Trial · NCT01797965
Long-Term Extension Study in Participants With Multiple Sclerosis Who Have Completed Study 205MS301 (NCT01064401) to Evaluate the Safety and Efficacy of BIIB019
NCT01797965, Phase 3, Terminated, Biogen; results first posted 2019-12-04
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ConductScience Library. Long-Term Extension Study in Participants With Multiple Sclerosis Who Have Completed Study 205MS301 (NCT01064401) to Evaluate the Safety and Efficacy of BIIB019. Trials, record NCT01797965. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01797965
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Long-Term Extension Study in Participants With Multiple Sclerosis Who Have Completed Study 205MS301 (NCT01064401) to Evaluate the Safety and Efficacy of BIIB019
- NCT number
- NCT01797965
- Status
- Terminated
- Phases
- Phase 3
- Enrollment
- 1,501 participants, actual
- Lead sponsor
- Biogen
- Conditions
- Relapsing-Remitting Multiple Sclerosis, Multiple Sclerosis
- Interventions
- BIIB019 (Daclizumab)
- First posted
- 2013-02-25
- Last updated
- 2019-12-04
- Other registries' IDs
- eudract:2012-003176-39
- Results first posted
- 2019-12-04
Source ClinicalTrials.gov
Registered outcomes43
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) | First dose of study drug in Study 303 to within 180 days of last dose (up to approximately 5.5 years) | An AE is defined as any untoward medical occurrence in a clinical investigation participant administered a pharmaceutical product; it does not necessarily have to have a causal relationship with this treatment. An AE could therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product. A SAE is any untoward medical occurrence or effect that at any dose results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability / incapacity, is a congenital anomaly / birth defect or is medically important due to other reasons than the above mentioned criteria. |
| Secondary | Annualized Relapse Rate (ARR) in the 205MS303 Treatment Period | Up to 4.6 years in the 303 study | 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 Study Neurologist. The unadjusted ARR was calculated by tabulating the total number of relapses experienced in the group divided by the number of days up to the end of study, and the ratio then multiplied by 365.25. Relapses that occurred after participants received alternative multiple sclerosis (MS) medications were excluded from the analyses. ARR was adjusted for relapse rate, IFN beta use, Expanded Disability Status Scale (EDSS) (\<=2.5 vs \>2.5) and age (\<=35 vs \>35) prior to start of study treatment in 205MS301, calculated using the negative binomial model. |
| Secondary | ARR in the 205MS301-303 Combined Study Period and 205MS301 Treatment Period | Up to 5.6 years combining 303 with the initial Study 301; Up to 1 year in the 301 study | 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 Study Neurologist. The unadjusted ARR was calculated by tabulating the total number of relapses experienced in the group divided by the number of days up to the end of study, and the ratio then multiplied by 365.25. Relapses that occurred after participants received alternative MS medications were excluded from the analyses. ARR was adjusted for relapse rate, IFN beta use, EDSS (\<=2.5 vs \>2.5) and age (\<=35 vs \>35) prior to start of study treatment in 301, calculated using the negative binomial model. |
| Secondary | Number of Participants With Relapse in the 205MS303 Treatment Period | Up to 4.6 years in the 303 study | 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 Study Neurologist. |
| Secondary | Number of Participants With Relapse in the 205MS301-303 Combined Study Period | Up to 5.6 years combining 303 with the initial Study 301 | 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 Study Neurologist. |
