Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| 2009-015318-23 | EudraCT Number |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| AbbVie | INDUSTRY |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Primary Objective is to assess the safety of extended treatment with Daclizumab High Yield Process (DAC HYP, BIIB019) monotherapy in participants with relapsing remitting multiple sclerosis (RRMS). Secondary Objective is to assess the long-term immunogenicity of DAC HYP and to assess the durability of response to DAC HYP in preventing multiple sclerosis (MS) relapse, slowing disability progression, and reducing new MS lesion formation in this study population.
This study will provide participants who complete Study 205MS202 (NCT00870740) with the option to receive continued open-label Daclizumab High Yield Process (DAC HYP) monotherapy and to evaluate the long-term safety, efficacy, and immunogenicity of DAC HYP monotherapy in participants with relapsing remitting multiple sclerosis (RRMS). Approximately 60 to 100 participants will be enrolled into an optional open-label, 16-week autoinjector substudy at a selected subset of sites which will run concurrently during the main study, and will evaluate the systemic exposure and local tolerability of subcutaneous administration of DAC HYP by autoinjector. The 2013-2014 trivalent influenza vaccine will be offered to all eligible participants as an optional substudy to assess the effect of DAC-HYP treatment on the immune response to vaccination,
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| BIIB019 | Experimental | Participants received BIIB019, 150 mg subcutaneous injection every 4 weeks up to Week 288. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| BIIB019 (Daclizumab) | Biological | Administered as specified in the treatment arm. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs), Discontinuation Due to AEs, Withdrawals Due to AEs | An AE is defined as any untoward medical occurrence in a clinical investigation participant administered a drug; it does not necessarily have to have a causal relationship with this treatment. 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. | Baseline up to 24 weeks after last dose of treatment (Up to 300 weeks) |
| Area Under the Concentration-Time Curve Over the Dosing Interval (AUC0-t) After Dose 4 for Daclizumab | Day 90 (Week 12) at predose and 8, 24, 72 and 120 hours post-dose and 7, 10, 14, 21 and 28 days post-dose |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With New or Newly Enlarging T2 Hyperintense Lesions Compared to Baseline | New or newly enlarging T2 hyperintense lesions evaluated by magnetic resonance imaging (MRI) and analyzed by a central reader. | From Baseline through 288 weeks |
| Annual Change in Volume of New or Newly Enlarging T2 Hyperintense Lesions Compared to Baseline |
Not provided
Main Study Eligibility:
Key Inclusion Criteria:
Key Exclusion Criteria:
Subjects with any significant change in their medical status from the previous study that would prelude administration of Daclizumab High Yield Process (DAC HYP) as determined by the Investigator including laboratory tests or a current clinically significant condition that, in the opinion of the Investigator, would have excluded the subject's participation in the 205MS201 (NCT00390221) or 205MS202 (NCT00870740) studies. The Investigator must re-review the subject's medical fitness for participation and must consider any diseases that would preclude treatment.
Any subject who has permanently discontinued study treatment in Study 205MS202 (NCT00870740) due to an adverse event.
Current enrollment in any investigational drug study other than Study 205MS202 (NCT00870740).
Ongoing treatment with any approved or experimental disease-modifying treatment for multiple sclerosis.
For subjects currently taking valproic acid, carbamazepine, lamotrigine, or phenytoin:
Subjects who are currently receiving treatment with isoniazid, propylthiouracil, or nimesulide at the time of study entry and are not able to discontinue the agent or change to an alternative medication allowed by the protocol.
NOTE: Other protocol defined Inclusion/Exclusion criteria may apply.
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Medical Director | Biogen | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Research Site | Brno | 625 00 | Czechia | |||
| Research Site |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 32451615 | Derived | Gold R, Radue EW, Giovannoni G, Selmaj K, Havrdova EK, Montalban X, Stefoski D, Sprenger T, Robinson RR, Fam S, Smith J, Chalkias S, Giannattasio G, Lima G, Castro-Borrero W. Long-term safety and efficacy of daclizumab beta in relapsing-remitting multiple sclerosis: 6-year results from the SELECTED open-label extension study. J Neurol. 2020 Oct;267(10):2851-2864. doi: 10.1007/s00415-020-09835-y. Epub 2020 May 25. | |
| 27461166 |
| Label | URL |
|---|---|
| The website of the National Multiple Sclerosis Society, an organization dedicated to providing information to individuals with MS their families and healthcare providers | View source |
Not provided
Not provided
Out of 410 enrolled participants, 60 participants who received at least 6 consecutive monthly doses of DAC HYP in this study and had provided written informed consent were enrolled in to the autoinjector substudy and 91 participants who received seasonal trivalent influenza vaccine were enrolled in vaccine substudy (exploratory analyses).
