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

• Register: ClinicalTrials.gov
• Last refreshed on: 19 February 2015
• Main ID: NCT02142205
• Date of registration: 16/05/2014
• Prospective Registration: No
• Primary sponsor: Biogen Idec
• Public title: Safety and Efficacy of Natalizumab (BG00002, Tysabri®) in Russian Participants With Relapsing Remitting Multiple Sclerosis (RRMS)
• Scientific 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®).
• Date of first enrolment: May 2012
• Target sample size: 100
• Recruitment status: Completed
• URL: http://clinicaltrials.gov/show/NCT02142205
• Study type: Interventional
• Study design: Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
• Phase: Phase 4

Countries of recruitment

Russian Federation

Contacts

• Name: Medical Director
• Affiliation: Biogen Idec

Key inclusion & exclusion 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



Age minimum: 18 Years
Age maximum: 60 Years
Gender: Both

Health Condition(s) or Problem(s) studied

Relapsing-Remitting Multiple Sclerosis

Intervention(s)

Biological: BG00002

Primary Outcome(s)

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

Secondary Outcome(s)

Number of participants that do not experience a relapse [Time Frame: Up to Week 52]

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]

Changes in Timed 25 foot walk from baseline [Time Frame: Up to Week 48]

Number of participates that are Anti JCV antibody positive at baseline [Time Frame: At Baseline]

Percentage of participants that do not experience a relapse or progression in EDSS score [Time Frame: Month 12]

Impact on participants quality of life using SF-36 and MSIS-29 self-assessment questionnaires [Time Frame: Up to Week 48]

Changes in cognition as assessed by the Symbol digit modalities test (SDMT) [Time Frame: Up to Week 48]

Number of conversion of Gd lesions into black holes [Time Frame: At Month 12]

Percentage of participants that do not develop new GD+ and new or newly enlarging T2 hyper intense lesions [Time Frame: At Week 48]

Number of new T2 hyper intense lesions [Time Frame: At Week 48]

Number of newly enlarging T2 hyper intense lesions [Time Frame: At Week 48]

Number of participants that do not experience a progression in EDSS score [Time Frame: Up to Week 48]

Proportion of participants free of disease activity: no clinical & no MRI activity [Time Frame: Up to Week 48]

Change in EDSS scores [Time Frame: Up to Week 48]

Duration of time to progression as measured by EDSS score [Time Frame: Up to Week 48]

Annualized relapse rate (ARR) [Time Frame: Up to Week 52]

Number of T1 gadolinium (Gd) enhancing lesions [Time Frame: At Week 48]

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]

Number of new hypo intense T1 lesions (black holes) [Time Frame: At Week 48]

Percentage of participants with improvement in EDSS scores [Time Frame: Up to Week 48]

Time course to first relapse [Time Frame: Up to Week 52]

Changes from baseline in nine hole peg test (9HPT) [Time Frame: Up to Week 48]

Changes from baseline in visual function test (VFT) [Time Frame: Up to Week 48]

Secondary ID(s)

RUS-TYS-11-10158

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

Biogen Idec International GmbH