Relapsing-Remitting Multiple SclerosisPhase 2SELECTIONNCT00870740
Safety and Efficacy Extension Study of Daclizumab High Yield Process (DAC HYP) in Participants With Multiple Sclerosis Who Have Completed Study 205MS201 (NCT00390221) to Treat Relapsing-Remitting Multiple Sclerosis
A Phase 2 study testing BIIB019 (Daclizumab High Yield Process) in people with Relapsing-Remitting Multiple Sclerosis, run by Biogen at 58 sites in 8 countries.
Trial summary
The primary objective of the study was to assess the safety and immunogenicity of extended treatment with DAC HYP. This evaluation included the following major components: An assessment of safety and immunogenicity of extended treatment with DAC HYP when administered to MS subjects who had completed 52 weeks of active… Read more about this study
- Who is it for?
- Ages 18 to 55 years
- Conditions the study is for
- Relapsing-Remitting Multiple Sclerosis
- What is being tested?
- BIIB019 (Daclizumab High Yield Process)
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 517 participants
- Where
- 58 sitesin 8 countries
- Study dates
- Feb 2009to Oct 2012
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 55 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Participated in Study 205MS201 (NCT00390221) for at least 52 weeks and was compliant with the 205MS201 protocol in the opinion of the Investigator.
Who cannot join
- Subjects with any significant change in their medical status from 205MS201 that would preclude administration of DAC HYP, as determined by the Investigator
- Any subject who has permanently discontinued study treatment in Study 205MS201 except subjects who were unblinded during evaluation of an adverse event (AE) and found to be on placebo
- Planned ongoing treatment with any approved or experimental treatment for MS except for the protocol-allowed use of concomitant interferon-beta
- NOTE: Other protocol defined Inclusion/Exclusion criteria may apply.
Trial locations and contacts
58 sites in 8 countries.
58 sites in 8 countries
Russia11 sites
Research Site
Kazan'
Research Site
Krasnoyarsk
Research Site
Moscow
Research Site
Nizhny Novgorod
Research Site
Novosibirsk
Research Site
Omsk
Research Site
Saint Petersburg
Research Site
Samara
Research Site
Smolensk
Research Site
Ufa
Research Site
Yaroskavl
Hungary9 sites
Research Site
Budapest
Research Site
Debrecen
Research Site
Esztergom
Research Site
Győr
Research Site
Kecskemét
Research Site
Miskolc
Research Site
Nyíregyháza
Research Site
Siófok
Research Site
Zalaegerszeg
Ukraine8 sites
Research Site
Chernivtsi
Research Site
Dnipropetrovsk
Research Site
Donetsk
Research Site
Kharkiv
Research Site
Kiev
Research Site
Lviv
Research Site
Poltava
Research Site
Zaporizhzhya
Poland7 sites
Research Site
Bialystok
Research Site
Gdansk
Research Site
Katowice
Research Site
Krakow
Research Site
Lodz
Research Site
Lublin
Research Site
Warsaw
Czechia6 sites
Research Site
Brno
Research Site
Hraddec Kralove
Research Site
Olomouc
Research Site
Pilsen
Research Site
Prague
Research Site
Teplice
Germany6 sites
Research Site
Bayreuth
Research Site
Erlangen
Research Site
Marburg
Research Site
Osnabrück
Research Site
Regensburg
Research Site
Rostock
India6 sites
Research Site
Andra-Pradeash
Research Site
Bangalore
Research Site
Jaipur
Research Site
Kolkata
Research Site
Mumbai
Research Site
Visakhapatnam
United Kingdom5 sites
Research Site
Devon
Research Site
London
Research Site
Nottingham
Research Site
Sheffield
Research Site
Stoke-on-Trent
About this study
Official title: A Double-Blind, Multicenter, Extension Study to Evaluate the Safety and Efficacy of DAC HYP in Subjects With Multiple Sclerosis Who Have Completed Treatment in Study 205MS201 (SELECT)
The primary objective of the study was to assess the safety and immunogenicity of extended treatment with DAC HYP. This evaluation included the following major components:
- An assessment of safety and immunogenicity of extended treatment with DAC HYP when administered to MS subjects who had completed 52 weeks of active therapy with DAC HYP in Study 201.
