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

Information source: Biogen
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Relapsing Remitting Multiple Sclerosis (RRMS)

Intervention: BG00002 (natalizumab) (Drug)

Phase: Phase 4

Status: Completed

Sponsored by: Biogen

Official(s) and/or principal investigator(s):
Medical Director, Study Director, Affiliation: Biogen

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.

Clinical Details

Official title: 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

Study design: Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome:

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

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

Change From Baseline in Maximum Walking Distance (MWD)

Change From Baseline in Expanded Disability Status Scale (EDSS)

Secondary outcome:

Correlation Between the EDSS and MWD (Pearson Correlation Coefficient)

Correlation Between the EDSS and MWD (Spearman Correlation Coefficient)

Correlation Between the T100T and T25FW (Pearson Correlation Coefficient)

Correlation Between the T100T and T25FW (Spearman Correlation Coefficient)

Correlation Between the EDSS and T25FW (Pearson Correlation Coefficient)

Correlation Between the EDSS and T25FW (Spearman Correlation Coefficient)

Correlation Between the EDSS and T100T (Pearson Correlation Coefficient)

Correlation Between the EDSS and T100T (Spearman Correlation Coefficient)

Improvement in Timed 25FT Walk Speed and T100T Speed at Week 24 and 48

Eligibility

Minimum age: 18 Years. Maximum age: 60 Years. Gender(s): Both.

Criteria:

Key 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

- 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. Key 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

- 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.

Locations and Contacts

Biogen Idec Investigative Site, Liege, Belgium

Biogen Idec Investigative Site, Puebla, Mexico

Biogen Idec Investigative Site, Bialystok, Poland

Biogen Idec Investigative Site, Bydgoszcz, Poland

Biogen Idec Investigative Site, Lotz, Poland

Biogen Idec Investigative Site, Poznan, Poland

Biogen Idec Investigative Site, Warszawa, Poland

Biogen Idec Investigative Site, Bucharest, Romania

Biogen Idec Investigative Site, Mures, Romania

Biogen Idec Investigative Site, Riyadh, Saudi Arabia

Biogen Idec Investigative Site, Dnipropetrovsk, Ukraine

Biogen Idec Investigative Site, Kharkiv, Ukraine

Biogen Idec Investigative Site, Kyiv, Ukraine

Biogen Idec Investigative Site, Lviv, Ukraine

Biogen Idec Investigative Site, Simferopol, Ukraine

Additional Information

Starting date: August 2009
Last updated: November 11, 2014

Page last updated: August 23, 2015

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