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Trial record 2 of 21 for:    "Bone Disease" | "Prednisolone phosphate"

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

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ClinicalTrials.gov Identifier: NCT01790022
Recruitment Status : Unknown
Verified February 2013 by Denis Poddubnyy, Saratov State Medical University.
Recruitment status was:  Active, not recruiting
First Posted : February 12, 2013
Last Update Posted : February 12, 2013
Sponsor:
Collaborator:
Charite University, Berlin, Germany
Information provided by (Responsible Party):
Denis Poddubnyy, Saratov State Medical University

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Ankylosing Spondylitis Drug: Methylprednisolone Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 20 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Study Start Date : July 2012
Estimated Primary Completion Date : March 2013


Arm Intervention/treatment
Experimental: Methylprednisolone 500 mg
Methylprednisolone 500 mg administered intravenously at baseline
Drug: Methylprednisolone
Other Name: Metypred, Medrol, Solu-Medrol




Primary Outcome Measures :
  1. 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)



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01790022


Locations
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Russian Federation
Department of Rheumatology, Saratov Region Hospital
Saratov, Russian Federation
Sponsors and Collaborators
Saratov State Medical University
Charite University, Berlin, Germany

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Responsible Party: Denis Poddubnyy, MD, Saratov State Medical University
ClinicalTrials.gov Identifier: NCT01790022     History of Changes
Other Study ID Numbers: METALL 2012
First Posted: February 12, 2013    Key Record Dates
Last Update Posted: February 12, 2013
Last Verified: February 2013
Additional relevant MeSH terms:
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Bone Diseases, Infectious
Bone Diseases
Methylprednisolone
Methylprednisolone Acetate
Methylprednisolone Hemisuccinate
Prednisolone
Prednisolone acetate
Prednisolone hemisuccinate
Prednisolone phosphate
Spondylitis
Spondylitis, Ankylosing
Infection
Musculoskeletal Diseases
Spinal Diseases
Spondylarthropathies
Spondylarthritis
Ankylosis
Joint Diseases
Arthritis
Anti-Inflammatory Agents
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Gastrointestinal Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Neuroprotective Agents
Protective Agents