- An assessment of safety and immunogenicity during a 6-month washout period from DAC HYP.
- An assessment of safety and immunogenicity during reinitiation of therapy with DAC HYP after a 6-month washout period.
- An assessment of safety and immunogenicity of DAC HYP when administered to MS subjects who previously received placebo during Study 201.
The secondary objective is to assess the durability of the effect of DAC HYP on multiple sclerosis (MS) disease activity as measured by brain magnetic resonance imaging (MRI) scans and clinical MS relapses.
Read the detailed description
This study, an extension to Study 205MS201 (NCT00390221), will evaluate the long-term safety, efficacy, and immunogenicity of DAC HYP in MS. In Study 205MS201, study treatment was scheduled to stop at the Week 52 visit. This extension study will provide for the initiation of active therapy with DAC HYP among participants who received placebo during Weeks 0 through 52 in 205MS201. In addition, participants who received active therapy with DAC HYP during Weeks 0 through 52 in Study 205MS201 will continue DAC HYP therapy or resume DAC HYP therapy after a 6-month washout period in this study.
- Conditions
- Relapsing-Remitting Multiple Sclerosis
- Being tested
- BIIB019 (Daclizumab High Yield Process), Placebo
- Keywords
- MS, Multiple Sclerosis
- Medical subject headings
- Multiple Sclerosis, Relapsing-Remitting, Multiple Sclerosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BIIB019 (Daclizumab High Yield Process)Biological
Also called Daclizumab HYP, DAC HYP
SC injection
PlaceboDrug
Placebo SC injection
| Study group | Role | What they receive |
|---|---|---|
| Group 1: DAC HYP 150 mg | Experimental | Participants who received placebo in 205MS201 receive DAC HYP 150 mg subcutaneous (SC) injection every 4 weeks for a total of 13 doses. Receives: Biological: BIIB019 (Daclizumab High Yield Process) |
| Group 1: DAC HYP 300 mg | Experimental | Participants who received placebo in 205MS201 receive DAC HYP 300 mg SC injection every 4 weeks for a total of 13 doses. Receives: Biological: BIIB019 (Daclizumab High Yield Process) |
| Group 2: Washout then DAC HYP 150 mg | Experimental | Participants who received DAC HYP 150 mg SC injection in 205MS201 undergo a washout period (placebo SC every 4 weeks for a total of 5 doses) and then receive DAC HYP 150 mg SC every 4 weeks for a total of 8 doses. Receives: Biological: BIIB019 (Daclizumab High Yield Process); Drug: Placebo |
| Group 2: DAC HYP 150 mg | Experimental | Participants who received DAC HYP 150 mg SC injection in 205MS201 receive DAC HYP 150 mg SC every 4 weeks for a total of 13 doses. Receives: Biological: BIIB019 (Daclizumab High Yield Process) |
| Group 3: Washout then DAC HYP 300 mg | Experimental | Participants who received DAC HYP 300 mg SC in 205MS201 undergo a washout period (placebo SC every 4 weeks for a total of 5 doses) and then receive DAC HYP 300 mg SC every 4 weeks for a total of 8 doses. Receives: Biological: BIIB019 (Daclizumab High Yield Process); Drug: Placebo |
| Group 3: DAC HYP 300 mg | Experimental | Participants who received DAC HYP 300 mg SC in 205MS201 receive DAC HYP 300 mg SC every 4 weeks for a total of 13 doses. Receives: Biological: BIIB019 (Daclizumab High Yield Process) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants With Treatment-emergent Adverse Events (AEs)
Treatment-emergent AE: any untoward medical occurrence after the first dose of study treatment that did not necessarily have a causal relationship with this treatment. Serious AE (SAE): any untoward medical occurrence that at any dose: resulted in death; in the view of the Investigator, placed the subject at immediate risk of death (a life-threatening event); required inpatient hospitalization or prolongation of existing hospitalization; resulted in persistent or significant disability/incapacity; resulted in a congenital anomaly/birth defect. An SAE could also have been a medically significant event that, in the opinion of the Investigator, jeopardized the subject or required intervention to prevent one of the other outcomes listed in the definition above.
