Back to resultsEfficacy and Safety of MEthylprednisolone Administered Intravenously for the Treatment of Patients With Active AnkyLosing spondyLitis (METALL) (METALL)
Primary Purpose
Ankylosing Spondylitis
Status
Unknown status
Phase
Phase 2
Locations
Russian Federation
Study Type
Interventional
Intervention
Methylprednisolone
Sponsored by
About this trial
This is an interventional treatment trial for Ankylosing Spondylitis
Eligibility 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.
Sites / Locations
- Department of Rheumatology, Saratov Region Hospital
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Methylprednisolone 500 mg
Arm Description
Methylprednisolone 500 mg administered intravenously at baseline
Outcomes
Primary Outcome Measures
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)
Secondary Outcome Measures
Full Information
NCT ID
NCT01790022
First Posted
February 9, 2013
Last Updated
February 9, 2013
Sponsor
Saratov State Medical University
Collaborators
Charite University, Berlin, Germany
1. Study Identification
Unique Protocol Identification Number
NCT01790022
Brief Title
Efficacy and Safety of MEthylprednisolone Administered Intravenously for the Treatment of Patients With Active AnkyLosing spondyLitis (METALL)
Acronym
METALL
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 Type
Interventional
2. Study Status
Record Verification Date
February 2013
Overall Recruitment Status
Unknown status
Study Start Date
July 2012 (undefined)
Primary Completion Date
March 2013 (Anticipated)
Study Completion Date
undefined (undefined)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Saratov State Medical University
Collaborators
Charite University, Berlin, Germany
4. Oversight
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Ankylosing Spondylitis
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
20 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Methylprednisolone 500 mg
Arm Type
Experimental
Arm Description
Methylprednisolone 500 mg administered intravenously at baseline
Intervention Type
Drug
Intervention Name(s)
Methylprednisolone
Other Intervention Name(s)
Metypred, Medrol, Solu-Medrol
Primary Outcome Measure Information:
Title
The Assessment of Spondyloarthritis International Society 40 (ASAS40) response
Description
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)
Time Frame
Week 2
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Facility Information:
Facility Name
Department of Rheumatology, Saratov Region Hospital
City
Saratov
Country
Russian Federation
12. IPD Sharing Statement
Learn more about this trial
Efficacy and Safety of MEthylprednisolone Administered Intravenously for the Treatment of Patients With Active AnkyLosing spondyLitis (METALL)
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