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Trial record 1 of 1 for:    DECIDE "daclizumab"
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Efficacy and Safety of BIIB019 (Daclizumab High Yield Process) Versus Interferon β 1a in Participants With Relapsing-Remitting Multiple Sclerosis ((DECIDE))

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ClinicalTrials.gov Identifier: NCT01064401
Recruitment Status : Completed
First Posted : February 8, 2010
Results First Posted : July 11, 2016
Last Update Posted : July 11, 2016
Sponsor:
Collaborator:
AbbVie
Information provided by (Responsible Party):
Biogen

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition Relapsing-Remitting Multiple Sclerosis
Interventions Biological: BIIB019 (Daclizumab High Yield Process)
Drug: Interferon beta-1a Placebo
Biological: Interferon beta-1a
Drug: Daclizumab High Yield Process Placebo
Enrollment 1841
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Interferon Beta-1a Daclizumab High Yield Process
Hide Arm/Group Description Interferon beta-1a (IFN β-1a) 30 µg intramuscular (IM) injection once weekly plus placebo to daclizumab high yield process (DAC HYP) subcutaneous (SC) once every 4 weeks for 96 to 144 weeks DAC HYP 150 mg SC injection once every 4 weeks plus placebo to IFN β-1a intramuscular IM injection once weekly for 96 to 144 weeks
Period Title: Overall Study
Started 922 919
Completed 694 724
Not Completed 228 195
Reason Not Completed
Adverse Event             47             56
Lack of Efficacy             46             23
Lost to Follow-up             12             9
Consent Withdrawn             98             80
Investigator Decision             4             6
Death             4             0
Pregnancy             4             7
Noncompliance             7             8
Site Closure             4             5
Other             2             1
Arm/Group Title Interferon Beta-1a Daclizumab High Yield Process Total
Hide Arm/Group Description IFN β-1a 30 µg IM injection once weekly plus placebo to DAC HYP SC once every 4 weeks for 96 to 144 weeks DAC HYP 150 mg SC injection once every 4 weeks plus placebo to IFN β-1a IM injection once weekly for 96 to 144 weeks Total of all reporting groups
Overall Number of Baseline Participants 922 919 1841
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 922 participants 919 participants 1841 participants
36.2  (9.32) 36.4  (9.36) 36.3  (9.34)
Age, Customized  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 922 participants 919 participants 1841 participants
18 to 19 years 25 14 39
20 to 29 years 227 236 463
30 to 39 years 327 322 649
40 to 49 years 256 250 506
50 to 55 years 86 96 182
> 55 years 1 1 2
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 922 participants 919 participants 1841 participants
Female
627
  68.0%
625
  68.0%
1252
  68.0%
Male
295
  32.0%
294
  32.0%
589
  32.0%
1.Primary Outcome
Title Adjusted Annualized Relapse Rate (ARR)
Hide Description 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. Only relapses confirmed by Independent Neurology Evaluation Committee (INEC) are included in this analysis. Adjusted ARR was estimated from a negative binomial regression model adjusted for the baseline relapse rate, history of prior IFN beta use, baseline Expanded Disability Status Scale score (EDSS; ≤ 2.5 vs > 2.5) and baseline age (≤ 35 vs > 35 years). Data after participants switched to alternative MS medications are excluded.
Time Frame Up to 144 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
participants with a relapse
Arm/Group Title Interferon Beta-1a Daclizumab High Yield Process
Hide Arm/Group Description:
IFN β-1a 30 µg IM injection once weekly plus placebo to DAC HYP SC once every 4 weeks for 96 to 144 weeks
DAC HYP 150 mg subcutaneous (SC) injection once every 4 weeks plus placebo to IFN β-1a intramuscular (IM) injection once weekly for 96 to 144 weeks
Overall Number of Participants Analyzed 392 260
Overall Number of Units Analyzed
Type of Units Analyzed: Relapses
643 402
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: relapses per person-years
0.393
(0.353 to 0.438)
0.216
(0.191 to 0.244)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Interferon Beta-1a, Daclizumab High Yield Process
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value < 0.0001
Comments Estimated from a negative binomial regression model adjusted for the baseline relapse rate, history of prior IFN beta use, baseline EDSS (≤ 2.5 vs > 2.5) and baseline age (≤ 35 vs > 35 years).
