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Completed

NCT Number: NCT01433250

A Study to Evaluate the Safety, Tolerability and Efficacy of AIN457 in Patients With Relapsing-remitting Multiple Sclerosis

The study will assess the long-term safety and tolerability of AIN457 in patients with relapsing-remitting multiple sclerosis (RRMS). In addition the long-term pattern of maintenance of efficacy and health related quality of life will be explored.

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Key information

Age range

18 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Novartis Investigative Site, Hradec Králové, Czech Republic, Czechia

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Was exposed to AIN457 or placebo in study CAIN457B2201 and completed the CAIN457B2201 study, up to at and including Visit 10 (week 24).

Exclusion criteria

  • Have been treated with:
  • immunosuppressive medications such as azathioprine or methotrexate within 1 month prior to enrollment, if lymphocyte count normal.
  • immunoglobulins and/or monoclonal antibodies (with the exception of AIN457) within 2 month prior to enrollment, or if the immunosuppressive effects are likely to persist at enrollment (such as presence of B cell depletion after rituximab treatment).
  • Have received total lymphoid irradiation, bone marrow transplantation, alemtuzumab, cladribine, cyclophosphamide, mitoxantrone or other immunosuppressive treatments with long-lasting (over 6 months) or permanent effects.
  • Have received any live or live attenuated vaccines (including live vaccines for varicella-zoster virus or measles) within 2 months prior to enrollment.
  • A diagnosis of chronic disease of the immune system other than MS, or of an immunodeficiency syndrome.
  • Current severe depression.
  • Pregnant or nursing (lactating) women.
  • Malignancy diagnosed since enrollment in the core study (except for successfully-treated basal or squamous cell carcinoma of skin).
  • A new diagnosis of diabetes
  • Positive testing for tuberculosis (QuantiFeron or chest X-ray).
  • Subjects with clinically significant cardiac abnormalities
  • Unable or unwilling to undergo multiple venipunctures
  • Unable to undergo MRI scans due to newly acquired claustrophobia or metallic implants incompatible with MRI.

Other protocol-defined inclusion/exclusion criteria may apply

Treatment and study plan

AIN457

Drug

(10mg/kg i.v.).

Other names: AIN457 core/ AIN extension

Primary outcomes

  1. Measure: Number of Subjects With Adverse Events, Number of Abnormalities in Safety Assessments

    Time frame: 97 weeks

    Safety outcomes will be described in Adverse events section as there was not an efficacy primary outcome

Secondary outcomes

  1. Distribution of Patients With Relapses to End of Study (EOS) (All Subjects)

    Time frame: week 97

    Description: number of relapses based on neurological assessments and EDSS

  2. Number Lesions Measured in the Brain by Magnetic Resonance Imaging. T1 Weighted MRI

    Time frame: weeks 13,25,37,53,73 and 97

    Measures of absolute number of gadolinium [Gd]-enhancing lesions on T1-weighted scans

  3. Number Lesions Measured in the Brain by Magnetic Resonance Imaging. T2 Weighted MRI

    Time frame: weeks 13,25,37,53,73 and 97

    Measures of absolute number of gadolinium [Gd]-enhancing lesions on T2-weighted lesions

  4. Change in Brain Volume at End of Study.

    Time frame: week 97

    Change in volume from start to end of study

  5. Measure of Disability: Expanded Disability Status Scale (EDSS).

    Time frame: Baseline to week 97

    The EDSS is a scale for assessing neurological impairment in MS (Kurtzke 1983) including (1) a series of scores in each of eight functional systems, and (2) the EDSS steps (ranging from 0 (normal) to 10 (death due to MS). The functional systems are Visual, Brain Stem, Pyramidal, Cerebellar, Sensory, Bowel and Bladder, Cerebral and Other functions.

Sponsors and collaborators

Lead sponsor

Novartis Pharmaceuticals

Industry

Registry information

Official study title

An Open Label Extension Study to Evaluate the Safety, Tolerability and Efficacy of AIN457 in Patients With Relapsing-remitting Multiple Sclerosis

Important dates

Study start
2012
Primary completion
2014
Study completion
2014
First posted
Sep 13, 2011
Registry last updated
Mar 14, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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