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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 (SELECTION)

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ClinicalTrials.gov Identifier: NCT00870740
Recruitment Status : Completed
First Posted : March 27, 2009
Results First Posted : August 30, 2016
Last Update Posted : August 30, 2016
Sponsor:
Collaborator:
AbbVie
Information provided by (Responsible Party):
Biogen

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition Relapsing-Remitting Multiple Sclerosis
Interventions Biological: BIIB019 (Daclizumab High Yield Process)
Drug: Placebo
Enrollment 517

Recruitment Details  
Pre-assignment Details  
Arm/Group Title Placebo + DAC HYP 150 mg Placebo + DAC HYP 300 mg DAC HYP 150 mg + Washout DAC HYP 150 mg for 2 Years DAC HYP 300 mg + Washout DAC HYP 300 mg for 2 Years
Hide Arm/Group Description Participants who previously received placebo in study 205MS201 (NCT00390221) received DAC HYP 150 mg subcutaneous (SC) injection every 4 weeks for a total of 13 doses. Participants who previously received placebo in study 205MS201 received DAC HYP 300 mg SC injection every 4 weeks for a total of 13 doses. Participants who previously received DAC HYP 150 mg SC injection in study 205MS201 underwent a washout period (placebo SC every 4 weeks for a total of 5 doses) and then received DAC HYP 150 mg SC every 4 weeks for a total of 8 doses. Participants who previously received DAC HYP 150 mg SC injection in study 205MS201 received DAC HYP 150 mg SC every 4 weeks for a total of 13 doses. Participants who previously received DAC HYP 300 mg SC in study 205MS201 underwent a washout period (placebo SC every 4 weeks for a total of 5 doses) and then received DAC HYP 300 mg SC every 4 weeks for a total of 8 doses. Participants who previously received DAC HYP 300 mg SC in study 205MS201 received DAC HYP 300 mg SC every 4 weeks for a total of 13 doses.
Period Title: Overall Study
Started 86 [1] 84 [1] 86 [1] 86 [1] 88 [1] 87 [1]
Completed 74 75 76 74 77 70
Not Completed 12 9 10 12 11 17
Reason Not Completed
Adverse Event             2             1             3             2             1             6
Consent Withdrawn             6             3             4             6             6             5
Investigator Decision             2             0             1             0             0             0
Subject Non-compliance             0             0             0             0             0             1
Death             0             0             0             0             1             0
Not Specified             2             5             2             4             3             5
[1]
number randomized and dosed
Arm/Group Title Placebo + DAC HYP 150 mg Placebo + DAC HYP 300 mg DAC HYP 150 mg + Washout DAC HYP 150 mg for 2 Years DAC HYP 300 mg + Washout DAC HYP 300 mg for 2 Years Total
Hide Arm/Group Description Participants who previously received placebo in study 205MS201 (NCT00390221) received DAC HYP 150 mg subcutaneous (SC) injection every 4 weeks for a total of 13 doses. Participants who previously received placebo in study 205MS201 received DAC HYP 300 mg SC injection every 4 weeks for a total of 13 doses. Participants who previously received DAC HYP 150 mg SC injection in study 205MS201 underwent a washout period (placebo SC every 4 weeks for a total of 5 doses) and then received DAC HYP 150 mg SC every 4 weeks for a total of 8 doses. Participants who previously received DAC HYP 150 mg SC injection in study 205MS201 received DAC HYP 150 mg SC every 4 weeks for a total of 13 doses. Participants who previously received DAC HYP 300 mg SC in study 205MS201 underwent a washout period (placebo SC every 4 weeks for a total of 5 doses) and then received DAC HYP 300 mg SC every 4 weeks for a total of 8 doses. Participants who previously received DAC HYP 300 mg SC in study 205MS201 received DAC HYP 300 mg SC every 4 weeks for a total of 13 doses. Total of all reporting groups