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | BIIB019 | Participants received BIIB019, 150 mg subcutaneous injection every 4 weeks up to Week 276. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| trivalent seasonal influenza vaccine | Biological | All participants who participate in the 2013-2014 influenza vaccine substudy will receive the vaccine at the study site |
|
New or newly enlarging T2 hyperintense lesions evaluated by MRI and analyzed by a central reader. |
| From Baseline through 288 weeks |
| Number of Participants With Total Number of New Gadolinium-enhancing Lesions | New Gadolinium-enhancing lesions was evaluated by MRI and analyzed by a central reader. | From Baseline through 288 weeks |
| Annual Change in Number of T1 Hypointense Lesions | From Baseline through 288 weeks |
| Annual Change in Volume of New Gadolinium-Enhancing Lesions | From Baseline through 288 weeks |
| Annual Change in Volume of T1 Hypointense Lesions | Volume of T1 hypointense lesions was evaluated by MRI and analyzed by a central reader. | From Baseline through 288 weeks |
| Percent Change in Total Brain Volume | To assess brain atrophy, total brain volume was be measured by MRI and analyzed by a central reader. | From Baseline through 288 weeks |
| Number of Participants With Antibodies to DAC HYP | Up to Week 288 |
| Annualized Relapse Rate (ARR) | Relapses are defined as new or recurrent neurologic 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 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. Adjusted ARR was reported. | Week 288 |
| Number of Participants With Sustained Disability Progression for 12 Weeks | Sustained disability progression defined by at least a 1.0-point increase on the Expanded Disability Status Scale (EDSS) from a baseline EDSS ≥1.0 that is sustained for 12 weeks, or at least a 1.5-point increase on the EDSS from a baseline EDSS <1.0 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. | Week 48 up to Week 288 |
| Number of Participants With Sustained Disability Progression for 24 Weeks | Sustained disability progression defined by at least a 1.0-point increase on the Expanded Disability Status Scale (EDSS) from a baseline EDSS ≥1.0 that is sustained for 24 weeks, or at least a 1.5-point increase on the EDSS from a baseline EDSS <1.0 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, with higher scores indicating more disability. | Week 48 up to Week 288 |
| Observed Maximum Concentration (Cmax) After Dose 4 for Daclizumab | Day 90 (Week 12) at predose and 8, 24, 72 and 120 hours post-dose and 7, 10, 14, 21 and 28 days post-dose |
| Time to Reach Maximum Concentration (Tmax) for Daclizumab After Dose 4 | Day 90 (Week 12) at predose and 8, 24, 72 and 120 hours post-dose and 7, 10, 14, 21 and 28 days post-dose |
| Observed Minimum Concentration (Cmin) for Daclizumab After Dose 4 | Day 90 (Week 12) at predose and 8, 24, 72 and 120 hours post-dose and 7, 10, 14, 21 and 28 days post-dose |
| Participant-Reported Pain Visual Analog Scale (VAS) Score | The VAS is a 10 cm-long horizontal line labeled with 2 extremes of pain at either end ("0 [no pain]" on the left and "100 [very painful]" on the right). The participant rates their perceived pain of each injection by placing a vertical mark on the line to indicate the level of pain. | First injection (Day 1) and fourth injection (Day 90) 0 hour, 30 minutes, 60 minutes and 8 hours post-dose |
| Summary of Injection Site Assessment Performed by Clinician | Injection site assessment was performed by clinician and are defined as erythema (redness) rated on a 4 point scale ranging from 0-3, where 0=none, 1=mild, 2=moderate and 3=severe; pigmentation changes (skin discoloration other than redness) rated on a 3 point scale from 0-2, where 0=none, 1=hypopigmentation and 2=hyperpigmentation; induration (swelling) rated on a 4 point scale ranging from 0-3, where 0=none, 1=mild, 2=moderate and 3=severe; tenderness to pressure rated on a 4 point scale ranging from 0-3, where 0=none, 1=mild, 2=moderate and 3=severe; and local temperature changes of injection sites rated on a 3 point scale where 0=normal, 1=warm and 1=hot. Only those score categories for which there was at least 1 participant are reported. Here, Injection=Inj, post-dose=PD | First injection (Day 1) and fourth injection (Day 90) 30 minutes; 8, 24, 72, and 120 hours; and 7, 10, and 14 days post-dose |
