Terbinafine Treatment of Axial Spondyloarthropathy

  • STATUS
    Recruiting
  • End date
    Oct 15, 2024
  • participants needed
    20
  • sponsor
    Oregon Health and Science University
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Updated on 21 November 2021
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spondyloarthropathy
axial spondyloarthritis
spondyloarthropathies

Summary

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

Description

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.

Details
Condition Axial Spondyloarthopathy, Axial Spondyloarthritis, Psoriatic Spondylitis, Spondylitis Secondary to Inflammatory Bowel Disease, Ankylosing spondylitis, Ankylosing Spondylitis
Treatment Laboratory testing, Terbinafine Tablets
Clinical Study IdentifierNCT05119712
SponsorOregon Health and Science University
Last Modified on21 November 2021

Eligibility

 Yes No Not Sure

Inclusion Criteria

Subjects age 18 and older of either sex will be included
Subjects must be willing and able to provide informed consent
Subjects must have been diagnosed with ankylosing spondylitis, axial spondyloarthritis, psoriatic spondylitis or spondylitis secondary to inflammatory bowel disease by a physician and must be willing to request records to validate the diagnosis
Subjects must complete a symptom questionnaire called a BASDAI (Bath Ankylosing Spondylitis Disease Activity Index) and must have a score of four or above to indicate active disease and the potential to improve
Subjects must agree to remain on a stable treatment regimen for their joint disease for the duration of the trial and for one month before the study begins
Subjects must be willing to provide stool samples and be willing to have routine lab studies every 8 weeks during the duration of the study

Exclusion Criteria

Pregnant or lactating women will not be included
Subjects must not be allergic or intolerant to terbinafine
Subjects must not be taking medications that have the potential for serious interactions with terbinafine. These drugs include desipramine, cimetidine, fluconazole, cyclosporine and rifampin
Subjects must not have taken antibiotics within 3 months of starting the study drug and collecting the baseline stool specimen
Subjects with the following blood dyscrasias will not be included
Hemoglobin <9g/dL or Hematocrit <30% White blood cell count <3.0 K/cu mm
Absolute neutrophil count <1.2 K/cu mm Platelet count <100 K/cu mm Subjects
with an estimated GFR 50 ml/min Subjects with a total bilirubin, AST, or ALT
more than 1.5 times the upper limit of normal at screening
Severe, progressive, or uncontrolled chronic liver disease including fibrosis, cirrhosis, or recent or active hepatitis
History of any lymphoproliferative disorder such as Epstein Barr virus (EBV) related lymphoproliferative disorder, history of lymphoma, leukemia, or signs and symptoms suggest of current lymphatic disease
Current malignancy or history of malignancy, with the exception of adequately treated or excised non-metastatic basal cell or squamous cell cancer of the skin, or cervical carcinoma in situ
Have or have had an opportunistic infection (e.g., herpes zoster [shingles], cytomegalovirus, Pneumocystis carinii, aspergillosis and aspergilloma, histoplasmosis, or mycobacteria other than TB) within 6 months prior to screening
Have a known infection with human immunodeficiency virus (HIV)
Have current signs and symptoms of systemic lupus erythematosus, or severe, progressive, or uncontrolled renal, hepatic, hematologic, endocrine, pulmonary, cardiac (New York Heart Association class III or IV), neurologic, or cerebral diseases
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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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