Ankylosing Spondylitis Clinical Trial
— METALLOfficial 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
Verified date | February 2013 |
Source | Saratov State Medical University |
Contact | n/a |
Is FDA regulated | No |
Health authority | Russia: Ethics Committee |
Study type | Interventional |
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.
Status | Active, not recruiting |
Enrollment | 20 |
Est. completion date | |
Est. primary completion date | March 2013 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years and older |
Eligibility |
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) a 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. |
Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
Russian Federation | Department of Rheumatology, Saratov Region Hospital | Saratov |
Lead Sponsor | Collaborator |
---|---|
Saratov State Medical University | Charite University, Berlin, Germany |
Russian Federation,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | The Assessment of Spondyloarthritis International Society 40 (ASAS40) response | The Assessment of Spondyloarthritis International Society 40 (ASAS40) response is defined as an improvement of =40% and =2 points in at least 3 out of four following domains (and no worsening in remaining domain): Patient global Pain Function (as measured by the Bath Ankylosing Spondylitis Functional Index - BASFI) Inflammation (mean of the Bath Ankylosing Spondylitis Disease Activity Index - BASDAI question 5 and 6) |
Week 2 | No |
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