Relapsing-Remitting Multiple Sclerosis Clinical Trial
— (DECIDE)Official title:
Multicenter, Double-blind, Randomized, Parallel-group, Monotherapy, Active-control Study to Determine the Efficacy and Safety of Daclizumab High Yield Process (DAC HYP) Versus Avonex® (Interferon β 1a) in Patients With Relapsing-Remitting Multiple Sclerosis
| Verified date | August 2015 |
| Source | Biogen |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | United States: Food and Drug Administration |
| Study type | Interventional |
The primary study objective is to test the superiority of Daclizumab High Yield Process (DAC
HYP) compared to interferon β 1a (IFN β-1a) in preventing multiple sclerosis (MS) relapse in
participants with relapsing remitting multiple sclerosis.
The secondary study objectives are to test the superiority of DAC HYP compared to IFN β-1a
in slowing functional decline and disability progression and maintaining quality of life in
this participant population.
| Status | Completed |
| Enrollment | 1841 |
| Est. completion date | July 2014 |
| Est. primary completion date | March 2014 |
| Accepts healthy volunteers | No |
| Gender | Both |
| Age group | 18 Years to 55 Years |
| Eligibility |
Key Inclusion Criteria: - Must have a confirmed diagnosis of Relapsing Remitting Multiple Sclerosis (RRMS), and a cranial magnetic resonance imaging (MRI) demonstrating lesion(s) consistent with MS - Must have a baseline Expanded Disability Status Scale (EDSS) between 0.0 and 5.0, inclusive - Male subjects and female subjects of childbearing potential must be willing to practice effective contraception during the study and be willing and able to continue contraception for 4 months after their last dose of study treatment Key Exclusion Criteria: - Known intolerance, contraindication to, or history of non-compliance with Avonex® 30 µg - History of treatment with Daclizumab High Yield Process (Dac HYP) - History of malignancy - History of severe allergic or anaphylactic reactions - Known hypersensitivity to study drugs or their excipients - History of abnormal laboratory results indicative of any significant disease - History of human immunodeficiency virus (HIV) or other immunodeficient conditions - History of drug or alcohol abuse (as defined by the Investigator) within the 2 years prior to randomization - History of seizure disorder or unexplained blackouts OR history of a seizure within 6 months prior to Baseline - History of suicidal ideation or an episode of clinically severe depression (as determined by the Investigator) within 3 months prior to Day 1 - An MS relapse that has occurred within the 50 days prior to randomization AND/OR the subject has not stabilized from a previous relapse prior to randomization - Known history of, or positive screening test result for hepatitis C virus or hepatitis B virus - Varicella or herpes zoster virus infection or any severe viral infection within 6 weeks before screening - Exposure to varicella zoster virus within 21 days before screening NOTE: Other protocol-defined Inclusion/Exclusion criteria may apply. |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
| Country | Name | City | State |
|---|---|---|---|
| Argentina | Research Site | Ciudad Autónoma de Buenos Aires | Buenos Aires |
| Argentina | Research Site | Godoy Cruz | Mendoza |
| Argentina | Research Site | Rosario | Santa Fe |
| Australia | Research Site | Auchenflower | Queensland |
| Australia | Research Site | Camperdown | New South Wales |
| Australia | Research Site | Fitzroy | Victoria |
| Australia | Research Site | Heidelberg West | Victoria |
| Australia | Research Site | New Lambton Heights | New South Wales |
| Australia | Research Site | Woodville | South Australia |
| Brazil | Research Site | Belo Horizonte | Bahia |
| Brazil | Research Site | Brasilia | Distrito Federal |
| Brazil | Research Site | Campinas | Sao Paulo |
| Brazil | Research Site | Porto Alegre | Rio Grande |
| Brazil | Research Site | Recife | Pernambuco |
| Brazil | Research Site | Ribeirão Preto | Sao Paulo |
| Brazil | Research Site | Rio de Janeiro | |
| Brazil | Research Site | Sao Paulo | Rio Grande |
| Canada | Research Site | Calgary | Alberta |
| Canada | Research Site | Edmonton | Alberta |
| Canada | Research Site | Gatineau | Quebec |
