Clinical Trials/NCT00871780

NCT00871780

Completed

Phase 4

A Prospective, Open-label, Non-randomized, Clinical Trial to Determine if Natalizumab (Tysabri®) Improves Ambulatory Measures in Relapsing-remitting Multiple Sclerosis (RRMS) Patients "TIMER" Study

Biogen1 site in 1 country224 target enrollmentAugust 2009

ConditionsRelapsing Remitting Multiple Sclerosis (RRMS)

InterventionsBG00002 (natalizumab)

DrugsBG00002 (natalizumab)

Overview

Phase: Phase 4
Intervention: BG00002 (natalizumab)
Conditions: Relapsing Remitting Multiple Sclerosis (RRMS)
Sponsor: Biogen
Enrollment: 224
Locations: 1
Primary Endpoint: Change From Baseline in the Timed 100-meter Walk Test (T100T)
Status: Completed
Last Updated: 9 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

August 2009

End Date

July 2012

Last Updated

9 years ago

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

Biogen

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•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

Exclusion Criteria

•Unless otherwise specified, candidates will be excluded from study entry if any of the following exclusion criteria exist at the time of the Screening Visit:
•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

Arms & Interventions

Natalizumab

natalizumab 300 mg IV every 4 weeks for 48 weeks

Intervention: BG00002 (natalizumab)

Outcomes

Primary Outcomes

Change From Baseline in the Timed 100-meter Walk Test (T100T)

Time Frame: Baseline, Week 24, Week 48

In the T100T, the participant is instructed to walk as fast as possible for a distance of 100 meters.

Change From Baseline in the Timed 25-foot Walk Test (T25FW)

Time Frame: Baseline, Week 24, Week 48

In the T25FW, the participant is instructed to walk as fast as possible for a distance of 25 feet.

Change From Baseline in Maximum Walking Distance (MWD)

Time Frame: Baseline, Week 24, Week 48

Change From Baseline in Expanded Disability Status Scale (EDSS)

Time Frame: Baseline, Week 24, Week 48

EDSS assesses disability in 8 functional systems. An overall score ranging from 0 (normal) to 10 (death due to MS) was calculated.

Secondary Outcomes

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 T100T (Spearman Correlation Coefficient)(Baseline, Week 24, Week 48)
Correlation Between the EDSS and T25FW (Pearson Correlation Coefficient)(Baseline, Week 24, Week 48)
Correlation Between the EDSS and T25FW (Spearman Correlation Coefficient)(Baseline, Week 24, Week 48)
Correlation Between the EDSS and T100T (Pearson Correlation Coefficient)(Baseline, Week 24, Week 48)
Improvement in Timed 25FT Walk Speed and T100T Speed at Week 24 and 48(Baseline, Week 24, Week 48)