Method Negative Binomial Regression
Comments [Not Specified]
Method of Estimation Estimation Parameter Rate Ratio
Estimated Value 0.550
Confidence Interval (2-Sided) 95%
0.469 to 0.645
Estimation Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Interferon Beta-1a, Daclizumab High Yield Process
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Percent Reduction
Estimated Value 45.0
Confidence Interval (2-Sided) 95%
35.5 to 53.1
Estimation Comments [Not Specified]
2.Secondary Outcome
Title Adjusted Mean Number of New or Newly Enlarging T2 Hyperintense Lesions up to Week 96
Hide Description The quantity of lesions is assessed by brain magnetic resonance imaging (MRI). The adjusted mean number is estimated from a negative binomial regression model, adjusted for baseline volume of T2 from a negative binomial regression model, adjusted for baseline volume of T2 hyperintense lesions, history of prior IFN beta use and baseline age (≤ 35 vs > 35 years). To account for the timing of the MRI measurement, the logarithmic transformation of the scan number of the MRI assessment is included in the model as the 'offset' parameter. Observed data after participants switched to alternative MS medications are excluded. Missing data are not imputed. Only observed new or newly enlarging T2 lesions at the last visit of the participant up to Week 96 visit are used in this analysis.
Time Frame up to 96 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
participants with baseline and at least one post-baseline MRI measurement
Arm/Group Title Interferon Beta-1a Daclizumab High Yield Process
Hide Arm/Group Description:
IFN β-1a 30 µg IM injection once weekly plus placebo to DAC HYP SC once every 4 weeks for 96 to 144 weeks
DAC HYP 150 mg SC injection once every 4 weeks plus placebo to IFN β-1a IM injection once weekly for 96 to 144 weeks
Overall Number of Participants Analyzed 841 864
Mean (95% Confidence Interval)
Unit of Measure: lesions
9.44
(8.46 to 10.54)
4.31
(3.85 to 4.81)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Interferon Beta-1a, Daclizumab High Yield Process
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value < 0.0001
Comments Estimated from a negative binomial regression model, adjusted for baseline volume of T2 hyperintense lesions, history of prior IFN beta use and baseline age (≤ 35 vs > 35 years).
Method Negative Binomial Regression
Comments The logarithmic transformation of the scan number of the MRI assessment was included in the model as the 'offset' parameter.
Method of Estimation Estimation Parameter Percent Reduction
Estimated Value 54.4
Confidence Interval (2-Sided) 95%
46.9 to 60.8
Estimation Comments [Not Specified]
3.Secondary Outcome
Title Proportion of Participants With Sustained Disability Progression at 144 Weeks
Hide Description Sustained disability progression is defined as: at least a 1.0-point increase on the 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 MS on a scale that ranges from 0 to 10, with higher scores indicating more disability. Estimated proportion of participants with progression is based on the Kaplan-Meier product limit method. Participants were censored at the time of withdrawal/switch if they withdrew from study or switched to alternative MS medication without a progression. Participants with a tentative progression at the End of Treatment Period Visit (or the last EDSS assessment prior to alternative MS start date) and no confirmation assessment were censored at their last EDSS assessment.
Time Frame Baseline through 144 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Interferon Beta-1a Daclizumab High Yield Process
Hide Arm/Group Description:
IFN β-1a 30 µg IM injection once weekly plus placebo to DAC HYP SC once every 4 weeks for 96 to 144 weeks
DAC HYP 150 mg SC injection once every 4 weeks plus placebo to IFN β-1a IM injection once weekly for 96 to 144 weeks
Overall Number of Participants Analyzed 922 919
Measure Type: Number
Unit of Measure: proportion of participants
0.203 0.162
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Interferon Beta-1a, Daclizumab High Yield Process
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.1575
Comments Based on Cox Proportional Hazards model, adjusted by baseline EDSS values as continuous variable, history of prior IFN beta use, and baseline age (≤ 35 vs > 35 years).
Method Cox Proportional Hazard
Comments [Not Specified]
Method of Estimation Estimation Parameter Cox Proportional Hazard
Estimated Value 0.84
Confidence Interval (2-Sided) 95%
0.66 to 1.07
Estimation Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Interferon Beta-1a, Daclizumab High Yield Process
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Percent Reduction
Estimated Value 16.1
Confidence Interval (2-Sided) 95%
-7.0 to 34.2
Estimation Comments [Not Specified]
4.Secondary Outcome
Title Proportion of Participants Relapse-free at Week 144
Hide Description 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. Only relapses confirmed by INEC are included in this analysis. Data after participants switched to alternative MS medications are excluded. The estimated proportion of subjects relapse-free at Week 144 is based on the Kaplan-Meier product limit method.
