Tysabri Effects on Cognition and Neurodegeneration in Multiple Sclerosis

NCT01071512 | Completed Results

• 1 other identifier: 10-094A
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

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).

Conditions

Multiple Sclerosis

Keywords

MRI; OCT; Tysabri; Multiple Sclerosis; cognition

Outcome Measures

Primary Outcomes (1)

• Change in Cognitive Function Over Time

  Cognitive function was assessed using the oral version of the Symbol Digit Modalities Test (SDMT). The number of correct responses in 90 seconds was recorded (possible range 0-110). For analysis, SDMT scores were converted to z-scores using published age and education based norms. A negative z-score indicates a SDMT score below the mean based on the age and education based norms, for example a z-score of -2 = 2 standard deviations below the mean; a positive z-score indicating a score above the mean. Higher scores indicate better cognitive function.

  Baseline, 48 weeks, 96 weeks

Secondary Outcomes (4)

• Change Over Time in Retinal Nerve Fiber Layer Thickness

  Baseline, 24, 48, 72, and 96 weeks

• Change Over Time in Brain Parenchymal Fraction

  Baseline, 48 weeks, 96 weeks

• Change Over Time in Normalized Thalamic Volume

  Baseline, 48 weeks, 96 weeks

• Change Over Time in Normalized Hippocampal Volume

  Baseline, 48 weeks, 96 weeks

Study Arms (1)

Tysabri

EXPERIMENTAL

Natalizumab 300 mg IV every 4 weeks

Drug: Tysabri

Interventions

Tysabri DRUG

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.

Also known as: Natalizumab

Tysabri

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Chicago: lead
• Biogen: collaborator

Study Sites (1)

University of Chicago

Chicago, Illinois, 60637, United States

Location

MeSH Terms

Conditions

Multiple Sclerosis

Interventions

Natalizumab

Condition Hierarchy (Ancestors)

Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Nervous System Diseases; Demyelinating Diseases; Autoimmune Diseases; Immune System Diseases

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Results Point of Contact

• Title: Dr. Adil Javed
• Organization: University of Chicago

ajaved@neurology.bsd.uchicago.edu

773.834.0558

Study Officials

• Jacqueline Bernard, M.D.

  University of Chicago

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 17, 2010
• First Posted: February 19, 2010
• Study Start: April 1, 2010
• Primary Completion: January 1, 2016
• Study Completion: January 1, 2016
• Last Updated: October 25, 2017
• Results First Posted: September 6, 2017

Record last verified: 2017-09

Locations

US (1)