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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01864148
Other study ID # 215MS201
Secondary ID EUDRACT #: 2011-
Status Completed
Phase Phase 2
First received May 24, 2013
Last updated December 20, 2016
Start date August 2013
Est. completion date March 2016

Study information

Verified date December 2016
Source Biogen
Contact n/a
Is FDA regulated No
Health authority France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)Serbia: Medicines and Medical Devices Agency of SerbiaSpain: Spanish Agency of MedicinesCzech Republic: State Institute for Drug ControlHungary: National Institute of PharmacyCanada: Health CanadaUnited Kingdom: Medicines and Healthcare Products Regulatory AgencyPoland: Office for Registration of Medicinal Products, Medical Devices and Biocidal ProductsUnited States: Food and Drug AdministrationRussia: Ministry of Health of the Russian FederationItaly: The Italian Medicines Agency
Study type Interventional

Clinical Trial Summary

The primary objective of the study is to evaluate the efficacy of BIIB033 in participants with active relapsing MS when used concurrently with Avonex.

Secondary objectives of this study in this study population are to assess the safety, tolerability, and population PK of BIIB033 when used concurrently with Avonex


Recruitment information / eligibility

Status Completed
Enrollment 419
Est. completion date March 2016
Est. primary completion date December 2015
Accepts healthy volunteers No
Gender Both
Age group 18 Years to 58 Years
Eligibility Key Inclusion Criteria:

- Diagnosis of Relapsing Remitting Multiple Sclerosis (RRMS) or onset of Secondary Progressive Multiple Sclerosis (SPMS)

- RRMS and SPMS subjects must have evidence of ongoing disease activity within 12 months of enrollment.

- All male and female subjects of childbearing potential must practice effective contraception during the study and be willing and able to continue contraception for at least 6 months after their last dose of study treatment

Key Exclusion Criteria:

- A Multiple Sclerosis (MS) relapse that has occurred within the 90 days prior to Day 1/Baseline and/or the subject has not stabilized from a previous relapse prior to Screening

- Previous history of clinically significant disease.

- Plans to undergo elective major procedures/surgeries at any time during the study.

- Treatment with any investigational Multiple Sclerosis (MS) drugs within 3 weeks or 5 times the half life (whichever is longer) prior to Day 1/Baseline

- Relapsing Remitting Multiple Sclerosis (RRMS) subjects with any history of inadequate response to any approved interferon ß preparation

- History of Human Immunodeficiency Virus (HIV), hepatitis C virus antibody, or hepatitis B virus

- History or evidence of drug or alcohol abuse within 2 years prior to Randomization

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


Intervention

Drug:
BIIB033 (anti-LINGO-1 mAb)
Administered as specified in the treatment arm
Other:
Placebo
Participants receive placebo
Drug:
Interferon Beta-1a
All participants receive Interferon Beta-1a intramuscular (IM) injections once weekly