| Canada | Research Site | Greenfield Park | Quebec |
| Canada | Research Site | London | Ontario |
| Canada | Research Site | Montréal | Quebec |
| Canada | Research Site | Ottawa | Ontario |
| Canada | Research Site | Regina | Saskatchewan |
| Canada | Research Site | Saint John | Newfoundland and Labrador |
| Canada | Research Site | Vancouver | British Columbia |
| Czech Republic | Research Site | Brno | Jihocesky Kraj |
| Czech Republic | Research Site | Brno | |
| Czech Republic | Research Site | Havirov | Severomoravksy Krav |
| Czech Republic | Research Site | Hradec Kralove | |
| Czech Republic | Research Site | Jihlava | |
| Czech Republic | Research Site | Jihlava | Kraj Vysocina |
| Czech Republic | Research Site | Olomouc | Olomoucký kraj |
| Czech Republic | Research Site | Ostrava | |
| Czech Republic | Research Site | Pardubice | |
| Czech Republic | Research Site | Praha 10 | Praha |
| Czech Republic | Research Site | Praha 2 | Praha |
| Denmark | Research Site | Århus | |
| Denmark | Research Site | Copenhagen | |
| Denmark | Research Site | Glostrup | |
| Denmark | Research Site | Odense C | |
| Finland | Research Site | Helsinki | |
| Finland | Research Site | Oulu | |
| Finland | Research Site | Seinäjoki | |
| Finland | Research Site | Tampere | Western Finalnd |
| Finland | Research Site | Turku | |
| France | Research Site | Amiens | Picardie |
| France | Research Site | Bobigny | Ile-de-france |
| France | Research Site | Bourdeaux | |
| France | Research Site | Caen Cedex 5 | Basse-normandie |
| France | Research Site | Dijon | |
| France | Research Site | Lille | |
| France | Research Site | Lomme | |
| France | Research Site | Lyon | Rhone-alpes |
| France | Research Site | Marseille Cedex 9 | |
| France | Research Site | Nancy | |
| France | Research Site | Nice | Provence Alpes Cote D'azur |
| France | Research Site | Paris | Ile-de-france |
| France | Research Site | Paris Cedex 5 | Ile-de-france |
| France | Research Site | Strasbourg | Alsace |
| France | Research Site | Toulouse Cedex 3 | |
| Georgia | Research Site | Tbilisi | |
| Germany | Research Site | Bad Mergentheim | Baden-Wurttemberg |
| Germany | Research Site | Bamberg | Bayern |
| Germany | Research Site | Bayreuth | Bayern |
| Germany | Research Site | Berlin | |
| Germany | Research Site | Dresden | Sachsen |
| Germany | Research Site | Essen | Nordrhein Westfalen |
| Germany | Research Site | Freiburg | Baden-wuerttemberg |
| Germany | Research Site | Hamburg | |
| Germany | Research Site | Koln | Nordrhein Westfalen |
| Germany | Research Site | Marburg | Hessen |
| Germany | Research Site | München | Bayern |
| Germany | Research Site | Munster | Nordrhein-Westfalen |
| Germany | Research Site | Neuburg an der Donau | Bayern |
| Germany | Research Site | Trier | Rheinland-Pfalz |
| Germany | Research Site | Tübingen | |
| Greece | Research Site | Athens | Attica |
| Greece | Research Site | Heraklion | Crete |
| Greece | Research Site | Thessaloniki | Macedoni |
| Hungary | Research Site | Budapest | |
| Hungary | Research Site | Esztergom | |
| Hungary | Research Site | Gyor | Gyor-moson-sopron |
| Hungary | Research Site | Miskolc | |
| Hungary | Research Site | Nyíregyháza | |
| Hungary | Research Site | Székesfehérvár | Fejer |
| Hungary | Research Site | Veszprém | |
| India | Research Site | Bangalore | Karnataka |
| India | Research Site | Delhi | Dwivdee |
| India | Research Site | Hyderabad | Andhra Pradesh |
| India | Research Site | Mumbai | Maharashtra |
| India | Research Site | Nagpur | Maharashtra |
| India | Research Site | New Delhi | |
| India | Research Site | Trivandrum | Kerala |
| Ireland | Research Site | Dublin | |
| Israel | Research Site | Ashkelon | Ashqelon |
| Israel | Research Site | Beer-Sheva | |
| Israel | Research Site | Haifa | |
| Israel | Research Site | Kfar Saba | |
| Israel | Research Site | Petach Tikva | Petah Tiqwa |
| Israel | Research Site | Tzfat | |
| Israel | Research Site | Tzrifin | Beer Yaakov |
| Italy | Research Site | Bari | |
| Italy | Research Site | Cagliari | |
| Italy | Research Site | Catania | |
| Italy | Research Site | Cefalù | PA |
| Italy | Research Site | Firenze | |
| Italy | Research Site | Genova | |
| Italy | Research Site | Milano | |
| Italy | Research Site | Orbassano | Torino |