| Brno |
| 656 91 |
| Czechia |
| Research Site | Hradec Králové | 500 02 | Czechia |
| Research Site | Prague | 100 34 | Czechia |
| Research Site | Teplice | 415 29 | Czechia |
| Research Site | Bayreuth | 95445 | Germany |
| Research Site | Erlangen | 91054 | Germany |
| Research Site | Marburg | 35043 | Germany |
| Research Site | Rostock | 18147 | Germany |
| Research Site | Budapest | 1076 | Hungary |
| Research Site | Budapest | 1083 | Hungary |
| Research Site | Budapest | 1115 | Hungary |
| Research Site | Budapest | 1125 | Hungary |
| Research Site | Budapest | 1134 | Hungary |
| Research Site | Debrecen | 4032 | Hungary |
| Research Site | Esztergom | 2500 | Hungary |
| Research Site | Győr | 9024 | Hungary |
| Research Site | Kecskemét | 6000 | Hungary |
| Research Site | Miskolc | 3526 | Hungary |
| Research Site | Miskolc | 3533 | Hungary |
| Research Site | Nyíregyháza | 4400 | Hungary |
| Research Site | Siófok | 8600 | Hungary |
| Research Site | Bangalore | 560034 | India |
| Research Site | Hyderabad | 500082 | India |
| Research Site | Kolkata | 700068 | India |
| Research Site | Mumbai | 400012 | India |
| Research Site | Rajasthan | 302021 | India |
| Research Site | Bialystok | 15-276 | Poland |
| Research Site | Bialystok | 15-420 | Poland |
| Research Site | Gdansk | 80-803 | Poland |
| Research Site | Katowice | 40-749 | Poland |
| Research Site | Katowice | 40-752 | Poland |
| Research Site | Krakow | 31-505 | Poland |
| Research Site | Lodz | 93-121 | Poland |
| Research Site | Lublin | 20954 | Poland |
| Research Site | Warsaw | 02-097 | Poland |
| Research Site | Warsaw | 02-957 | Poland |
| Research Site | Kazan' | 420021 | Russia |
| Research Site | Krasnoyarsk | 660049 | Russia |
| Research Site | Moscow | 107150 | Russia |
| Research Site | Moscow | 115682 | Russia |
| Research Site | Moscow | 6127018 | Russia |
| Research Site | Nizhny Novgorod | 603076 | Russia |
| Research Site | Novosibirsk | 630087 | Russia |
| Research Site | Omsk | 644033 | Russia |
| Research Site | Saint Petersburg | 194291 | Russia |
| Research Site | Samara | 443095 | Russia |
| Research Site | Smolensk | 214018 | Russia |
| Research Site | Ufa | 450005 | Russia |
| Research Site | Yaroskavi | 150030 | Russia |
| Research Site | Chernivtsi | 58018 | Ukraine |
| Research Site | Dnipropetrovsk | 49027 | Ukraine |
| Research Site | Donetsk | 83003 | Ukraine |
| Research Site | Kharkiv | 61068 | Ukraine |
| Research Site | Kiev | 03110 | Ukraine |
| Research Site | Kiev | 2125 | Ukraine |
| Research Site | Kyiv | 03110 | Ukraine |
| Research Site | Poltava | 36024 | Ukraine |
| Research Site | Zaporizhia | 69035 | Ukraine |
| Research Site | Zaporizhia | 69600 | Ukraine |
| Research Site | London | SE59RF | United Kingdom |
| Research Site | Nottingham | NG72UH | United Kingdom |
| Research Site | Plymouth | PL68DH | United Kingdom |
| Research Site | Sheffield | S102JF | United Kingdom |
| Research Site | Stoke-on-Trent | ST47LN | United Kingdom |
| Derived |
| Gold R, Radue EW, Giovannoni G, Selmaj K, Havrdova E, Stefoski D, Sprenger T, Montalban X, Cohan S, Umans K, Greenberg SJ, Ozen G, Elkins J. Safety and efficacy of daclizumab in relapsing-remitting multiple sclerosis: 3-year results from the SELECTED open-label extension study. BMC Neurol. 2016 Jul 26;16:117. doi: 10.1186/s12883-016-0635-y. |
| 27411694 | Derived | Gold R, Stefoski D, Selmaj K, Havrdova E, Hurst C, Holman J, Tornesi B, Akella S, McCroskery P. Pregnancy Experience: Nonclinical Studies and Pregnancy Outcomes in the Daclizumab Clinical Study Program. Neurol Ther. 2016 Dec;5(2):169-182. doi: 10.1007/s40120-016-0048-2. Epub 2016 Jul 13. |
| COMPLETED |
|
| NOT COMPLETED |
|
|
All participants who were randomized and received at least 1 dose of study drug.
