These findings contrasted with the results observed in the open phase of the study, which showed that more than 50% of the patients were improved over 50%, and that mean attack frequency and emotional impact were markedly decreased.
Of the 249 patients in the open phase of the study, 238 (95.6%) received DMARDs at baseline.
A second patient was withdrawn during the augmentation phase due to lithium non-compliance, leaving 29 completers of this open phase of the study.
Dougados et al. found 69.6% of DAS28 responders after 24 weeks of treatment in the open phase of the RELIEF study [ 13].
At 30 weeks, patients entered an uncontrolled, open-label, open-ended phase of the study in which all patients received ExQW (2 mg) regardless of initial randomization.
To evaluate the efficacy during the open label phase of the study, MSF during the open label study was calculated the same way.
To recruit people who are representative of the population being studied, the study allows people who do not have the capacity to give informed consent to participate in the open-label phase of the study (acute and stabilization).
During the open label phase of the study, the patient had the possibility to treat multiple migraine attacks.
These between-group differences decreased and were no longer significant in the open-label phase of the study.
TRAE decreased in the open-label phase of the study with neck pain (4.6%), muscular weakness (3.9%), eyelid ptosis (2.5%), muscle tightness (2.2%) and injection site pain (2.0%) the only TRAEs occurring in ≥2% of patients.
In the open-label phase of the study, 5 volunteers received 10 µg AMA-1 in 0.5 mL of AS01B (referred to as the low dose AMA-1/AS01B group) administered intramuscularly in the non-dominant arm.
