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10.1212/NXI.0000000000000117 http://scihub22266oqcxt.onion/10.1212/NXI.0000000000000117 C4442097!4442097!26185773     free     free     free Deprecated: Implicit conversion from float 233.6 to int loses precision in C:\Inetpub\vhosts\kidney.de\httpdocs\pget.php on line 534 Deprecated: Implicit conversion from float 233.6 to int loses precision in C:\Inetpub\vhosts\kidney.de\httpdocs\pget.php on line 534 Deprecated: Implicit conversion from float 233.6 to int loses precision in C:\Inetpub\vhosts\kidney.de\httpdocs\pget.php on line 534 Deprecated: Implicit conversion from float 233.6 to int loses precision in C:\Inetpub\vhosts\kidney.de\httpdocs\pget.php on line 534 Deprecated: Implicit conversion from float 233.6 to int loses precision in C:\Inetpub\vhosts\kidney.de\httpdocs\pget.php on line 534 Deprecated: Implicit conversion from float 233.6 to int loses precision in C:\Inetpub\vhosts\kidney.de\httpdocs\pget.php on line 534       Neurol+Neuroimmunol+Neuroinflamm 2015 ; 2 (4): ä Nephropedia Template TP {{tp|p=26185773|t=2015. Randomized phase 1b trial of MOR103, a human antibody to GM-CSF, in multiple sclerosis |pdf=|usr=}}{{26185773}} gab.com Text Randomized phase 1b trial of MOR103, a human antibody to GM-CSF, in multiple sclerosis JO: Neurol Neuroimmunol Neuroinflamm http://www.kidney.de/pget.php?&tw=1&pmid=26185773 #FOAvip Objectives:: To determine the safety, pharmacokinetics (PK), and immunogenicity of the recombinant human monoclonal antibody MOR103 to granulocyte-macrophage colony-stimulating factor (GM-CSF) in patients with multiple sclerosis (MS) with clinical or MRI activity. Methods:: In this 20-week, randomized, double-blind, placebo-controlled phase 1b dose-escalation trial (registration number NCT01517282), adults with relapsing-remitting MS (RRMS) or secondary progressive MS (SPMS) received an IV infusion of placebo (n = 6) or MOR103 0.5 (n = 8), 1.0 (n = 8), or 2.0 (n = 9) mg/kg every 2 weeks for 10 weeks. Patients had to have ?10 gadolinium (Gd)-enhancing brain lesions on T1-weighted MRI at baseline. The primary objective was safety. Results:: Most treatment-emergent adverse events (TEAEs) were mild to moderate in severity. The most frequent was nasopharyngitis. Between-group differences in TEAE numbers were small. There were no TEAE-related trial discontinuations, infusion-related reactions, or deaths. Nine patients experienced MS exacerbations: 3, 5, 1, and 0 patient(s) in the placebo, 0.5, 1.0, and 2.0 mg/kg groups, respectively. A few T1 Gd-enhancing lesions and/or new or enlarging T2 lesions indicative of inflammation were observed in all treatment groups. No clinically significant changes were observed in other clinical assessments or laboratory safety assessments. No anti-MOR103 antibodies were detected. PK evaluations indicated dose linearity with low/no drug accumulation over time. Conclusions:: MOR103 was generally well-tolerated in patients with RRMS or SPMS. No evidence of immunogenicity was found. Classification of evidence:: This phase 1b study provides Class I evidence that MOR103 has acceptable tolerability in patients with MS. Twit Text FOAVip Randomized phase 1b trial of MOR103, a human antibody to GM-CSF, in multiple sclerosis ????Neurol Neuroimmunol Neuroinflamm http://www.kidney.de/pget.php?&tw=1&pmid=26185773 #FOAvip Twit Text # Free Paper on # # # # # LINK http://www.kidney.de/pget.php?&tw=1&pmid=26185773 #FOAvip English Wikipedia <ref>{{Cite pmid|26185773}}</ref> Randomized phase 1b trial of MOR103, a human antibody to GM-CSF, in multiple sclerosis #MMPMID26185773 Constantinescu CS; Asher A; Fryze W; Kozubski W; Wagner F; Aram J; Tanasescu R; Korolkiewicz RP; Dirnberger-Hertweck M; Steidl S; Libretto SE; Sprenger T; Radue EW Neurol Neuroimmunol Neuroinflamm 2015[Aug]; 2 (4): ä PMID26185773show ga Objectives:: To determine the safety, pharmacokinetics (PK), and immunogenicity of the recombinant human monoclonal antibody MOR103 to granulocyte-macrophage colony-stimulating factor (GM-CSF) in patients with multiple sclerosis (MS) with clinical or MRI activity. Methods:: In this 20-week, randomized, double-blind, placebo-controlled phase 1b dose-escalation trial (registration number NCT01517282), adults with relapsing-remitting MS (RRMS) or secondary progressive MS (SPMS) received an IV infusion of placebo (n = 6) or MOR103 0.5 (n = 8), 1.0 (n = 8), or 2.0 (n = 9) mg/kg every 2 weeks for 10 weeks. Patients had to have ?10 gadolinium (Gd)-enhancing brain lesions on T1-weighted MRI at baseline. The primary objective was safety. Results:: Most treatment-emergent adverse events (TEAEs) were mild to moderate in severity. The most frequent was nasopharyngitis. Between-group differences in TEAE numbers were small. There were no TEAE-related trial discontinuations, infusion-related reactions, or deaths. Nine patients experienced MS exacerbations: 3, 5, 1, and 0 patient(s) in the placebo, 0.5, 1.0, and 2.0 mg/kg groups, respectively. A few T1 Gd-enhancing lesions and/or new or enlarging T2 lesions indicative of inflammation were observed in all treatment groups. No clinically significant changes were observed in other clinical assessments or laboratory safety assessments. No anti-MOR103 antibodies were detected. PK evaluations indicated dose linearity with low/no drug accumulation over time. Conclusions:: MOR103 was generally well-tolerated in patients with RRMS or SPMS. No evidence of immunogenicity was found. Classification of evidence:: This phase 1b study provides Class I evidence that MOR103 has acceptable tolerability in patients with MS. äRandomized phase 1b trial of MOR103, a human antibody to GM-CSF, in mu(epmc).pdf DeepDyve Pubget Overpricing