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | BIIB019 | Participants received BIIB019, 150 mg subcutaneous injection every 4 weeks up to Week 276. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Number of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs), Discontinuation Due to AEs, Withdrawals Due to AEs | An AE is defined as any untoward medical occurrence in a clinical investigation participant administered a drug; it does not necessarily have to have a causal relationship with this treatment. 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. | Safety population included participants who provided informed consent and received at least 1 dose of DAC HYP during the study. | Posted | Count of Participants | Participants | Baseline up to 24 weeks after last dose of treatment (Up to 300 weeks) |
|
|
| ||||||||||||||||||||||||||||||||||||
| Primary | Area Under the Concentration-Time Curve Over the Dosing Interval (AUC0-t) After Dose 4 for Daclizumab | Pharmacokinetic analysis population included all participants in the Autoinjector Substudy with a sufficient number of samples available for analysis by randomized treatment group. | Posted | Mean | Standard Deviation | hr*mg/mL | Day 90 (Week 12) at predose and 8, 24, 72 and 120 hours post-dose and 7, 10, 14, 21 and 28 days post-dose |
|
| |||||||||||||||||||||||||||||||||||||
| Secondary | Number of Participants With New or Newly Enlarging T2 Hyperintense Lesions Compared to Baseline | New or newly enlarging T2 hyperintense lesions evaluated by magnetic resonance imaging (MRI) and analyzed by a central reader. | Intent-to-treat (ITT) population included participants who provided informed consent and received at least 1 dose of DAC HYP during the study. Here 'n' indicates number of participants who were evaluable at specific time points. | Posted | Count of Participants | Participants | From Baseline through 288 weeks |
|
| |||||||||||||||||||||||||||||||||||||
| Secondary | Annual Change in Volume of New or Newly Enlarging T2 Hyperintense Lesions Compared to Baseline | New or newly enlarging T2 hyperintense lesions evaluated by MRI and analyzed by a central reader. | ITT population included participants who provided informed consent and received at least 1 dose of DAC HYP during the study. Here 'n' indicates number of participants who were evaluable at specific time points. | Posted | Mean | Standard Deviation | mm^3 | From Baseline through 288 weeks |
|
| ||||||||||||||||||||||||||||||||||||
| Secondary | Number of Participants With Total Number of New Gadolinium-enhancing Lesions | New Gadolinium-enhancing lesions was evaluated by MRI and analyzed by a central reader. | ITT population included participants who provided informed consent and received at least 1 dose of DAC HYP during the study. Here 'n' indicates number of participants who were evaluable at specific time points. | Posted | Count of Participants | Participants | From Baseline through 288 weeks |
|
| |||||||||||||||||||||||||||||||||||||
| Secondary | Annual Change in Number of T1 Hypointense Lesions | T1 hypointense lesions changes reflect tissue destruction. Volume of T1 hypointense lesions is deemed a more valuable assessment. Hence number of T1 hypointense lesions were not assessed and reported. | Posted | From Baseline through 288 weeks |
|
| ||||||||||||||||||||||||||||||||||||||||
| Secondary | Annual Change in Volume of New Gadolinium-Enhancing Lesions | Gd enhancing lesion volume reflects acute inflammatory activity. The number of Gd lesions is a more valuable outcome measure. Hence the volume of Gd enhancing lesions was not assessed and reported. | Posted | From Baseline through 288 weeks |
|
| ||||||||||||||||||||||||||||||||||||||||
| Secondary | Annual Change in Volume of T1 Hypointense Lesions | Volume of T1 hypointense lesions was evaluated by MRI and analyzed by a central reader. | ITT population included participants who provided informed consent and received at least 1 dose of DAC HYP during the study. Here 'n' indicates number of participants who were evaluable at specific time points. | Posted | Mean | Standard Deviation | mm^3 | From Baseline through 288 weeks |
|
| ||||||||||||||||||||||||||||||||||||
| Secondary | Percent Change in Total Brain Volume | To assess brain atrophy, total brain volume was be measured by MRI and analyzed by a central reader. | ITT population included participants who provided informed consent and received at least 1 dose of DAC HYP during the study. Here 'n' indicates number of participants who were evaluable at specific time points. | Posted | Mean | Standard Deviation | percent change | From Baseline through 288 weeks |
|
| ||||||||||||||||||||||||||||||||||||
| Secondary | Number of Participants With Antibodies to DAC HYP | Safety population included participants who provided informed consent and received at least 1 dose of DAC HYP during the study. Here number of participants analyzed is the participants who were evaluated for this outcome measure. | Posted | Count of Participants | Participants | Up to Week 288 |
