This is a pilot study to determine if further research is warranted to assess if anti-fungal therapy is an effective adjunctive treatment for axial spondyloarthropathy
The purpose of this trial is to determine if terbinafine is an effective therapy for ankylosing spondylitis. Benefit will be determined by a reduction of the BASDAI by two or more. The primary endpoint is the BASDAI at the completion of 16 weeks of terbinafine versus the BASDAI at the start of the trial and at the completion of the placebo. The secondary endpoint with the percent of patients whose BASDAI improves by two or more while on terbinafine (week 16) versus the percent of subjects with a similar improvement after 16 weeks of placebo.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
500mg oral terbinafine or placebo daily
Laboratory testing at screening, baseline, week 8, 16, 24 and 32.
Subjects with the potential to become pregnant will have a baseline urine pregnancy test prior to starting study drug.
Oregon Health & Science University
Portland, Oregon, United States
Change in BASDAI score
BASDAI score after the completion of 16 weeks of terbinafine treatment versus the BASDAI score after 16 weeks on placebo. Benefit is defined by a reduction of BASDAI score of 2 or more.
Time frame: 16 weeks
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