Ankylosing Spondylitis Clinical Trial
Official title:
Retrospective, Multicentric, National, Observational Study, to Follow-up the Patients Who Participated in the Loadet Study (RELOADET Study)
Previous studies suggest that an increase in doses of weekly etanercept from 50 mg to 100 mg
improves the efficacy of the treatment in patients with cutaneous psoriasis, rheumatoid
arthritis, and psoriatic arthritis. In this same line of study, during the 2007 2008 period,
we conducted a multicenter, double-blind, 12-week Study (LoadET, 0881A3-102090) comparing
the efficacy of etanercept at a standard dose (50 mg/week) versus a double dose (100
mg/week) in subjects with AS refractory to conventional therapy. The interim results of said
study do not appear to support the value of doubling the dose of etanercept in the treatment
of subjects with AS. Once this study was finalised, the subjects continued to be monitored
by their regular physician, who decided on the dose and treatment to follow according to the
conditions of standard clinical practice.
The objective of this observational study is to evaluate the course of the disease in the
long-term (three years) under the conditions of standard clinical practice, in subjects who
had participated in the LoadET study. Therefore, we would like to follow-up on those
patients by reviewing their clinical histories for the three-year period between the
finalisation of their participation in the LoadET Study (0881A3-102090) and now. This will
allow us to assess the efficacy and survival of the drug, as well as the possible appearance
of side effects in the three years following the finalisation of the study by comparing the
results according to if the subjects had received 50 mg/week or 100 mg/week during the
LoadET study (0881A3 102090).
Given that this is a follow-up study of subjects who participated in the LoadET study (0881A3-102090), we have planned the inclusion of all subjects who completed said study, that is, 97 of the 108 subjects in the LoadET study. ;
Observational Model: Cohort, Time Perspective: Retrospective
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