Relapsing-Remitting Multiple SclerosisSTRIVENCT01485003
Observational Study of Tysabri in Early Relapsing-Remitting Multiple Sclerosis in Anti-JC Virus Antibody Negative Participants
An observational study of Relapsing-Remitting Multiple Sclerosis, run by Biogen at 44 sites in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Relapsing-Remitting Multiple Sclerosis
- What is being tested?
- natalizumab
- How many people
- 231 participants
- Where
- 44 sitesUnited States
- Study dates
- 7 Feb 2012to 26 Nov 2018
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Study participants will be recruited by participating neurologists from among their MS patients who opt to begin treatment with Tysabri.
Who may be able to join
- 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.
Who cannot join
- 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.
Show all 12Show fewer
- 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.
Trial locations and contacts
44 sites in 1 country.
44 sites in 1 country
United States44 sites
Research Site
Atlanta, Georgia, 30309
Research Site
Aurora, Colorado, 80045
Research Site
Baltimore, Maryland, 21287
Research Site
Boston, Massachusetts, 02215
Research Site
Chicago, Illinois, 60612
Research Site
Cincinnati, Ohio, 45219
Research Site
Cleveland, Ohio, 44195
Research Site
Dallas, Texas, 75235
Research Site
East Lansing, Michigan, 48824
Research Site
Fort Collins, Colorado, 80528
Research Site
Freehold, New Jersey, 07728
Research Site
Gahanna, Ohio, 43230
Research Site
Homewood, Alabama, 35209
Research Site
Indianapolis, Indiana, 46256
Research Site
Indianapolis, Indiana, 46260
Research Site
Jacksonville, Florida, 32209
Research Site
La Jolla, California, 92037
Research Site
Lake Barrington, Illinois, 60010
Research Site
Lexington, Massachusetts, 02421
Research Site
Lincoln, Nebraska, 68521
Research Site
Los Angeles, California, 90032
Research Site
Louisville, Kentucky, 40207
Research Site
New Orleans, Louisiana, 70121
Research Site
New York, New York, 10016
Research Site
New York, New York, 10021
Research Site
Newark, Delaware, 19713
Research Site
Newport News, Virginia, 23601
Research Site
Norfolk, Virginia, 23502
Research Site
Overland Park, Kansas, 66212
Research Site
Patchogue, New York, 11772
Research Site
Peoria, Illinois, 61603
Research Site
Plainview, New York, 11803
Research Site
Portland, Oregon, 97225
Research Site
Round Rock, Texas, 78681
Research Site
Salt Lake City, Utah, 84103
Research Site
Seattle, Washington, 98101
Research Site
Staten Island, New York, 10306
Research Site
Stony Brook, New York, 11794
Research Site
Sun City, Arizona, 85351
Research Site
Tacoma, Washington, 98405
Research Site
Uniontown, Ohio, 44685
Research Site
Washington D.C., District of Columbia, 20007
Research Site
Wellesley Hills, Massachusetts, 02481
Research Site
Worcester, Massachusetts, 01655
About this study
Official title: 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])
- Conditions
- Relapsing-Remitting Multiple Sclerosis
- Being tested
- natalizumab
- Medical subject headings
- Multiple Sclerosis, Relapsing-Remitting
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
natalizumabBiological
Also called BG00002, Tysabri
Natalizumab will not be provided as a part of this study. Participants will receive natalizumab as prescribed by their treating physician.
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of Participants who are overall disease activity-free at 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.
Measured: Baseline and Months 12 and 24
Proportion of participants who are clinical disease activity-free at Months 36 and 48
Clinical disease activity-free is defined as no sustained EDSS progression and no relapses at Month 36 and 48.
Measured: Baseline and Months 36 and 48
Secondary outcomes (19)
Identification of baseline prognostic factors that predict overall disease-free status
Measured: Baseline and Month 12
Identification of yearly overall disease-free response factors that predict overall disease-free status
Measured: Month 12 and Month 24
Number of Participants with Clinical Disease-Free Status Measured by Relapses
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.
Measured: Months 12, 24, 36, and 48
Identification of baseline prognostic factors that predict clinical disease-free status
Measured: Month 12
Identification of yearly clinical disease-free response factors that predict clinical disease-free status
Measured: Months 24, 36 and 48
Annualized Relapse Rate
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.
Measured: Months 12, 24, 36, and 48
Percentage of participants with Sustained EDSS progression
Measured: Baseline and Months 12, 24, 36, and 48
Sustained EDSS improvement
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.