Overall Number of Baseline Participants 86 84 86 86 88 87 517
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 86 participants 84 participants 86 participants 86 participants 88 participants 87 participants 517 participants
38.2  (9.78) 37.8  (7.98) 36.8  (8.76) 36.2  (9.30) 36.2  (9.03) 36.0  (7.60) 36.9  (8.77)
Age, Customized  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 86 participants 84 participants 86 participants 86 participants 88 participants 87 participants 517 participants
18 to 19 years 0 0 0 0 1 1 2
20 to 29 years 19 13 19 25 20 16 112
30 to 39 years 26 37 29 28 35 41 196
40 to 49 years 29 28 33 27 24 25 166
50 to 55 years 11 6 5 6 7 3 38
> 55 years 1 0 0 0 1 1 3
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 86 participants 84 participants 86 participants 86 participants 88 participants 87 participants 517 participants
Female
53
  61.6%
54
  64.3%
59
  68.6%
53
  61.6%
59
  67.0%
48
  55.2%
326
  63.1%
Male
33
  38.4%
30
  35.7%
27
  31.4%
33
  38.4%
29
  33.0%
39
  44.8%
191
  36.9%
1.Primary Outcome
Title Number of Participants With Treatment-emergent Adverse Events (AEs)
Hide Description 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.
Time Frame Up to 72 weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Safety population: all randomized participants who received study treatment. Participants who discontinued study treatment due to an AE and/or withdrew from the study due to an AE that started prior to 205MS202 (NCT00870740) and that was treatment-emergent under 205MS201 (NCT00390221) are included in this summary.
Arm/Group Title Placebo + DAC HYP 150 mg Placebo + DAC HYP 300 mg DAC HYP 150 mg + Washout DAC HYP 150 mg for 2 Years DAC HYP 300 mg + Washout DAC HYP 300 mg for 2 Years
Hide Arm/Group Description:
Participants who previously received placebo in study 205MS201 (NCT00390221) received DAC HYP 150 mg subcutaneous (SC) injection every 4 weeks for a total of 13 doses.
Participants who previously received placebo in study 205MS201 received DAC HYP 300 mg SC injection every 4 weeks for a total of 13 doses.
Participants who previously received DAC HYP 150 mg SC injection in study 205MS201 underwent a washout period (placebo SC every 4 weeks for a total of 5 doses) and then received DAC HYP 150 mg SC every 4 weeks for a total of 8 doses.
Participants who previously received DAC HYP 150 mg SC injection in study 205MS201 received DAC HYP 150 mg SC every 4 weeks for a total of 13 doses.
Participants who previously received DAC HYP 300 mg SC in study 205MS201 underwent a washout period (placebo SC every 4 weeks for a total of 5 doses) and then received DAC HYP 300 mg SC every 4 weeks for a total of 8 doses.
Participants who previously received DAC HYP 300 mg SC in study 205MS201 received DAC HYP 300 mg SC every 4 weeks for a total of 13 doses.
Overall Number of Participants Analyzed 86 84 86 86 88 87
Measure Type: Number
Unit of Measure: participants
Participants with an AE 61 57 70 57 61 62
Participants with a moderate or severe AE 37 33 45 41 35 35
Participants with a severe AE 1 3 3 2 4 4
Participants with a possibly/definitely related AE 18 12 24 13 22 22
Participants with an SAE 15 11 18 15 15 11
2.Primary Outcome
Title Number of Participants With Abnormalities in Vital Signs
Hide Description 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.
Time Frame Up to Week 72
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Safety population: all randomized participants who received study treatment; n=number of subjects who had a baseline assessment and at least one post-baseline assessment for that vital sign.
Arm/Group Title Placebo + DAC HYP 150 mg Placebo + DAC HYP 300 mg DAC HYP 150 mg + Washout DAC HYP 150 mg for 2 Years DAC HYP 300 mg + Washout DAC HYP 300 mg for 2 Years
Hide Arm/Group Description:
Participants who previously received placebo in study 205MS201 (NCT00390221) received DAC HYP 150 mg subcutaneous (SC) injection every 4 weeks for a total of 13 doses.
Participants who previously received placebo in study 205MS201 received DAC HYP 300 mg SC injection every 4 weeks for a total of 13 doses.
Participants who previously received DAC HYP 150 mg SC injection in study 205MS201 underwent a washout period (placebo SC every 4 weeks for a total of 5 doses) and then received DAC HYP 150 mg SC every 4 weeks for a total of 8 doses.
Participants who previously received DAC HYP 150 mg SC injection in study 205MS201 received DAC HYP 150 mg SC every 4 weeks for a total of 13 doses.
Participants who previously received DAC HYP 300 mg SC in study 205MS201 underwent a washout period (placebo SC every 4 weeks for a total of 5 doses) and then received DAC HYP 300 mg SC every 4 weeks for a total of 8 doses.
Participants who previously received DAC HYP 300 mg SC in study 205MS201 received DAC HYP 300 mg SC every 4 weeks for a total of 13 doses.
Overall Number of Participants Analyzed 86 84 86 86 88 87
Measure Type: Number
Unit of Measure: participants
SBP >180 mmHg w/>40 mmHg ↑ BL; n=86,84,85,85,88,87 0 0 0 0 0 0
SBP <90 mmHg w/>30 mmHg ↓ BL; n=86,84,85,85,88,87 1 1 0 0 1 0
DBP >120 mmHg w/>20 mmHg ↑ BL; n=86,84,85,85,88,87 0 0 0 0 0 0
DBP <50 mmHg w/>20 mmHg ↓ BL; n=86,84,85,85,88,87 1 0 0 0 0 0
Pulse >120 bpm w/>20 bpm ↑ BL; n=86,84,85,85,88,87 0 0 0 0 0 0
Pulse <50 bpm w/>20 bpm ↓ BL; n=86,84,85,85,88,87 0 1 1 1 1 0
Temperature >38C w/≥1C ↑ BL; n=86,84,85,84,88,87 0 0 0 0 0 0
3.Primary Outcome
Title Number of Participants With Potentially Clinically Significant Hematology Laboratory Abnormalities
Hide Description Hematology parameters evaluated include: white blood cells, lymphocytes, neutrophils, red blood cells (RBC), hemoglobin, and platelets.
Time Frame Up to 72 Weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Number of participants in the safety population (all randomized participants who received study treatment) with at least one post-baseline value.
Arm/Group Title Placebo + DAC HYP 150 mg Placebo + DAC HYP 300 mg DAC HYP 150 mg + Washout DAC HYP 150 mg for 2 Years DAC HYP 300 mg + Washout DAC HYP 300 mg for 2 Years
Hide Arm/Group Description:
Participants who previously received placebo in study 205MS201 (NCT00390221) received DAC HYP 150 mg subcutaneous (SC) injection every 4 weeks for a total of 13 doses.
Participants who previously received placebo in study 205MS201 received DAC HYP 300 mg SC injection every 4 weeks for a total of 13 doses.
Participants who previously received DAC HYP 150 mg SC injection in study 205MS201 underwent a washout period (placebo SC every 4 weeks for a total of 5 doses) and then received DAC HYP 150 mg SC every 4 weeks for a total of 8 doses.
Participants who previously received DAC HYP 150 mg SC injection in study 205MS201 received DAC HYP 150 mg SC every 4 weeks for a total of 13 doses.
Participants who previously received DAC HYP 300 mg SC in study 205MS201 underwent a washout period (placebo SC every 4 weeks for a total of 5 doses) and then received DAC HYP 300 mg SC every 4 weeks for a total of 8 doses.
Participants who previously received DAC HYP 300 mg SC in study 205MS201 received DAC HYP 300 mg SC every 4 weeks for a total of 13 doses.
