Efficacy and Safety of MEthylprednisolone Administered Intravenously for the Treatment of Patients With Active AnkyLosing spondyLitis (METALL)

Overview

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.

Full Title of Study: “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”

Study Type

• Study Type: Interventional
• Study Design
  • Allocation: N/A
  • Intervention Model: Single Group Assignment
  • Primary Purpose: Treatment
  • Masking: None (Open Label)
• Study Primary Completion Date: March 2013

Interventions

• Drug: Methylprednisolone

Arms, Groups and Cohorts

• Experimental: Methylprednisolone 500 mg
  • Methylprednisolone 500 mg administered intravenously at baseline

Clinical Trial Outcome Measures

Primary Measures

• The Assessment of Spondyloarthritis International Society 40 (ASAS40) response
  • Time Frame: Week 2
  • 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)

Participating in This Clinical Trial

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.

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

• Lead Sponsor
  • Saratov State Medical University
• Collaborator
  • Charite University, Berlin, Germany
• Provider of Information About this Clinical Study
  • Principal Investigator: Denis Poddubnyy, MD – Saratov State Medical University