Time Frame 144 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Interferon Beta-1a Daclizumab High Yield Process
Hide Arm/Group Description:
IFN β-1a 30 µg IM injection once weekly plus placebo to DAC HYP SC once every 4 weeks for 96 to 144 weeks
DAC HYP 150 mg SC injection once every 4 weeks plus placebo to IFN β-1a IM injection once weekly for 96 to 144 weeks
Overall Number of Participants Analyzed 922 919
Measure Type: Number
Unit of Measure: proportion of participants
0.508 0.673
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Interferon Beta-1a, Daclizumab High Yield Process
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value < 0.0001
Comments Based on Cox proportional hazards model, adjusted for baseline relapse rate, history of prior IFN beta use, baseline EDSS (EDSS ≤ 2.5 vs EDSS > 2.5) and baseline age (≤ 35 vs > 35 years).
Method Cox Proportional Hazard
Comments [Not Specified]
Method of Estimation Estimation Parameter Cox Proportional Hazard
Estimated Value 0.59
Confidence Interval (2-Sided) 95%
0.50 to 0.69
Estimation Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Interferon Beta-1a, Daclizumab High Yield Process
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Percent Reduction in Risk of Relapse
Estimated Value 40.9
Confidence Interval (2-Sided) 95%
30.8 to 49.5
Estimation Comments [Not Specified]
5.Secondary Outcome
Title Percentage of Participants With a ≥ 7.5 Point Worsening From Baseline in the Multiple Sclerosis Impact Scale (MSIS-29) Physical Impact Score at 96 Weeks
Hide Description 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. If a participant was missing data for less than 10 of the 20 items that make up the physical score, then the mean of the non-missing items were used for the missing items. If a participant was missing 10 or more of the 20 items that make up the physical score, or missing the questionnaire entirely, or if the questionnaire was completed after the participant switched to alternative MS medication, a random effects model was used to estimate the MSIS-29 physical score.
Time Frame Baseline and 96 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
participants with a baseline and Week 96 assessment
Arm/Group Title Interferon Beta-1a Daclizumab High Yield Process
Hide Arm/Group Description:
IFN β-1a 30 µg IM injection once weekly plus placebo to DAC HYP SC once every 4 weeks for 96 to 144 weeks
DAC HYP 150 mg SC injection once every 4 weeks plus placebo to IFN β-1a IM injection once weekly for 96 to 144 weeks
Overall Number of Participants Analyzed 912 906
Measure Type: Number
Unit of Measure: percentage of participants
23 19
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Interferon Beta-1a, Daclizumab High Yield Process
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0176
Comments Based on logistic regression model, adjusted for baseline MSIS-29 physical score, baseline Beck Depression Inventory (BDI) score, history of prior IFN beta use, and baseline age (≤ 35 vs > 35 years).
Method Regression, Logistic
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 0.76
Confidence Interval (2-Sided) 95%
0.60 to 0.95
Estimation Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Interferon Beta-1a, Daclizumab High Yield Process
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Percent Reduction in Odds of Worsening
Estimated Value 24.2
Confidence Interval (2-Sided) 95%
4.7 to 39.6
Estimation Comments [Not Specified]
Time Frame All events were collected from Baseline through Week 164 (end of Post-dosing period).
Adverse Event Reporting Description Treatment emergent events are reported. Events are considered treatment emergent if they occurred on or after the first dosing date and up to 180 days after the last dosing date.
 
Arm/Group Title IFN Beta-1a 30 mcg DAC HYP 150 mg
Hide Arm/Group Description IFN β-1a 30 µg IM injection once weekly plus placebo to DAC HYP SC once every 4 weeks for 96 to 144 weeks DAC HYP 150 mg subcutaneous (SC) injection once every 4 weeks plus placebo to IFN β-1a intramuscular (IM) injection once weekly for 96 to 144 weeks
All-Cause Mortality
IFN Beta-1a 30 mcg DAC HYP 150 mg
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Hide Serious Adverse Events
IFN Beta-1a 30 mcg DAC HYP 150 mg
Affected / at Risk (%) Affected / at Risk (%)
Total   194/922 (21.04%)   221/919 (24.05%) 
Blood and lymphatic system disorders     
Agranulocytosis  1  0/922 (0.00%)  1/919 (0.11%) 
Anaemia  1  1/922 (0.11%)  1/919 (0.11%) 
Iron deficiency anaemia  1  1/922 (0.11%)  1/919 (0.11%) 
Lymphadenitis  1  0/922 (0.00%)  3/919 (0.33%) 
Lymphadenopathy  1  0/922 (0.00%)  5/919 (0.54%) 
Lymphoid tissue hyperplasia  1  0/922 (0.00%)  1/919 (0.11%) 
Lymphopenia  1  0/922 (0.00%)  1/919 (0.11%) 
Thrombocytopenia  1  0/922 (0.00%)  2/919 (0.22%) 
Cardiac disorders     
Acute myocardial infarction  1  3/922 (0.33%)  0/919 (0.00%) 
Angina unstable  1  1/922 (0.11%)  0/919 (0.00%) 
Bradycardia  1  0/922 (0.00%)  1/919 (0.11%) 
Cardio-respiratory arrest  1  0/922 (0.00%)  1/919 (0.11%) 
Palpitations  1  0/922 (0.00%)  1/919 (0.11%) 
Pericarditis  1  1/922 (0.11%)  0/919 (0.00%) 
Congenital, familial and genetic disorders     
Dermoid cyst  1  0/922 (0.00%)  1/919 (0.11%) 
Ear and labyrinth disorders     
Vertigo  1  0/922 (0.00%)  1/919 (0.11%) 
Endocrine disorders     
Hyperthyroidism  1  1/922 (0.11%)  1/919 (0.11%) 
Eye disorders     
Cystoid macular oedema  1  0/922 (0.00%)  1/919 (0.11%) 
Gastrointestinal disorders     
Abdominal pain  1  1/922 (0.11%)  1/919 (0.11%) 
Abdominal pain upper  1  1/922 (0.11%)  0/919 (0.00%) 
Anal fistula  1  0/922 (0.00%)  1/919 (0.11%) 
Aphthous stomatitis  1  0/922 (0.00%)  1/919 (0.11%) 
Colitis microscopic  1  0/922 (0.00%)  1/919 (0.11%) 
Colitis ulcerative  1  0/922 (0.00%)  1/919 (0.11%) 
Constipation  1  1/922 (0.11%)  0/919 (0.00%) 
Diarrhoea  1  0/922 (0.00%)  1/919 (0.11%) 
Enterocolitis  1  0/922 (0.00%)  1/919 (0.11%) 
Gastritis erosive  1  0/922 (0.00%)  1/919 (0.11%) 
Haemorrhoids  1  0/922 (0.00%)  1/919 (0.11%) 
Inguinal hernia  1  1/922 (0.11%)  2/919 (0.22%) 
Mouth cyst  1  1/922 (0.11%)  0/919 (0.00%) 
Nausea  1  0/922 (0.00%)  1/919 (0.11%) 
Oroantral fistula  1  1/922 (0.11%)  0/919 (0.00%) 
Vomiting  1  0/922 (0.00%)  1/919 (0.11%) 
General disorders     
Asthenia  1  0/922 (0.00%)  1/919 (0.11%) 
Chest pain  1  0/922 (0.00%)  1/919 (0.11%) 
Influenza like illness  1  1/922 (0.11%)  0/919 (0.00%) 
Multi-organ failure  1  0/922 (0.00%)  1/919 (0.11%) 
Hepatobiliary disorders     
Acute hepatic failure  1  0/922 (0.00%)  1/919 (0.11%) 
Cholecystitis  1  0/922 (0.00%)  1/919 (0.11%) 
Cholelithiasis  1  3/922 (0.33%)  1/919 (0.11%) 
Drug-induced liver injury  1  0/922 (0.00%)  1/919 (0.11%) 
Hepatitis acute  1  0/922 (0.00%)  1/919 (0.11%) 
Hepatitis toxic  1  1/922 (0.11%)  2/919 (0.22%) 
Immune system disorders     
Anaphylactic reaction  1  1/922 (0.11%)  0/919 (0.00%) 
Drug hypersensitivity  1  0/922 (0.00%)  1/919 (0.11%) 
Infections and infestations     
Appendicitis  1  0/922 (0.00%)  2/919 (0.22%) 
Appendicitis perforated  1  0/922 (0.00%)  1/919 (0.11%) 
Bacterial infection  1  0/922 (0.00%)  1/919 (0.11%) 
Bronchitis  1  1/922 (0.11%)  0/919 (0.00%) 
Cellulitis  1  0/922 (0.00%)  2/919 (0.22%) 
Chronic tonsillitis  1  0/922 (0.00%)  1/919 (0.11%) 
Cystitis  1  0/922 (0.00%)  1/919 (0.11%) 
Dengue fever  1  0/922 (0.00%)  1/919 (0.11%) 
Device related infection  1  0/922 (0.00%)  1/919 (0.11%) 
Ear infection  1  0/922 (0.00%)  1/919 (0.11%) 
Enteritis infectious  1  0/922 (0.00%)  1/919 (0.11%) 
Enterocolitis infectious  1  0/922 (0.00%)  1/919 (0.11%) 
Erysipelas  1  1/922 (0.11%)  0/919 (0.00%) 
Fungal infection  1  0/922 (0.00%)  1/919 (0.11%) 
Hepatitis A  1  0/922 (0.00%)  1/919 (0.11%) 
Influenza  1  0/922 (0.00%)  1/919 (0.11%) 
Intervertebral discitis  1  1/922 (0.11%)  0/919 (0.00%) 
Lobar pneumonia  1  0/922 (0.00%)  1/919 (0.11%) 
Ludwig angina  1  0/922 (0.00%)  1/919 (0.11%) 
Lung infection  1  0/922 (0.00%)  1/919 (0.11%) 
Lyme disease  1  1/922 (0.11%)  1/919 (0.11%) 
Meningitis viral  1  0/922 (0.00%)  1/919 (0.11%) 
Neuroborreliosis  1  0/922 (0.00%)  1/919 (0.11%) 
Parotitis  1  0/922 (0.00%)  1/919 (0.11%) 
Pelvic abscess  1  0/922 (0.00%)  1/919 (0.11%) 
Perirectal abscess  1  1/922 (0.11%)  0/919 (0.00%) 
Peritonitis  1  1/922 (0.11%)  0/919 (0.00%) 
Pneumonia  1  2/922 (0.22%)  5/919 (0.54%) 
Pulmonary tuberculosis  1  0/922 (0.00%)  1/919 (0.11%) 
Pyelonephritis  1  0/922 (0.00%)  1/919 (0.11%) 
Pyelonephritis acute  1  1/922 (0.11%)  1/919 (0.11%) 
Reiter's syndrome  1  0/922 (0.00%)  1/919 (0.11%) 
Sepsis  1  0/922 (0.00%)  1/919 (0.11%) 
Strongyloidiasis  1  1/922 (0.11%)  0/919 (0.00%) 
Upper respiratory tract infection  1  0/922 (0.00%)  1/919 (0.11%) 
Urinary tract infection  1  2/922 (0.22%)  8/919 (0.87%) 
Varicella  1  1/922 (0.11%)  1/919 (0.11%) 
Viral infection  1  1/922 (0.11%)  2/919 (0.22%) 
Viral myocarditis  1  1/922 (0.11%)  0/919 (0.00%) 
Injury, poisoning and procedural complications     
Ankle fracture  1  2/922 (0.22%)  2/919 (0.22%) 
Clavicle fracture  1  0/922 (0.00%)  1/919 (0.11%) 
Concussion  1  1/922 (0.11%)  0/919 (0.00%) 
Face injury  1  1/922 (0.11%)  0/919 (0.00%) 
Fall  1  2/922 (0.22%)  4/919 (0.44%) 
Fibula fracture  1  1/922 (0.11%)  2/919 (0.22%) 
Foreign body  1  0/922 (0.00%)  1/919 (0.11%) 
Hand fracture  1  1/922 (0.11%)  0/919 (0.00%) 
Hip fracture  1  0/922 (0.00%)  1/919 (0.11%) 
Ligament injury  1  1/922 (0.11%)  0/919 (0.00%) 
Ligament rupture  1  1/922 (0.11%)  0/919 (0.00%) 
Meniscus injury  1  1/922 (0.11%)  0/919 (0.00%) 
Multiple injuries  1  1/922 (0.11%)  0/919 (0.00%) 
Nail avulsion  1  0/922 (0.00%)  1/919 (0.11%) 
Post procedural haemorrhage  1  0/922 (0.00%)  1/919 (0.11%) 
Road traffic accident  1  2/922 (0.22%)  0/919 (0.00%) 
Tibia fracture  1  0/922 (0.00%)  1/919 (0.11%) 
Investigations     
Alanine aminotransferase increased  1  2/922 (0.22%)  0/919 (0.00%) 
Amylase increased  1  0/922 (0.00%)  1/919 (0.11%) 
Aspartate aminotransferase increased  1  2/922 (0.22%)  0/919 (0.00%) 
Hepatic enzyme increased  1  0/922 (0.00%)  1/919 (0.11%) 
Smear cervix abnormal  1  0/922 (0.00%)  1/919 (0.11%) 