Measured: Up to 72 weeks
Number of Participants With Abnormalities in Vital Signs
For participants who took DAC HYP during 205MS201 (NCT00390221) the baseline is defined as the baseline from 205MS201, and for participants who took placebo during 205MS201 the baseline is defined as the baseline from 205MS202 (NCT00870740). All post-baseline data are taken after first dose in 205MS202 only. SBP=systolic blood pressure; DBP=diastolic blood pressure; bpm=beats per minute; ↑ BL=increase from baseline; ↓ BL=decrease from baseline.
Measured: Up to Week 72
Number of Participants With Potentially Clinically Significant Hematology Laboratory Abnormalities
Hematology parameters evaluated include: white blood cells, lymphocytes, neutrophils, red blood cells (RBC), hemoglobin, and platelets.
Measured: Up to 72 Weeks
Number of Participants With Abnormalities in Blood Chemistry Laboratory Data
For each abnormality a subject can be counted once. If a subject has more than one occurrence of the same abnormality the highest toxicity grade is counted. ALT=alanine aminotransferase; AST=aspartate aminotransferase; ALP=alkaline phosphatase; GGT=gamma-glutamyl transferase; TSH=thyroid stimulating hormone, ULN=upper limit of normal.
Measured: Up to 72 Weeks
Number of Participants With Development of Anti-DAC Antibodies (ADAb) and Neutralizing Antibodies (NAb) Post-baseline
Number of participants positive and negative for ADAb and NAb, based on all post-baseline immunogenicity assessments during treatment period and follow-up. Participants are stratified differently in this Outcome Measure as per the pre-specified statistical analysis plan.
Measured: Up to 72 weeks
Secondary outcomes (8)
Adjusted Annualized Relapse Rate
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 Independent Neurology Evaluation Committee (INEC). Relapse rate is calculated as: (Total number of relapses that occurred during the 205MS202 [NCT00870740] treatment phase divided by the total number of days followed in the treatment phase for 205MS202), multiplied by 365 days. Participants who received an alternative multiple sclerosis (MS) medication during 205MS201 (NCT00390221; Year 1) are not included in the summary of relapses and relapse rate for this study (Year 2). Participants are stratified differently in this Outcome Measure as per the pre-specified statistical analysis plan.
Measured: Up to 72 weeks
Estimated Proportion of Participants With a Relapse
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 INEC. Estimated using Kaplan-Meier analysis where time to first relapse is calculated from date of first dose in the study to date of first confirmed relapse. Participants who received an alternative MS medication before the first relapse were censored at the time of taking the alternative MS medication.
Measured: Up to 72 weeks
Mean Number of New Gadolinium-enhancing Lesions
Evaluated by magnetic resonance imaging (MRI) by a central reader. Number of new Gd lesions since the previous scan (the previous scan for Week 20 was Week 52 of study 205MS201 [NCT00390221]). The number of Gd lesions may be imputed using last observation carried forward or using the mean value across all subjects within the treatment group. Baseline visits are not imputed. Participants are stratified differently in this Outcome Measure as per the pre-specified statistical analysis plan.
Measured: Week 20, Week 52
Mean Number of New or Newly-enlarging T2 Hyperintense Lesions
Lesions detected on T2-weighted sequences represent a range of histopathology related to MS, including edema, inflammation, demyelination, gliosis, and axon loss. Evaluated by MRI by a central reader. New or newly enlarging T2 lesions since baseline of study 205MS202 (NCT00870740). For post-baseline visits, the number of T2 lesions may be imputed using the mean value across all participants within the treatment group, if the participant has non-missing baseline data. Baseline visits are not imputed. Participants are stratified differently in this Outcome Measure as per the pre-specified statistical analysis plan.
Measured: Baseline, Week 20, Week 52
Mean Volume of New T1 Hypointense Lesions
T1-weighted scans detect areas of hypointensity that represent a greater degree of tissue destruction and axon loss than T2 hyperintense lesions and are more highly correlated with clinical disability measures and neurological deficit. Evaluated by MRI by a central reader. Baseline is volume of new T1 hypointense lesions since baseline in study 205MS201 (NCT00390221). Scans at Week 20 and Week 52 in 205MS202 are relative to baseline in 205MS202 (NCT00870740). For post-baseline visits, the total volume of T1 lesions may be imputed using the mean value across all subjects within the treatment group. Baseline visits are not imputed.
