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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register.
Register: ClinicalTrials.gov
Last refreshed on: 16 December 2017
Main ID:  NCT01462318
Date of registration: 14/07/2011
Prospective Registration: Yes
Primary sponsor: Biogen
Public title: An Open-Label Immunogenicity and Pharmacokinetics Study of Daclizumab High Yield Process Prefilled Syringe in Relapsing Remitting Multiple Sclerosis OBSERVE
Scientific title: A Multicenter, Single-Arm, Open-Label Study to Evaluate the Immunogenicity and Pharmacokinetics of BIIB019, Daclizumab High Yield Process (DAC HYP), Prefilled Syringe Administered by Subcutaneous Injection in Subjects With Relapsing-Remitting Multiple Sclerosis
Date of first enrolment: November 2011
Target sample size: 133
Recruitment status: Completed
URL:  https://clinicaltrials.gov/show/NCT01462318
Study type:  Interventional
Study design:  Intervention model: Single Group Assignment. Primary purpose: Other. Masking: None (Open Label).  
Phase:  Phase 3
Countries of recruitment
Czech Republic Hungary Poland Russian Federation United States
Contacts
Name:     Medical Director
Address: 
Telephone:
Email:
Affiliation:  Biogen
Key inclusion & exclusion criteria

Key Inclusion Criteria:

- Must have a confirmed diagnosis of RRMS according to McDonald criteria and previous
cranial magnetic resonance imaging demonstrating lesion(s) consistent with MS

- Must have a baseline Expanded Disability Status Scale (EDSS) between 0.0 and 5.0,
inclusive

- Must have had 1 or more clinical relapses within the previous 2 years

- Women of child bearing potential must be willing to practice effective contraception
during the study and 4 months after the last dose

Key Exclusion Criteria:

- Other chronic disease of the immune system, malignancies, acute urologic, pulmonary,
gastrointestinal disease

- Female subjects who are currently pregnant or breastfeeding

Key Inclusion criteria for 3-Year Treatment Extension:

To be eligible for participation in the 3-year treatment extension, participants must meet
the following eligibility criteria at the time of reinitiation of DAC HYP:

- Must have been compliant with the 205MS302 (NCT01462318) protocol during the initial
24-week treatment period and the 20-week washout period in the opinion of the
Investigator

- Must resume DAC HYP treatment =12 weeks after completion of the washout period (i.e.,
=12 weeks after their Week 44 visit).

- Participants who are currently receiving an approved IFN ß preparation must
discontinue interferon (IFN) ß treatment at the time of reinitiation of DAC HYP dosing
(no washout is required).

Key Inclusion criteria for the TP-DI Sub-study:

To be eligible for participation in the TP-DI Sub-Study, subjects must meet the following
eligibility criteria at the Screening Visit at Week 40:

- Must have been compliant with the 205MS302 (NCT01462318) protocol during the initial
24-week treatment period and through Week 40 of the 20-week washout period in the
opinion of the Investigator.

- Must agree to resume DAC HYP treatment =12 weeks after completion of the washout
period (i.e., =12 weeks after their Week 44 visit).

- Must have normal liver function test results (total bilirubin =1.5 × upper limit of
normal (ULN), alanine aminotransferase/aspartate aminotransferase =2 × ULN, and
prothrombin time/partial thromboplastin time =1.2 × ULN).

- Must have normal renal function as estimated creatinine clearance >60 mL/min
(Cockcroft-Gault formula).

NOTE: Other protocol defined Inclusion/Exclusion criteria may apply.