Measured: 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
Measured: Baseline and Months 12, 24, 36, and 48
Change from baseline in number of new T1 hypointense lesions as assessed by MRI
Measured: Baseline and Months 12, 24, 36, and 48
Change form baseline in number of T1 lesions with Gd-enhancing lesions as assessed by MRI
Measured: Baseline and Months 12, 24, 36, and 48
MRI brain atrophy as assessed by MRI
Measured: Baseline and Months 12, 24, 36, and 48
Change from baseline in retinal nerve fiber layer (RNFL) thickness as assessed by OCT
Measured: Baseline and Month 24 and Month 48
Change from baseline in low contrast visual acuity
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.
Measured: Baseline and Month 24 and Month 48
Change from baseline in high contrast visual acuity
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.
Measured: Baseline and Month 24 and Month 48
Cognitive impairment as assessed by change from baseline in SDMT
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).
Measured: Baseline and Months 12, 24, 36 and 48
Capacity for work as assessed by change from baseline in WPAI questionnaire
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.
Measured: Baseline and Months 12, 24, 36 and 48
Quality of Life as measured by MSIS-29
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.
Measured: Baseline and Months 12, 24, 36 and 48
Number of Participants with Clinical Disease-Free Status Measured by EDSS
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.
Measured: Months 12, 24, 36 and 48
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Dec 2011 (estimated)
- Study start7 Feb 2012
- Primary completion26 Nov 2018
- Study completion26 Nov 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Relapsing-Remitting Multiple SclerosisStudies of the same condition, open and under way.
- More trials run by BiogenThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 231 participants (actual)
Sponsor and investigators
- Lead sponsor
- Biogen
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Medical Director, Study director, Biogen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01485003
- Sponsor's protocol ID
- 101MS407
- Acronym
- STRIVE
- Status last verified
- Feb 2019
- First submitted
- 1 Dec 2011
- Last updated
- 12 Feb 2019
- Results posted
- No
Publications
Perumal J, Balabanov R, Balcer L, Galetta S, Sun Z, Li H, Rutledge D, Avila RL, Fox RJ. Long-Term Effectiveness and Safety of Natalizumab in African American and Hispanic/Latino Patients with Early Relapsing-Remitting Multiple Sclerosis: STRIVE Data Analysis. Neurol Ther. 2023 Jun;12(3):833-848. doi: 10.1007/s40120-023-00461-0. Epub 2023 Mar 26.
PubMed 36966440Perumal J, Balabanov R, Su R, Chang R, Balcer LJ, Galetta SL, Avila RL, Rutledge D, Fox RJ. Correction to: Improvements in Cognitive Processing Speed, Disability, and Patient-Reported Outcomes in Patients with Early Relapsing-Remitting Multiple Sclerosis Treated with Natalizumab: Results of a 4-year, Real-World, Open-Label Study. CNS Drugs. 2023 Mar;37(3):275-289. doi: 10.1007/s40263-022-00982-6.
PubMed 36780107Perumal J, Balabanov R, Su R, Chang R, Balcer LJ, Galetta SL, Avila RL, Rutledge D, Fox RJ. Improvements in Cognitive Processing Speed, Disability, and Patient-Reported Outcomes in Patients with Early Relapsing-Remitting Multiple Sclerosis Treated with Natalizumab: Results of a 4-year, Real-World, Open-Label Study. CNS Drugs. 2022 Sep;36(9):977-993. doi: 10.1007/s40263-022-00950-0. Epub 2022 Sep 5.
PubMed 36064841Perumal J, Balabanov R, Su R, Chang R, Balcer L, Galetta S, Campagnolo DI, Avila R, Lee L, Rutledge D, Fox RJ. Natalizumab in Early Relapsing-Remitting Multiple Sclerosis: A 4-Year, Open-Label Study. Adv Ther. 2021 Jul;38(7):3724-3742. doi: 10.1007/s12325-021-01722-w. Epub 2021 May 20.
PubMed 34014549Perumal J, Fox RJ, Balabanov R, Balcer LJ, Galetta S, Makh S, Santra S, Hotermans C, Lee L. Outcomes of natalizumab treatment within 3 years of relapsing-remitting multiple sclerosis diagnosis: a prespecified 2-year interim analysis of STRIVE. BMC Neurol. 2019 Jun 8;19(1):116. doi: 10.1186/s12883-019-1337-z.
PubMed 31176355
Study at a glance
From the registry record, last updated by the sponsor on 12 Feb 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, Observational, Open-Label, Single-Arm Study of Tysabri in Early Relapsing-Remitting Multiple Sclerosis in Anti-JCV Antibody Negative Patients
- ClinicalTrials.gov ID
- NCT01485003
- Acronym / sponsor ID
- STRIVE / 101MS407
- Conditions
- Relapsing-Remitting Multiple Sclerosis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 231 participants (actual)
- Lead sponsor
- BiogenIndustry (pharma, biotech, devices)
- Study start
- 7 Feb 2012 (actual)
- Primary completion
- 26 Nov 2018 (actual)
- Study completion
- 26 Nov 2018 (actual)
- First posted
- 5 Dec 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Study participants will be recruited by participating neurologists from among their MS patients who opt to begin treatment with Tysabri.