|
| ||||||||||||||||||||||||||||||||||||||
| Secondary | Annualized Relapse Rate (ARR) | Relapses are defined as new or recurrent neurologic 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 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. Adjusted ARR was reported. | ITT population included participants who provided informed consent and received at least 1 dose of DAC HYP during the study. | Posted | Number | 95% Confidence Interval | relapses per person-year | Week 288 |
|
| ||||||||||||||||||||||||||||||||||||
| Secondary | Number of Participants With Sustained Disability Progression for 12 Weeks | Sustained disability progression defined by at least a 1.0-point increase on the Expanded Disability Status Scale (EDSS) from a baseline EDSS ≥1.0 that is sustained for 12 weeks, or at least a 1.5-point increase on the EDSS from a baseline EDSS <1.0 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. | ITT population included participants who provided informed consent and received at least 1 dose of DAC HYP during the study. | Posted | Count of Participants | Participants | Week 48 up to Week 288 |
|
| |||||||||||||||||||||||||||||||||||||
| Secondary | Number of Participants With Sustained Disability Progression for 24 Weeks | Sustained disability progression defined by at least a 1.0-point increase on the Expanded Disability Status Scale (EDSS) from a baseline EDSS ≥1.0 that is sustained for 24 weeks, or at least a 1.5-point increase on the EDSS from a baseline EDSS <1.0 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, with higher scores indicating more disability. | ITT population included participants who provided informed consent and received at least 1 dose of DAC HYP during the study. | Posted | Count of Participants | Participants | Week 48 up to Week 288 |
|
| |||||||||||||||||||||||||||||||||||||
| Secondary | Observed Maximum Concentration (Cmax) After Dose 4 for Daclizumab | Pharmacokinetic analysis population included all participants with a sufficient number of samples available for analysis. | Posted | Mean | Standard Deviation | mg/mL | Day 90 (Week 12) at predose and 8, 24, 72 and 120 hours post-dose and 7, 10, 14, 21 and 28 days post-dose |
|
| |||||||||||||||||||||||||||||||||||||
| Secondary | Time to Reach Maximum Concentration (Tmax) for Daclizumab After Dose 4 | Pharmacokinetic analysis population included all participants with a sufficient number of samples available for analysis. | Posted | Median | Full Range | hour | Day 90 (Week 12) at predose and 8, 24, 72 and 120 hours post-dose and 7, 10, 14, 21 and 28 days post-dose |
|
| |||||||||||||||||||||||||||||||||||||
| Secondary | Observed Minimum Concentration (Cmin) for Daclizumab After Dose 4 | Pharmacokinetic analysis population included all participants with a sufficient number of samples available for analysis. | Posted | Mean | Standard Deviation | mg/mL | Day 90 (Week 12) at predose and 8, 24, 72 and 120 hours post-dose and 7, 10, 14, 21 and 28 days post-dose |
|
| |||||||||||||||||||||||||||||||||||||
| Secondary | Participant-Reported Pain Visual Analog Scale (VAS) Score | The VAS is a 10 cm-long horizontal line labeled with 2 extremes of pain at either end ("0 [no pain]" on the left and "100 [very painful]" on the right). The participant rates their perceived pain of each injection by placing a vertical mark on the line to indicate the level of pain. | The participants who were enrolled in auto-injector sub study were evaluated in this outcome measure. Here 'n' indicates number of participants who were evaluable at specific time points. | Posted | Mean | Standard Deviation | score on a scale | First injection (Day 1) and fourth injection (Day 90) 0 hour, 30 minutes, 60 minutes and 8 hours post-dose |
|
| ||||||||||||||||||||||||||||||||||||
| Secondary | Summary of Injection Site Assessment Performed by Clinician | Injection site assessment was performed by clinician and are defined as erythema (redness) rated on a 4 point scale ranging from 0-3, where 0=none, 1=mild, 2=moderate and 3=severe; pigmentation changes (skin discoloration other than redness) rated on a 3 point scale from 0-2, where 0=none, 1=hypopigmentation and 2=hyperpigmentation; induration (swelling) rated on a 4 point scale ranging from 0-3, where 0=none, 1=mild, 2=moderate and 3=severe; tenderness to pressure rated on a 4 point scale ranging from 0-3, where 0=none, 1=mild, 2=moderate and 3=severe; and local temperature changes of injection sites rated on a 3 point scale where 0=normal, 1=warm and 1=hot. Only those score categories for which there was at least 1 participant are reported. Here, Injection=Inj, post-dose=PD | The participants who were enrolled in auto-injector sub study were evaluated in this outcome measure. Here 'n' indicates number of participants who were evaluable at specific time points. | Posted | Count of Participants | Participants | First injection (Day 1) and fourth injection (Day 90) 30 minutes; 8, 24, 72, and 120 hours; and 7, 10, and 14 days post-dose |
