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Dose Escalation Study to Evaluate the Penetration and Pharmacodynamic Effects of Baminercept in the Cerebrospinal Fluid (CSF)and Safety in Subjects With Secondary Progressive Multiple Sclerosis (SPMS)

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ClinicalTrials.gov Identifier: NCT01181089
Recruitment Status : Withdrawn
First Posted : August 13, 2010
Last Update Posted : September 16, 2013
Sponsor:
Information provided by (Responsible Party):
Biogen

Study Description
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Brief Summary:
This is a prospective, randomized, multicenter, dose escalation study to determine subject safety, pharmacokinetic, and pharmacodynamic responses in patients with SPMS

Condition or disease Intervention/treatment Phase
Secondary Progressive Multiple Sclerosis Biological: Placebo Biological: Baminercept Phase 1 Phase 2

Detailed Description:
This study is a prospective, randomized, placebo-controlled, blinded, dose escalation study of 3 to 4 cohorts with defined number of patients per cohort receiving active drug or placebo for a period of 4 months followed by safety monitoring for an additional 4 months after the last dose
Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Official Title: A Multicenter, Randomized, Blinded, Placebo-Controlled, Dose Escalation Study to Evaluate the Penetration and Pharmacodynamic Effects of Baminercept in the Cerebrospinal Fluid (CSF) and Safety in Subjects With Secondary Progressive Multiple Sclerosis
Study Start Date : September 2010

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Arms and Interventions
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Outcome Measures
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Primary Outcome Measures :
  1. Measure: Change in cerebrospinal fluid levels of secondary lymphoid organs chemokines from baseline with baminercept relative to placebo [ Time Frame: after 4 months of treatment ]

Secondary Outcome Measures :
  1. Number of subjects experiencing Serious Adverse Event (SAE) and Adverse Event (AE) with baminercept relative to placebo [ Time Frame: 8 months (4 months on drug, 4 months post-drug) ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years to 57 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • A diagnosis of Secondary Progressive Multiple Sclerosis
  • Aged 18 to 57 years old, at the time of informed consent

Exclusion Criteria:

  • History of clinically important (as determined by the investigator) cardiac, endocrinologic, pulmonary, neurologic, immune, psychiatric, hepatic, renal or hematologic insufficiency or any other major disease other than MS ( Multiple Sclerosis)
  • Inability in the opinion of the Investigator to comply with study requirements
  • Other protocol-defined criteria may apply
Contacts and Locations
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No Contacts or Locations Provided
More Information
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Responsible Party: Biogen
ClinicalTrials.gov Identifier: NCT01181089    
Other Study ID Numbers: 104MS101
First Posted: August 13, 2010    Key Record Dates
Last Update Posted: September 16, 2013
Last Verified: January 2012
Additional relevant MeSH terms:
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Neoplasm Metastasis
Multiple Sclerosis
Multiple Sclerosis, Chronic Progressive
Sclerosis
Pathologic Processes
Demyelinating Autoimmune Diseases, CNS
Autoimmune Diseases of the Nervous System
 Nervous System Diseases
Demyelinating Diseases
Autoimmune Diseases
Immune System Diseases
Neoplastic Processes
Neoplasms