Transaminases increased  1  1/922 (0.11%)  0/919 (0.00%) 
Metabolism and nutrition disorders     
Dehydration  1  0/922 (0.00%)  1/919 (0.11%) 
Diabetic ketoacidosis  1  0/922 (0.00%)  1/919 (0.11%) 
Hypokalaemia  1  0/922 (0.00%)  1/919 (0.11%) 
Tetany  1  0/922 (0.00%)  1/919 (0.11%) 
Musculoskeletal and connective tissue disorders     
Back pain  1  1/922 (0.11%)  0/919 (0.00%) 
Bursitis  1  0/922 (0.00%)  1/919 (0.11%) 
Fibromyalgia  1  1/922 (0.11%)  0/919 (0.00%) 
Intervertebral disc protrusion  1  0/922 (0.00%)  1/919 (0.11%) 
Lupus-like syndrome  1  0/922 (0.00%)  1/919 (0.11%) 
Patellofemoral pain syndrome  1  1/922 (0.11%)  0/919 (0.00%) 
Plica syndrome  1  0/922 (0.00%)  1/919 (0.11%) 
Spinal osteoarthritis  1  0/922 (0.00%)  1/919 (0.11%) 
Spondyloarthropathy  1  0/922 (0.00%)  1/919 (0.11%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)     
Adenoma benign  1  0/922 (0.00%)  1/919 (0.11%) 
Benign neoplasm  1  0/922 (0.00%)  1/919 (0.11%) 
Benign ovarian tumour  1  0/922 (0.00%)  1/919 (0.11%) 
Benign salivary gland neoplasm  1  0/922 (0.00%)  2/919 (0.22%) 
Brain neoplasm malignant  1  0/922 (0.00%)  1/919 (0.11%) 
Endometrial cancer  1  1/922 (0.11%)  0/919 (0.00%) 
Fibroadenoma of breast  1  1/922 (0.11%)  0/919 (0.00%) 
Invasive ductal breast carcinoma  1  0/922 (0.00%)  1/919 (0.11%) 
Malignant melanoma  1  1/922 (0.11%)  0/919 (0.00%) 
Meningioma  1  0/922 (0.00%)  1/919 (0.11%) 
Ovarian germ cell teratoma benign  1  1/922 (0.11%)  0/919 (0.00%) 
Pancreatic carcinoma metastatic  1  1/922 (0.11%)  0/919 (0.00%) 
Squamous cell carcinoma  1  1/922 (0.11%)  0/919 (0.00%) 
Squamous cell carcinoma of the cervix  1  1/922 (0.11%)  0/919 (0.00%) 
Squamous cell carcinoma of the oral cavity  1  1/922 (0.11%)  0/919 (0.00%) 
Testicular seminoma (pure)  1  1/922 (0.11%)  0/919 (0.00%) 
Thyroid cancer  1  0/922 (0.00%)  1/919 (0.11%) 
Tongue neoplasm malignant stage unspecified  1  1/922 (0.11%)  0/919 (0.00%) 
Transitional cell carcinoma  1  0/922 (0.00%)  1/919 (0.11%) 
Uterine cancer  1  0/922 (0.00%)  1/919 (0.11%) 
Uterine leiomyoma  1  1/922 (0.11%)  3/919 (0.33%) 
Nervous system disorders     
Complex partial seizures  1  0/922 (0.00%)  1/919 (0.11%) 
Convulsion  1  1/922 (0.11%)  4/919 (0.44%) 
Dizziness  1  0/922 (0.00%)  1/919 (0.11%) 
Epilepsy  1  1/922 (0.11%)  0/919 (0.00%) 
Headache  1  0/922 (0.00%)  1/919 (0.11%) 
Migraine  1  0/922 (0.00%)  1/919 (0.11%) 
Multiple sclerosis  1  3/922 (0.33%)  2/919 (0.22%) 
Multiple sclerosis relapse  1  124/922 (13.45%)  97/919 (10.55%) 
Muscle spasticity  1  1/922 (0.11%)  0/919 (0.00%) 
Myasthenia gravis  1  0/922 (0.00%)  1/919 (0.11%) 
Optic neuritis  1  1/922 (0.11%)  0/919 (0.00%) 
Relapsing-remitting multiple sclerosis  1  1/922 (0.11%)  0/919 (0.00%) 
Sciatica  1  0/922 (0.00%)  1/919 (0.11%) 
Speech disorder  1  1/922 (0.11%)  0/919 (0.00%) 
Status epilepticus  1  0/922 (0.00%)  1/919 (0.11%) 
Tension headache  1  1/922 (0.11%)  0/919 (0.00%) 
Toxic encephalopathy  1  0/922 (0.00%)  1/919 (0.11%) 
Transient ischaemic attack  1  0/922 (0.00%)  1/919 (0.11%) 
Trigeminal neuralgia  1  1/922 (0.11%)  0/919 (0.00%) 
Uhthoff's phenomenon  1  0/922 (0.00%)  1/919 (0.11%) 
Pregnancy, puerperium and perinatal conditions     
