Efficacy and Safety of Oral BG00012 in Relapsing-Remitting Multiple Sclerosis

Relapsing-Remitting Multiple Sclerosis Clinical Trial

— DEFINE  

Official title:

A Randomized, Multicenter, Double-Blind, Placebo-Controlled, Dose-Comparison Study to Determine the Efficacy and Safety of BG00012 in Subjects With Relapsing-Remitting Multiple Sclerosis

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00420212
• Other study ID #: 109MS301
• Status: Completed
• Phase: Phase 3
• First received: January 8, 2007
• Last updated: January 13, 2015
• Start date: January 2007
• Est. completion date: February 2011

Study information

• Verified date: January 2015
• Source: Biogen
• Contact: n/a
• Is FDA regulated: No
• Health authority: Romania: National Medicines AgencyFrance: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)Ukraine: State Pharmacological Center - Ministry of HealthNetherlands: The Central Committee on Research Involving Human Subjects (CCMO)Mexico: Federal Commission for Protection Against Health RisksGuatemala: Ministry of Public Health and Social AssistanceAustralia: Department of Health and Ageing Therapeutic Goods AdministrationIndia: Ministry of HealthSouth Africa: Department of HealthUnited States: Institutional Review BoardAustria: Agency for Health and Food SafetyNew Zealand: MedsafeCzech Republic: State Institute for Drug ControlGreece: National Organization of MedicinesSweden: Medical Products AgencySlovakia: State Institute for Drug ControlGermany: Federal Institute for Drugs and Medical DevicesCroatia: Ministry of Health and Social CareCanada: Health CanadaUnited Kingdom: Medicines and Healthcare Products Regulatory AgencyIsrael: Ethics CommissionPoland: Office for Registration of Medicinal Products, Medical Devices and Biocidal ProductsUnited States: Food and Drug AdministrationBelgium: Federal Agency for Medicines and Health Products, FAMHP
• Study type: Interventional

Clinical Trial Summary

To determine if treatment with BG00012 can decrease the number of MS relapses during a certain time period. To determine if, over time, BG00012 treatment can decrease the number of certain types of brain lesions commonly seen in MS patients and slow down the time it takes for the disease to get worse.

The purpose of this study is also to determine the safety of BG00012 and how well it is tolerated. Another goal is to see what effect BG00012 may have on tests and evaluations used to assess MS.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1234
• Est. completion date: February 2011
• Est. primary completion date: February 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 55 Years

Eligibility

Key Inclusion Criteria:

• Unless otherwise specified, to be eligible to participate in this study, candidates must meet the following eligibility criteria at the time of the randomization:

• Must have a confirmed diagnosis of RRMS according to McDonald criteria #1-4.

• Must have a baseline EDSS between 0.0 and 5.0, inclusive.

• Must have relapsing-remitting disease course.

Key Exclusion Criteria:

• Unless otherwise specified, candidates will be excluded from study entry if any of the following exclusion criteria exist at randomization:

• Other chronic disease of the immune system, malignancies, acute urologic, pulmonary, gastrointestinal disease.

• Pregnant or nursing women.

Note: Other protocol-defined inclusion/exclusion criteria may apply.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Multiple Sclerosis
• Multiple Sclerosis, Relapsing-Remitting
• Relapsing-Remitting Multiple Sclerosis
• Sclerosis

