Observational Study of Tysabri in Early Relapsing-Remitting Multiple Sclerosis in Anti-JC Virus Antibody Negative Participants (STRIVE)

February 11, 2019 updated by: Biogen

A Multicenter, Observational, Open-Label, Single-Arm Study of Tysabri in Early Relapsing-Remitting Multiple Sclerosis in Anti-JCV Antibody Negative Patients

The primary objective of the study is to determine which baseline and yearly response factors (clinical and para clinical) predict overall disease-free status at Month 12 and Month 24, and clinical disease-free status in subsequent Months 36 and 48. The secondary objectives are: To identify prognostic factors at Baseline that predict overall disease-free status at Month 12, and to assess if yearly overall disease-free response factors predict overall disease-free status at Month 24; To evaluate clinical disease-free status (relapse, Expanded Disability Status Scale [EDSS]) at each analysis time point of Months 12, 24, 36, and 48; To identify prognostic factors at Baseline that predict clinical disease-free status at Month 12, and to assess yearly clinical disease-free response factors that predict clinical disease-free status (relapse, EDSS) in subsequent years at Months 24, 36, and 48; To evaluate the impact of Tysabri at each analysis time point of Months 12, 24, 36, and 48 on the following: annualized relapse rate (ARR), sustained EDSS progression and improvement (24-week sustained); To evaluate the impact of Tysabri at each analysis time point of Months 12, 24, 36, and 48 on the following: magnetic resonance image (MRI) measures: T2, T1, T1 with Gadolinium (Gd), brain atrophy; To evaluate the impact of Tysabri at Month 24 and Month 48 on the following: optical coherence tomography (OCT), Low and High Contrast Visual Acuity Assessment; To evaluate the impact of Tysabri at each analysis time point of Months 12, 24, 36, and 48 on the following: cognitive impairment (Symbol Digit Modalities Test [SDMT]), capacity for work (Work Productivity and Activity Impairment Questionnaire [WPAI]), quality of life (QoL) (Multiple Sclerosis Impact Scale [MSIS-29])

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
231

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Alabama
      • Homewood, Alabama, United States, 35209
        • Research Site
    • Arizona
      • Sun City, Arizona, United States, 85351
        • Research Site
    • California
      • La Jolla, California, United States, 92037
        • Research Site
      • Los Angeles, California, United States, 90032
        • Research Site
    • Colorado
      • Aurora, Colorado, United States, 80045
        • Research Site
      • Fort Collins, Colorado, United States, 80528
        • Research Site
    • Delaware
      • Newark, Delaware, United States, 19713
        • Research Site
    • District of Columbia
      • Washington, District of Columbia, United States, 20007
        • Research Site
    • Florida
      • Jacksonville, Florida, United States, 32209
        • Research Site
    • Georgia
      • Atlanta, Georgia, United States, 30309
        • Research Site
    • Illinois
      • Chicago, Illinois, United States, 60612
        • Research Site
      • Lake Barrington, Illinois, United States, 60010
        • Research Site
      • Peoria, Illinois, United States, 61603
        • Research Site
    • Indiana
      • Indianapolis, Indiana, United States, 46260
        • Research Site
      • Indianapolis, Indiana, United States, 46256
        • Research Site
    • Kansas
      • Overland Park, Kansas, United States, 66212
        • Research Site
    • Kentucky
      • Louisville, Kentucky, United States, 40207
        • Research Site
    • Louisiana
      • New Orleans, Louisiana, United States, 70121
        • Research Site
    • Maryland
      • Baltimore, Maryland, United States, 21287
        • Research Site
    • Massachusetts
      • Boston, Massachusetts, United States, 02215
        • Research Site
      • Lexington, Massachusetts, United States, 02421
        • Research Site
      • Wellesley Hills, Massachusetts, United States, 02481
        • Research Site
      • Worcester, Massachusetts, United States, 01655
        • Research Site
    • Michigan
      • East Lansing, Michigan, United States, 48824
        • Research Site
    • Nebraska
      • Lincoln, Nebraska, United States, 68521
        • Research Site
    • New Jersey
      • Freehold, New Jersey, United States, 07728
        • Research Site
    • New York
      • New York, New York, United States, 10016
        • Research Site
      • New York, New York, United States, 10021
        • Research Site
      • Patchogue, New York, United States, 11772
        • Research Site
      • Plainview, New York, United States, 11803
        • Research Site
      • Staten Island, New York, United States, 10306
        • Research Site
      • Stony Brook, New York, United States, 11794
        • Research Site
    • Ohio
      • Cincinnati, Ohio, United States, 45219
        • Research Site
      • Cleveland, Ohio, United States, 44195
        • Research Site
      • Gahanna, Ohio, United States, 43230
        • Research Site
      • Uniontown, Ohio, United States, 44685
        • Research Site
    • Oregon
      • Portland, Oregon, United States, 97225
        • Research Site
    • Texas
      • Dallas, Texas, United States, 75235
        • Research Site
      • Round Rock, Texas, United States, 78681
        • Research Site
    • Utah
      • Salt Lake City, Utah, United States, 84103
        • Research Site
    • Virginia
      • Newport News, Virginia, United States, 23601
        • Research Site
      • Norfolk, Virginia, United States, 23502
        • Research Site
    • Washington
      • Seattle, Washington, United States, 98101
        • Research Site
      • Tacoma, Washington, United States, 98405
        • Research Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Study participants will be recruited by participating neurologists from among their MS patients who opt to begin treatment with Tysabri.

