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

January 19, 2010
April 27, 2012
December 2009
April 2012   (final data collection date for primary outcome measure)
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 ]
Same as current
Complete list of historical versions of study NCT01051817 on ClinicalTrials.gov Archive Site
  • 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 ]
Same as current
Not Provided
Not Provided
 
Effect of Multiple Infusions of AIN457 on Disease Activity in Relapsing-remitting Multiple Sclerosis
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

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

Not Provided
Interventional
Phase 2
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
  • Multiple Sclerosis
  • Relapsing-remitting
  • Drug: AIN457
  • Drug: Placebo
  • Experimental: AIN457
    Intervention: Drug: AIN457
  • Placebo Comparator: Placebo
    Intervention: Drug: Placebo
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
73
April 2012
April 2012   (final data collection date for primary outcome measure)

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

Both
18 Years to 55 Years
No
Contact information is only displayed when the study is recruiting subjects
Russian Federation,   Czech Republic,   Ukraine
 
NCT01051817
CAIN457B2201, 2009-011626-34
Not Provided
Novartis ( Novartis Pharmaceuticals )
Novartis Pharmaceuticals
Not Provided
Study Director: Novartis Pharmaceuticals Novartis Pharmaceuticals
Novartis
April 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP