Daclizumab HYP Extension Study for Subjects with Multiple Sclerosis WhoHave Completed 203MS301.
- Conditions
- Relapsing-remitting Multiple SclerosisMedDRA version: 14.1Level: PTClassification code 10063399Term: Relapsing-remitting multiple sclerosisSystem Organ Class: 10029205 - Nervous system disordersTherapeutic area: Diseases [C] - Nervous System Diseases [C10]
- Registration Number
- EUCTR2012-003176-39-IT
- Lead Sponsor
- BIOGEN IDEC RESEARCH LTD
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 1841
1. 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. 2. Must be a subject currently participating in Study 205MS301 who has completed either the Week 144 Visit or the End of Study Visit (Week 96). Note: Subjects who are not able to enroll into 205MS303 at the time of their Week 144/End of Study Visit may be eligible to enroll into 205MS303 at a later time if they are still participating in the 6-month follow-up period of 205MS301 at the time of expected rollover into 205MS303. 3. 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.
Are the trial subjects under 18? no
Number of subjects for this age range: 0
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 1841
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range
Medical History 1. Any subject who permanently discontinued study treatment in Study 205MS301 prior to the end of the study treatment period, or had an Early Termination visit in Study 205MS301. Note: Subjects for whom dosing was temporarily suspended in Study 205MS301 are not excluded from participation in this extension study if the criteria for resuming DAC HYP treatment under the Study 205MS301 protocol have been met at the time of enrollment into Study 205MS303. 2. Any significant change in the subject's medical history that would preclude administration of DAC HYP, including laboratory tests or a current clinically significant condition that, in the opinion of the Investigator, would have excluded the subject's participation in Study 205MS301. The Investigator must re review the subject's medical fitness for participation and consider any factors that would preclude treatment in Study 205MS303, including: • History of any significant cardiac, endocrine, hematological, hepatic, immunologic, metabolic, urologic, pulmonary, gastrointestinal, dermatologic, psychiatric, renal, neurological (other than MS), and/or other major disease (e.g., malignancy) that would preclude administration of DAC HYP. • Clinically significant laboratory abnormalities (hematology and blood chemistry) from the most recently available test in Study 205MS301, as determined by the Investigator. Laboratory findings mandating discontinuation of study treatment as defined in Protocol 205MS301 are exclusionary. 3. Any of the following abnormal blood tests within the 7 days prior to Day 1: • alanine aminotransferase/serum glutamate pyruvate transaminase (ALT/SGPT), aspartate aminotransferase/serum glutamic oxaloacetic transaminase (AST/SGOT), or gamma-glutamyl-transferase (GGT) >3x the upper limit of normal (ULN) Note: Subjects ending 205MS301 on a treatment suspension may not enroll into 205MS303 until ALT/SGPT and AST/SGOT are minor or = 2x ULN. • total bilirubin >2x ULN (subjects with an established diagnosis of Gilbert's syndrome are excluded if total bilirubin is >2.5x ULN) Note: Subjects ending 205MS301 on a treatment suspension may not enroll into 205MS303 until total bilirubin minor or =1x ULN (subjects with an established diagnosis of Gilbert's syndrome may not enroll into 205MS303 until total bilirubin is minor or = 1.5x ULN). 4. Other medical reasons that, in the opinion of the Investigator and/or Biogen Idec, make the subject unsuitable for enrollment. Treatment History 5. Treatment with any prohibited concomitant medication during Study 205MS301. Note: Subjects who start an approved, open-label IFN ß preparation after completion of dosing in Study 205MS301 are not excluded, but IFN ß treatment must be discontinued before the first dose of DAC HYP in Study 205MS303 is given. Miscellaneous 6. Female subjects who are currently pregnant or breastfeeding, or considering becoming pregnant while in the study. 7. Previous participation in Study 205MS303. 8. History of drug or alcohol abuse (as defined by the Investigator) at any time after the start of Study 205MS301. 9. Unwillingness or inability to comply with the requirements of the protocol, including the presence of any condition (physical, mental, or social) that is likely to affect the subject's ability to comply with the protocol.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: The primary objective of the study is to assess the safety and tolerability of long-term treatment with DAC HYP monotherapy in subjects who completed Study 205MS301.;Secondary Objective: • To assess the long-term immunogenicity of DAC HYP administered by PFS • To describe MS-related outcomes, including MS relapse, disability progression, MS lesion formation, and patient-reported impact of MS, following long-term treatment with DAC HYP • To assess the safety, tolerability, and efficacy of switching to DAC HYP in subjects previously on long-term treatment with interferon ß 1a in Study 205MS301 • To evaluate PD parameters that may be associated with treatment response.;Primary end point(s): Primary End Points include incidence of AEs including serious AEs (SAEs), discontinuation of DAC HYP due to AEs, and withdrawals due to AEs;Timepoint(s) of evaluation of this end point: As necessary
- Secondary Outcome Measures
Name Time Method