Description

Key Inclusion Criteria:

  • Documented diagnosis of Relapsing Multiple Sclerosis (McDonald 2010 Criteria ).
  • <3 year disease duration.
  • Must have an Expanded Disability Status Scale (EDSS) score from 0 to 4.0, inclusive.
  • Anti-JCV antibody negative test within 6 months of Screening Visit.
  • Must satisfy the approved therapeutic indications for Tysabri.
  • Must be treatment-naïve to disease-modifying therapy (DMT) or have been treated with DMT (including but not limited to Avonex, Betaseron, Rebif, Copaxone, Extavia, or Gilenya) for ≤36 months total prior to date of informed consent.
  • Decision to treat with Tysabri must precede enrollment.

Key Exclusion Criteria:

  • Any prior treatment with Tysabri.
  • Anti-JCV antibody positive at any timepoint prior to the Screening Visit.
  • Contraindications to treatment with Tysabri as described in the US Prescribing Information.
  • History of progressive multifocal leukoencephalopathy (PML) or other opportunistic infections, or an increased risk for such infections.
  • History of diagnosis of Primary Progressive Multiple Sclerosis (PPM) and/or Secondary Progressive Multiple Sclerosis (SPMS).
  • Receiving immunomodulatory or immunosuppressive therapy.
  • Prior history of immunosuppressive use (mitoxantrone, azathioprine, methotrexate, cyclophosphamide, mycophenolate, cladribine, rituximab).
  • Immunocompromised at the time of enrollment.
  • Known active malignancies (subjects with cutaneous basal cell carcinoma that has been completely excised prior to study entry remain eligible).
  • Women breastfeeding, pregnant, or planning to become pregnant; women who are not post-menopausal or surgically sterile who are unwilling to practice contraception.
  • Inability to comply with study requirements.

NOTE: Other protocol defined Inclusion/Exclusion criteria may apply.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Proportion of Participants who are overall disease activity-free at Months 12 and 24
Time Frame: Baseline and Months 12 and 24
Overall disease activity-free is defined as no relapses, no disability progression (RRMS), and absence of MRI disease activity (no gadolinium [gd])+ lesions, no new or enlarging T2-hyperintense lesions). A clinical relapse is defined as new or recurrent neurological symptoms, not associated with fever, lasting for at least 24 hours, and followed by a period of 30 days of stability or improvement. Sustained disability progression defined by at least a 1.0-point increase on the EDSS from a Baseline EDSS ≥1.0 that is sustained for 12 or 24 weeks, or at least a 1.5-point increase on the EDSS from a Baseline EDSS <1.0 that is sustained for 12 or 24 weeks. The EDSS measures the disability status of people with multiple sclerosis on a scale that ranges from 0 to 10, with higher scores indicating more disability.
Baseline and Months 12 and 24
Proportion of participants who are clinical disease activity-free at Months 36 and 48
Time Frame: Baseline and Months 36 and 48
Clinical disease activity-free is defined as no sustained EDSS progression and no relapses at Month 36 and 48.
Baseline and Months 36 and 48