Measured: Baseline, Week 20, Week 52
Mean Percentage Change From Baseline in Total Lesion Volume of T2 Hyperintense Lesions
Lesions detected on T2-weighted sequences represent a range of histopathology related to MS, including edema, inflammation, demyelination, gliosis, and axon loss. Evaluated by MRI by a central reader. Baseline values = baseline for study 205MS202 (NCT00870740). For post-baseline visits, the total volume of T2 lesions may be imputed using the mean value across all subjects within the treatment group. Baseline visits are not imputed.
Measured: Baseline, Week 52
Mean Percentage Change From Baseline in Total Volume of Non-gadolinium (Gd)-Enhancing T1 Hypointense Lesions
T1-weighted scans detect areas of hypointensity that represent a greater degree of tissue destruction and axon loss than T2 hyperintense lesions and are more highly correlated with clinical disability measures and neurological deficit. Evaluated by MRI by a central reader. Baseline values = baseline for study 205MS202 (NCT00870740). For post-baseline visits, the total volume of T1 lesions may be imputed using the mean value across all participants within the treatment group. Baseline visits are not imputed.
Measured: Baseline, Week 52
Rate of Percentage Change From Baseline in Mean Total Brain Volume
Total brain volume was measured by MRI and analyzed by a central reader. Rate of percentage change from baseline calculated using an analysis of covariance adjusting for baseline normalized brain volume. Baseline values = baseline for study 205MS202 (NCT00870740). Missing values post-baseline were imputed using the average value across subjects in the treatment group.
Measured: Baseline, Week 52
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Mar 2009 (estimated)
- Study startFeb 2009
- Primary completionMay 2012
- Study completionOct 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Relapsing-Remitting Multiple SclerosisStudies of the same condition, open and under way.
- More trials run by BiogenThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 517 participants (actual)
Sponsor and investigators
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00870740
- Sponsor's protocol ID
- 205-MS-202
- Other IDs
- EUDRA CT No.: 2008-005559-46
- Acronym
- SELECTION
- Status last verified
- Jul 2016
- First submitted
- 26 Mar 2009
- Last updated
- 30 Aug 2016
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Publications
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.
PubMed 27411694Giovannoni G, Gold R, Selmaj K, Havrdova E, Montalban X, Radue EW, Stefoski D, McNeill M, Amaravadi L, Sweetser M, Elkins J, O'Neill G; SELECTION Study Investigators. Daclizumab high-yield process in relapsing-remitting multiple sclerosis (SELECTION): a multicentre, randomised, double-blind extension trial. Lancet Neurol. 2014 May;13(5):472-81. doi: 10.1016/S1474-4422(14)70039-0. Epub 2014 Mar 19.
PubMed 24656609
Study at a glance
From the registry record, last updated by the sponsor on 30 Aug 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Double-Blind, Multicenter, Extension Study to Evaluate the Safety and Efficacy of DAC HYP in Subjects With Multiple Sclerosis Who Have Completed Treatment in Study 205MS201 (SELECT)
- ClinicalTrials.gov ID
- NCT00870740
- Acronym / sponsor ID
- SELECTION / 205-MS-202
- Conditions
- Relapsing-Remitting Multiple Sclerosis
- Keywords
- MS, Multiple Sclerosis
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 517 participants (actual)
- Lead sponsor
- BiogenIndustry (pharma, biotech, devices)
- Collaborators
- AbbVie
- Study start
- Feb 2009
- Primary completion
- May 2012 (actual)
- Study completion
- Oct 2012 (actual)
- First posted
- 27 Mar 2009 (estimated)
- Results
- Posted 30 Aug 2016
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The primary objective of the study was to assess the safety and immunogenicity of extended treatment with DAC HYP. This evaluation included the following major components:
- An assessment of safety and immunogenicity of extended treatment with DAC HYP when administered to MS subjects who had completed 52 weeks of active therapy with DAC HYP in Study 201.
- An assessment of safety and immunogenicity during a 6-month washout period from DAC HYP.
- An assessment of safety and immunogenicity during reinitiation of therapy with DAC HYP after a 6-month washout period.