Overall Number of Participants Analyzed 85 84 85 85 88 87
Measure Type: Number
Unit of Measure: participants
White Blood Cell Count <3.0*10^9 cells/L 0 3 3 4 3 2
White Blood Cell Count ≥16.0*10^9 cells/L 4 2 1 1 3 1
Lymphocytes <0.8*10^9 cells/L 5 4 6 3 2 5
Lymphocytes <0.5*10^9 cells/L 1 0 1 1 1 0
Lymphocytes >12*10^9 cells/L 0 0 0 0 0 0
Neutrophils ≤1.0*10^9 cells/L 0 0 1 0 0 1
Neutrophils <1.5*10^9 cells/L 0 4 2 2 5 2
Neutrophils ≥12*10^9 cells/L 4 3 2 1 4 2
RBC Count ≤3.3*10^12 cells/L 0 0 0 0 0 0
RBC Count ≥6.8*10^12 cells/L 0 0 0 0 0 0
Hemoglobin ≤100 g/L 1 5 3 3 3 3
Platelet Count ≤100*10^9 cells/L 0 0 0 0 0 1
Platelet Count ≥600*10^9 cells/L 0 2 1 0 1 0
4.Primary Outcome
Title Number of Participants With Abnormalities in Blood Chemistry Laboratory Data
Hide Description 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.
Time Frame Up to 72 Weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Safety Population: all randomized participants who received study treatment; n=number of participants whose baseline value for 205MS202 (NCT00870740) was normal (i.e. not high or low) and who had at least one post-baseline value during the study.
Arm/Group Title Placebo + DAC HYP 150 mg Placebo + DAC HYP 300 mg DAC HYP 150 mg + Washout DAC HYP 150 mg for 2 Years DAC HYP 300 mg + Washout DAC HYP 300 mg for 2 Years
Hide Arm/Group Description:
Participants who previously received placebo in study 205MS201 (NCT00390221) received DAC HYP 150 mg subcutaneous (SC) injection every 4 weeks for a total of 13 doses.
Participants who previously received placebo in study 205MS201 received DAC HYP 300 mg SC injection every 4 weeks for a total of 13 doses.
Participants who previously received DAC HYP 150 mg SC injection in study 205MS201 underwent a washout period (placebo SC every 4 weeks for a total of 5 doses) and then received DAC HYP 150 mg SC every 4 weeks for a total of 8 doses.
Participants who previously received DAC HYP 150 mg SC injection in study 205MS201 received DAC HYP 150 mg SC every 4 weeks for a total of 13 doses.
Participants who previously received DAC HYP 300 mg SC in study 205MS201 underwent a washout period (placebo SC every 4 weeks for a total of 5 doses) and then received DAC HYP 300 mg SC every 4 weeks for a total of 8 doses.
Participants who previously received DAC HYP 300 mg SC in study 205MS201 received DAC HYP 300 mg SC every 4 weeks for a total of 13 doses.
Overall Number of Participants Analyzed 86 84 86 86 88 87
Measure Type: Number
Unit of Measure: participants
ALT ≤ULN; n=84,81,78,81,83,79 65 62 61 62 60 55
ALT >1 to <3 ULN; n=84,81,78,81,83,79 18 17 16 19 20 20
ALT 3 to 5 ULN; n=84,81,78,81,83,79 0 1 0 0 0 3
ALT >5 to 10 ULN; n=84,81,78,81,83,79 1 1 1 0 2 0
ALT >10 to 20 ULN; n=84,81,78,81,83,79 0 0 0 0 1 1
ALT >20 ULN; n=84,81,78,81,83,79 0 0 0 0 0 0
AST ≤ULN; n=85,81,81,84,85,84 72 66 71 63 68 62
AST >1 to <3 ULN; n=85,81,81,84,85,84 13 14 9 20 14 18
AST 3 to 5 ULN; n=85,81,81,84,85,84 0 1 1 1 2 2
AST >5 to 10 ULN; n=85,81,81,84,85,84 0 0 0 0 0 2
AST >10 to 20 ULN; n=85,81,81,84,85,84 0 0 0 0 0 0
AST >20 ULN; n=85,81,81,84,85,84 0 0 0 0 1 0