Abortion spontaneous  1  1/922 (0.11%)  2/919 (0.22%) 
Ectopic pregnancy  1  3/922 (0.33%)  2/919 (0.22%) 
Psychiatric disorders     
Adjustment disorder with mixed disturbance of emotion and conduct  1  1/922 (0.11%)  0/919 (0.00%) 
Anxiety  1  0/922 (0.00%)  1/919 (0.11%) 
Bipolar disorder  1  1/922 (0.11%)  0/919 (0.00%) 
Completed suicide  1  1/922 (0.11%)  0/919 (0.00%) 
Depression  1  2/922 (0.22%)  3/919 (0.33%) 
Depression suicidal  1  0/922 (0.00%)  1/919 (0.11%) 
Emotional distress  1  1/922 (0.11%)  0/919 (0.00%) 
Mood disorder due to a general medical condition  1  0/922 (0.00%)  1/919 (0.11%) 
Substance abuse  1  0/922 (0.00%)  1/919 (0.11%) 
Suicidal ideation  1  1/922 (0.11%)  1/919 (0.11%) 
Suicide attempt  1  2/922 (0.22%)  0/919 (0.00%) 
Renal and urinary disorders     
Calculus urinary  1  1/922 (0.11%)  0/919 (0.00%) 
Hydronephrosis  1  0/922 (0.00%)  1/919 (0.11%) 
Nephrolithiasis  1  0/922 (0.00%)  3/919 (0.33%) 
Renal colic  1  0/922 (0.00%)  1/919 (0.11%) 
Urinary retention  1  1/922 (0.11%)  0/919 (0.00%) 
Reproductive system and breast disorders     
Adenomyosis  1  0/922 (0.00%)  1/919 (0.11%) 
Endometrial disorder  1  0/922 (0.00%)  1/919 (0.11%) 
Endometriosis  1  0/922 (0.00%)  1/919 (0.11%) 
Metrorrhagia  1  1/922 (0.11%)  0/919 (0.00%) 
Ovarian cyst  1  1/922 (0.11%)  2/919 (0.22%) 
Uterine polyp  1  1/922 (0.11%)  0/919 (0.00%) 
Respiratory, thoracic and mediastinal disorders     
Asthma  1  0/922 (0.00%)  1/919 (0.11%) 
Dysphonia  1  0/922 (0.00%)  1/919 (0.11%) 
Interstitial lung disease  1  0/922 (0.00%)  1/919 (0.11%) 
Pleurisy  1  1/922 (0.11%)  0/919 (0.00%) 
Pneumonia aspiration  1  0/922 (0.00%)  1/919 (0.11%) 
Pulmonary embolism  1  0/922 (0.00%)  2/919 (0.22%) 
Skin and subcutaneous tissue disorders     
Angioedema  1  0/922 (0.00%)  2/919 (0.22%) 
Decubitus ulcer  1  0/922 (0.00%)  1/919 (0.11%) 
Dermal cyst  1  1/922 (0.11%)  0/919 (0.00%) 
Dermatitis  1  0/922 (0.00%)  3/919 (0.33%) 
Drug reaction with eosinophilia and systemic symptoms  1  0/922 (0.00%)  1/919 (0.11%) 
Leukocytoclastic vasculitis  1  0/922 (0.00%)  1/919 (0.11%) 
Lichenoid keratosis  1  0/922 (0.00%)  1/919 (0.11%) 
Pityriasis rubra pilaris  1  0/922 (0.00%)  1/919 (0.11%) 
Psoriasis  1  0/922 (0.00%)  1/919 (0.11%) 
Pustular psoriasis  1  0/922 (0.00%)  1/919 (0.11%) 
Rash maculo-papular  1  0/922 (0.00%)  1/919 (0.11%) 
Toxic skin eruption  1  0/922 (0.00%)  1/919 (0.11%) 
Surgical and medical procedures     
Abortion induced  1  0/922 (0.00%)  1/919 (0.11%) 
Angioplasty  1  0/922 (0.00%)  1/919 (0.11%) 
Hysterectomy  1  1/922 (0.11%)  1/919 (0.11%) 
Ovarian cystectomy  1  1/922 (0.11%)  0/919 (0.00%) 
Rehabilitation therapy  1  0/922 (0.00%)  1/919 (0.11%) 
Spinal decompression  1  0/922 (0.00%)  1/919 (0.11%) 
Vascular disorders     
Aortic aneurysm  1  1/922 (0.11%)  0/919 (0.00%) 
Deep vein thrombosis  1  0/922 (0.00%)  1/919 (0.11%) 
Hypotension  1  0/922 (0.00%)  1/919 (0.11%) 
Kawasaki's disease  1  0/922 (0.00%)  1/919 (0.11%) 
Varicose vein  1  1/922 (0.11%)  0/919 (0.00%) 
Vasculitis  1  0/922 (0.00%)  1/919 (0.11%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 16.1
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
IFN Beta-1a 30 mcg DAC HYP 150 mg