Intervention

Drug:
• BG00012

• Placebo

Locations

Country	Name	City	State
Australia	Research Site	Camperdown	New South Wales
Australia	Research Site	Chatswood	New South Wales
Australia	Research Site	Fitzroy
Australia	Research Site	Geelong
Australia	Research Site	Heidelberg
Australia	Research Site	Kogarah
Australia	Research Site	Liverpool
Australia	Research Site	Melbourne
Australia	Research Site	Newcastle
Austria	Research Site	Graz
Austria	Research Site	Innsbruck
Austria	Research Site	Linz
Austria	Research Site	Wien	Vienna
Belgium	Research Site	Antwerpen
Belgium	Research Site	Brugge
Belgium	Research Site	Charleroi
Belgium	Research Site	Diepenbeek
Belgium	Research Site	Leuven
Belgium	Research Site	Lommel
Belgium	Research Site	Sijsele-Damme
Belgium	Research Site	Woluwe
Bosnia and Herzegovina	Research Site	Banja Luka	Republic of Srpksa
Canada	Research Site	Burnaby	British Columbia
Canada	Research Site	Halifax	Nova Scotia
Canada	Research Site	Levis	Quebec
Canada	Research Site	Montreal
Canada	Research Site	Ottawa	Ontario
Canada	Research Site	Quebec City	Quebec
Canada	Research Site	Regina	Saskatchewan
Croatia	Research Site	Zagreb
Czech Republic	Research Site	Brno
Czech Republic	Research Site	Jihlava
Czech Republic	Research Site	Opava
Czech Republic	Research Site	Ostrava
Czech Republic	Research Site	Plzen
Czech Republic	Research Site	Praha
Czech Republic	Research Site	Teplice
France	Research Site	Clermont Ferrand
France	Research Site	Nice
France	Research Site	Paris
France	Research Site	Rennes
Germany	Research Site	Bad Neustadt-Saale
Germany	Research Site	Berlin
Germany	Research Site	Bochum
Germany	Research Site	Dusseldorf
Germany	Research Site	Essen
Germany	Research Site	Gieben
Germany	Research Site	Halle
Germany	Research Site	Hamburg
Germany	Research Site	Hannover
Germany	Research Site	Leipzig
Germany	Research Site	Minden
Germany	Research Site	Munchen
Germany	Research Site	Munster
Germany	Research Site	Osnabruck
Germany	Research Site	Westerstede
Greece	Research Site	Athens
Greece	Research Site	Ioannina
Greece	Research Site	Thessaloniki
Guatemala	Research Site	Guatemala City
India	Research Site	Chenna
India	Research Site	Coimbatore
India	Research Site	Delhi
India	Research Site	Hyderabad
India	Research Site	Kolkata
India	Research Site	Lucknow
India	Research Site	Mangalore
India	Research Site	Mumbai
India	Research Site	New Delhi
India	Research Site	Pune
Israel	Research Site	Ashkelon
Israel	Research Site	Beer Yaakov
Israel	Research Site	Jerusalem
Israel	Research Site	Tel Hashomer
Italy	Research Site	Roma
Macedonia, The Former Yugoslav R	Research Site	Skopje
Mexico	Research Site	Guadalajara
Mexico	Research Site	Mexico City
Mexico	Research Site	San Luis Potosi
Moldova, Republic of	Research Site	Chisinau
Moldova, Republic of	Research Site	Kishinev
Netherlands	Research Site	Breda
Netherlands	Research Site	Sittard
New Zealand	Research Site	Christchurch
New Zealand	Research Site	Grafton
New Zealand	Research Site	Hamilton
Poland	Research Site	Bialystok
Poland	Research Site	Gdansk
Poland	Research Site	Katowice
Poland	Research Site	Krakow
Poland	Research Site	Poznan
Poland	Research Site	Szczecin
Poland	Research Site	Warsaw
Romania	Research Site	Bucuresti
Romania	Research Site	Cluj-Napoca
Romania	Research Site	Timisoara
Serbia	Research Site	Belgrade
Serbia	Research Site	Kragujevac
Serbia	Research Site	Nis
Serbia	Research Site	Novi Sad
Slovakia	Research Site	Bratislava
Slovakia	Research Site	Kosice
Slovakia	Research Site	Martin
South Africa	Research Site	Cape Town
South Africa	Research Site	Durban
South Africa	Research Site	Rosebank
Switzerland	Research Site	Basel
Switzerland	Research Site	St. Gallen
Switzerland	Research Site	Zurich
Ukraine	Research Site	Kharkiv
Ukraine	Research Site	Kyiv
Ukraine	Research Site	Lviv
Ukraine	Research Site	Odessa
Ukraine	Research Site	Poltava
Ukraine	Research Site	Zaporozhye
United Kingdom	Research Site	London
United Kingdom	Research Site	Newcastle
United Kingdom	Research Site	Oxford
United Kingdom	Research Site	Sheffield
United Kingdom	Research Site	Staffordshire
United States	Research Site	Albany	New York
United States	Research Site	Atlanta	Georgia
United States	Research Site	Brighton	Massachusetts
United States	Research Site	Columbia	Missouri
United States	Research Site	Dayton	Ohio
United States	Research Site	Des Moines	Iowa
United States	Research Site	East Providence	Rhode Island
United States	Research Site	Erie	Pennsylvania
United States	Research Site	Evanston	Illinois
United States	Research Site	Farmington Hills	Michigan
United States	Research Site	Fort Wayne	Indiana
United States	Research Site	Gilbert	Arizona
United States	Research Site	Henderson	Nevada
United States	Research Site	Hershey	Pennsylvania
United States	Research Site	Hopedale	Massachusetts
United States	Research Site	Indianapolis	Indiana
United States	Research Site	Las Vegas	Nevada
United States	Research Site	Lebanon	New Hampshire
United States	Research Site	Lexington	Massachusetts
United States	Research Site	Lexington	Kentucky
United States	Research Site	Minneapolis	Minnesota
United States	Research Site	New Haven	Connecticut
United States	Research Site	Newport News	Virginia
United States	Research Site	Palos Heights	Illinois
United States	Research Site	Phoenix	Arizona
United States	Research Site	Pittsburgh	Pennsylvania
United States	Research Site	Providence	Rhode Island
United States	Research Site	Raleigh	North Carolina
United States	Research Site	San Antonio	Texas
United States	Research Site	San Francisco	California
United States	Research Site	Seattle	Washington
United States	Research Site	Springfield	Massachusetts
United States	Research Site	St. Louis	Missouri
United States	Research Site	Staten Island	New York
United States	Research Site	Vero Beach	Florida
United States	Research Site	Washington	District of Columbia
United States	Research Site	Wichita	Kansas
United States	Research Site	Wien	Virginia
United States	Research Site	Worcester	Massachusetts
Virgin Islands (U.S.)	Research Site	Vienna

