Efficacy and Safety Study of Oral BG00012 With Active Reference in Relapsing-Remitting Multiple Sclerosis

Relapsing-Remitting Multiple Sclerosis Clinical Trial

— CONFIRM  

Official title:

A Randomized, Multicenter, Placebo-Controlled and Active Reference (Glatiramer Acetate) Comparison Study to Evaluate the Efficacy and Safety of BG00012 in Subjects With Relapsing-Remitting Multiple Sclerosis

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00451451
• Other study ID #: 109MS302
• Status: Completed
• Phase: Phase 3
• First received: March 21, 2007
• Last updated: January 13, 2015
• Start date: June 2007
• Est. completion date: August 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 HealthIreland: Irish Medicines BoardMexico: Federal Commission for Protection Against Health RisksBulgaria: Ministry of HealthSpain: Spanish Agency of MedicinesEstonia: The State Agency of MedicineUnited States: Institutional Review BoardNew Zealand: MedsafeCzech Republic: State Institute for Drug ControlGreece: National Organization of MedicinesSlovakia: State Institute for Drug ControlGermany: Federal Institute for Drugs and Medical DevicesCroatia: Ministry of Health and Social CareCanada: Health CanadaLatvia: State Agency of MedicinesPoland: 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. Other goals of the study are 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 MS to get worse.

Other objectives of the study are to determine the safety and tolerability of BG00012, as well as the effect it may have on tests and evaluations used to assess MS. Additionally, glatiramer acetate is being used to compare its benefits and risks with placebo and BG00012.

Description:

Multiple sclerosis (MS) is a chronic disease of the central nervous system that affects approximately 400,000 persons in North America and 365,000 persons in Europe. It is predominantly a disease of young adults, primarily women, with disease onset typically occurring between the ages of 20 and 40.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1417
• Est. completion date: August 2011
• Est. primary completion date: August 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 55 Years

Eligibility

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

Key Inclusion Criteria:

• Must have 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:

• Other chronic disease of immune system, malignancies, 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