Key inclusion criteria (7 listed)
- 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.
Key exclusion criteria (12 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| natalizumabAlso: BG00002, TysabriNatalizumab will not be provided as a part of this study. Participants will receive natalizumab as prescribed by their treating physician. | Biological | – |
Primary outcome
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.
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.
19 secondary outcomes
Identification of baseline prognostic factors that predict overall disease-free status
Time frame: 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
Number of Participants with Clinical Disease-Free Status Measured by Relapses
Time frame: Months 12, 24, 36, and 48
Identification of baseline prognostic factors that predict clinical disease-free status
Time frame: Month 12
Identification of yearly clinical disease-free response factors that predict clinical disease-free status
Time frame: Months 24, 36 and 48
Annualized Relapse Rate
Time frame: Months 12, 24, 36, and 48
Percentage of participants with Sustained EDSS progression
Time frame: Baseline and Months 12, 24, 36, and 48
Sustained EDSS improvement
Time frame: 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
Change from baseline in number of new T1 hypointense lesions as assessed by MRI
Time frame: 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
MRI brain atrophy as assessed by MRI
Time frame: 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
Change from baseline in low contrast visual acuity
Time frame: Baseline and Month 24 and Month 48
Change from baseline in high contrast visual acuity
Time frame: 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
Capacity for work as assessed by change from baseline in WPAI questionnaire
Time frame: 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
Number of Participants with Clinical Disease-Free Status Measured by EDSS
Time frame: Months 12, 24, 36 and 48
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Feb 2019.
- Derived from this study: PubMed 36966440Perumal J, Balabanov R, Balcer L, Galetta S, Sun Z, Li H, Rutledge D, Avila RL, Fox RJ. Long-Term Effectiveness and Safety of Natalizumab in African American and Hispanic/Latino Patients with Early Relapsing-Remitting Multiple Sclerosis: STRIVE Data Analysis. Neurol Ther. 2023 Jun;12(3):833-848. doi: 10.1007/s40120-023-00461-0. Epub 2023 Mar 26.
- Derived from this study: PubMed 36780107Perumal J, Balabanov R, Su R, Chang R, Balcer LJ, Galetta SL, Avila RL, Rutledge D, Fox RJ. Correction to: Improvements in Cognitive Processing Speed, Disability, and Patient-Reported Outcomes in Patients with Early Relapsing-Remitting Multiple Sclerosis Treated with Natalizumab: Results of a 4-year, Real-World, Open-Label Study. CNS Drugs. 2023 Mar;37(3):275-289. doi: 10.1007/s40263-022-00982-6.
- Derived from this study: PubMed 36064841Perumal J, Balabanov R, Su R, Chang R, Balcer LJ, Galetta SL, Avila RL, Rutledge D, Fox RJ. Improvements in Cognitive Processing Speed, Disability, and Patient-Reported Outcomes in Patients with Early Relapsing-Remitting Multiple Sclerosis Treated with Natalizumab: Results of a 4-year, Real-World, Open-Label Study. CNS Drugs. 2022 Sep;36(9):977-993. doi: 10.1007/s40263-022-00950-0. Epub 2022 Sep 5.
- Derived from this study: PubMed 34014549Perumal J, Balabanov R, Su R, Chang R, Balcer L, Galetta S, Campagnolo DI, Avila R, Lee L, Rutledge D, Fox RJ. Natalizumab in Early Relapsing-Remitting Multiple Sclerosis: A 4-Year, Open-Label Study. Adv Ther. 2021 Jul;38(7):3724-3742. doi: 10.1007/s12325-021-01722-w. Epub 2021 May 20.
- Derived from this study: PubMed 31176355Perumal J, Fox RJ, Balabanov R, Balcer LJ, Galetta S, Makh S, Santra S, Hotermans C, Lee L. Outcomes of natalizumab treatment within 3 years of relapsing-remitting multiple sclerosis diagnosis: a prespecified 2-year interim analysis of STRIVE. BMC Neurol. 2019 Jun 8;19(1):116. doi: 10.1186/s12883-019-1337-z.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Medical Director study director
Biogen
44 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Relapsing-Remitting Multiple Sclerosis, run by Biogen at 44 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Feb 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 44 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of Participants who are overall disease activity-free at Months 12 and 24 (time frame: Baseline and Months 12 and 24). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01485003, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Feb 2019; AzTrials last refreshed its copy on 6 Nov 2026.