Efficacy and Safety of MEthylprednisolone Administered Intravenously for the Treatment of Patients With Active AnkyLosing spondyLitis (METALL)
This trial is active, not recruiting.
|Sponsor||Saratov State Medical University|
|Collaborator||Charite University, Berlin, Germany|
|Start date||July 2012|
|End date||March 2013|
|Trial size||20 participants|
|Trial identifier||NCT01790022, METALL 2012|
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.
|Endpoint classification||efficacy study|
|Intervention model||single group assignment|
Methylprednisolone 500 mg administered intravenously at baseline
The Assessment of Spondyloarthritis International Society 40 (ASAS40) response
time frame: Week 2
Male or female participants at least 18 years old.
- 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.
- 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.
|Official title||Efficacy and Safety of MEthylprednisolone Administered Intravenously for the Treatment of Patients With Active AnkyLosing spondyLitis (METALL) - a 12-week, Prospective, Open-label, Pilot Study|
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