| Secondary | Number of Participants With Sustained Disability Progression in the 205MS303 Treatment Period | Up to 4.6 years in Study 303 | Sustained disability progression is defined as at least a 1.0-point increase on the Expanded Disability Status Scale (EDSS) from 303 baseline EDSS ≥1.0 that is sustained for 24 weeks, or at least a 1.5-point increase on the EDSS from 303 baseline EDSS of 0, that is sustained for 24 weeks. The EDSS measures the disability status of people with multiple sclerosis 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. Higher scores indicate more disability. |
| Secondary | Number of Participants With Sustained Disability Progression in the 205MS301-303 Combined Study Period | Up to 5.6 years combining 303 with the initial Study 301 | Sustained disability progression is defined as at least a 1.0-point increase on the Expanded Disability Status Scale (EDSS) from 303 baseline EDSS ≥1.0 that is sustained for 24 weeks, or at least a 1.5-point increase on the EDSS from 303 baseline EDSS of 0, that is sustained for 24 weeks. The EDSS measures the disability status of people with multiple sclerosis 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. Higher scores indicate more disability. |
| Secondary | Number of Participants With New or Newly Enlarging T2 Hyperintense Lesions in the 205MS303 Treatment Period | Baseline 303, Weeks 48, 96, 144, 192, 240 in Study 303 | T2 Hyperintense Lesions were assessed by magnetic resonance imaging (MRI) and were analyzed by a central MRI reader. The number of participants with New or Newly Enlarging T2 Hyperintense Lesions relative to the 303 Baseline in the 303 Treatment Period is reported. |
| Secondary | Number of Participants With New or Newly Enlarging T2 Hyperintense Lesions in the 205MS301 Treatment Period | Baseline 301, Weeks 24, 96, 144 in Study 301 | T2 Hyperintense Lesions were assessed by MRI and were analyzed by a central MRI reader. The number of participants with New or Newly Enlarging T2 Hyperintense Lesions relative to the 301 Baseline in the 301 Treatment Period is reported. |
| Secondary | Number of Participants With Gadolinium-enhancing (Gd+) Lesions in the 205MS303 Treatment Period | 301-303: Baseline 303, Weeks 48, 96, 144, 192, 240; 203-303 and 302-303: Week 96 | Gd+ lesions were evaluated by MRI and were analyzed by a central MRI reader. |
1 to 10 of 43Source ClinicalTrials.gov
See all 43 registered outcomesOutcomes43
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) | First dose of study drug in Study 303 to within 180 days of last dose (up to approximately 5.5 years) | Safety Population consisted of all participants who completed Study 301, 203 or 302 and had at least 1 dose of DAC HYP during Study 303. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Annualized Relapse Rate (ARR) in the 205MS303 Treatment Period | Up to 4.6 years in the 303 study | Intent-to-treat (ITT) Population consisted of all participants who completed Study 301, 203 or 302 and received at least 1 dose of DAC HYP during Study 303. | relapses per year | MEAN |
| SECONDARY | ARR in the 205MS301-303 Combined Study Period and 205MS301 Treatment Period | Up to 5.6 years combining 303 with the initial Study 301; Up to 1 year in the 301 study | 301-303 ITT Population consisted of all participants who completed Study 301 and received at least 1 dose of DAC HYP during Study 303. | relapses per year | MEAN |
| SECONDARY | Number of Participants With Relapse in the 205MS303 Treatment Period | Up to 4.6 years in the 303 study | ITT Population consisted of all participants who completed Study 301, 203 or 302 and had at least 1 dose of DAC HYP during Study 303. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Participants With Relapse in the 205MS301-303 Combined Study Period | Up to 5.6 years combining 303 with the initial Study 301 | 301-303 ITT Population consisted of all participants who completed Study 301 and had at least 1 dose of DAC HYP during Study 303. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Participants With Sustained Disability Progression in the 205MS303 Treatment Period | Up to 4.6 years in Study 303 | ITT Population consisted of all participants who completed Study 301, 203 or 302 and had at least 1 dose of DAC HYP during Study 303. