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Safety Study of Natalizumab to Treat Multiple Sclerosis (MS)

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; Secondary Progressive Multiple Sclerosis

Intervention: natalizumab (Drug); standard of care (Other)

Phase: Phase 1

Status: Completed

Sponsored by: Biogen

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

Summary

The primary objective of this study is to compare the pharmacokinetic (PK) and pharmacodynamics (PD) of single subcutaneous (SC) and intramuscular (IM) doses of 300 mg natalizumab to intravenous (IV) administration of 300 mg natalizumab in multiple sclerosis (MS) participants. The secondary objectives are to investigate the safety, tolerability and PK of repeated natalizumab doses administered SC and IM, to investigate the immunogenicity of repeated natalizumab doses administered SC and IM, to explore proof of concept within the secondary progressive multiple sclerosis (SPMS) population using change from baseline in clinical measures including: expanded disability status scale (EDSS), multiple sclerosis functional composite scale (MSFC), symbol digit modalities test (SDMT), visual analogue scale (VAS), and visual function test; and brain magnetic resonance imaging (MRI) measures including: number of new or newly-enlarging T2 hyperintense lesions, number of new T1 hypointense lesions, number of new gadolinium-enhancing (Gd+) lesions, whole brain atrophy, magnetization transfer ratio (MTR), and diffusion tensor imaging (DTI) and to observe the effect of natalizumab administered IV and SC on brain MRI measures in participants with relapsing forms of MS.

Clinical Details

Official title: A Randomized, Open-Label, Dose-Ranging Study to Evaluate the Pharmacokinetics and Initial Safety of Subcutaneous and Intramuscular Natalizumab in Subjects With Multiple Sclerosis

Study design: Allocation: Randomized, Endpoint Classification: Pharmacokinetics/Dynamics Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome:

Maximum observed concentration (Cmax) of natalizumab

Time to maximum observed concentration (Tmax) of natalizumab

Area under the curve to the last measurable concentration (AUC0-last) of natalizumab

Apparent volume of distribution of natalizumab

Half-life of natalizumab

Area under the curve extrapolated to infinity (AUC0-∞) of natalizumab

Apparent Clearance of natalizumab

α4-integrin saturation

Secondary outcome:

Number of Participants with adverse events

Number of participants with abnormalities in vital signs

Number of participants with changes in the physical examination

Number of participants with abnormal laboratory test results

Number of participants with natalizumab antibodies

Change from Baseline in expanded disability status scale (EDSS)

Change form Baseline in Multiple Sclerosis Functional Composite Scale (MFSC)

Change from Baseline in Symbol Digit Modalities Test (SDMT)

Change from Baseline in visual analog scale (VAS)

Change from Baseline in visual function test

Number of new or newly enlarging T2 hyperintense lesions

Number of new gadolinium-enhanced lesions

Number of new T1 hypointense lesions

Whole brain atrophy

Percent change in magnetization transfer ratio (MTR)

Diffusion tensor imaging (DTI)

Injection site pain assessment

Eligibility

Minimum age: 18 Years. Maximum age: 65 Years. Gender(s): Both.

Criteria:

Key Inclusion Criteria:

- For arms 1,2,3 and 4: Diagnosis of Secondary Progressive Multiple Sclerosis (SPMS)

- For arms 5 and 6: Diagnosis of relapsing forms of Multiple Sclerosis (MS).

- No past history of receiving natalizumab.

Key Exclusion Criteria:

- For arms 1,2,3 and 4 Diagnosis of primary progressive MS or relapsing-remitting MS.

- Form arms 5 and 6: Diagnosis of primary progressive MS or secondary progressive MS

without the occurrence of relapses. NOTE: Other protocol defined inclusion/exclusion criteria may apply.

Locations and Contacts

Research Site, Phoenix, Arizona 85006, United States

Research Site, Scottsdale, Arizona 85259, United States

Research Site, Berkeley, California 94705, United States

Research Site, Centennial, Colorado 80112, United States

Research Site, Maitland, Florida 32751, United States

Research Site, Vero Beach, Florida 32960, United States

Research Site, Peoria, Illinois 61637, United States

Research Site, Farmington Hills, Michigan 48334, United States

Research Site, Buffalo, New York 14203, United States

Research Site, Dallas, Texas 75214, United States

Research Site, Round Rock, Texas 78681, United States

Research Site, Vienna, Virginia 22182, United States

Additional Information

Starting date: October 2007
Last updated: September 5, 2014

Page last updated: August 23, 2015

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