• Glatiramer Acetate

Locations

Country	Name	City	State
Belarus	Research Site	Gomel
Belarus	Research Site	Minsk
Belarus	Research Site	Vitebsk
Belgium	Research Site	Lommel
Belgium	Research Site	Sijsele-Damme
Belgium	Research Site	Woluwe
Bosnia and Herzegovina	Research Site	Banja Luka	Republic Srpska
Bosnia and Herzegovina	Research Site	Sarajevo B&H Federation
Bosnia and Herzegovina	Research Site	Tuzla	B&H Federation
Bulgaria	Research Site	Plovdiv
Bulgaria	Research Site	Rousse
Bulgaria	Research Site	Sofia
Bulgaria	Research Site	Stara Zagora
Bulgaria	Research Site	Varna
Canada	Research Site	Edmonton
Canada	Research Site	London
Canada	Research Site	Montreal
Canada	Research Site	Osijek
Costa Rica	Research Site	San Jose
Croatia	Research Site	Rijeka
Croatia	Research Site	Zagreb
Czech Republic	Research Site	Ostrava
Czech Republic	Research Site	Ostrava-Moravska
Czech Republic	Research Site	Praha
Estonia	Research Site	Kuressaare
Estonia	Research Site	Parnu
Estonia	Research Site	Tallinn
Estonia	Research Site	Tartu
France	Research Site	Caen
France	Research Site	Dijon
France	Research Site	Marseille
France	Research Site	Montpellier
France	Research Site	Nancy
France	Research Site	Nimes
France	Research Site	Strasbourg
Germany	Research Site	Bamberg
Germany	Research Site	Bayreuth
Germany	Research Site	Berg Starnberger
Germany	Research Site	Berlin
Germany	Research Site	Dusseldorf
Germany	Research Site	Erbach
Germany	Research Site	Erlangen
Germany	Research Site	Giessen
Germany	Research Site	Halle (Saale)
Germany	Research Site	Hanburg
Germany	Research Site	Heidelberg
Germany	Research Site	Koln
Germany	Research Site	Magdeburg
Germany	Research Site	Marburg
Germany	Research Site	Munchen
Germany	Research Site	Regensburg
Germany	Research Site	Schwerin
Greece	Research Site	Athens
Greece	Research Site	Larisa
Greece	Research Site	Patra
Greece	Research Site	Thessaloniki
India	Research Site	Ahmedabad
India	Research Site	Bangalore
India	Research Site	Calicut
India	Research Site	Chandigarh
India	Research Site	Chennai
India	Research Site	Cochin
India	Research Site	Coimbatore
India	Research Site	Kochi
India	Research Site	Kolkata
India	Research Site	Lucknow
India	Research Site	Ludhiana
India	Research Site	Mangalore
India	Research Site	Mumbai
India	Research Site	New Delhi
India	Research Site	Pune
Ireland	Research Site	Cork
Ireland	Research Site	Dublin
Ireland	Research Site	Galway
Israel	Research Site	Holon
Israel	Research Site	Safed
Latvia	Research Site	Riga
Macedonia, The Former Yugoslav R	Research Site	Skopje
Mexico	Research Site	Aguascalientes
Mexico	Research Site	Guadalajara
Mexico	Research Site	Guadalajara	Jal
Mexico	Research Site	Mexico
Mexico	Research Site	Mexico DF
Mexico	Research Site	Mexico DF
Mexico	Research Site	Monterray
Mexico	Research Site	Monterrey	Nuevo Leon
Mexico	Research Site	Morelia	Michoacan
Moldova, Republic of	Research Site	Chisinau
Moldova, Republic of	Research Site	Kishinev
New Zealand	Research Site	Hamilton
Poland	Research Site	Bialystok
Poland	Research Site	Gdansk
Poland	Research Site	Katowice
Poland	Research Site	Lodz
Poland	Research Site	Lublin
Poland	Research Site	Poznan
Poland	Research Site	Szczecin
Poland	Research Site	Warsaw
Poland	Research Site	Warszawa
Poland	Research Site	Wroclaw
Puerto Rico	Research Site	Guaynabo
Romania	Research Site	Bucuresti
Romania	Research Site	Iasi
Romania	Research Site	Oradea
Romania	Research Site	Tirgu Mures
Romania	Research Site	Tirgu-Mures
Serbia	Research Site	Belgrade
Serbia	Research Site	Kragujevac
Serbia	Research Site	Nis
Serbia	Research Site	Novi Sad
Slovakia	Research Site	Kosice
Slovakia	Research Site	Martin
Spain	Research Site	Barcelona
Spain	Research Site	Bilbao
Spain	Research Site	Cordoba
Spain	Research Site	Gandia
Spain	Research Site	Madrid
Spain	Research Site	Malaga
Spain	Research Site	Santiago de Compostela
Spain	Research Site	Sevilla
Ukraine	Research Site	Kharkiv
Ukraine	Research Site	Kyiv
Ukraine	Research Site	Lviv
Ukraine	Research Site	Odessa
Ukraine	Research Site	Poltava
Ukraine	Research Site	Simferopol
Ukraine	Research Site	Zaporozhye
United States	Research Site	Amherst	New York
United States	Research Site	Augusta	Georgia
United States	Research Site	Baltimore	Maryland
United States	Research Site	Bellevue	Ohio
United States	Research Site	Birmingham	Alabama
United States	Research Site	Boston	Massachusetts
United States	Research Site	Boulder	Colorado
United States	Research Site	Buffalo	New York
United States	Research Site	Burlington	Vermont
United States	Research Site	Cedarhurst	New York
United States	Research Site	Charlotte	North Carolina
United States	Research Site	Cleveland	Ohio
United States	Research Site	Clinton Township	Michigan
United States	Research Site	Colorado Springs	Colorado
United States	Research Site	Columbus	Ohio
United States	Research Site	Columbus	Georgia
United States	Research Site	Cordova	Tennessee
United States	Research Site	Cullman	Alabama
United States	Research Site	Dallas	Texas
United States	Research Site	Dover	New Hampshire
United States	Research Site	Edmond	Oklahoma
United States	Research Site	Eugene	Oregon
United States	Research Site	Fort Collins	Colorado
United States	Research Site	Franklin	Tennessee
United States	Research Site	Freehold	New Jersey
United States	Research Site	Galveston	Texas
United States	Research Site	Grand Rapids	Michigan
United States	Research Site	Houston	Texas
United States	Research Site	Huntsville	Alabama
United States	Research Site	Indianapolis	Indiana
United States	Research Site	Kansas City	Kansas
United States	Research Site	Knoxville	Tennessee
United States	Research Site	La Jolla	California
United States	Research Site	Lebanon	New Hampshire
United States	Research Site	Loma Linda	California
United States	Research Site	Louisville	Kentucky
United States	Research Site	Madison	Wisconsin
United States	Research Site	Maitland	Florida
United States	Research Site	Medford	Oregon
United States	Research Site	Memphis	Tennessee
United States	Research Site	Meridan	Idaho
United States	Research Site	Miami	Florida
United States	Research Site	Milwaukee	Wisconsin
United States	Research Site	Mineola	New York
United States	Research Site	Naples	Florida
United States	Research Site	Nashville	Tennessee
United States	Research Site	Pasadena	California
United States	Research Site	Patchogue	New York
United States	Research Site	Philadelphia	Pennsylvania
United States	Research Site	Phoenix	Arizona
United States	Research Site	Pittsburgh	Pennsylvania
United States	Research Site	Plainview	New York
United States	Research Site	Pompano Beach	Florida
United States	Research Site	Portland	Oregon
United States	Research Site	Richmond	Virginia
United States	Research Site	Round Rock	Texas
United States	Research Site	Sacramento	California
United States	Research Site	Salt Lake City	Utah
United States	Research Site	San Antonio	Texas
United States	Research Site	Sarasota	Florida
United States	Research Site	Seattle	Washington
United States	Research Site	Shreveport	Louisiana
United States	Research Site	Souderton	Pennsylvania
United States	Research Site	St. Petersburg	Florida
United States	Research Site	Staten Island	New York
United States	Research Site	Stony Brook	New York
United States	Research Site	Tacoma	Washington
United States	Research Site	Tallahassee	Florida
United States	Research Site	Tampa	Florida
United States	Research Site	Teaneck	New Jersey
United States	Research Site	Walnut Creek	California
United States	Research Site	Winston-Salem	North Carolina