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Participants With Sustained Disability Progression in the 205MS301-303 Combined Study Period | Up to 5.6 years combining 303 with the initial Study 301 | 301-303 ITT Population consisted of all participants who completed Study 301 and had at least 1 dose of DAC HYP during Study 303. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Participants With New or Newly Enlarging T2 Hyperintense Lesions in the 205MS303 Treatment Period | Baseline 303, Weeks 48, 96, 144, 192, 240 in Study 303 | 301-303 ITT population consisted of all participants who completed Study 301 and received at least 1 dose of DAC HYP during Study 303. No data was collected for participants from the 203 and 302 studies. Number analyzed is the number of participants with data available at the given timepoint. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Participants With New or Newly Enlarging T2 Hyperintense Lesions in the 205MS301 Treatment Period | Baseline 301, Weeks 24, 96, 144 in Study 301 | 301-303 ITT population consisted of all participants who completed Study 301 and received at least 1 dose of DAC HYP during Study 303. Number analyzed is the number of participants with data available at the given timepoint. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Participants With Gadolinium-enhancing (Gd+) Lesions in the 205MS303 Treatment Period | 301-303: Baseline 303, Weeks 48, 96, 144, 192, 240; 203-303 and 302-303: Week 96 | ITT Population consisted of all participants who completed Study 301, 203 or 302 and received at least one dose of DAY HYP in Study 303. Number analyzed is the number of participants with data available at the given timepoint. | Participants | COUNT_OF_PARTICIPANTS |
1 to 10 of 43Source ClinicalTrials.gov
See all 43 outcomesResults by group927
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) | IFN β-1a 30 µg (301)/DAC HYP 150 mg (303) | Participants with AEs | 541 | Participants | |
| Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) | DAC HYP 150 mg (301) /DAC HYP 150 mg (303) | Participants with AEs | 560 | Participants | |
| Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) | DAC HYP 150 mg (203) /DAC HYP 150 mg (303) | Participants with AEs | 172 | Participants | |
| Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) | DAC HYP 150 mg (302) /DAC HYP 150 mg (303) | Participants with AEs | 53 | Participants | |
| Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) | IFN β-1a 30 µg (301)/DAC HYP 150 mg (303) | Participants with SAEs | 157 | Participants | |
| Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) | DAC HYP 150 mg (301) /DAC HYP 150 mg (303) | Participants with SAEs | 190 | Participants | |
| Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) | DAC HYP 150 mg (203) /DAC HYP 150 mg (303) | Participants with SAEs | 38 | Participants | |
| Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) | DAC HYP 150 mg (302) /DAC HYP 150 mg (303) | Participants with SAEs | 15 | Participants | |
| Annualized Relapse Rate (ARR) in the 205MS303 Treatment Period | IFN β-1a 30 µg (301)/DAC HYP 150 mg (303) | 0.158 | 95% Confidence Interval 0.134 to 0.188 | relapses per year | |
| Annualized Relapse Rate (ARR) in the 205MS303 Treatment Period | DAC HYP 150 mg (301) /DAC HYP 150 mg (303) | 0.163 | 95% Confidence Interval 0.138 to 0.193 | relapses per year |
1 to 10 of 927Source ClinicalTrials.gov
See all 927 results by groupParticipant flow12
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | IFN β-1a 30 µg (301)/DAC HYP 150 mg (303) | 597 | |
| Overall Study | STARTED | DAC HYP 150 mg (301) /DAC HYP 150 mg (303) | 607 | |
| Overall Study | STARTED | DAC HYP 150 mg (302) /DAC HYP 150 mg (303) | 70 | |
| Overall Study | STARTED | DAC HYP 150 mg (203) /DAC HYP 150 mg (303) | 227 | |
| Overall Study | COMPLETED | IFN β-1a 30 µg (301)/DAC HYP 150 mg (303) | 48 | |
