Safety and Efficacy of Natalizumab in Combination With Avonex in the Treatment of Multiple Sclerosis

Conditions

Multiple Sclerosis, Relapsing-Remitting

Keywords

Multiple Sclerosis, MS

Brief summary

The purpose of this study is to determine if natalizumab in combination with AVONEX is safe and effective in delaying progression of individuals diagnosed with relapsing remitting Multiple Sclerosis (MS).

Strijbis EMM, Mostert J, Comtois J, Salter A, Repovic P, Bowen JD, Uitdehaag BMJ, Cutter GR, Koch MW.

2024-12-303 citations

10.1212/wnl.0000000000210153

Association of age and inflammatory disease activity in the pivotal natalizumab clinical trials in relapsing-remitting multiple sclerosis

Eva Strijbis, E.M.E. Coerver, Jop Mostert, Zoé L. E. van Kempen, Joep Killestein et al. (10 authors)

Journal of Neurology Neurosurgery & Psychiatry2023-05-1210 citations

10.1136/jnnp-2022-330887

Long-Term Effectiveness and Safety of Natalizumab in African American and Hispanic/Latino Patients with Early Relapsing-Remitting Multiple Sclerosis: STRIVE Data Analysis.

Perumal J, Balabanov R, Balcer L, Galetta S, Sun Z, Li H, Rutledge D, Avila RL, Fox RJ.

2023-03-263 citations

10.1007/s40120-023-00461-0

Natalizumab plus interferon beta-1a for relapsing multiple sclerosis.

Rudick RA, Stuart WH, Calabresi PA, Confavreux C, Galetta SL, Radue EW, Lublin FD, Weinstock-Guttman B, Wynn DR, Lynn F, Panzara MA, Sandrock AW, SENTINEL Investigators.

2006-03-01927 citations

10.1056/nejmoa044396

Interventions

DRUGNatalizumab

Natalizumab, 300 mg, monthly IV infusion for up to 116 weeks.

DRUGPlacebo

Placebo monthly infusion for up to 116 weeks.

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

TRIPLE (Subject, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to 55 Years

Healthy volunteers

No

Inclusion criteria

* Diagnosis of MS as defined by McDonald et al, criteria, # 1- 4 * Between the ages of 18 and 55, inclusive * Baseline EDSS score between 0.0 and 5.0, inclusive * Have been treated with Avonex for at least the 12 months prior to randomization * Have experienced at least one relapse (while on Avonex) within the 12 months prior to randomization. * Cranial MRI scan demonstrating lesions consistent with MS. * Have given written informed consent to participate in the study.

Exclusion criteria

* Primary progressive, secondary progressive, or progressive relapsing MS. * MS relapse has occurred within 50 days of randomization * A clinically significant infectious illness within 30 days prior to randomization * History of, or abnormal lab result, indicative of significant disease, that in the opinion of the investigator, would preclude the administration of a recombinant humanized antibody immunomodulating agent or Avonex for 116 weeks. * History of severe allergic or anaphylactic reactions or known drug hypersensitivity. * Unable to perform the Timed 25-Foot Walk, 9HPT and PASAT 3 * Abnormal blood tests at Screening Visit

Design outcomes

Primary

Measure	Time frame
Primary objectives of this study are to determine if natalizumab is effective in reducing the rate of clinical relapse at 1 year and in slowing the progression of disability at 2 years as measured by EDSS.	1 year and 2 years

Secondary

Measure	Time frame
If this combination reduces MRI lesions and the overall rate of clinical relapses	1 year and 2 years

Countries

Austria, Belgium, France, Germany, Israel, Italy, United States

Outcome results

None listed