In addition to the open-label enrolment protocol, the fact that only 86 patients completed both treatments and the use of onset of "meaningful" pain relief as the primary outcome measure make it difficult to draw firm conclusions regarding the superior efficacy of IFNS over OTFC.
The detailed clinical characterisation will allow inclusion of patients into studies of novel treatment interventions, including targeted interventions in small scale open label studies; and enrolment into multi-national clinical trials.
ACT KNOW, the first randomised controlled trial ever performed in knowlesi malaria, is a two-arm open-label trial with enrolments over a 2-year period at three district sites in Sabah, powered to show a difference in proportion of patients negative for malaria by microscopy at 24 h between treatment arms (clinicaltrials.gov #NCT01708876).
This was a phase 2, open-label, single-arm, multicentre study with planned enrolment of approximately 44 patients at nine centres in the United States and Europe (http://clinicaltrials.gov/ct2/show/NCT00122343; Protocol 019).
The off-label use of bevacizumab was explained to all patients before study enrolment, and all patients provided informed consent.
Local ethics committee approval was obtained before enrolment of any patient into this multicentre, national, open-label, phase II trial.
58 Thus, patients who began the open-label study may have been successfully treated with adalimumab and those who had an unsatisfactory experience may have dropped out prior to the open-label extension, whereas the DMARD-treated patients may not have been successfully treated at enrolment.
Slowly enrolment has picked up.
School enrolment has increased.
The enrolment rate is falling.
But school enrolment is soaring.
