Effect of Multiple Infusions of AIN457 on Disease Activity in Relapsing-remitting Multiple Sclerosis - Full Text View

Sponsor:	Novartis Pharmaceuticals
Information provided by (Responsible Party):	Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier:	NCT01051817

Purpose

This study will assess the effect of AIN457 to reduce disease activity in patients with relapsing-remitting multiple sclerosis.

Condition	Intervention	Phase
Multiple Sclerosis Relapsing-remitting	Drug: AIN457 Drug: Placebo	Phase 2

Study Type:	Interventional
Study Design:	Allocation: Randomized Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Treatment
Official Title:	A Randomized, Multi-center, Double-blind, Proof-of-concept Study to Assess the Effect of Multiple Infusions of AIN457 (10 mg/kg) Versus Placebo on Disease Activity (MRI Scans) in Patients With Relapsing-remitting Multiple Sclerosis

Resource links provided by NLM:

MedlinePlus related topics: Autoimmune Diseases MRI Scans Multiple Sclerosis Nuclear Scans

U.S. FDA Resources

Further study details as provided by Novartis:

Primary Outcome Measures:

Effect on the number of combined unique active lesions (CUAL) observed on brain MRI scans [ Time Frame: week 4, 8, 12, 16, 20 and 24 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Evaluate safety and tolerability [ Time Frame: first dose administration till week 24 ] [ Designated as safety issue: Yes ]
Effect on number of relapses (derived measures as annualized relapse rate/ proportion of relapse-free patients) [ Time Frame: first dose administration till week 24 ] [ Designated as safety issue: No ]
effect on additional MRI parameters observed on brain MRI scans (new/ all T1-weighted lesions, new / enlarging T2-weighted lesions, new MRI disease activity) [ Time Frame: week 4, 8, 12, 16, 20 and 24 ] [ Designated as safety issue: No ]
determine the proportion of subjects without any new disease activity (no new Gd+ or new/ enlarging T2 MRI lesions, no relapses) [ Time Frame: first dose administration till week 24 ] [ Designated as safety issue: No ]
determine steady state plasma concentration in RRMS patients [ Time Frame: first dose administration till week 24 ] [ Designated as safety issue: No ]

Enrollment:	73
Study Start Date:	December 2009
Study Completion Date:	April 2012
Primary Completion Date:	April 2012 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: AIN457	Drug: AIN457
Placebo Comparator: Placebo	Drug: Placebo

Eligibility

Criteria

Inclusion Criteria:

disease diagnosis of relapsing-remitting multiple sclerosis
An Expanded Disability Status Scale score of 0-5.0
naïve patients (without any treatment) and patients previously treated with MS drugs are allowed to participate this study after an appropriate washout period

Exclusion criteria:

presence/ history of several in the protocol specified diseases, assessed at screening by the physician
previous treatment (within 1 months prior to randomization) of systemic corticosteroids, ACTH (adrenocorticotropic hormone), Interferon-beta (IFN-β) or/and glatiramer acetate
previous treatment (within 16 weeks prior to randomization) of immunosuppressive medications such as azathioprine or methotrexate
previous treatment (within 6 months prior to randomization, but only if the immunosuppressive effects are not likely to persist at randomization) of immunoglobulins and/or monoclonal antibodies (including natalizumab and rituximab)
unable to undergo MRI scans
pregnant or nursing (lactating) women

Other protocol-defined inclusion/exclusion criteria may apply

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT01051817

Locations

Czech Republic
Novartis Investigative Site
Hradec Kralove, Czech Republic
Novartis Investigative Site
Ostrava, Czech Republic
Novartis Investigative Site
Ostrava-Moravska, Czech Republic
Novartis Investigative Site
Praha, Czech Republic
Novartis Investigative Site
Teplice, Czech Republic
Russian Federation
Novartis Investigative Site
Kazan, Russian Federation
Novartis Investigative Site
Moscow, Russian Federation
Novartis Investigative Site
Nizhny Novgorod, Russian Federation
Novartis Investigative Site
Smolensk, Russian Federation
Novartis Investigative Site
Yaroslavl, Russian Federation
Ukraine
Novartis Investigative Site
Kharkiv, Ukraine
Novartis Investigative Site
Kyiv, Ukraine
Novartis Investigative Site
Odessa, Ukraine
Novartis Investigative Site
Vinnitsa, Ukraine

Sponsors and Collaborators

Novartis Pharmaceuticals

Investigators

Study Director:

Novartis Pharmaceuticals

More Information

No publications provided

Responsible Party:	Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier:	NCT01051817 History of Changes
Other Study ID Numbers:	CAIN457B2201, 2009-011626-34
Study First Received:	January 19, 2010
Last Updated:	April 27, 2012
Health Authority:	Sweden: Medical Products Agency Russia: Pharmacological Committee, Ministry of Health Ukraine: State Pharmacological Center - Ministry of Health Czech Republic: State Institute for Drug Control Serbia and Montenegro: Agency for Drugs and Medicinal Devices

Keywords provided by Novartis:

Multiple sclerosis
demyelinating autoimmune diseases
interleukin-17
monoclonal human antibody

Additional relevant MeSH terms:

Multiple Sclerosis
Sclerosis
Multiple Sclerosis, Relapsing-Remitting
Demyelinating Autoimmune Diseases, CNS
Autoimmune Diseases of the Nervous System

Nervous System Diseases
Demyelinating Diseases
Autoimmune Diseases
Immune System Diseases
Pathologic Processes

ClinicalTrials.gov processed this record on May 24, 2012