ALP ≤ULN; n=84,84,84,84,86,86 76 83 80 80 81 82
ALP >1 to 2.5 ULN; n=84,84,84,84,86,86 8 1 4 4 5 4
ALP >2.5 to 5 ULN; n=84,84,84,84,86,86 0 0 0 0 0 0
ALP >5 to 20 ULN; n=84,84,84,84,86,86 0 0 0 0 0 0
ALP >20 ULN; n=84,84,84,84,86,86 0 0 0 0 0 0
GGT ≤ULN; n=81,79,81,82,84,82 74 71 74 74 73 73
GGT >1 to 2.5 ULN; n=81,79,81,82,84,82 5 8 5 6 8 9
GGT >2.5 to 5 ULN; n=81,79,81,82,84,82 2 0 2 2 2 0
GGT >5 to 20 ULN; n=81,79,81,82,84,82 0 0 0 0 1 0
GGT >20 ULN; n=81,79,81,82,84,82 0 0 0 0 0 0
Total Bilirubin ≤ULN; n=81,79,83,81,85,80 74 73 81 76 78 75
Total Bilirubin >1 to 1.5 ULN; n=81,79,83,81,85,80 5 6 2 4 4 5
Total Bilirubin >1.5 to 3 ULN; n=81,79,83,81,85,80 2 0 0 1 2 0
Total Bilirubin >3 to 10 ULN; n=81,79,83,81,85,80 0 0 0 0 0 0
Total Bilirubin >10 ULN; n=81,79,83,81,85,80 0 0 0 0 1 0
TSH-3rd Gen Abnormal; n=79,79,74,77,79,79 2 1 2 2 2 2
Free Thyroxine (T4) Abnormal; n=78,80,73,73,80,79 4 4 5 4 4 3
Total Thyroxine (T4) Abnormal; n=76,80,74,72,80,79 3 10 6 4 9 9
5.Primary Outcome
Title Number of Participants With Development of Anti-DAC Antibodies (ADAb) and Neutralizing Antibodies (NAb) Post-baseline
Hide Description 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.
Time Frame Up to 72 weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
All participants in the Safety Population (all randomized participants who received study treatment) with a post-baseline ADAb assessment.
Arm/Group Title Placebo + DAC HYP DAC HYP + Washout DAC HYP for 2 Years
Hide Arm/Group Description:
Participants who previously received placebo in study 205MS201 (NCT00390221) received DAC HYP 150 mg or 300 mg SC injection every 4 weeks for a total of 13 doses.
Participants who previously received DAC HYP 150 mg or 300 mg SC injection in study 205MS201 underwent a washout period (placebo SC every 4 weeks for a total of 5 doses) and then received DAC HYP 150 mg or 300 mg SC, respectively, every 4 weeks for a total of 8 doses.
Participants who previously received DAC HYP 150 mg or 300 mg SC injection in study 205MS201 received DAC HYP 150 mg or 300 mg SC, respectively, every 4 weeks for a total of 13 doses.
Overall Number of Participants Analyzed 169 171 170
Measure Type: Number
Unit of Measure: participants
ADAb Positive 7 21 3
ADAb Negative 162 150 167
NAb Positive 4 4 1
NAb Negative 165 167 169
6.Secondary Outcome
Title Adjusted Annualized Relapse Rate
Hide Description 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.
Time Frame Up to 72 weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Per-protocol population: all randomized participants who received study treatment, excluding 18 participants from a single site (protocol violation) plus 75 participants for whom the time between the last dose of study treatment in 205MS201 (NCT00390221) and the first dose in 205MS202 (NCT00870740) was 56 days or longer.
Arm/Group Title Placebo + DAC HYP DAC HYP + Washout DAC HYP for 2 Years
Hide Arm/Group Description:
Participants who previously received placebo in study 205MS201 (NCT00390221) received DAC HYP 150 mg or 300 mg SC injection every 4 weeks for a total of 13 doses.