Sponsors (1)

Lead Sponsor	Collaborator
Biogen

Countries where clinical trial is conducted

United States,  Belarus,  Belgium,  Bosnia and Herzegovina,  Bulgaria,  Canada,  Costa Rica,  Croatia,  Czech Republic,  Estonia,  France,  Germany,  Greece,  India,  Ireland,  Israel,  Latvia,  Macedonia, The Former Yugoslav Republic of,  Mexico,  Moldova, Republic of,  New Zealand,  Poland,  Puerto Rico,  Romania,  Serbia,  Slovakia,  Spain,  Ukraine, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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 Expanded Disability Status Scale (EDSS ) score(=2.0 versus>2.0), age (<40 versus =40 years), region, and the number of relapses in the 1 year prior to enrollment.	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 hyperintense lesion count were calculated from a negative binomial regression model adjusted for region and baseline T2 hyperintense lesion volume.	2 years	No
Secondary	Number of New T1 Hypointense Lesions	The number of new T1 hypointense lesions at 2 years that developed in each subject compared to baseline assessed on brain magnetic resonance imaging (MRI) scans. The estimates of mean T1 hypointense lesion count were calculated from a negative binomial regression model adjusted for region and baseline T1 hypointense lesion volume.	2 years	No
Secondary	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 neurologic 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	Proportion of Subjects Experiencing Progression of Disability Assessed Using the Expanded Disability Status Scale (EDSS)	EDSS is based on a standardized neurological exam and focuses on symptoms that commonly occur in MS. 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 =1.5 point increase in subjects with a baseline EDSS=0, and required that the increase from baseline was confirmed = 12weeks 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