| Overall Study | COMPLETED | DAC HYP 150 mg (301) /DAC HYP 150 mg (303) | 38 | |
| Overall Study | COMPLETED | DAC HYP 150 mg (302) /DAC HYP 150 mg (303) | 62 | |
| Overall Study | COMPLETED | DAC HYP 150 mg (203) /DAC HYP 150 mg (303) | 154 | |
| Overall Study | NOT COMPLETED | IFN β-1a 30 µg (301)/DAC HYP 150 mg (303) | 549 | |
| Overall Study | NOT COMPLETED | DAC HYP 150 mg (301) /DAC HYP 150 mg (303) | 569 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 participant flowAdverse events1,304
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 | Events |
|---|---|---|---|---|---|---|
| other | Lymphadenopathy | Blood and lymphatic system disorders | IFN β-1a 30 µg (301)/DAC HYP 150 mg (303) | 47 | 597 | |
| other | Lymphadenopathy | Blood and lymphatic system disorders | DAC HYP 150 mg (301) /DAC HYP 150 mg (303) | 71 | 606 | |
| other | Lymphadenopathy | Blood and lymphatic system disorders | DAC HYP 150 mg (302) /DAC HYP 150 mg (303) | 3 | 70 | |
| other | Lymphadenopathy | Blood and lymphatic system disorders | DAC HYP 150 mg (203) /DAC HYP 150 mg (303) | 7 | 227 | |
| other | Diarrhoea | Gastrointestinal disorders | IFN β-1a 30 µg (301)/DAC HYP 150 mg (303) | 42 | 597 | |
| other | Diarrhoea | Gastrointestinal disorders | DAC HYP 150 mg (301) /DAC HYP 150 mg (303) | 35 | 606 | |
| other | Diarrhoea | Gastrointestinal disorders | DAC HYP 150 mg (302) /DAC HYP 150 mg (303) | 2 | 70 | |
| other | Diarrhoea | Gastrointestinal disorders | DAC HYP 150 mg (203) /DAC HYP 150 mg (303) | 10 | 227 | |
| other | Toothache | Gastrointestinal disorders | IFN β-1a 30 µg (301)/DAC HYP 150 mg (303) | 17 | 597 | |
| other | Toothache | Gastrointestinal disorders | DAC HYP 150 mg (301) /DAC HYP 150 mg (303) | 14 | 606 |
1 to 10 of 1,304Source ClinicalTrials.gov
See all 1,304 adverse eventsAdverse event totals12
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | IFN β-1a 30 µg (301)/DAC HYP 150 mg (303) | 2 | 597 |
| Total, all-cause mortality | DAC HYP 150 mg (301) /DAC HYP 150 mg (303) | 4 | 606 |
| Total, all-cause mortality | DAC HYP 150 mg (302) /DAC HYP 150 mg (303) | 0 | 70 |
| Total, all-cause mortality | DAC HYP 150 mg (203) /DAC HYP 150 mg (303) | 0 | 227 |
| Total, other adverse events | IFN β-1a 30 µg (301)/DAC HYP 150 mg (303) | 463 | 597 |
| Total, other adverse events | DAC HYP 150 mg (301) /DAC HYP 150 mg (303) | 476 | 606 |
| Total, other adverse events | DAC HYP 150 mg (302) /DAC HYP 150 mg (303) | 42 | 70 |
| Total, other adverse events | DAC HYP 150 mg (203) /DAC HYP 150 mg (303) | 116 | 227 |
| Total, serious adverse events | IFN β-1a 30 µg (301)/DAC HYP 150 mg (303) | 157 | 597 |
| Total, serious adverse events | DAC HYP 150 mg (301) /DAC HYP 150 mg (303) | 190 | 606 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 adverse event totalsPapers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 27411694 | DERIVED |
Source 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 comparisons3
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| IFN β-1a 30 µg (301)/DAC HYP 150 mg (303) vs DAC HYP 150 mg (301) /DAC HYP 150 mg (303): Number of Participants Who Are Free From Disease Activity in the 205MS303 Treatment Period | Trial comparisons |
| IFN β-1a 30 µg (301)/DAC HYP 150 mg (303) vs DAC HYP 150 mg (301) /DAC HYP 150 mg (303): Number of Participants With Relapse in the 205MS301-303 Combined Study Period | Trial comparisons |
| IFN β-1a 30 µg (301)/DAC HYP 150 mg (303) vs DAC HYP 150 mg (301) /DAC HYP 150 mg (303): Number of Participants With Sustained Disability Progression in the 205MS301-303 Combined Study Period | Trial comparisons |
Tests2
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
| Test | Named as | Source |
|---|---|---|
| Paced Visual Serial Addition Test | Secondary outcome | ConductCognition |
| Symbol Coding | Secondary outcome | ConductCognition |
Data dates
The day each source was copied for this release.
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.
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