|
Baseline up to 24 weeks after last dose of treatment (Up to 300 weeks)
Treatment emergent AEs are presented regardless of seriousness or relationship to investigational product.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | BIIB019 | Participants received BIIB019, 150 mg subcutaneous injection every 4 weeks up to Week 276. | 148 | 410 | 296 | 410 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Febrile neutropenia | Blood and lymphatic system disorders | MedDRA 16.1 | Systematic Assessment |
| |
| Haemolytic anaemia | Blood and lymphatic system disorders | MedDRA 16.1 | Systematic Assessment |
| |
| Haemorrhagic anaemia | Blood and lymphatic system disorders | MedDRA 16.1 | Systematic Assessment |
| |
| Histiocytosis haematophagic | Blood and lymphatic system disorders | MedDRA 16.1 | Systematic Assessment |
| |
| Iron deficiency anaemia | Blood and lymphatic system disorders | MedDRA 16.1 | Systematic Assessment |
| |
| Lymphadenitis | Blood and lymphatic system disorders | MedDRA 16.1 | Systematic Assessment |
| |
| Lymphadenopathy | Blood and lymphatic system disorders | MedDRA 16.1 | Systematic Assessment |
| |
| Lymphoid tissue hyperplasia | Blood and lymphatic system disorders | MedDRA 16.1 | Systematic Assessment |
| |
| Pancytopenia | Blood and lymphatic system disorders | MedDRA 16.1 | Systematic Assessment |
| |
| Thrombocytopenic purpura | Blood and lymphatic system disorders | MedDRA 16.1 | Systematic Assessment |
| |
| Myocardial infarction | Cardiac disorders | MedDRA 16.1 | Systematic Assessment |
| |
| Dermoid cyst | Congenital, familial and genetic disorders | MedDRA 16.1 | Systematic Assessment |
| |
| Vertigo | Ear and labyrinth disorders | MedDRA 16.1 | Systematic Assessment |
| |
| Goitre | Endocrine disorders | MedDRA 16.1 | Systematic Assessment |
| |
| Choroiditis | Eye disorders | MedDRA 16.1 | Systematic Assessment |
| |
| Abdominal hernia | Gastrointestinal disorders | MedDRA 16.1 | Systematic Assessment |
| |
| Colitis | Gastrointestinal disorders | MedDRA 16.1 | Systematic Assessment |
| |
| Colitis ulcerative | Gastrointestinal disorders | MedDRA 16.1 | Systematic Assessment |
| |
| Crohn's disease | Gastrointestinal disorders | MedDRA 16.1 | Systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA 16.1 | Systematic Assessment |
| |
| Enterocolitis haemorrhagic | Gastrointestinal disorders | MedDRA 16.1 | Systematic Assessment |
| |
| Gastritis | Gastrointestinal disorders | MedDRA 16.1 | Systematic Assessment |
| |
| Ileus | Gastrointestinal disorders | MedDRA 16.1 | Systematic Assessment |
| |
| Ileus paralytic | Gastrointestinal disorders | MedDRA 16.1 | Systematic Assessment |
| |
| Lip oedema | Gastrointestinal disorders | MedDRA 16.1 | Systematic Assessment |
| |
| Obstruction gastric | Gastrointestinal disorders | MedDRA 16.1 | Systematic Assessment |
| |
| Impaired healing | General disorders | MedDRA 16.1 | Systematic Assessment |
| |
| Autoimmune hepatitis | Hepatobiliary disorders | MedDRA 16.1 | Systematic Assessment |
| |
| Cholecystitis acute | Hepatobiliary disorders | MedDRA 16.1 | Systematic Assessment |
| |
| Cholelithiasis | Hepatobiliary disorders | MedDRA 16.1 | Systematic Assessment |
| |
| Hepatitis | Hepatobiliary disorders | MedDRA 16.1 | Systematic Assessment |
| |
| Jaundice hepatocellular | Hepatobiliary disorders | MedDRA 16.1 | Systematic Assessment |
| |
| Liver disorder | Hepatobiliary disorders | MedDRA 16.1 | Systematic Assessment |
| |
| Anaphylactic reaction | Immune system disorders | MedDRA 16.1 | Systematic Assessment |
| |
| Drug hypersensitivity | Immune system disorders | MedDRA 16.1 | Systematic Assessment |
| |
| Acute sinusitis | Infections and infestations | MedDRA 16.1 | Systematic Assessment |
| |
| Appendicitis | Infections and infestations | MedDRA 16.1 | Systematic Assessment |
| |
| Bronchitis | Infections and infestations | MedDRA 16.1 | Systematic Assessment |
| |
| Clostridium difficile colitis | Infections and infestations | MedDRA 16.1 | Systematic Assessment |
| |
| Diverticulitis | Infections and infestations | MedDRA 16.1 | Systematic Assessment |
| |
| Erysipelas | Infections and infestations | MedDRA 16.1 | Systematic Assessment |
| |
| Furuncle | Infections and infestations | MedDRA 16.1 | Systematic Assessment |
| |
| Gastrointestinal infection | Infections and infestations | MedDRA 16.1 | Systematic Assessment |
| |
| Hepatitis c | Infections and infestations | MedDRA 16.1 | Systematic Assessment |
| |
| Herpes zoster | Infections and infestations | MedDRA 16.1 | Systematic Assessment |
| |
| Hiv infection | Infections and infestations | MedDRA 16.1 | Systematic Assessment |
| |
| Infectious mononucleosis | Infections and infestations | MedDRA 16.1 | Systematic Assessment |
