In this study, efficacy of methylprednisolone in reduction of signs and symptoms (back pain,
stiffness, joint pain and swelling) of active ankylosing spondylitis (AS) will be
investigated. It is expected, that a single dose of methylprednisolone 500 mg given
intravenously at baseline will lead to a rapid reduction of symptoms of active AS, which can
be seen already 2 weeks after drug administration.
Inclusion Criteria:
- Age of ≥18 years.
- Definite diagnosis of AS according to the modified New York criteria.
- History of an inadequate response to ≥2 nonsteroidal antiinflammatory drugs (NSAIDs)
taken for at least 2 weeks each or NSAIDs intolerance.
- Active disease as defined by the Bath Ankylosing Spondylitis DIsease Activity Index
(BASDAI) value of ≥4 at screening despite concomitant treatment with an NSAID or
without NSAIDs in case of intolerance.
Exclusion Criteria:
- The female subject is pregnant or lactating.
- Patients with other chronic inflammatory articular disease or systemic autoimmune
disease.
- History of inadequate response to previous anti-tumour necrosis factor (TNF) α
therapy.
- Treatment with any other investigational drug within 4 weeks of 5 half-life of the
drug (whichever is longer) prior to baseline.
- Treatments with disease modifying anti-rheumatic drugs (DMARDs) other than
methotrexate within 4 weeks prior to screening (8 weeks for leflunomide or 4 weeks
with a standard cholestyramine wash-out).
- Treatment with intravenous, intramuscular or intraarticular/periarticular steroids
within 4 weeks prior to screening.
- History of oesophageal, gastric, duodenal or intestinal ulceration, clinically
relevant gastrointestinal bleeding.
- History of or current signs of coronary heart disease, myocardial infarction, stroke
or transient ischemic attack, peripheral arterial thrombotic events.
- Congestive heart failure (NYHA III-IV)
- Uncontrolled arterial hypertension.
- History of diabetes mellitus.
- History of glaucoma.
- Major surgery within 12 weeks prior to screening.
- Evidence of any other severe uncontrolled gastrointestinal, hepatic, renal,
pulmonary, cardiovascular, nervous or endocrine disorders.
- Any active current viral, bacterial or fungal infection, a history of recurrent
clinically significant infection, infections requiring treatment with antibiotics
within 4 weeks prior to baseline.
- History of chronic infection with hepatitis B or C, history of HIV infection.
- Primary or secondary immunodeficiency.
- Any other conditions making the patient unsuitable in the opinion of the investigator
for the participation in the current study.