Participants who previously received DAC HYP 150 mg or 300 mg SC injection in study 205MS201 underwent a washout period (placebo SC every 4 weeks for a total of 5 doses) and then received DAC HYP 150 mg or 300 mg SC, respectively, every 4 weeks for a total of 8 doses.
Participants who previously received DAC HYP 150 mg or 300 mg SC injection in study 205MS201 received DAC HYP 150 mg or 300 mg SC, respectively, every 4 weeks for a total of 13 doses.
Overall Number of Participants Analyzed 163 132 129
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: relapses per person-years
0.179
(0.123 to 0.261)
0.302
(0.215 to 0.423)
0.165
(0.105 to 0.259)
7.Secondary Outcome
Title Estimated Proportion of Participants With a Relapse
Hide Description 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.
Time Frame Up to 72 weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Per-protocol population: all randomized participants who received study treatment, excluding 18 participants from a single site (protocol violation) plus 75 participants for whom the time between the last dose of study treatment in 205MS201 (NCT00390221) and the first dose in 205MS202 (NCT00870740) was 56 days or longer.
Arm/Group Title Placebo + DAC HYP 150 mg Placebo + DAC HYP 300 mg DAC HYP 150 mg + Washout DAC HYP 150 mg for 2 Years DAC HYP 300 mg + Washout DAC HYP 300 mg for 2 Years
Hide Arm/Group Description:
Participants who previously received placebo in study 205MS201 (NCT00390221) received DAC HYP 150 mg subcutaneous (SC) injection every 4 weeks for a total of 13 doses.
Participants who previously received placebo in study 205MS201 received DAC HYP 300 mg SC injection every 4 weeks for a total of 13 doses.
Participants who previously received DAC HYP 150 mg SC injection in study 205MS201 underwent a washout period (placebo SC every 4 weeks for a total of 5 doses) and then received DAC HYP 150 mg SC every 4 weeks for a total of 8 doses.
Participants who previously received DAC HYP 150 mg SC injection in study 205MS201 received DAC HYP 150 mg SC every 4 weeks for a total of 13 doses.
Participants who previously received DAC HYP 300 mg SC in study 205MS201 underwent a washout period (placebo SC every 4 weeks for a total of 5 doses) and then received DAC HYP 300 mg SC every 4 weeks for a total of 8 doses.
Participants who previously received DAC HYP 300 mg SC in study 205MS201 received DAC HYP 300 mg SC every 4 weeks for a total of 13 doses.
Overall Number of Participants Analyzed 84 79 64 65 68 64
Measure Type: Number
Unit of Measure: proportion of participants
0.186 0.166 0.249 0.160 0.235 0.111
8.Secondary Outcome
Title Mean Number of New Gadolinium-enhancing Lesions
Hide Description 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.
Time Frame Week 20, Week 52
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Per-protocol population: all randomized participants who received study treatment, excluding 18 participants from a single site (protocol violation) plus 75 participants for whom the time between the last dose of study treatment in 205MS201 (NCT00390221) and the first dose in 205MS202 (NCT00870740) was 56 days or longer.
Arm/Group Title Placebo + DAC HYP DAC HYP + Washout DAC HYP for 2 Years
Hide Arm/Group Description:
Participants who previously received placebo in study 205MS201 (NCT00390221) received DAC HYP 150 mg or 300 mg SC injection every 4 weeks for a total of 13 doses.
Participants who previously received DAC HYP 150 mg or 300 mg SC injection in study 205MS201 (NCT00390221) underwent a washout period (placebo SC every 4 weeks for a total of 5 doses) and then received DAC HYP 150 mg or 300 mg SC every 4 weeks for a total of 8 doses.
Participants who previously received DAC HYP 150 mg or 300 mg SC injection in study 205MS201 (NCT00390221) received DAC HYP 150 mg or 300 mg SC every 4 weeks for a total of 13 doses.
