Terbinafine Treatment of Axial Spondyloarthropathy

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.