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Results were similar relative to extension study baseline.
Overall, prolactin results for most patients did not shift categories from the core study baseline to extension study LOCF endpoint.
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The proportion of patients who achieved ≥30% reduction in FIQ total score from double-blind baseline to extension-study endpoint was also determined.
The proportions of patients who achieved ≥30% and ≥50% reductions in overall pain VAS from baseline to extension-study endpoint were also determined in accordance with recommendations for chronic-pain trials [ 34].
According to the extension study protocol, velaglucerase alfa was to be administered in a 60-min intravenous infusion every other week (EOW).
Although 163 events of prolonged intervals of 8 weeks or more occurred, the majority of the prolongation of intervals was due to transition from the randomised study to the extension study (median interval of the transition was 10.1 weeks).
Relative to the extension study baseline, however, there were decreases for the PETiT scores: −0.9 (SD 6.6) at month 6 and −1.9 (SD 7.2) at extension study LOCF endpoint.
Patients who completed the core study and had serum ferritin levels ≥500 μg/l could elect to enter an extension study, which was initially intended to be 3 years, but was extended to 4 years after a protocol amendment.
Similarly, of the 14 subjects, two subjects with pre-existing antibodies to TPO rolled over from their respective parent studies to roll-over extension study, hence these subjects were counted only once in the total incidence.
What's innovative here is Lilly developed a statistical model to try and use the extension study to measure whether solanezumab is having an effect on the progression of the disease.
In another phase I trial, several patients with stable disease have advanced to a multicenter, open label, extension study to collect long-term safety data (http://www.clinicaltrials.gov/ct2/show/NCT01158079).gov/ct2/show/NCT01158079
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