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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier:
NCT01051817
First received: January 19, 2010
Last updated: April 27, 2012
Last verified: April 2012
  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:


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

Ages Eligible for Study:   18 Years to 55 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 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:
Sclerosis
Multiple Sclerosis
Multiple Sclerosis, Relapsing-Remitting
Pathologic Processes
Demyelinating Autoimmune Diseases, CNS
Autoimmune Diseases of the Nervous System
Nervous System Diseases
Demyelinating Diseases
Autoimmune Diseases
Immune System Diseases

ClinicalTrials.gov processed this record on October 19, 2014