Tysabri Effects on Cognition and Neurodegeneration in Multiple Sclerosis

This study is currently recruiting participants. (see Contacts and Locations)
Verified December 2013 by University of Chicago
Sponsor:
Collaborator:
Biogen Idec
Information provided by (Responsible Party):
University of Chicago
ClinicalTrials.gov Identifier:
NCT01071512
First received: February 17, 2010
Last updated: December 6, 2013
Last verified: December 2013
  Purpose

The long-term objective is to further establish the role of Tysabri in preventing neurological degeneration in multiple sclerosis (MS) and to establish powerful and efficient new markers for neurological degeneration in MS. The study intends to correlate cognition with two instruments and their measurements-MRI and OCT (optical coherence tomography).


Condition Intervention
Multiple Sclerosis
Drug: Tysabri

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Tysabri Effects on Cognition and Neurodegeneration in Multiple Sclerosis

Resource links provided by NLM:


Further study details as provided by University of Chicago:

Primary Outcome Measures:
  • specific MRI parameters and RNFL (retinal nerve fiber layer) thickness in OCT optical coherence tomography in correlation with cognition measurements [ Time Frame: 2 years ] [ Designated as safety issue: No ]

Estimated Enrollment: 20
Study Start Date: April 2010
Estimated Study Completion Date: January 2016
Estimated Primary Completion Date: January 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Tysabri, less than 2 years of disease
Group 1, numbering 10 subjects, includes subjects with MS disease duration less than 2 years and who are naïve to a disease modifying treatment for MS or have failed 1 disease modifying treatment.
Drug: Tysabri
Infuse TYSABRI® 300 mg in 100 mL 0.9% Sodium Chloride Injection, USP over approximately one hour. After the infusion is complete, flush with 0.9% Sodium Chloride Injection, USP. Tysabri will be infused every four weeks.
Other Name: Natalizumab
Active Comparator: Tysabri, more than 2 years of disease
Group 2, numbering 10 subjects, includes subjects with MS disease duration more than 2 years and who have failed 1 0r more disease modifying treatment for MS.
Drug: Tysabri
Infuse TYSABRI® 300 mg in 100 mL 0.9% Sodium Chloride Injection, USP over approximately one hour. After the infusion is complete, flush with 0.9% Sodium Chloride Injection, USP. Tysabri will be infused every four weeks.
Other Name: Natalizumab

Detailed Description:

The specific aims are:

  1. To determine the effects of Tysabri on cognition (memory, thought processes, etc.)
  2. To determine the effects of Tysabri on specific MRI markers for cognitive dysfunction
  3. To determine the effects of Tysabri on retinal nerve fiber layer thickness (RNFL) using optical coherence tomography (OCT), a special instrument used in ophthalmology
  Eligibility

Ages Eligible for Study:   18 Years to 60 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 18 through 60 years of age inclusive
  • Diagnosis of relapsing remitting multiple sclerosis
  • Prior to treatment phase, have had disease activity with at least 1 documented relapse during the previous year OR 2 documented relapses during the previous 2 years OR one or more new MRI lesions (Gd+ and/or T2 hyperintense)
  • An Expanded Disability Status Scale (EDSS) score of 0-4.5 inclusive
  • Neurologically stable with no evidence of relapse or corticosteroid treatment within 30 days prior to treatment
  • Never been treated with Tysabri/natalizumab.

Exclusion Criteria:

  • Another type of MS other than relapsing remitting multiple sclerosis (RRMS)
  • A history of chronic disease of the immune system other than MS or a known immunodeficiency syndrome/immunocompromised
  • A history or presence of cancer (except for successfully treated basal or squamous cell carcinoma of skin)
  • Active systemic bacterial, viral or fungal infections, or diagnosis of AIDS, Hepatitis B, Hepatitis C infection defined as a positive HIV antibody, Hepatitis B surface antigen or Hepatitis C antibody tests, respectively
  • Have received any live or live attenuated vaccines (including for varicella-zoster virus or Measles) within the last 2 months
  • Have received total lymphoid irradiation or bone marrow transplantation
  • Have been treated with: corticosteroids or adrenocorticotropic hormones (ACTH) within the last month, IFN-β or glatiramer acetate within the last 3 months, immunosuppressive medications such as azathioprine or methotrexate within the last 6 months, immunoglobulins and/or monoclonal antibodies (including natalizumab) within the last 6 months, or cladribine, cyclophosphamide or mitoxantrone at any time.
  • Any medically unstable condition or a progressive neurological disorder, other than MS, which may affect participation in the study
  • History of any clinically significant cardiac, endocrinologic, hematologic, hepatic, immunologic, metabolic, urologic, pulmonary, neurologic, dermatologic, psychiatric, renal or other major disease
  • Unable to undergo MRI scans, including claustrophobia, have a pacemaker or history of hypersensitivity to gadolinium-DTPA
  • Have had a relapse within 30 days prior AND/OR not stabilized from a previous relapse
  • History of severe allergic or anaphylactic reactions or known drug hypersensitivity to natalizumab/Tysabri
  • A clinically significant infectious disease, such as cellulitis, pneumonia, septicemia
  • History of progressive multifocal leukoencephalopathy(PML)
  • Participation in any clinical research study evaluating another investigational drug or therapy within the last 6 months
  • History of Tysabri therapy
  • Abnormal screening blood test
  • Females who are not postmenopausal for at least 1 year, surgically sterile or willing to practice effective contraception during the study
  • Nursing mothers, pregnant women, and women planning to become pregnant while on study
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01071512

Contacts
Contact: Jacqueline Bernard, M.D. 773-702-4820 jbernard@neurology.bsd.uchicago.edu
Contact: Jessica Peyton 773-702-0159 jpeyton@neurology.bsd.uchicago.edu

Locations
United States, Illinois
University of Chicago Recruiting
Chicago, Illinois, United States, 60637
Contact: Jacqueline Bernard, M.D.    773-702-4820    jbernard@neurology.bsd.uchicago.edu   
Contact: Jessica Peyton    773-702-0159    jpeyton@neurology.bsd.uchicago.edu   
Principal Investigator: Jacqueline Bernard, M.D.         
Sponsors and Collaborators
University of Chicago
Biogen Idec
Investigators
Principal Investigator: Jacqueline Bernard, M.D. University of Chicago
  More Information

No publications provided

Responsible Party: University of Chicago
ClinicalTrials.gov Identifier: NCT01071512     History of Changes
Other Study ID Numbers: 10-094A
Study First Received: February 17, 2010
Last Updated: December 6, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by University of Chicago:
MRI
OCT
Tysabri
Multiple Sclerosis
cognition

Additional relevant MeSH terms:
Multiple Sclerosis
Nerve Degeneration
Sclerosis
Demyelinating Autoimmune Diseases, CNS
Autoimmune Diseases of the Nervous System
Nervous System Diseases
Demyelinating Diseases
Autoimmune Diseases
Immune System Diseases
Pathologic Processes

ClinicalTrials.gov processed this record on July 22, 2014