Age minimum: 18 Years
Age maximum: 65 Years
Gender: All
Health Condition(s) or Problem(s) studied
Relapsing-Remitting Multiple Sclerosis
Intervention(s)
Biological: BIIB019 (Daclizumab)
Drug: Dextromethorphan
Drug: Midazolam
Drug: Omeprazole
Drug: S-warfarin
Other: Caffeine
Other: Vitamin K
Primary Outcome(s)
Number of Participants With Anti-DAC HYP Binding Antibodies (ADAbs): Electrochemiluminescent (ECL) Anti-Drug Antibody (ADA) Assay [Time Frame: Up to 44 weeks]
Number of Participants With Anti-DAC HYP Neutralizing Antibodies (NAbs): ECL ADA Assay [Time Frame: Up to 44 weeks]
TP-DI Sub-study: Area-Under-the-Curve From Zero to Infinity (AUCinf) of Each Probe Drug [Time Frame: Week 43 (7 days prior to DAC HYP administration) and Week 53 (7 days after DAC HYP administration), pre-cocktail dose and at 0.5 and 1, 2, 3, 4, 6, 8, 10 , 24, 48, 72 and 96 hours post-probe drug cocktail administration]
TP-DI Sub-study: Dextromethorphan to Dextrorphan Urine Concentration Ratio [Time Frame: Week 43 (7 days prior to DAC HYP administration) and Week 53 (7 days after DAC HYP administration), pre-cocktail dose and for 12 hours after probe-drug cocktail administration]
Secondary Outcome(s)
Intensive PK Sub-study: Apparent Clearance (CL/F) of DAC HYP [Time Frame: Day 141 (Week 20) at pre-dose and 8, 24, 72 and 120 hours post-dose and 7, 10, 14 and 21 days post-dose]
Intensive PK Sub-study: Apparent Volume of Distribution (V/F) of DAC HYP [Time Frame: Day 141 (Week 20) at pre-dose and 8, 24, 72 and 120 hours post-dose and 7, 10, 14 and 21 days post-dose]
Intensive PK Sub-study: Area-Under-the-Curve From Start to End of the Dosing Interval (AUCtau) of DAC HYP [Time Frame: Day 1 and Day 141 (Week 20) at pre-dose and 8, 24, 72, and 120 hours post-dose and 7, 10, 14, and 21 days post-dose]
Intensive PK Sub-study: Cmax of DAC HYP [Time Frame: Day 1 and Day 141 (Week 20) at pre-dose and 8, 24, 72, and 120 hours post-dose and 7, 10, 14 and 21 days post-dose]
Intensive PK Sub-study: Elimination Half-life (t½) of DAC HYP [Time Frame: Day 141 (Week 20) at pre-dose and 8, 24, 72 and 120 hours post-dose and 7, 10, 14 and 21 days post-dose]
Intensive PK Sub-study: Minimum Concentrations (Cmin) of DAC HYP [Time Frame: Day 141 (Week 20) at pre-dose and 8, 24, 72 and 120 hours post-dose and 7, 10, 14 and 21 days post-dose]
Intensive PK Sub-study: Time to Reach Maximum Concentration (Tmax) of DAC HYP [Time Frame: Day 1 and Day 141 (Week 20) at pre-dose and 8, 24, 72, and 120 hours post-dose and 7, 10, 14 and 21 days post-dose]
TP-DI Sub-study: CL/F of Each Probe Drug [Time Frame: Week 43 (7 days prior to DAC HYP administration) and Week 53 (7 days after DAC HYP administration), pre-cocktail dose and at 0.5 and 1, 2, 3, 4, 6, 8, 10 , 24, 48, 72 and 96 hours post-probe drug cocktail administration]
TP-DI Sub-study: Cmax of Each Probe Drug [Time Frame: Week 43 (7 days prior to DAC HYP administration) and Week 53 (7 days after DAC HYP administration), pre-cocktail dose and at 0.5 and 1, 2, 3, 4, 6, 8, 10 , 24, 48, 72 and 96 hours post-probe drug cocktail administration]
TP-DI Sub-study: Omeprazole/Hydroxyomeprazole Concentration Ratio at 2 Hours Post-omeprazole Dosing [Time Frame: Week 43 (7 days prior to DAC HYP administration) and Week 53 (7 days after DAC HYP administration) at 2 hours after probe drug cocktail administration]
Secondary ID(s)
2010-023856-97
205MS302
Source(s) of Monetary Support
Please refer to primary and secondary sponsors
Secondary Sponsor(s)
Ethics review
Results
Results available: Yes
Date Posted: 14/03/2017
Date Completed:
URL: https://clinicaltrials.gov/ct2/show/results/NCT01462318
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