Locations

Country Name City State
Canada London Health Sciences Centre London
Czech Republic NEUROSPOL Sro Havirov
Czech Republic Fakultni Nemocnice Hradec Kralove Hradec Králové Královéhradecký kraj
Czech Republic Nemocnice Jihlava Prispevkova Organizace Jihlava Vysocina
Czech Republic Vseobecna Fakultni Nemocnice V Praze Praha Praha, hlavní mesto
Czech Republic Fakultni nemocnice v Motole Praha 5
Czech Republic Krajska Zdravotni As Nemocnice Teplice Oz Teplice Ústecký kraj
France Hôpital Nord Amiens Somme
France Hopital Gabriel Montpied Clermont-Ferrand
France Hôpital Roger Salengro Lille Nord
France CHRU Nancy Nancy
France Hôpital Guillaume Et René Laënnec Nantes Loire-Atlantique
France Fondation Rothschild Paris
France Hôpital Maison Blanche Reims Marne
Hungary Jahn Ferenc Dél-Pesti Kórház és Rendelöintézet Budapest
Hungary Uzsoki Utcai Korhaz Budapest
Hungary Pécsi Tudományegyetem Pécs
Hungary Szegedi Tudományegyetem Szent-Györgyi Albert Klinikai Központ Szeged Csongrád
Italy Azienda Ospedaliero Universitaria Policlinico-Vittorio Emanuele Catania Sicilia
Italy Fondazione Istituto San Raffaele G. Giglio di Cefalù Cefalù Palermo
Italy Azienda Ospedaliera S. Antonio Abate di Gallarate Gallarate Varese
Italy Azienda Ospedaliera Universitaria San Martino Genova Liguria
Italy Ospedale San Raffaele S.r.l. Milano Lombardia
Italy Azienda Ospedaliera Spedali Civili di Brescia - Presidio Ospedaliero di Montichiari Montichiari Lombardia
Italy Unità Operativa S.D. Centro Regionale per lo Studio e la Terapia della Sclerosi Multipla Roma Lazio
Netherlands Erasmus MC Rotterdam Zuid-Holland
Netherlands Orbis Medisch Centrum Sittard-Geleen
Poland Pomorskie Centrum Traumatologii im. M. Kopernika w Gdansku Gdansk
Poland Regionalny Szpital Specjalistyczny im. dr Wladyslawa Bieganskiego Grudziadz
Poland Gabriela Klodowska-Duda Neuro-Care NZOZ Site Management Organization Katowice
Poland M.A.- Lek A.M.Maciejowscy Spolka Cywilna Katowice
Poland Novo-Med Zielinski i wsp. Sp.J. Katowice Slaskie
Poland Prywatny Gabinet Neurologiczny K. Selmaj Lódz Lódzkie
Poland Neurologiczny NZOZ Centrum Leczenia SM Osrodek Badan Klinicznych Dr n. med. Hanka Hertmanowska Plewiska
Poland Niepubliczny Zaklad Opieki Zdrowotnej NEURO-KARD Ilkowski i Partnerzy Spolka Partnerska Lekarzy Poznan
Poland SPZOZ Wojewodzki Szpital Specjalistyczny w Rybniku Rybnik
Poland EUROMEDIS Sp. z o.o. Szczecin
Poland Wojskowy Instytut Medyczny Warszawa Mazowieckie
Russian Federation Kaluga Regional Hospital Kaluga
Russian Federation Republican Clinical Hospital For Rehabilitation Treatment Kazan
Russian Federation Krasnoyarsk State Medical Academy Krasnoyarsk
Russian Federation City Clinical Hospital # 11 Moscow
Russian Federation Perm State Medical Academy Perm
Russian Federation City Center of MS Treatment based on Saint-Petersburg City Clinical Hospital #31 Saint-Petersburg
Russian Federation City Clinical Emergency # 25 Volgograd
Serbia Clinical Center of Serbia Belgrade
Serbia Military Medical Academy Belgrade
Serbia Clinical Hospital Center Kragujevac Kragujevac
Serbia General Hospital Uzice Uzice
Spain Hospital Universitario Vall d'Hebron Barcelona Cataluña
Spain Hospital de Basurto Osakidetza Bilbao Vizcaya
Spain Hospital Universitario Reina Sofia Cordoba Córdoba
Spain Hospital Universitari de Bellvitge l'Hospitalet de Llobregat, Barceona
Spain Hospital Clinico San Carlos Madrid Madrid, Communidad Delaware
Spain Hospital Universitario Puerta de Hierro Majadahonda Majadahonda Madrid
Spain Hospital General Carlos Haya Malaga
Spain Hospital Universitario Virgen Macarena Sevilla
United Kingdom King's College Hospital London London, City of
United Kingdom Queen's Medical Centre Nottingham Nottinghamshire
United States Johns Hopkins Hospital Baltimore Maryland
United States Immunoe International Research Center Centennial Colorado
United States North Central Neurology Assoc PC Cullman Alabama
United States Michigan Institute For Neurological Disorders Farmington Hills Michigan
United States Multiple Sclerosis Center of North Eastern New York Latham New York
United States OMRF Multiple Sclerosis Center of Excellence Oklahoma City Oklahoma
United States Phoenix Neurological Associates Phoenix Arizona
United States Raleigh Neurology Associates PA Raleigh California
United States Washington University Saint Louis Missouri
United States Swedish Medical Center Seattle Washington
United States Stanford University Medical Center Stanford California

Sponsors (1)

Lead Sponsor Collaborator
Biogen

Countries where clinical trial is conducted

United States,  Canada,  Czech Republic,  France,  Hungary,  Italy,  Netherlands,  Poland,  Russian Federation,  Serbia,  Spain,  United Kingdom, 

Outcome

Type Measure Description Time frame Safety issue
Primary Number of participants experiencing confirmed improvement of neuro-physical and/or cognitive function and/or disability. Over 72 weeks No
Secondary Number of participants experiencing confirmed worsening of neuro-physical and/or cognitive function and/or disability Over 72 weeks No
Secondary Number of participants experiencing Adverse Events (AEs) Up to 84 weeks Yes
Secondary Number of participants experiencing Severe Adverse Events (SAEs) Up to 84 weeks Yes
Secondary BIIB033 population Pharmacokinetics assessment Up to 84 weeks No
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