- An assessment of safety and immunogenicity of DAC HYP when administered to MS subjects who previously received placebo during Study 201.
The secondary objective is to assess the durability of the effect of DAC HYP on multiple sclerosis (MS) disease activity as measured by brain magnetic resonance imaging (MRI) scans and clinical MS relapses.
Detailed description
This study, an extension to Study 205MS201 (NCT00390221), will evaluate the long-term safety, efficacy, and immunogenicity of DAC HYP in MS. In Study 205MS201, study treatment was scheduled to stop at the Week 52 visit. This extension study will provide for the initiation of active therapy with DAC HYP among participants who received placebo during Weeks 0 through 52 in 205MS201. In addition, participants who received active therapy with DAC HYP during Weeks 0 through 52 in Study 205MS201 will continue DAC HYP therapy or resume DAC HYP therapy after a 6-month washout period in this study.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| Group 1: DAC HYP 150 mg | Experimental | Biological: BIIB019 (Daclizumab High Yield Process)Participants who received placebo in 205MS201 receive DAC HYP 150 mg subcutaneous (SC) injection every 4 weeks for a total of 13 doses. |
| Group 1: DAC HYP 300 mg | Experimental | Biological: BIIB019 (Daclizumab High Yield Process)Participants who received placebo in 205MS201 receive DAC HYP 300 mg SC injection every 4 weeks for a total of 13 doses. |
| Group 2: Washout then DAC HYP 150 mg | Experimental | Biological: BIIB019 (Daclizumab High Yield Process), Drug: PlaceboParticipants who received DAC HYP 150 mg SC injection in 205MS201 undergo a washout period (placebo SC every 4 weeks for a total of 5 doses) and then receive DAC HYP 150 mg SC every 4 weeks for a total of 8 doses. |
| Group 2: DAC HYP 150 mg | Experimental | Biological: BIIB019 (Daclizumab High Yield Process)Participants who received DAC HYP 150 mg SC injection in 205MS201 receive DAC HYP 150 mg SC every 4 weeks for a total of 13 doses. |
| Group 3: Washout then DAC HYP 300 mg | Experimental | Biological: BIIB019 (Daclizumab High Yield Process), Drug: PlaceboParticipants who received DAC HYP 300 mg SC in 205MS201 undergo a washout period (placebo SC every 4 weeks for a total of 5 doses) and then receive DAC HYP 300 mg SC every 4 weeks for a total of 8 doses. |
| Group 3: DAC HYP 300 mg | Experimental | Biological: BIIB019 (Daclizumab High Yield Process)Participants who received DAC HYP 300 mg SC in 205MS201 receive DAC HYP 300 mg SC every 4 weeks for a total of 13 doses. |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Participated in Study 205MS201 (NCT00390221) for at least 52 weeks and was compliant with the 205MS201 protocol in the opinion of the Investigator.
Key exclusion criteria (4 listed)
- Subjects with any significant change in their medical status from 205MS201 that would preclude administration of DAC HYP, as determined by the Investigator
- Any subject who has permanently discontinued study treatment in Study 205MS201 except subjects who were unblinded during evaluation of an adverse event (AE) and found to be on placebo
- Planned ongoing treatment with any approved or experimental treatment for MS except for the protocol-allowed use of concomitant interferon-beta
- NOTE: Other protocol defined Inclusion/Exclusion criteria may apply.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| BIIB019 (Daclizumab High Yield Process)Also: Daclizumab HYP, DAC HYPSC injection | Biological | Group 1: DAC HYP 150 mg, Group 1: DAC HYP 300 mg, Group 2: DAC HYP 150 mg, Group 2: Washout then DAC HYP 150 mg, Group 3: DAC HYP 300 mg, Group 3: Washout then DAC HYP 300 mg |
| PlaceboPlacebo SC injection | Drug | Group 2: Washout then DAC HYP 150 mg, Group 3: Washout then DAC HYP 300 mg |
Primary outcome
Number of Participants With Treatment-emergent Adverse Events (AEs)
Time frame: Up to 72 weeks
Treatment-emergent AE: any untoward medical occurrence after the first dose of study treatment that did not necessarily have a causal relationship with this treatment. Serious AE (SAE): any untoward medical occurrence that at any dose: resulted in death; in the view of the Investigator, placed the subject at immediate risk of death (a life-threatening event); required inpatient hospitalization or prolongation of existing hospitalization; resulted in persistent or significant disability/incapacity; resulted in a congenital anomaly/birth defect. An SAE could also have been a medically significant event that, in the opinion of the Investigator, jeopardized the subject or required intervention to prevent one of the other outcomes listed in the definition above.
