Trial · NCT01064401

Efficacy and Safety of BIIB019 (Daclizumab High Yield Process) Versus Interferon β 1a in Participants With Relapsing-Remitting Multiple Sclerosis

NCT01064401, Phase 3, Completed, Biogen; results first posted 2016-07-11

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. Efficacy and Safety of BIIB019 (Daclizumab High Yield Process) Versus Interferon β 1a in Participants With Relapsing-Remitting Multiple Sclerosis. Trials, record NCT01064401. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01064401

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Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title: Efficacy and Safety of BIIB019 (Daclizumab High Yield Process) Versus Interferon β 1a in Participants With Relapsing-Remitting Multiple Sclerosis
NCT number: NCT01064401
Status: Completed
Phases: Phase 3
Enrollment: 1,841 participants, actual
Lead sponsor: Biogen
Conditions: Relapsing-Remitting Multiple Sclerosis
Interventions: BIIB019 (Daclizumab High Yield Process), Interferon beta-1a Placebo, Interferon beta-1a, Daclizumab High Yield Process Placebo
First posted: 2010-02-08
Last updated: 2016-07-11
Results first posted: 2016-07-11

Source ClinicalTrials.gov

Registered outcomes5

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

List	Outcome	Time frame	Description
Primary	Adjusted Annualized Relapse Rate (ARR)	Up to 144 weeks	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.
Secondary	Adjusted Mean Number of New or Newly Enlarging T2 Hyperintense Lesions up to Week 96	up to 96 weeks	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.
Secondary	Proportion of Participants With Sustained Disability Progression at 144 Weeks	Baseline through 144 weeks	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.
Secondary	Proportion of Participants Relapse-free at Week 144	144 weeks	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.
Secondary	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	Baseline and 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. 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.

Source ClinicalTrials.gov

Outcomes5

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	Adjusted Annualized Relapse Rate (ARR)	Up to 144 weeks	participants with a relapse	relapses per person-years	NUMBER
SECONDARY	Adjusted Mean Number of New or Newly Enlarging T2 Hyperintense Lesions up to Week 96	up to 96 weeks	participants with baseline and at least one post-baseline MRI measurement	lesions	MEAN
SECONDARY	Proportion of Participants With Sustained Disability Progression at 144 Weeks	Baseline through 144 weeks		proportion of participants	NUMBER
SECONDARY	Proportion of Participants Relapse-free at Week 144	144 weeks		proportion of participants	NUMBER
SECONDARY	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	Baseline and 96 weeks	participants with a baseline and Week 96 assessment	percentage of participants	NUMBER

Source ClinicalTrials.gov

Results by group10

Each measurement the trial posted, group by group, in the words and numbers it posted.

Outcome	Group	Value	Spread	Units
Adjusted Annualized Relapse Rate (ARR)	Interferon Beta-1a	0.393	95% Confidence Interval 0.353 to 0.438	relapses per person-years
Adjusted Annualized Relapse Rate (ARR)	Daclizumab High Yield Process	0.216	95% Confidence Interval 0.191 to 0.244	relapses per person-years
Adjusted Mean Number of New or Newly Enlarging T2 Hyperintense Lesions up to Week 96	Interferon Beta-1a	9.44	95% Confidence Interval 8.46 to 10.54	lesions
Adjusted Mean Number of New or Newly Enlarging T2 Hyperintense Lesions up to Week 96	Daclizumab High Yield Process	4.31	95% Confidence Interval 3.85 to 4.81	lesions
Proportion of Participants With Sustained Disability Progression at 144 Weeks	Interferon Beta-1a	0.203		proportion of participants
Proportion of Participants With Sustained Disability Progression at 144 Weeks	Daclizumab High Yield Process	0.162		proportion of participants
Proportion of Participants Relapse-free at Week 144	Interferon Beta-1a	0.508		proportion of participants
Proportion of Participants Relapse-free at Week 144	Daclizumab High Yield Process	0.673		proportion of participants
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	Interferon Beta-1a	23		percentage of participants
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	Daclizumab High Yield Process	19		percentage of participants

Source ClinicalTrials.gov

Participant flow6

How many started, completed or left each group, period by period.

Period	Milestone	Group	Participants
Overall Study	STARTED	Interferon Beta-1a	922
Overall Study	STARTED	Daclizumab High Yield Process	919
Overall Study	COMPLETED	Interferon Beta-1a	694
Overall Study	COMPLETED	Daclizumab High Yield Process	724
Overall Study	NOT COMPLETED	Interferon Beta-1a	228
Overall Study	NOT COMPLETED	Daclizumab High Yield Process	195

Source ClinicalTrials.gov

Adverse events496

Each adverse event the trial posted, group by group: the participants affected out of those at risk.

Type	Event	Organ system	Group	Affected	At risk
other	Lymphadenopathy	Blood and lymphatic system disorders	IFN Beta-1a 30 mcg	7	922
other	Lymphadenopathy	Blood and lymphatic system disorders	DAC HYP 150 mg	46	919
other	Diarrhoea	Gastrointestinal disorders	IFN Beta-1a 30 mcg	55	922
other	Diarrhoea	Gastrointestinal disorders	DAC HYP 150 mg	67	919
other	Nausea	Gastrointestinal disorders	IFN Beta-1a 30 mcg	46	922
other	Nausea	Gastrointestinal disorders	DAC HYP 150 mg	46	919
other	Asthenia	General disorders	IFN Beta-1a 30 mcg	55	922
other	Asthenia	General disorders	DAC HYP 150 mg	37	919
other	Fatigue	General disorders	IFN Beta-1a 30 mcg	76	922
other	Fatigue	General disorders	DAC HYP 150 mg	69	919

1 to 10 of 496Source ClinicalTrials.gov

See all 496 adverse events

Adverse event totals6

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	IFN Beta-1a 30 mcg
Total, all-cause mortality	DAC HYP 150 mg
Total, other adverse events	IFN Beta-1a 30 mcg	783	922
Total, other adverse events	DAC HYP 150 mg	731	919
Total, serious adverse events	IFN Beta-1a 30 mcg	194	922
Total, serious adverse events	DAC HYP 150 mg	221	919

Source ClinicalTrials.gov

Papers7

The papers the trial lists on ClinicalTrials.gov.

PMID	Listed as	Source
26444729	DERIVED	PubMed
27251051	DERIVED	PubMed
28104250	DERIVED	PubMed
28485186	DERIVED	PubMed
28984179	DERIVED	PubMed
37072219	DERIVED	PubMed
37652990	DERIVED	PubMed

Grants0

The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.

None in this release.

Trial comparisons1

Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.

Comparison
IFN Beta-1a 30 mcg vs DAC HYP 150 mg: serious adverse events

Source Trial comparisons

Tests0

The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.

None in this release.

Data dates

The day each source was copied for this release.

ClinicalTrials.gov: 2026-11-12; ClinicalTrials.gov
Results, from AACT: 2026-03-23; AACT
NIH grant links: 2026-11-13; NIH RePORTER

Sources 3

ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
ClinicalTrials.govNo license stated
NIH RePORTER's clinical studies and project filesPublic domain

Each source's terms

ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
ClinicalTrials.govnone stated
NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

For software

Read this trial from software.

The record and each of its lists are JSON, twenty rows a page. No key.

GET https://conductscience.org/api/trials/v1/NCT01064401

GET https://conductscience.org/api/trials/v1/NCT01064401/events?page=2

API reference For AI assistants