| Italy | Research Site | Padova | |
| Italy | Research Site | Roma | |
| Mexico | Research Site | Guadalajara | Jalisco |
| Mexico | Research Site | Mexico | Distrito Federal |
| Moldova, Republic of | Research Site | Chisinau | |
| Poland | Research Site | Bialystok | Podlaskie |
| Poland | Research Site | Bydgoszcz | Kujawsko-pomorskie |
| Poland | Research Site | Bydgoszczas | |
| Poland | Research Site | Gdansk | Pomorskie |
| Poland | Research Site | Grudziadz | Kujawsko-pomorskie |
| Poland | Research Site | Katowice | Slaskie |
| Poland | Research Site | Kielce | Swietokrzycie |
| Poland | Research Site | Kraków | Malopolskie |
| Poland | Research Site | Lódz | Lodzkie |
| Poland | Research Site | Lublin | Dolnoslaskie |
| Poland | Research Site | Olsztyn | Warminsko-mazurskie |
| Poland | Research Site | Plewiska | |
| Poland | Research Site | Poznan | Wielkopolskie |
| Poland | Research Site | Szczecin | Zachodniopomorskie |
| Poland | Research Site | Warszawa | Mazowieckie |
| Romania | Research Site | Bucurest | Bucuresti |
| Romania | Research Site | Cluj-Napoca | Cluj |
| Romania | Research Site | Iasi | |
| Romania | Research Site | Târgu Mures | |
| Romania | Research Site | Timisoara | Timis |
| Russian Federation | Research Site | Chelyabinsk | |
| Russian Federation | Research Site | Ekaterinburg | Ural |
| Russian Federation | Research Site | Kaluga | |
| Russian Federation | Research Site | Kazan | Povolje-Tatarstan |
| Russian Federation | Research Site | Kemerovo | |
| Russian Federation | Research Site | Krasnoyarsk | |
| Russian Federation | Research Site | Moscow | |
| Russian Federation | Research Site | Nizhny Novgorod | |
| Russian Federation | Research Site | Novosibirsk | |
| Russian Federation | Research Site | Perm | |
| Russian Federation | Research Site | Saint Petersburg | |
| Russian Federation | Research Site | Smolensk | |
| Russian Federation | Research Site | Tomsk | |
| Russian Federation | Research Site | Tumen | |
| Russian Federation | Research Site | Ufa | |
| Russian Federation | Research Site | Yaroslavl | Yaroslavlr |
| Serbia | Research Site | Belgrade | |
| Serbia | Research Site | Kragujevac | |
| Serbia | Research Site | Nis | |
| Serbia | Research Site | Novi Sad | |
| Spain | Research Site | Barcelona | |
| Spain | Research Site | Cordoba | |
| Spain | Research Site | Girona | |
| Spain | Research Site | L´Hospitalet de Llobregat | Barcelona |
| Spain | Research Site | Madrid | |
| Spain | Research Site | Sevilla | |
| Sweden | Research Site | Göteborg | |
| Sweden | Research Site | Linköping | |
| Sweden | Research Site | Malmö | |
| Sweden | Research Site | Stockholm | |
| Switzerland | Research Site | Basel | |
| Switzerland | Research Site | Lugano | |
| Ukraine | Research Site | Dnepropetrovsk | |
| Ukraine | Research Site | Kharkiv | |
| Ukraine | Research Site | Kyviv | |
| Ukraine | Research Site | Odessa | |
| Ukraine | Research Site | Poltava | |
| Ukraine | Research Site | Vinnitsa | |
| Ukraine | Research Site | Zaporozhye | |
| United Kingdom | Research Site | Brighton | |
| United Kingdom | Research Site | Bristol | |
| United Kingdom | Research Site | Edinburgh | |
| United Kingdom | Research Site | London | |
| United Kingdom | Research Site | New Castle Upon Tyne | |
| United Kingdom | Research Site | Nottingham | |
| United Kingdom | Research Site | Romford | |
| United Kingdom | Research Site | Salford | |
| United Kingdom | Research Site | Sheffield | |
| United States | Research Site | Albuquerque | New Mexico |
| United States | Research Site | Allentown | Pennsylvania |
| United States | Research Site | Atlanta | Georgia |
| United States | Research Site | Aurora | Colorado |
| United States | Research Site | Baltimore | Maryland |
| United States | Research Site | Buffalo | New York |
| United States | Research Site | Burlington | Vermont |
| United States | Research Site | Charlotte | North Carolina |
| United States | Research Site | Clinton Township | Michigan |
| United States | Research Site | Des Moines | Iowa |
| United States | Research Site | Evanston | Illinois |
| United States | Research Site | Fort Wayne | Indiana |
| United States | Research Site | Franklin | Tennessee |
| United States | Research Site | Gilbert | Arizona |