Number of Participants With Abnormalities in Vital Signs
Time frame: Up to Week 72
For participants who took DAC HYP during 205MS201 (NCT00390221) the baseline is defined as the baseline from 205MS201, and for participants who took placebo during 205MS201 the baseline is defined as the baseline from 205MS202 (NCT00870740). All post-baseline data are taken after first dose in 205MS202 only. SBP=systolic blood pressure; DBP=diastolic blood pressure; bpm=beats per minute; ↑ BL=increase from baseline; ↓ BL=decrease from baseline.
Number of Participants With Potentially Clinically Significant Hematology Laboratory Abnormalities
Time frame: Up to 72 Weeks
Hematology parameters evaluated include: white blood cells, lymphocytes, neutrophils, red blood cells (RBC), hemoglobin, and platelets.
Number of Participants With Abnormalities in Blood Chemistry Laboratory Data
Time frame: Up to 72 Weeks
For each abnormality a subject can be counted once. If a subject has more than one occurrence of the same abnormality the highest toxicity grade is counted. ALT=alanine aminotransferase; AST=aspartate aminotransferase; ALP=alkaline phosphatase; GGT=gamma-glutamyl transferase; TSH=thyroid stimulating hormone, ULN=upper limit of normal.
Number of Participants With Development of Anti-DAC Antibodies (ADAb) and Neutralizing Antibodies (NAb) Post-baseline
Time frame: Up to 72 weeks
Number of participants positive and negative for ADAb and NAb, based on all post-baseline immunogenicity assessments during treatment period and follow-up. Participants are stratified differently in this Outcome Measure as per the pre-specified statistical analysis plan.
8 secondary outcomes
Adjusted Annualized Relapse Rate
Time frame: Up to 72 weeks
Estimated Proportion of Participants With a Relapse
Time frame: Up to 72 weeks
Mean Number of New Gadolinium-enhancing Lesions
Time frame: Week 20, Week 52
Mean Number of New or Newly-enlarging T2 Hyperintense Lesions
Time frame: Baseline, Week 20, Week 52
Mean Volume of New T1 Hypointense Lesions
Time frame: Baseline, Week 20, Week 52
Mean Percentage Change From Baseline in Total Lesion Volume of T2 Hyperintense Lesions
Time frame: Baseline, Week 52
Mean Percentage Change From Baseline in Total Volume of Non-gadolinium (Gd)-Enhancing T1 Hypointense Lesions
Time frame: Baseline, Week 52
Rate of Percentage Change From Baseline in Mean Total Brain Volume
Time frame: Baseline, Week 52
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Aug 2016.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 27411694Gold 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.
- Derived from this study: PubMed 24656609Giovannoni G, Gold R, Selmaj K, Havrdova E, Montalban X, Radue EW, Stefoski D, McNeill M, Amaravadi L, Sweetser M, Elkins J, O'Neill G; SELECTION Study Investigators. Daclizumab high-yield process in relapsing-remitting multiple sclerosis (SELECTION): a multicentre, randomised, double-blind extension trial. Lancet Neurol. 2014 May;13(5):472-81. doi: 10.1016/S1474-4422(14)70039-0. Epub 2014 Mar 19.
- The website of the National Multiple Sclerosis Society, an organization dedicated to providing information to individuals with MS, their families and healthcare providers.Link provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Medical Director study director
Biogen
58 sites in 8 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing BIIB019 (Daclizumab High Yield Process) in people with Relapsing-Remitting Multiple Sclerosis, run by Biogen at 58 sites in 8 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 Aug 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 58 sites in Russia, Hungary, Ukraine, Poland, Czechia and 3 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 30 Aug 2016). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants With Treatment-emergent Adverse Events (AEs) (time frame: Up to 72 weeks). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00870740, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Aug 2016; AzTrials last refreshed its copy on 6 Nov 2026.