Sponsors (1)

Lead Sponsor	Collaborator
Biogen

Countries where clinical trial is conducted

United States,  Virgin Islands (U.S.),  Australia,  Austria,  Belgium,  Bosnia and Herzegovina,  Canada,  Croatia,  Czech Republic,  France,  Germany,  Greece,  Guatemala,  India,  Israel,  Italy,  Macedonia, The Former Yugoslav Republic of,  Mexico,  Moldova, Republic of,  Netherlands,  New Zealand,  Poland,  Romania,  Serbia,  Slovakia,  South Africa,  Switzerland,  Ukraine,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Proportion of Subjects Relapsed	A protocol-defined relapse was defined as new or recurrent neurologic symptoms not associated with fever or infection that lasted at least 24 hours, and were separated by at least 30 days from onset of a preceding relapse. All protocol-defined relapses were evaluated by an independent neurolgic evaluation committee. The proportion of subjects with a relapse was estimated using the Kaplan-Meier method, which was based on the time-to-first-relapse survival distribution.	2 years	No
Secondary	Number of New or Newly Enlarging T2 Hyperintense Lesions	The number of new or newly enlarging T2 hyperintense lesions at 2 years that developed in each subject compared to baseline assessed on brain magnetic resonance imaging (MRI) scans. The estimates of mean T2 lesion count were calculated from a negative binomial regression model adjusted for region and baselineT2 lesion volume	2 years	No
Secondary	Number of Gadolinium-enhancing T1-weighted Lesions	The number of Gd-enhancing lesions was assessed using brain MRI scans following administration of gadolinium, a contrast agent. The mean number of Gd-enhancing lesions at 2 years was the average of the number of lesions at 2 years in a treatment group.	2 years	No
Secondary	Number of Subjects With Gadolinium (Gd)-Enhancing Lesions	Note: This outcome measure represents the categorical analysis for the previously listed secondary outcome measure "Number of Gadolinium-enhancing T1-weighted lesions"	2 years	No
Secondary	Annualized Relapse Rate	A protocol-defined relapse was defined as new or recurrent neurologic symptoms not associated with fever or infection that lasted at least 24 hours, and were separated by at least 30 days from onset of a preceding relapse. All protocol-defined relapses were evaluated by an independent neurologic evaluation committee. The adjusted annualized relapse rate was calculated from a negative binomial regression model, adjusted for baseline EDSS (= 2.0 vs. >2.0), age (<40 versus =40 years), region, and the number of relapses in the 1 year prior to enrollment.	2 years	No
Secondary	Proportion of Subjects Experiencing Progression of Disability Assessed Using the Expanded Disability Status Scale (EDSS)	The EDSS is based on a standardized neurological examination and focuses on symptoms that commonly occur in MS. EDSS scores range from 0.0 (normal) to 10.0 (death due to MS). Disability progression was defined as = 1.0 point increase in subjects with a baseline EDSS of =1.0, or a =1.5 point increase in subjects with a baseline EDSS = 0, and required that the increase from baseline was confirmed =12 weeks later. The proportion of subjects with confirmed (12-week) disability progression was estimated using the Kaplan-Meier method, which was based on the time-to-first-progression survival distribution.	2 years	No