant-ineligible subjects with newly diagnosed multiple myeloma who are treated withcarfilzomib, melphalan, and prednisone (CMP) versus those treated with bortezomib (Velcade…
The primary objective is to evaluate the efficacy of CCX168 (avacopan) to induce and sustain remission in patients with active anti-neutrophil cytoplasmic antibody (ANCA)-associated vasculitis (AAV), when used in combination with cyclophosphamide…