Safety and Efficacy of Natalizumab (BG00002, Tysabri®) in Russian Part

A Prospective, Open-label, Non-randomized, Clinical Trial to Evaluate the Safety and Efficacy in RUSsian RRMS Patients on One Year Treatment With Natalizumab (TYSabri®).

CompletedPhase 4Relapsing MSNCT02142205

What it found

No results found

We found no results in the registry or in papers.

This trial finished 12 years ago. We found no results in the registry or in any paper that cites it.

What was tested

Treatment tested

  • Natalizumab

    Integrin alpha-4/beta-1 inhibitor|Integrin alpha-4/beta-7 inhibitor

What it measured

Main measures

  • Number of participants that experience Serious Adverse Events (SAEs) and adverse events (AEs)

    Up to Week 52

    Safety

Other measures (23)

  • Annualized relapse rate (ARR)

    Up to Week 52

    Relapses

  • Time course to first relapse

    Up to Week 52

    Relapses

  • Severity of relapse as measured by the Number of relapses requiring hospitalization and the Number of relapses requiring steroid treatment

    Up to Week 52

    Relapses

  • Number of participants that do not experience a relapse

    Up to Week 52

    Relapses

  • Change in EDSS scores

    Up to Week 48

    Disability progression

  • Duration of time to progression as measured by EDSS score

    Up to Week 48

    Disability progression

  • Number of participants that do not experience a progression in EDSS score

    Up to Week 48

    Disability progression

  • Percentage of participants with improvement in EDSS scores

    Up to Week 48

    Disability progression

  • Changes from baseline in nine hole peg test (9HPT)

    Up to Week 48

    Disability progressionArm and hand function

  • Changes in Timed 25 foot walk from baseline

    Up to Week 48

    Disability progressionWalking and mobility

Who could take part

Relapsing MS · 18 to 60

Show the full criteria

Inclusion criteria

Key Inclusion Criteria: * Must be natalizumab naïve. * Must have a documented diagnosis of a relapsing remitting form of MS as defined by the revised McDonald Committee criteria (Polman et al., 2011) * Must have had at least 1 relapse in the previous year: * Must be stable in disability for at least 30 days prior to enrollment to the study * Must be stable in symptomatic management of the disease, specifically spasticity, depression and fatigue for at least 30 days prior to enrollment to the study. * Must be considered by the Investigator to be free of signs and symptoms suggestive of Progressive multifocal leukoencephalopathy (PML) based on medical history, physical examination, or laboratory testing. * Must be willing to discontinue and remain free from concomitant immunosuppressive or immunomodulatory treatment (including IFN-beta and Glatiramer Acetate) while being treated with natalizumab during the study. Key Exclusion Criteria: Medical History: * Onset of a relapse within 50 days prior to first infusion. * Considered by the Investigator to be immunocompromised, based on medical history, physical examination, or laboratory testing or due to prior immunosuppressive treatment * History of, or available abnormal laboratory results indicative of, any significiant viral, cardiac, endocrinologic, hematologic, hepatic, immunologic, metabolic, urologic, pulmonary, gastrointestinal, dermatologic, psychiatric (including major depression), renal, and/or other major disease that would preclude the administration of a recombinant humanized antibody immunomodulating agent. The Investigator must re-review the subject's medical fitness for participation and consider any diseases that would preclude treatment. * History of malignancy (subjects with basal cell carcinoma that has been completely excised prior to study entry remain eligible) * Known history of human immunodeficiency virus infection or hematological malignancy * History of organ transplantation (including anti-rejection therapy) * A clinically significant infectious illness (e.g. abscess, pneumonia, septicemia) within 30 days prior to the Screening Visit. Treatment History: - Treatment with any kind of immunosuppressant medications (e.g., mitoxantrone, cyclophosphamide, cyclosporine, azathioprine, methotrexate, fingolimod, cladribine) within 6 months prior to Screening Miscellaneous: * Female subjects who are not postmenopausal for at least 1 year, surgically sterile (does not include tubal ligation), or unwilling to practice effective contraception (as defined by the Investigator) during the study * Women who are breastfeeding, pregnant, or planning to become pregnant while on study * Other unspecified reasons that, in the opinion of the Investigator and/or Biogen Idec, make the subject unsuitable for enrollment into this study. NOTE: Other protocol defined Inclusion/Exclusion criteria may apply

Exclusion criteria

Not separately supplied in the registry.

As registered. Criteria can change, so ask the trial team or your neurologist.

About this trial

In the sponsor's words

The primary objective is to evaluate the safety and tolerability of natalizumab (BG00002, Tysabri®) in the study population (Russian participants with relapsing remitting multiple sclerosis). The secondary objectives are to look at evaluation of severity of relapse, hospitalization and steroid use requirement; Expanded Disability Status Scale (EDSS), functional tests, quality of life self-assessment questionnaires including the short form health survey self-assessment questionnaire (SF-36) and multiple sclerosis impact scale 29 (MSIS-29), evidence of MRI disease activity, participants free of disease activity (clinical activity and/MRI activity) and anti JC Virus (JCV) antibody evaluation.

Papers

    Loading reviews and guidelines…

    Related trials

    History

      1. Started

        May 2012

      2. Main results due

        Dec 2013

      3. Finished

        Dec 2013

      Assembled by software from public sources.