| |
| Peritonsillar abscess | Infections and infestations | MedDRA 16.1 | Systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA 16.1 | Systematic Assessment |
| |
| Pyelonephritis acute | Infections and infestations | MedDRA 16.1 | Systematic Assessment |
| |
| Tonsillitis | Infections and infestations | MedDRA 16.1 | Systematic Assessment |
| |
| Upper respiratory tract infection | Infections and infestations | MedDRA 16.1 | Systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA 16.1 | Systematic Assessment |
| |
| Wound infection | Infections and infestations | MedDRA 16.1 | Systematic Assessment |
| |
| Cervical vertebral fracture | Injury, poisoning and procedural complications | MedDRA 16.1 | Systematic Assessment |
| |
| Concussion | Injury, poisoning and procedural complications | MedDRA 16.1 | Systematic Assessment |
| |
| Foot fracture | Injury, poisoning and procedural complications | MedDRA 16.1 | Systematic Assessment |
| |
| Lower limb fracture | Injury, poisoning and procedural complications | MedDRA 16.1 | Systematic Assessment |
| |
| Pubis fracture | Injury, poisoning and procedural complications | MedDRA 16.1 | Systematic Assessment |
| |
| Road traffic accident | Injury, poisoning and procedural complications | MedDRA 16.1 | Systematic Assessment |
| |
| Spinal column injury | Injury, poisoning and procedural complications | MedDRA 16.1 | Systematic Assessment |
| |
| Upper limb fracture | Injury, poisoning and procedural complications | MedDRA 16.1 | Systematic Assessment |
| |
| Wound | Injury, poisoning and procedural complications | MedDRA 16.1 | Systematic Assessment |
| |
| Alanine aminotransferase increased | Investigations | MedDRA 16.1 | Systematic Assessment |
| |
| Aspartate aminotransferase increased | Investigations | MedDRA 16.1 | Systematic Assessment |
| |
| Gamma-glutamyltransferase increased | Investigations | MedDRA 16.1 | Systematic Assessment |
| |
| Hepatic enzyme increased | Investigations | MedDRA 16.1 | Systematic Assessment |
| |
| Liver function test abnormal | Investigations | MedDRA 16.1 | Systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA 16.1 | Systematic Assessment |
| |
| Arthritis reactive | Musculoskeletal and connective tissue disorders | MedDRA 16.1 | Systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA 16.1 | Systematic Assessment |
| |
| Intervertebral disc disorder | Musculoskeletal and connective tissue disorders | MedDRA 16.1 | Systematic Assessment |
| |
| Osteoarthritis | Musculoskeletal and connective tissue disorders | MedDRA 16.1 | Systematic Assessment |
| |
| Anal cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 16.1 | Systematic Assessment |
| |
| Benign neoplasm of bladder | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 16.1 | Systematic Assessment |
| |
| Breast cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 16.1 | Systematic Assessment |
| |
| Carcinoid tumour pulmonary | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 16.1 | Systematic Assessment |
| |
| Clear cell renal cell carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 16.1 | Systematic Assessment |
| |
| Intraductal papilloma of breast | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 16.1 | Systematic Assessment |
| |
| Prolactinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 16.1 | Systematic Assessment |
| |
| T-cell lymphoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 16.1 | Systematic Assessment |
| |
| Uterine leiomyoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 16.1 | Systematic Assessment |
| |
| Grand mal convulsion | Nervous system disorders | MedDRA 16.1 | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA 16.1 | Systematic Assessment |
| |
| Ischaemic stroke | Nervous system disorders | MedDRA 16.1 | Systematic Assessment |
| |
| Multiple sclerosis | Nervous system disorders | MedDRA 16.1 | Systematic Assessment |
| |
| Multiple sclerosis relapse | Nervous system disorders | MedDRA 16.1 | Systematic Assessment |
| |
| Neurological decompensation | Nervous system disorders | MedDRA 16.1 | Systematic Assessment |
| |
| Vascular encephalopathy | Nervous system disorders | MedDRA 16.1 | Systematic Assessment |
| |
| Ectopic pregnancy | Pregnancy, puerperium and perinatal conditions | MedDRA 16.1 | Systematic Assessment |
| |
| Depression | Psychiatric disorders | MedDRA 16.1 | Systematic Assessment |
| |
| Suicide attempt | Psychiatric disorders | MedDRA 16.1 | Systematic Assessment |
| |
| Glomerulonephritis | Renal and urinary disorders | MedDRA 16.1 | Systematic Assessment |
| |
| Haematuria | Renal and urinary disorders | MedDRA 16.1 | Systematic Assessment |
| |
| Nephroptosis | Renal and urinary disorders | MedDRA 16.1 | Systematic Assessment |
| |
| Renal colic | Renal and urinary disorders | MedDRA 16.1 | Systematic Assessment |
| |
| Adenomyosis | Reproductive system and breast disorders | MedDRA 16.1 | Systematic Assessment |
| |