Overall Number of Participants Analyzed 163 132 129
Mean (Standard Deviation)
Unit of Measure: lesions
Week 20 0.3  (1.01) 1.1  (2.34) 0.2  (0.51)
Week 52 0.2  (0.80) 0.2  (0.64) 0.2  (1.21)
9.Secondary Outcome
Title Mean Number of New or Newly-enlarging T2 Hyperintense Lesions
Hide Description 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.
Time Frame Baseline, Week 20, Week 52
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Per-protocol population: all randomized participants who received study treatment, excluding 18 participants from a single site (protocol violation) plus 75 participants for whom the time between the last dose of study treatment in 205MS201 (NCT00390221) and the first dose in 205MS202 (NCT00870740) was 56 days or longer.
Arm/Group Title Placebo + DAC HYP DAC HYP + Washout DAC HYP for 2 Years
Hide Arm/Group Description:
Participants who previously received placebo in study 205MS201 (NCT00390221) received DAC HYP 150 mg or 300 mg SC injection every 4 weeks for a total of 13 doses.
Participants who previously received DAC HYP 150 mg or 300 mg SC injection in study 205MS201 (NCT00390221) underwent a washout period (placebo SC every 4 weeks for a total of 5 doses) and then received DAC HYP 150 mg or 300 mg SC every 4 weeks for a total of 8 doses.
Participants who previously received DAC HYP 150 mg or 300 mg SC injection in study 205MS201 (NCT00390221) received DAC HYP 150 mg or 300 mg SC every 4 weeks for a total of 13 doses.
Overall Number of Participants Analyzed 156 126 128
Mean (Standard Deviation)
Unit of Measure: lesions
Baseline 46.0  (36.48) 41.1  (36.36) 39.8  (32.63)
Week 20 1.1  (2.26) 2.6  (6.33) 0.5  (1.28)
Week 52 2.1  (3.68) 3.3  (6.95) 1.2  (4.33)
10.Secondary Outcome
Title Mean Volume of New T1 Hypointense Lesions
Hide Description 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.
Time Frame Baseline, Week 20, Week 52
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Per-protocol population: randomized participants who received study treatment, excluding 18 participants from a single site (protocol violation) plus 75 for whom the time between the last dose of study treatment in 205MS201 (NCT00390221) and the first dose in 205MS202 (NCT00870740) was ≥ 56 days; n=participants with measurement at given time point.
Arm/Group Title Placebo + DAC HYP 150 mg Placebo + DAC HYP 300 mg DAC HYP 150 mg + Washout DAC HYP 150 mg for 2 Years DAC HYP 300 mg + Washout DAC HYP 300 mg for 2 Years
Hide Arm/Group Description:
Participants who previously received placebo in study 205MS201 (NCT00390221) received DAC HYP 150 mg subcutaneous (SC) injection every 4 weeks for a total of 13 doses.
Participants who previously received placebo in study 205MS201 (NCT00390221) received DAC HYP 300 mg SC injection every 4 weeks for a total of 13 doses.
Participants who previously received DAC HYP 150 mg SC injection in study 205MS201 (NCT00390221) underwent a washout period (placebo SC every 4 weeks for a total of 5 doses) and then received DAC HYP 150 mg SC every 4 weeks for a total of 8 doses.
Participants who previously received DAC HYP 150 mg SC injection in study 205MS201 (NCT00390221) received DAC HYP 150 mg SC every 4 weeks for a total of 13 doses.
Participants who previously received DAC HYP 300 mg SC in study 205MS201 (NCT00390221) underwent a washout period (placebo SC every 4 weeks for a total of 5 doses) and then received DAC HYP 300 mg SC every 4 weeks for a total of 8 doses.
Participants who previously received DAC HYP 300 mg SC in study 205MS201 (NCT00390221) received DAC HYP 300 mg SC every 4 weeks for a total of 13 doses.
