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Safety and Efficacy Extension Study of Daclizumab High Yield Process (DAC HYP) (BIIB019) in Participants Who Have Completed Study 205MS202 (NCT00870740) to Treat Relapsing Remitting Multiple Sclerosis (SELECTED)

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ClinicalTrials.gov Identifier: NCT01051349
Recruitment Status : Completed
First Posted : January 18, 2010
Results First Posted : November 9, 2018
Last Update Posted : November 9, 2018
Sponsor:
Collaborator:
AbbVie
Information provided by (Responsible Party):
Biogen

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Relapsing-Remitting Multiple Sclerosis Biological: BIIB019 (Daclizumab) Biological: trivalent seasonal influenza vaccine Phase 2

Detailed Description:
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,

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 410 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Multicenter, Open-label, Extension Study to Evaluate the Long Term Safety and Efficacy of Daclizumab High Yield Process (DAC HYP) Monotherapy in Subjects With Multiple Sclerosis Who Have Completed Treatment in Study 205MS202 (SELECTION)
Actual Study Start Date : March 31, 2010
Actual Primary Completion Date : August 25, 2016
Actual Study Completion Date : August 25, 2016

Resource links provided by the National Library of Medicine

Drug Information available for: Daclizumab

Arm Intervention/treatment
Experimental: BIIB019
Participants received BIIB019, 150 mg subcutaneous injection every 4 weeks up to Week 288.
Biological: BIIB019 (Daclizumab)
Administered as specified in the treatment arm.
Other Names:
  • Daclizumab High Yield Process
  • DAC HYP

Biological: trivalent seasonal influenza vaccine
All participants who participate in the 2013-2014 influenza vaccine substudy will receive the vaccine at the study site




Primary Outcome Measures :
  1. Number of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs), Discontinuation Due to AEs, Withdrawals Due to AEs [ Time Frame: Baseline up to 24 weeks after last dose of treatment (Up to 300 weeks) ]
    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.

  2. Area Under the Concentration-Time Curve Over the Dosing Interval (AUC0-t) After Dose 4 for Daclizumab [ Time Frame: 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 Outcome Measures :
  1. Number of Participants With New or Newly Enlarging T2 Hyperintense Lesions Compared to Baseline [ Time Frame: From Baseline through 288 weeks ]
    New or newly enlarging T2 hyperintense lesions evaluated by magnetic resonance imaging (MRI) and analyzed by a central reader.

  2. Annual Change in Volume of New or Newly Enlarging T2 Hyperintense Lesions Compared to Baseline [ Time Frame: From Baseline through 288 weeks ]
    New or newly enlarging T2 hyperintense lesions evaluated by MRI and analyzed by a central reader.

  3. Number of Participants With Total Number of New Gadolinium-enhancing Lesions [ Time Frame: From Baseline through 288 weeks ]
    New Gadolinium-enhancing lesions was evaluated by MRI and analyzed by a central reader.

  4. Annual Change in Number of T1 Hypointense Lesions [ Time Frame: From Baseline through 288 weeks ]
  5. Annual Change in Volume of New Gadolinium-Enhancing Lesions [ Time Frame: From Baseline through 288 weeks ]
  6. Annual Change in Volume of T1 Hypointense Lesions [ Time Frame: From Baseline through 288 weeks ]
    Volume of T1 hypointense lesions was evaluated by MRI and analyzed by a central reader.

  7. Percent Change in Total Brain Volume [ Time Frame: From Baseline through 288 weeks ]
    To assess brain atrophy, total brain volume was be measured by MRI and analyzed by a central reader.

  8. Number of Participants With Antibodies to DAC HYP [ Time Frame: Up to Week 288 ]
  9. Annualized Relapse Rate (ARR) [ Time Frame: Week 288 ]
    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.

  10. Number of Participants With Sustained Disability Progression for 12 Weeks [ Time Frame: Week 48 up to Week 288 ]
    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.

  11. Number of Participants With Sustained Disability Progression for 24 Weeks [ Time Frame: Week 48 up to Week 288 ]
    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.

  12. Observed Maximum Concentration (Cmax) After Dose 4 for Daclizumab [ Time Frame: 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 ]
  13. Time to Reach Maximum Concentration (Tmax) for Daclizumab After Dose 4 [ Time Frame: 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 ]
  14. Observed Minimum Concentration (Cmin) for Daclizumab After Dose 4 [ Time Frame: 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 ]
  15. Participant-Reported Pain Visual Analog Scale (VAS) Score [ Time Frame: First injection (Day 1) and fourth injection (Day 90) 0 hour, 30 minutes, 60 minutes and 8 hours post-dose ]
    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.

  16. Summary of Injection Site Assessment Performed by Clinician [ Time Frame: 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 ]

    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




Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Main Study Eligibility:

Key Inclusion Criteria:

  • Ability to understand the purpose and risks of the study and provide signed and dated informed consent and authorization to use protected health information (PHI) in accordance with national and local subject privacy regulations.
  • Subjects who have completed 52 weeks in Study 205MS202 (NCT00870740) and were compliant with the 205MS202 protocol in the opinion of the Investigator.
  • Women of childbearing potential must practice effective contraception during the study and be willing and able to continue contraception for 4 months after their last dose of study treatment.

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 treated with any of these agents for fewer than 6 months prior to study entry are excluded from study participation unless they discontinue the agent(s) prior to study entry.
    • Subjects treated with 2 or more of these agents for more than 6 months prior to study entry are excluded from study participation unless they reduce to ≤1 agent prior to study entry.
    • Subjects who have had dose escalations of one of these agents within the 6 months prior to study entry are excluded from study participation unless they revert to a previous dose that had been used for at least 6 months prior to study entry or unless they discontinue the agent prior to study entry
  • 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.


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01051349


  Show 65 Study Locations
Sponsors and Collaborators
Biogen
AbbVie
Investigators
Study Director: Medical Director Biogen

Additional Information:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Biogen
ClinicalTrials.gov Identifier: NCT01051349     History of Changes
Other Study ID Numbers: 205-MS-203
2009-015318-23 ( EudraCT Number )
First Posted: January 18, 2010    Key Record Dates
Results First Posted: November 9, 2018
Last Update Posted: November 9, 2018
Last Verified: April 2018

Keywords provided by Biogen:
MS
Multiple Sclerosis

Additional relevant MeSH terms:
Sclerosis
Multiple Sclerosis
Multiple Sclerosis, Relapsing-Remitting
Pathologic Processes
Demyelinating Autoimmune Diseases, CNS
Autoimmune Diseases of the Nervous System
Nervous System Diseases
Demyelinating Diseases
Autoimmune Diseases
Immune System Diseases
Vaccines
Daclizumab
Immunoglobulin G
Immunologic Factors
Physiological Effects of Drugs
Immunosuppressive Agents