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54 Also recently described at the American Society of Clinical Oncology ASCOO) 2012 Annual Meeting is the RAISE trial; 52 this is an ongoing, randomized, double-blinded, placebo-controlled Phase III trial of ramucirumab or placebo in combination with FOLFIRI in patients with mCRC who failed a first-line bevacizumab-, oraliplatin-, or fluoropyrimidine-based regimen.
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The administration is raising trial balloons to pit veterans' benefits and retired pay against active-duty needs, especially the need for more, higher cost systems.
In the GO-RAISE trial, patients with active AS showed significant and sustained improvement in signs and symptoms with golimumab treatment.
Patient selection criteria and study design details of the phase 3, multicentre, randomised, placebo-controlled, double-blind, GO-RAISE trial have been previously described.
The GO-RAISE trial was designed to evaluate the efficacy of GLM in treating the signs and symptoms of active AS.
The current analyses of radiographic data in the GO-RAISE trial are limited by the lack of placebo control past the initial 24 weeks of the 208-week study period for radiographic progression.
The findings derived from an MRI substudy of the GO-RAISE trial, which evaluated golimumab in the treatment of active AS, 8 indicate that golimumab significantly reduced MRI-detected spinal inflammation in patients with AS.
As previously reported, clinical results of the GO-RAISE trial of golimumab in patients with AS showed significant improvements at week 24 in the signs and symptoms of AS as measured by the Assessment of SpondyloArthritis International Society improvement criteria and the BASDAI.
7 In the current radiographic analysis through 2 years and 4 years of the GO-RAISE trial, one is cautioned avoid making comparisons between the golimumab and placebo groups at weeks 104 and 208 because, for ethical reasons and consistent with the design of earlier studies, the placebo-controlled period was restricted to the first 6 months of the study.
We previously reported results of the double-blind, randomised, placebo-controlled, Phase 3 GO-RAISE study, in which golimumab was evaluated in patients with active AS, through week 24 1 and week 104 2 and now report findings through the completion of the 5-year GO-RAISE trial.
The phase 3, randomised, placebo-controlled, GO-RAISE trial evaluated the safety and efficacy of two doses of golimumab, a human monoclonal anti-TNF antibody, in patients with AS. 7 Safety and efficacy results through 2 years have been previously published.
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