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Efficacy and Safety Study of Peginterferon Beta-1a in Participants With Relapsing Multiple Sclerosis (ADVANCE)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Biogen
ClinicalTrials.gov Identifier:
NCT00906399
First received: May 20, 2009
Last updated: September 15, 2014
Last verified: September 2014
Results First Received: July 28, 2014  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition: Relapsing Multiple Sclerosis
Interventions: Drug: BIIB017 (peginterferon beta-1a)
Drug: Placebo

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
Year 1: Placebo Placebo every 2 weeks for 48 weeks
Year 1: Peginterferon Beta-1a Q4W 125 µg peginterferon beta-1a subcutaneously every 4 weeks (Q4W) for 48 weeks. Participants received a placebo injection 2 weeks after each active injection (in order to maintain the blind with Q2W arm).
Year 1: Peginterferon Beta-1a Q2W 125 µg peginterferon beta-1a subcutaneously every 2 weeks (Q2W) for 48 weeks.
Year 2: Placebo Followed by Peginterferon Beta-1a Q4W Placebo every 2 weeks for 48 weeks followed by 125 µg peginterferon beta-1a subcutaneously every 4 weeks for 48 weeks. Participants received a placebo injection 2 weeks after each active injection (in order to maintain the blind with Q2W arm).
Year 2: Placebo Followed by Peginterferon Beta-1a Q2W Placebo every 2 weeks for 48 weeks followed by 125 µg peginterferon beta-1a subcutaneously every 2 weeks for 48 weeks.
Year 2: Peginterferon Beta-1a Q4W 125 µg peginterferon beta-1a subcutaneously every 4 weeks (Q4W) for 48 weeks. Participants received a placebo injection 2 weeks after each active injection (in order to maintain the blind with Q2W arm).
Year 2: Peginterferon Beta-1a Q2W 125 µg peginterferon beta-1a subcutaneously every 2 weeks (Q2W) for 48 weeks.

Participant Flow for 2 periods

Period 1:   Year 1
    Year 1: Placebo   Year 1: Peginterferon Beta-1a Q4W   Year 1: Peginterferon Beta-1a Q2W   Year 2: Placebo Followed by Peginterferon Beta-1a Q4W   Year 2: Placebo Followed by Peginterferon Beta-1a Q2W   Year 2: Peginterferon Beta-1a Q4W   Year 2: Peginterferon Beta-1a Q2W
STARTED   500   501   515   0   0   0   0 
Completed Year 1 Study Treatment   456   438   438   0   0   0   0 
COMPLETED   456   438   439 [1]   0   0   0   0 
NOT COMPLETED   44   63   76   0   0   0   0 
Randomized But Not Treated                0                1                3                0                0                0                0 
Adverse Event                4                22                24                0                0                0                0 
Lost to Follow-up                4                4                2                0                0                0                0 
Withdrawal by Subject                30                32                36                0                0                0                0 
Physician Decision                0                1                3                0                0                0                0 
Death                2                1                1                0                0                0                0 
Not specified                4                2                7                0                0                0                0 
[1] 1 participant discontinued treatment before end of study period but remained to complete follow-up.

Period 2:   Year 2
    Year 1: Placebo   Year 1: Peginterferon Beta-1a Q4W   Year 1: Peginterferon Beta-1a Q2W   Year 2: Placebo Followed by Peginterferon Beta-1a Q4W   Year 2: Placebo Followed by Peginterferon Beta-1a Q2W   Year 2: Peginterferon Beta-1a Q4W   Year 2: Peginterferon Beta-1a Q2W
STARTED   0   0   0   228   228   438   438 
Completed Year 2 Study Treatment   0   0   0   200   196   391   411 
COMPLETED   0   0   0   198   193   391   409 
NOT COMPLETED   0   0   0   30   35   47   29 
Adverse Event                0                0                0                9                8                11                6 
Lost to Follow-up                0                0                0                1                4                2                4 
Withdrawal by Subject                0                0                0                17                18                27                13 
Physician Decision                0                0                0                0                2                6                3 
Death                0                0                0                1                0                0                3 
Not specified                0                0                0                2                3                1                0 



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Intent-to-treat population: participants who were randomized and received at least 1 dose of study treatment (peginterferon beta-1a or placebo).

