Relapsing-remitting Multiple Sclerosis MedDRA version: 19.0 Level: PT Classification code 10063399 Term: Relapsing-remitting multiple sclerosis System Organ Class: 10029205 - Nervous system disorders
Conditions
Interventions
Product Name: Daclizumab High Yield Process
Product Code: BIIB019
Pharmaceutical Form: Solution for injection
INN or Proposed INN: Daclizumab
Current Sponsor code: BIIB019
Other descriptive name: Dacl
Sponsors
Biogen Idec Ltd.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Ability to understand the purpose and risks of the study and provide signed and dated informed consent and authorization to use PHI in accordance with national and local subject privacy regulations. 2. Must be a subject from Study 205MS202 who completed at least 52 weeks and must have been compliant with the 205MS202 protocol in the opinion of the Investigator. 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. Autoinjector PK Substudy Inclusion Criteria: To be eligible for enrollment into the autoinjector substudy, subjects must also meet the following eligibility criteria at the time of randomization into the substudy: 4. Ability to understand the purpose and risks of the substudy and provide signed and dated informed consent. 5. Must have received at least 6 consecutive monthly doses of 150 mg DAC HYP in Study 205MS203. Note: Subjects are allowed to receive both vialed material and PFS material prior to randomization. 6. Must have a Body Mass Index within the range 18 to 32 kg/m2, inclusive. Inclusion criteria for the 2013-2014 Influenza Vaccine Substudy: 1. Subjects must provide specific informed consent for the 2013-2014 Influenza Vaccine Substudy 2. Subjects must have completed at least 3 months of uninterrupted therapy with DAC HYP prior to entering the 2013-2014 Influenza Vaccine Substudy 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 450 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 1. Subjects with any significant change in their medical status from the previous study 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 the 205MS201 or 205MS202 studies. The Investigator must re review the subject's medical fitness for participation and must consider any diseases that would preclude treatment. 2. Any subject who has permanently discontinued study treatment in Study 205MS202 due to an AE. 3. Current enrollment in any investigational drug study other than 205MS202. 4. Ongoing treatment with any approved or experimental diseasemodifying treatment for MS. 5.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 may use an alternative medication allowed by the protocol as needed. Note: Subjects who have been taking 1 of these medications at a stable dose for at least 6 consecutive months prior to study entry may continue to receive the medication without alteration and are eligible for study participation. 6. 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 prior to initiation of study treatment in this study. 7. 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. Autoinjector PK Substudy Exclusion Criteria: Subjects will be excluded from enrollment into the autoinjector substudy if any of the following exclusion criteria exist at the time of randomization into the substudy: 8. Any clinically significant adverse event, in the opinion of the Investigator, that is ongoing at the time of randomization. 9. ALT or AST greater than the upper limit of normal (>ULN). Testing must have been performed within 30 days prior to randomization. 10. Unwillingness or inability to comply with the requirements of the substudy. Exclusion Criteria for the 2013-2014 Influenza Vaccine Substudy: 1. Subject has had a severe allergic reaction (e.g., anaphylaxis) to eggs, egg proteins (a vaccine component), or any other component of the trivalent seasonal influenza vaccine. 2. Subject has had a serious reaction to previous influenza vaccination. 3. Subject has a known latex allergy. 4. Subject was previously vaccinated for the 2013-2014 influenza season strain. 5. Subject had a respiratory illness in the 2 weeks preceding the planned vaccination with the 2013-2014 trivalent seasonal influenza vaccine. 6. Subj
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To assess the safety of extended treatment with DAC HYP monotherapy in subjects with RRMS.;Secondary Objective: To assess the long-term immunogenicity of DAC HYP and to assess the durability of response to DAC HYP in preventing MS relapse, slowing disability progression, and reducing new MS lesion formation in this study population.;Primary end point(s): The primary endpoints of the study are AEs, including SAEs, discontinuation of DAC HYP due to AEs, and withdrawals due to AEs. The primary endpoint for the autoinjector PK substudy is: Daclizumab area-under-the-curve over the dosing interval (AUC0-) after substudy Dose 4;Timepoint(s) of evaluation of this end point: Clinical Adverse Events: All treatment-emergent events during 205MS203 will be included in the evaluation of safety. Treatment emergent includes any event that either occurs or worsens in severity after the onset of study treatment in 205MS203. Clinical Adverse Events over Time: In order to assess whether the incidence of events changes over time, the incidence will also be summarized by time period. Autoinjector PK Substudy: After the first and fourth injection in the substudy at the following timepoints: Pre-dose (30 minutes before the first injection) and post dose at 8hr, 24hr, 72 hr, 120 hr, 7 days, 10 days, 14 days, 21 days, and 28 days (prior to the next dose). | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): • Immunogenicity • Sustained disability progression defined by at least a 1.0-point increase on the 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 • Annual change in total number and volume of new or newly enlarging T2 hyperintense lesions, Gd-enhancing lesions, T1 hypointense lesions, and brain atrophy on brain MRI • Annualized Relapse Rate (ARR) Autoinjector PK Substudy: Additional daclizumab PK parameters for substudy Dose 4 including: o Observed maximum concentration (Cmax) o Time to reach maximum concentration (Tmax) o Observed minimum concentration (Cmin) Local tolerability as assessed by the following: o subject-reported injection site pain (visual analog scale [VAS]) o clinician injection site assessments ;Timepoint(s) of evaluation of this end point: Immunogenicity -at baseline, every 12 weeks through week 48, at week 96, at week 144, at week 192, at week 240, at week 288, at final study visit, at relapse assessment if applicable, and at early termination visit if applicable. EDSS- at baseline,EDSS- at baseline, every 24 weeks, and at early termination visit if applicable MRI - at baseline, week 48, 96, 192, 240, and 288. ARR- annually Autoinjector PK Substudy: Additional PK parameters: After fourth injection Injection site assessments: After first and fourth injections | — |
Countries
Czech Republic, Germany, Hungary, India, Russian Federation, Ukraine, United Kingdom
Contacts
Public ContactClinical trial information desk
Biogen Idec
Outcome results
None listed