| United States | Research Site | Indianapolis | Indiana |
| United States | Research Site | Kansas City | Kansas |
| United States | Research Site | Kirkland | Washington |
| United States | Research Site | Knoxville | Tennessee |
| United States | Research Site | La Jolla | California |
| United States | Research Site | Latham | New York |
| United States | Research Site | Lebanon | New Hampshire |
| United States | Research Site | Lexington | Kentucky |
| United States | Research Site | Little Rock | Arkansas |
| United States | Research Site | Medford | Oregon |
| United States | Research Site | Milwaukee | Wisconsin |
| United States | Research Site | Naples | Florida |
| United States | Research Site | New Brunswick | New Jersey |
| United States | Research Site | New York | New York |
| United States | Research Site | Philadelphia | Pennsylvania |
| United States | Research Site | Phoenix | Arizona |
| United States | Research Site | Pittsburg | Pennsylvania |
| United States | Research Site | Pompano Beach | Florida |
| United States | Research Site | Portland | Oregon |
| United States | Research Site | Providence | Rhode Island |
| United States | Research Site | Raleigh | North Carolina |
| United States | Research Site | Rochester | New York |
| United States | Research Site | Saint Louis | Missouri |
| United States | Research Site | Salt Lake City | Utah |
| United States | Research Site | Seattle | Washington |
| United States | Research Site | Springfield | Massachusetts |
| United States | Research Site | St. Petersburg | Florida |
| United States | Research Site | Sunrise | Florida |
| United States | Research Site | Tacoma | Washington |
| United States | Research Site | Tucson | Arizona |
| United States | Research Site | Winston Salem | North Carolina |
| United States | Research Site | Worchester | Massachusetts |
| Lead Sponsor | Collaborator |
|---|---|
| Biogen | AbbVie |
United States, Argentina, Australia, Brazil, Canada, Czech Republic, Denmark, Finland, France, Georgia, Germany, Greece, Hungary, India, Ireland, Israel, Italy, Mexico, Moldova, Republic of, Poland, Romania, Russian Federation, Serbia, Spain, Sweden, Switzerland, Ukraine, United Kingdom,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Annualized Relapse Rate(ARR) | Relapses are defined as new or recurrent neurological symptoms not associated with fever or infection, lasting at least 24 hours, and accompanied by new objective neurological findings upon examination by the Examining Neurologist. The ARR will be calculated as the total number of relapses experienced in the treatment group divided by the number of days in the study, and the ratio multiplied by 365. | Up to 144 weeks | No |
| Secondary | Number of new or newly enlarging T2 hyperintense lesions on brain MRI | Assessed by magnetic resonance imaging (MRI) | 96 weeks | No |
| Secondary | Percentage of participants with sustained disability progression | Sustained disability progression is defined as: at least a 1.0-point increase on the Expanded Disability Status Scale (EDSS) from Baseline EDSS =1.0 that is sustained for 12 weeks, or at least a 1.5-point increase on the EDSS from baseline EDSS = 0 that is sustained for 12 weeks. The EDSS measures the disability status of people with multiple sclerosis on a scale that ranges from 0 to 10, with higher scores indicating more disability. | Baseline and 96 weeks | No |
| Secondary | Percentage of participants who are relapse-free | Relapses are defined as new or recurrent neurological symptoms not associated with fever or infection, lasting at least 24 hours, and accompanied by new objective neurological findings upon examination by the Examining Neurologist. | 96 weeks | No |
| Secondary | Percentage of participants with a =7.5 point worsening from baseline in the MSIS-29 physical score at 96 weeks | The MSIS-29 is a 29-item disease-specific patient-reported outcome measure that has been developed and validated to examine the physical and psychological impact of MS from a patient's perspective; it measures physical and psychological items. Worsening in the MSIS-29 physical score is defined as an increase of 7.5 points in the MSIS-29 physical score at 96 weeks compared to baseline. | Baseline and 96 weeks | No |
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