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Safety and Efficacy of Natalizumab (BG00002, Tysabri®) in Russian Participants With Relapsing Remitting Multiple Sclerosis (RRMS)

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ClinicalTrials.gov Identifier: NCT02142205
Recruitment Status : Completed
First Posted : May 20, 2014
Last Update Posted : May 20, 2014
Sponsor:
Information provided by (Responsible Party):
Biogen

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Relapsing-Remitting Multiple Sclerosis Biological: BG00002 Phase 4

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 100 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: 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®).
Study Start Date : May 2012
Actual Primary Completion Date : December 2013
Actual Study Completion Date : December 2013

Resource links provided by the National Library of Medicine

Drug Information available for: Natalizumab

Arm Intervention/treatment
Experimental: BG00002 (natalizumab)
300 mg IV infusion every 4 weeks
Biological: BG00002
IV Infusion
Other Name: Tysabri®




Primary Outcome Measures :
  1. Number of participants that experience Serious Adverse Events (SAEs) and adverse events (AEs) [ Time Frame: Up to Week 52 ]

Secondary Outcome Measures :
  1. Annualized relapse rate (ARR) [ Time Frame: Up to Week 52 ]
  2. Time course to first relapse [ Time Frame: Up to Week 52 ]
  3. Severity of relapse as measured by the Number of relapses requiring hospitalization and the Number of relapses requiring steroid treatment [ Time Frame: Up to Week 52 ]
  4. Number of participants that do not experience a relapse [ Time Frame: Up to Week 52 ]
  5. Change in EDSS scores [ Time Frame: Up to Week 48 ]
  6. Duration of time to progression as measured by EDSS score [ Time Frame: Up to Week 48 ]
  7. Number of participants that do not experience a progression in EDSS score [ Time Frame: Up to Week 48 ]
  8. Percentage of participants with improvement in EDSS scores [ Time Frame: Up to Week 48 ]
    Measured by at least 1.0 point for 3 months sustained for participants with EDSS greater than or equal to, 2 at baseline

  9. Changes from baseline in nine hole peg test (9HPT) [ Time Frame: Up to Week 48 ]
    A brief, standardized, quantitative test of upper extremity function. Both the dominant and non-dominant hands are tested twice. The participant is seated at a table with a small, shallow container holding 9 pegs and a wood or plastic block containing 9 empty holes. On a start command when a stopwatch is started, the partipant picks up the 9 pegs one at a time as quickly as possible, puts them in the 9 holes, and, once they are in the holes, removes them again as quickly as possible one at a time, replacing them into the shallow container. The total time to complete the task is recorded

  10. Changes in Timed 25 foot walk from baseline [ Time Frame: Up to Week 48 ]
    A quantitative mobility and leg function performance test based on a timed 25-walk. It is the first component of the Multiple Sclerosis Functional Composite (MSFC) to be administered at each visit. The participant is directed to one end of a clearly marked 25-foot course and is instructed to walk 25 feet as quickly as possible, but safely. The time is calculated from the initiation of the instruction to start and ends when the participant has reached the 25-foot mark. The task is immediately administered again by having the participant walk back the same distance. Assistive devices may be used

  11. Changes in cognition as assessed by the Symbol digit modalities test (SDMT) [ Time Frame: Up to Week 48 ]
    A simple substitution task that gives the examinee 90 seconds to pair specific numbers with given geometric figures. Examinees can give either written or spoken responses, making the test well suited for use with individuals who have motor disabilities or speech disorders. Because it involves only geometric figures and numbers, the SDMT is relatively free of cultural bias and can be administered to individuals who do not speak English.

  12. Changes from baseline in visual function test (VFT) [ Time Frame: Up to Week 48 ]
  13. Impact on participants quality of life using SF-36 and MSIS-29 self-assessment questionnaires [ Time Frame: Up to Week 48 ]
  14. Percentage of participants that do not experience a relapse or progression in EDSS score [ Time Frame: Month 12 ]
  15. Number of T1 gadolinium (Gd) enhancing lesions [ Time Frame: At Week 48 ]
  16. Number of new T2 hyper intense lesions [ Time Frame: At Week 48 ]
    Compared to baseline

  17. Number of newly enlarging T2 hyper intense lesions [ Time Frame: At Week 48 ]
    Compared to baseline

  18. Number of new hypo intense T1 lesions (black holes) [ Time Frame: At Week 48 ]
  19. Number of conversion of Gd lesions into black holes [ Time Frame: At Month 12 ]
  20. Percentage of participants that do not experience a relapse as measured by an EDSS score that is not indicative of progression [ Time Frame: At Month 12 ]
  21. Percentage of participants that do not develop new GD+ and new or newly enlarging T2 hyper intense lesions [ Time Frame: At Week 48 ]
  22. Proportion of participants free of disease activity: no clinical & no MRI activity [ Time Frame: Up to Week 48 ]
  23. Number of participates that are Anti JCV antibody positive at baseline [ Time Frame: At Baseline ]


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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02142205


Locations
Russian Federation
Research Site
Belgorod, Russian Federation
Research Site
Kaluga, Russian Federation
Research Site
Kazan, Russian Federation
Research Site
Krasnodar, Russian Federation
Research Site
Kursk, Russian Federation
Research Site
Moscow, Russian Federation
Research Site
Nizhniy Novgorod, Russian Federation
Research Site
Perm, Russian Federation
Research Site
Rostov-on-Don, Russian Federation
Research Site
Saint-Petersburg, Russian Federation
Research Site
Smolensk, Russian Federation
Sponsors and Collaborators
Biogen
Investigators
Study Director: Medical Director Biogen

Responsible Party: Biogen
ClinicalTrials.gov Identifier: NCT02142205     History of Changes
Other Study ID Numbers: RUS-TYS-11-10158
First Posted: May 20, 2014    Key Record Dates
Last Update Posted: May 20, 2014
Last Verified: May 2014

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
Natalizumab
Immunologic Factors
Physiological Effects of Drugs