Affected / at Risk (%) Affected / at Risk (%)
Total   783/922 (84.92%)   731/919 (79.54%) 
Blood and lymphatic system disorders     
Lymphadenopathy  1  7/922 (0.76%)  46/919 (5.01%) 
Gastrointestinal disorders     
Diarrhoea  1  55/922 (5.97%)  67/919 (7.29%) 
Nausea  1  46/922 (4.99%)  46/919 (5.01%) 
General disorders     
Asthenia  1  55/922 (5.97%)  37/919 (4.03%) 
Fatigue  1  76/922 (8.24%)  69/919 (7.51%) 
Influenza like illness  1  345/922 (37.42%)  88/919 (9.58%) 
Injection site erythema  1  47/922 (5.10%)  40/919 (4.35%) 
Injection site pain  1  102/922 (11.06%)  96/919 (10.45%) 
Pyrexia  1  134/922 (14.53%)  104/919 (11.32%) 
Infections and infestations     
Bronchitis  1  43/922 (4.66%)  61/919 (6.64%) 
Influenza  1  56/922 (6.07%)  82/919 (8.92%) 
Nasopharyngitis  1  197/922 (21.37%)  226/919 (24.59%) 
Oral herpes  1  44/922 (4.77%)  57/919 (6.20%) 
Pharyngitis  1  69/922 (7.48%)  77/919 (8.38%) 
Upper respiratory tract infection  1  124/922 (13.45%)  148/919 (16.10%) 
Urinary tract infection  1  96/922 (10.41%)  92/919 (10.01%) 
Investigations     
Alanine aminotransferase increased  1  66/922 (7.16%)  69/919 (7.51%) 
Aspartate aminotransferase increased  1  44/922 (4.77%)  48/919 (5.22%) 
Musculoskeletal and connective tissue disorders     
Arthralgia  1  62/922 (6.72%)  71/919 (7.73%) 
Back pain  1  70/922 (7.59%)  86/919 (9.36%) 
Myalgia  1  49/922 (5.31%)  42/919 (4.57%) 
Pain in extremity  1  58/922 (6.29%)  55/919 (5.98%) 
Nervous system disorders     
Dizziness  1  37/922 (4.01%)  48/919 (5.22%) 
Headache  1  175/922 (18.98%)  159/919 (17.30%) 
Hypoaesthesia  1  54/922 (5.86%)  54/919 (5.88%) 
Multiple sclerosis relapse  1  428/922 (46.42%)  293/919 (31.88%) 
Paraesthesia  1  57/922 (6.18%)  42/919 (4.57%) 
Psychiatric disorders     
Depression  1  56/922 (6.07%)  72/919 (7.83%) 
Insomnia  1  54/922 (5.86%)  42/919 (4.57%) 
Respiratory, thoracic and mediastinal disorders     
Cough  1  46/922 (4.99%)  53/919 (5.77%) 
Oropharyngeal pain  1  41/922 (4.45%)  69/919 (7.51%) 
Skin and subcutaneous tissue disorders     
Rash  1  26/922 (2.82%)  64/919 (6.96%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 16.1
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.
Our agreement is subject to confidentiality but generally the PI can publish, for noncommercial purposes only, results and methods of the trial, but no other Sponsor Confidential Information. PI must give Sponsor no less than 60 days to review any manuscript for a proposed publication and must delay publication for up to an additional 90 days thereafter if Sponsor needs to file any patent application to protect any of Sponsor's intellectual property contained in the proposed publication.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Biogen Study Medical Director
Organization: Biogen
EMail: clinicaltrials@biogen.com
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Layout table for additonal information
Responsible Party: Biogen
ClinicalTrials.gov Identifier: NCT01064401    
Other Study ID Numbers: 205MS301
2009-012500-11
First Submitted: January 26, 2010
First Posted: February 8, 2010
Results First Submitted: May 31, 2016
Results First Posted: July 11, 2016
Last Update Posted: July 11, 2016