| Ovarian cyst | Reproductive system and breast disorders | MedDRA 16.1 | Systematic Assessment |
| |
| Postmenopausal haemorrhage | Reproductive system and breast disorders | MedDRA 16.1 | Systematic Assessment |
| |
| Uterine inflammation | Reproductive system and breast disorders | MedDRA 16.1 | Systematic Assessment |
| |
| Epistaxis | Respiratory, thoracic and mediastinal disorders | MedDRA 16.1 | Systematic Assessment |
| |
| Idiopathic pulmonary fibrosis | Respiratory, thoracic and mediastinal disorders | MedDRA 16.1 | Systematic Assessment |
| |
| Interstitial lung disease | Respiratory, thoracic and mediastinal disorders | MedDRA 16.1 | Systematic Assessment |
| |
| Angioedema | Skin and subcutaneous tissue disorders | MedDRA 16.1 | Systematic Assessment |
| |
| Dermatitis | Skin and subcutaneous tissue disorders | MedDRA 16.1 | Systematic Assessment |
| |
| Dermatitis allergic | Skin and subcutaneous tissue disorders | MedDRA 16.1 | Systematic Assessment |
| |
| Drug eruption | Skin and subcutaneous tissue disorders | MedDRA 16.1 | Systematic Assessment |
| |
| Eczema | Skin and subcutaneous tissue disorders | MedDRA 16.1 | Systematic Assessment |
| |
| Erythema nodosum | Skin and subcutaneous tissue disorders | MedDRA 16.1 | Systematic Assessment |
| |
| Erythrodermic psoriasis | Skin and subcutaneous tissue disorders | MedDRA 16.1 | Systematic Assessment |
| |
| Photodermatosis | Skin and subcutaneous tissue disorders | MedDRA 16.1 | Systematic Assessment |
| |
| Psoriasis | Skin and subcutaneous tissue disorders | MedDRA 16.1 | Systematic Assessment |
| |
| Seborrhoeic dermatitis | Skin and subcutaneous tissue disorders | MedDRA 16.1 | Systematic Assessment |
| |
| Stevens-johnson syndrome | Skin and subcutaneous tissue disorders | MedDRA 16.1 | Systematic Assessment |
| |
| Toxic skin eruption | Skin and subcutaneous tissue disorders | MedDRA 16.1 | Systematic Assessment |
| |
| Urticaria | Skin and subcutaneous tissue disorders | MedDRA 16.1 | Systematic Assessment |
| |
| Drug detoxification | Surgical and medical procedures | MedDRA 16.1 | Systematic Assessment |
| |
| Eyelid operation | Surgical and medical procedures | MedDRA 16.1 | Systematic Assessment |
| |
| Mammoplasty | Surgical and medical procedures | MedDRA 16.1 | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Lymphadenopathy | Blood and lymphatic system disorders | MedDRA 16.1 | Systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA 16.1 | Systematic Assessment |
| |
| Bronchitis | Infections and infestations | MedDRA 16.1 | Systematic Assessment |
| |
| Nasopharyngitis | Infections and infestations | MedDRA 16.1 | Systematic Assessment |
| |
| Pharyngitis | Infections and infestations | MedDRA 16.1 | Systematic Assessment |
| |
| Respiratory tract infection viral | Infections and infestations | MedDRA 16.1 | Systematic Assessment |
| |
| Upper respiratory tract infection | Infections and infestations | MedDRA 16.1 | Systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA 16.1 | Systematic Assessment |
| |
| Viral infection | Infections and infestations | MedDRA 16.1 | Systematic Assessment |
| |
| Fall | Injury, poisoning and procedural complications | MedDRA 16.1 | Systematic Assessment |
| |
| Alanine aminotransferase increased | Investigations | MedDRA 16.1 | Systematic Assessment |
| |
| Aspartate aminotransferase increased | Investigations | MedDRA 16.1 | Systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA 16.1 | Systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA 16.1 | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA 16.1 | Systematic Assessment |
| |
| Multiple sclerosis relapse | Nervous system disorders | MedDRA 16.1 | Systematic Assessment |
| |
| Dermatitis allergic | Skin and subcutaneous tissue disorders | MedDRA 16.1 | Systematic Assessment |
| |
| Rash | Skin and subcutaneous tissue disorders | MedDRA 16.1 | Systematic Assessment |
|
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.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Biogen Study Medical Director | Biogen | 866-633-4636 | clinicaltrials@biogen.com |
| ID | Term |
|---|---|
| D020529 | Multiple Sclerosis, Relapsing-Remitting |
| D009103 | Multiple Sclerosis |
| ID | Term |
|---|---|
| D020278 | Demyelinating Autoimmune Diseases, CNS |
| D020274 | Autoimmune Diseases of the Nervous System |
| D009422 | Nervous System Diseases |
| D003711 | Demyelinating Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D000077561 | Daclizumab |
| C000598527 | daclizumab HYP |
| ID | Term |
|---|---|
| D061067 | Antibodies, Monoclonal, Humanized |
| D000911 | Antibodies, Monoclonal |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
| D007162 | Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |
Not provided
Not provided
| Title | Measurements |
|---|---|
|
| Participants withdrawing from study due to AE |
|
|
|
|
|
|
|
| Title | Denominators | Categories | ||||
|---|---|---|---|---|---|---|
|
|
|
|
|
|
|
|
|
|