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Identification of baseline prognostic factors that predict overall disease-free status
Time Frame: Baseline and Month 12
Baseline and Month 12
Identification of yearly overall disease-free response factors that predict overall disease-free status
Time Frame: Month 12 and Month 24
Month 12 and Month 24
Number of Participants with Clinical Disease-Free Status Measured by Relapses
Time Frame: Months 12, 24, 36, and 48
A clinical relapse is a new or recurrent neurological symptoms, not associated with fever, lasting for at least 24 hours, and followed by a period of 30 days of stability or improvement.
Months 12, 24, 36, and 48
Identification of baseline prognostic factors that predict clinical disease-free status
Time Frame: Month 12
Month 12
Identification of yearly clinical disease-free response factors that predict clinical disease-free status
Time Frame: Months 24, 36 and 48
Months 24, 36 and 48
Annualized Relapse Rate
Time Frame: Months 12, 24, 36, and 48
A clinical relapse is defined as new or recurrent neurological symptoms, not associated with fever, lasting for at least 24 hours, and followed by a period of 30 days of stability or improvement. The ARR will be calculated by tabulating the total number of relapses experienced in the group divided by the number of days up to the end of study, and the ratio then multiplied by 365.
Months 12, 24, 36, and 48
Percentage of participants with Sustained EDSS progression
Time Frame: Baseline and Months 12, 24, 36, and 48
Baseline and Months 12, 24, 36, and 48
Sustained EDSS improvement
Time Frame: Baseline and Months 12, 24, 36, and 48
Sustained improvement in disability is defined as participants with Baseline EDSS of at least 2.0 who experience a ≥1.0 decrease in EDSS that is sustained for 24 weeks.
Baseline and Months 12, 24, 36, and 48
Change form baseline in number of new or newly enlarging T2 hyperintense lesions as assessed by MRI
Time Frame: Baseline and Months 12, 24, 36, and 48
Baseline and Months 12, 24, 36, and 48
Change from baseline in number of new T1 hypointense lesions as assessed by MRI
Time Frame: Baseline and Months 12, 24, 36, and 48
Baseline and Months 12, 24, 36, and 48
Change form baseline in number of T1 lesions with Gd-enhancing lesions as assessed by MRI
Time Frame: Baseline and Months 12, 24, 36, and 48
Baseline and Months 12, 24, 36, and 48
MRI brain atrophy as assessed by MRI
Time Frame: Baseline and Months 12, 24, 36, and 48
Baseline and Months 12, 24, 36, and 48
Change from baseline in retinal nerve fiber layer (RNFL) thickness as assessed by OCT
Time Frame: Baseline and Month 24 and Month 48
Baseline and Month 24 and Month 48
Change from baseline in low contrast visual acuity
Time Frame: Baseline and Month 24 and Month 48
Low-contrast visual acuity testing captures the minimum size at which individuals can perceive letters of a particular contrast level (shade of gray on white background). Using the low-contrast Sloan letter charts at 2.5% and 1.25% low contrast levels, participants will be asked to read each of the 2 charts at a 2-meter distance using a standardized testing protocol.
Baseline and Month 24 and Month 48
Change from baseline in high contrast visual acuity
Time Frame: Baseline and Month 24 and Month 48
High contrast acuity testing is important to help determine the smallest letters a person can read on a standardized visual acuity chart or on a card held 14 - 20 feet away. A visual acuity test is a routine part of an eye examination.
Baseline and Month 24 and Month 48
Cognitive impairment as assessed by change from baseline in SDMT
Time Frame: Baseline and Months 12, 24, 36 and 48
SDMT is a screening test for cognitive impairment. Participants are given 90 seconds in which to pair specific numbers with given geometric figures using a key. Scores range from 0 to 110 (best).
Baseline and Months 12, 24, 36 and 48
Capacity for work as assessed by change from baseline in WPAI questionnaire
Time Frame: Baseline and Months 12, 24, 36 and 48
The Work Productivity and Activity Impairment (WPAI) questionnaire is a validated instrument to measure impairments in work and activities. The WPAI yields four types of scores: 1. Absenteeism (work time missed) 2. Presenteeism (impairment at work / reduced on-the-job effectiveness) 3. Work productivity loss (overall work impairment / absenteeism plus presenteeism) 4. Activity Impairment WPAI outcomes are expressed as impairment percentages, with higher numbers indicating greater impairment and less productivity.
Baseline and Months 12, 24, 36 and 48
Quality of Life as measured by MSIS-29
Time Frame: Baseline and Months 12, 24, 36 and 48
The 29-item Multiple Sclerosis Impact Scale (MSIS-29) is a participant-reported outcome measure to assess the impact of MS on day-to-day life during the past 2 weeks from a participant's perspective; it measures 20 physical items and 9 psychological items. The physical score is generated by summing individual items and then transforming to a scale with a range of 0 to 100, where high scores indicate worse health.
Baseline and Months 12, 24, 36 and 48
Number of Participants with Clinical Disease-Free Status Measured by EDSS
Time Frame: Months 12, 24, 36 and 48
Expanded Disability Status Scale (EDSS) is a method of quantifying disability in 8 Functional Systems (FS) and allows neurologists to assign a Functional System Score (FSS) in each of these. The FSS include pyramidal, cerebellar, brainstem, sensory, bowel and bladder, visual, cerebral (or mental), and other. Each of the FSS is an ordinal clinical rating scale ranging from 0 to 5 or 6, with higher scores indicating more disability. These ratings are then used in conjunction with observations and information concerning gait and use of assistive devices to rate the EDSS. The EDSS is an ordinal clinical rating scale ranging from 0 (normal neurologic examination) to 10 (death due to MS) in half-point increments. Each of the FSS and the EDSS are single-item scales and there is no composite or summed score.
Months 12, 24, 36 and 48

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Biogen

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
February 7, 2012

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
November 26, 2018

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
November 26, 2018

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
December 1, 2011

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 2, 2011

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
December 5, 2011

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
February 12, 2019

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 11, 2019

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
February 1, 2019

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 101MS407

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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