Reporting Groups
  Description
Placebo Placebo every 2 weeks for 48 weeks
Peginterferon Beta-1a Q4W 125 µg peginterferon beta-1a subcutaneously every 4 weeks (Q4W) for 48 weeks. Participants received a placebo injection 2 weeks after each active injection (in order to maintain the blind with Q2W arm).
Peginterferon Beta-1a Q2W 125 µg peginterferon beta-1a subcutaneously every 2 weeks (Q2W) for 48 weeks
Total Total of all reporting groups

Baseline Measures
   Placebo   Peginterferon Beta-1a Q4W   Peginterferon Beta-1a Q2W   Total 
Overall Participants Analyzed 
[Units: Participants]
 500   500   512   1512 
Age 
[Units: Years]
Mean (Standard Deviation)
 36.3  (9.74)   36.4  (9.87)   36.9  (9.79)   36.5  (9.80) 
Gender 
[Units: Participants]
       
Female   358   352   361   1071 
Male   142   148   151   441 
Expanded Disability Status Scale (EDSS) [1] 
[Units: Units on a scale]
Mean (Standard Deviation)
 2.44  (1.180)   2.48  (1.244)   2.47  (1.255)   2.46  (1.226) 
[1] The EDSS measures the disability status of people with multiple sclerosis (MS) on a scale that ranges from 0 to 10. The range of main categories include 0 (normal neurologic exam), to 5 (ambulatory without aid or rest for 200 meters/disability severe enough to impair full daily activities), to 10 (death due to MS).


  Outcome Measures
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1.  Primary:   Annualized Relapse Rate (ARR) at 1 Year   [ Time Frame: 1 Year ]

2.  Secondary:   Number of New Or Newly Enlarging T2 Hyperintense Lesions at 1 Year   [ Time Frame: 1 Year ]

3.  Secondary:   Proportion of Participants Relapsed at 1 Year   [ Time Frame: Year 1 ]

4.  Secondary:   Estimated Proportion of Participants With Sustained Disability Progression at 1 Year   [ Time Frame: 1 Year ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.


Results Point of Contact:  
Name/Title: Biogen Idec Study Medical Director
Organization: Biogen Idec
e-mail: clinicaltrials@biogenidec.com


Publications of Results:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Biogen
ClinicalTrials.gov Identifier: NCT00906399     History of Changes
Other Study ID Numbers: 105MS301
2008-006333-27 ( EudraCT Number )
Study First Received: May 20, 2009
Results First Received: July 28, 2014
Last Updated: September 15, 2014
Health Authority: Belgium: Federal Agency for Medicinal Products and Health Products
Bulgaria: Bulgarian Drug Agency
France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)
Romania: Ministry of Public Health
Spain: Agencia Española de Medicamentos y Productos Sanitarios
Serbia: Ethics Committee
Mexico: Federal Commission for Protection Against Health Risks
Ukraine: State Expert Centre of the Ministry of Health of Ukraine
Greece: Ministry of Health and Welfare
Greece: Ethics Committee
Colombia: INVIMA Instituto Nacional de Vigilancia de Medicamentos y Alimentos
Estonia: The State Agency of Medicine
New Zealand: Medsafe
Czech Republic: State Institute for Drug Control
Peru: Instituto Nacional de Salud
Poland: Ministry of Health
Russia: Ethics Committee
Netherlands: Independent Ethics Committee
Czech Republic: Ethics Committee
Peru: Ethics Committee
Germany: Ethics Commission
Germany: Federal Institute for Drugs and Medical Devices
Serbia and Montenegro: Agency for Drugs and Medicinal Devices
Croatia: Ministry of Health and Social Care
Georgia: Ministry of Health
Canada: Health Canada
United Kingdom: Medicines and Healthcare Products Regulatory Agency
Latvia: State Agency of Medicines
United States: Food and Drug Administration
Chile: Instituto de Salud Pública de Chile
India: Central Drugs Standard Control Organization
Romania: Ethics Committee
Russia: Ministry of Health of the Russian Federation