Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE4
350 participants
INTERVENTIONAL
2003-06-30
2007-05-31
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
FACTORIAL
DOUBLE
Interventions
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Methotrexate
IV methylprednisolone
Eligibility Criteria
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Inclusion Criteria
* Diagnosis of MS
* A relapsing-remitting course
* Expanded Disability Status Scale (EDSS) score 0.0-5.5 inclusive at Baseline
* Currently receiving AVONEX® therapy
* Treated with AVONEX® for at least 6 consecutive months prior
* Breakthrough disease (clinical relapse or gadolinium-enhancing MRI lesion) during the prior 12 months, at least 6 months after initiating AVONEX therapy.
Exclusion Criteria
* History of poorly-controlled hypertension, diabetes mellitus, or peptic ulcer disease
* History of aseptic bone necrosis, osteoporosis, or osteoporosis-related bone fracture
* History of steroid-induced psychosis.
* History of or abnormal laboratory results indicating significant illness
* History of severe allergic or anaphylactic reactions or known drug hypersensitivity or intolerance to MTX, IVMP, or AVONEX®.
* History of allergy to albumin
* History of any episode of suicidal ideation or severe depression within 3 months of the Screening Visit.
* History of seizure within 3 months prior to the Screening Visit.
* Diagnosis of primary progressive, secondary progressive, or progressive relapsing MS
* MS relapse with onset within 60 days prior to the Baseline Visit
* Any metallic or electronic material or device in the body, or condition that precludes the subject from undergoing MRI with gadolinium administration
* A clinically significant infectious illness (e.g., cellulitis, abscess, pneumonia, septicemia) within 30 days of the Screening Visit
* Abnormal blood tests, performed at the Screening Visit, which exceed any of the limits defined by the study.
18 Years
55 Years
ALL
No
Sponsors
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Biogen
INDUSTRY
Responsible Party
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Biogen Idec
Principal Investigators
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Jeffrey A. Cohen, MD
Role: PRINCIPAL_INVESTIGATOR
The Cleveland Clinic
Locations
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MS Academic Coordinating Center
Cleveland, Ohio, United States
Countries
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Other Identifiers
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C-865
Identifier Type: -
Identifier Source: org_study_id