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

NCT02142205 | Completed Phase 4

• 1 other identifier: RUS-TYS-11-10158
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 11

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.

Conditions

Relapsing-Remitting Multiple Sclerosis

Outcome Measures

Primary Outcomes (1)

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

  Up to Week 52

Secondary Outcomes (23)

• Annualized relapse rate (ARR)

  Up to Week 52

• Time course to first relapse

  Up to Week 52

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

  Up to Week 52

• Number of participants that do not experience a relapse

  Up to Week 52

• Change in EDSS scores

  Up to Week 48

Study Arms (1)

BG00002 (natalizumab)

EXPERIMENTAL

300 mg IV infusion every 4 weeks

Biological: BG00002

Interventions

BG00002 BIOLOGICAL

IV Infusion

Also known as: Tysabri®

BG00002 (natalizumab)

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Biogen: lead

Study Sites (11)

Research Site

Belgorod, Russia

Location

Research Site

Kaluga, Russia

Location

Research Site

Kazan', Russia

Location

Research Site

Krasnodar, Russia

Location

Research Site

Kursk, Russia

Location

Research Site

Moscow, Russia

Location

Research Site

Nizhny Novgorod, Russia

Location

Research Site

Perm, Russia

Location

Research Site

Rostov-on-Don, Russia

Location

Research Site

Saint Petersburg, Russia

Location

Research Site

Smolensk, Russia

Location

MeSH Terms

Conditions

Multiple Sclerosis, Relapsing-Remitting

Interventions

Natalizumab

Condition Hierarchy (Ancestors)

Multiple Sclerosis; Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Nervous System Diseases; Demyelinating Diseases; Autoimmune Diseases; Immune System Diseases

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Study Officials

• Medical Director

  Biogen

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 16, 2014
• First Posted: May 20, 2014
• Study Start: May 1, 2012
• Primary Completion: December 1, 2013
• Study Completion: December 1, 2013
• Last Updated: May 20, 2014

Record last verified: 2014-05

Locations

RU (11)