Brief Summary

The primary objective of the study is to evaluate the evolution of walking capacity as measured by the timed 100-meter walk test (T100T), timed 25-foot walk test (T25FW), maximum walking distance (MWD), and Expanded Disability Status Scale (EDSS) during the first year of therapy with natalizumab. The secondary objectives of this study are as follows:

To evaluate the correlation between the MWD and EDSS and both walking tests, the T100T and the T25FW at Baseline, at Week 24 and at Week 48 of therapy.
To determine how well each of the walking tests, T100T or T25FW, predicts walking limitations in all participants and in the subgroups of participants stratified by baseline EDSS.

Trial Health

On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment

224

participants targeted

Target at P75+ for phase_4

Timeline

Completed

Started Aug 2009

Typical duration for phase_4

Geographic Reach

6 countries

15 active sites

Status

completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

2.9 years study duration

First Submitted

Initial submission to the registry

March 26, 2009

Completed

4 days until next milestone

First Posted

Study publicly available on registry

March 30, 2009

Completed

4 months until next milestone

Study Start

First participant enrolled

August 1, 2009

Completed

2.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2012

Completed

Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2012

Completed

2.4 years until next milestone

Results Posted

Study results publicly available

November 18, 2014

Completed

Last Updated

March 21, 2017

Status Verified

February 1, 2017

Enrollment Period

2.9 years

First QC Date

March 26, 2009

Results QC Date

November 11, 2014

Last Update Submit

February 14, 2017

Conditions

Relapsing Remitting Multiple Sclerosis (RRMS)

Keywords

TYSABRI naiveRelapsing-remitting multiple sclerosis (RRMS)

Outcome Measures

Primary Outcomes (4)

Change From Baseline in the Timed 100-meter Walk Test (T100T)
In the T100T, the participant is instructed to walk as fast as possible for a distance of 100 meters.
Baseline, Week 24, Week 48
Change From Baseline in the Timed 25-foot Walk Test (T25FW)
In the T25FW, the participant is instructed to walk as fast as possible for a distance of 25 feet.
Baseline, Week 24, Week 48
Change From Baseline in Maximum Walking Distance (MWD)
Baseline, Week 24, Week 48
Change From Baseline in Expanded Disability Status Scale (EDSS)
EDSS assesses disability in 8 functional systems. An overall score ranging from 0 (normal) to 10 (death due to MS) was calculated.
Baseline, Week 24, Week 48

Secondary Outcomes (9)

Correlation Between the EDSS and MWD (Pearson Correlation Coefficient)
Baseline, Week 24, Week 48
Correlation Between the EDSS and MWD (Spearman Correlation Coefficient)
Baseline, Week 24, Week 48
Correlation Between the T100T and T25FW (Pearson Correlation Coefficient)
Baseline, Week 24, Week 48
Correlation Between the T100T and T25FW (Spearman Correlation Coefficient)
Baseline, Week 24, Week 48
Correlation Between the EDSS and T25FW (Pearson Correlation Coefficient)
Baseline, Week 24, Week 48
+4 more secondary outcomes

Study Arms (1)

Natalizumab

EXPERIMENTAL

natalizumab 300 mg IV every 4 weeks for 48 weeks

Drug: BG00002 (natalizumab)

Interventions

BG00002 (natalizumab)DRUG

Also known as: Tysabri®

Natalizumab

Eligibility Criteria

Age18 Years - 60 Years

Sexall

Healthy VolunteersNo

Age GroupsAdult (18-64)

You may qualify if:

Must give written informed consent and provide all authorizations required by local law (for example, Protected Health Information \[PHI\])
Men or women between 18 and 60 years of age, inclusive
Must have Expanded Disability Status Scale (EDSS) less than or equal to 5.5 at baseline
Must be able to walk at least 100 m without assistive devices
Must be natalizumab-naïve
Must have a documented diagnosis of a relapsing remitting form of multiple sclerosis (MS0 as defined by the revised McDonald Committee criteria (Polman et al., 2005)
Must have had a recent (within 3 months from baseline) magnetic resonance imaging (MRI)
Must have had at least 1 relapse in the previous year and must satisfy the locally approved therapeutic indications for Tysabri. If Tysabri is not yet approved in a specific country, patients must fulfill the following criteria:
Patients with high disease activity despite treatment with a beta-interferon defined as patients who have failed to respond to a full and adequate course of a beta-interferon
Patients must have had at least 1 relapse in the previous year while on therapy, and have at least 9 T2 hyperintense lesions in cranial MRI or at least 1 gadolinium (Gd)-enhancing lesion
Patients with rapidly evolving severe relapsing remitting multiple sclerosis defined as patients who have had 2 or more disabling relapses in one year and 1 or more Gd-enhancing lesions on brain MRI or significant increase in T2 lesions as compared to a previous MRI
Must be stable in disability for at least 30 days prior to enrollment to the study
Must be stable in symptomatic management of the disease, specifically spasticity, depression and fatigue for at least 30 days prior to enrollment to the study
Must be considered by the Investigator to be free of signs and symptoms suggestive of progressive multifocal leukoencephalopathy (PML) based on medical history, physical examination, or laboratory testing
Must be willing to discontinue and remain free from concomitant immunosuppressive or immunomodulatory treatment (including interferon \[IFN\] and glatiramer acetate \[GA\]) while being treated with natalizumab during the study.

You may not qualify if:

Onset of a relapse within 50 days prior to first infusion
Considered by the Investigator to be immunocompromised, based on medical history, physical examination, or laboratory testing or due to prior immunosuppressive treatment
History of, or available abnormal laboratory results indicative of, any significant cardiac, endocrinologic, hematologic, hepatic, immunologic, metabolic, urologic, pulmonary, gastrointestinal, dermatologic, psychiatric (including major depression), renal, and/or other major disease that would preclude the administration of a recombinant humanized antibody immunomodulating agent. The Investigator must re-review the subject's medical fitness for participation and consider any diseases that would preclude treatment
History of malignancy (subjects with basal cell carcinoma that has been completely excised prior to study entry remain eligible)
Known history of human immunodeficiency virus infection or hematological malignancy
History of organ transplantation (including anti-rejection therapy)
A clinically significant infectious illness (cellulitis, abscess, pneumonia, septicemia) within 30 days prior to the Screening Visit
Treatment with immunosuppressant medications (mitoxantrone, cyclophosphamide, cyclosporine, azathioprine, methotrexate) within 6 months prior to Screening
Female subjects who are not postmenopausal for at least 1 year, surgically sterile (does not include tubal ligation), or willing to practice effective contraception (as defined by the Investigator) during the study
Women who are breastfeeding, pregnant, or planning to become pregnant while on study
Current enrollment in any other study treatment or disease study
Unwillingness or inability to comply with the requirements of this protocol, including the presence of any condition (physical, mental, or social) that is likely to affect the subject's ability to comply with the study protocol
Subjects with walking impairment due to causes other than MS
Other unspecified reasons that, in the opinion of the Investigator and/or Biogen Idec, make the subject unsuitable for enrollment into this study
NOTE: Other eligibility criteria may apply.

Contact the study team to confirm eligibility.