Overall Number of Participants Analyzed 84 79 64 65 68 64
Mean (Standard Deviation)
Unit of Measure: mm^3
Baseline; n=83, 79, 63, 64, 66, 64 232.13  (467.811) 228.90  (390.587) 126.50  (288.580) 94.20  (281.450) 52.26  (184.170) 44.92  (150.363)
Week 20; n=81, 74, 62, 65, 63, 63 36.17  (114.019) 62.76  (143.280) 161.98  (829.086) 6.29  (24.095) 12.37  (32.361) 4.66  (19.386)
Week 52; n=81, 74, 62, 65, 63, 63 88.46  (239.741) 109.42  (231.734) 142.31  (628.500) 17.18  (39.881) 43.60  (88.084) 21.42  (82.566)
11.Secondary Outcome
Title Mean Percentage Change From Baseline in Total Lesion Volume of T2 Hyperintense Lesions
Hide Description 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.
Time Frame Baseline, Week 52
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Per-protocol population (with a baseline and post-baseline assessment): randomized participants who received study treatment, excluding 18 participants from a single site (protocol violation) plus 75 for whom the time between the last dose of study treatment in 205MS201 (NCT00390221) and the first dose in 205MS202 (NCT00870740) was ≥ 56 days.
Arm/Group Title Placebo + DAC HYP 150 mg Placebo + DAC HYP 300 mg DAC HYP 150 mg + Washout DAC HYP 150 mg for 2 Years DAC HYP 300 mg + Washout DAC HYP 300 mg for 2 Years
Hide Arm/Group Description:
Participants who previously received placebo in study 205MS201 (NCT00390221) received DAC HYP 150 mg subcutaneous (SC) injection every 4 weeks for a total of 13 doses.
Participants who previously received placebo in study 205MS201 received DAC HYP 300 mg SC injection every 4 weeks for a total of 13 doses.
Participants who previously received DAC HYP 150 mg SC injection in study 205MS201 underwent a washout period (placebo SC every 4 weeks for a total of 5 doses) and then received DAC HYP 150 mg SC every 4 weeks for a total of 8 doses.
Participants who previously received DAC HYP 150 mg SC injection in study 205MS201 received DAC HYP 150 mg SC every 4 weeks for a total of 13 doses.
Participants who previously received DAC HYP 300 mg SC in study 205MS201 underwent a washout period (placebo SC every 4 weeks for a total of 5 doses) and then received DAC HYP 300 mg SC every 4 weeks for a total of 8 doses.
Participants who previously received DAC HYP 300 mg SC in study 205MS201 received DAC HYP 300 mg SC every 4 weeks for a total of 13 doses.
Overall Number of Participants Analyzed 81 75 62 65 64 63
Mean (Standard Deviation)
Unit of Measure: percentage change in volume
-7.75  (21.952) -8.44  (13.942) -0.78  (22.243) -4.90  (25.935) -5.40  (16.672) -8.98  (11.673)
12.Secondary Outcome
Title Mean Percentage Change From Baseline in Total Volume of Non-gadolinium (Gd)-Enhancing T1 Hypointense Lesions
Hide Description 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.
Time Frame Baseline, Week 52
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Per-protocol population (with a baseline and post-baseline assessment): randomized participants who received study treatment, excluding 18 participants from a single site (protocol violation) plus 75 for whom the time between the last dose of study treatment in 205MS201 (NCT00390221) and the first dose in 205MS202 (NCT00870740) was ≥ 56 days.
Arm/Group Title Placebo + DAC HYP 150 mg Placebo + DAC HYP 300 mg DAC HYP 150 mg + Washout DAC HYP 150 mg for 2 Years DAC HYP 300 mg + Washout DAC HYP 300 mg for 2 Years
Hide Arm/Group Description:
Participants who previously received placebo in study 205MS201 (NCT00390221) received DAC HYP 150 mg subcutaneous (SC) injection every 4 weeks for a total of 13 doses.
Participants who previously received placebo in study 205MS201 received DAC HYP 300 mg SC injection every 4 weeks for a total of 13 doses.
Participants who previously received DAC HYP 150 mg SC injection in study 205MS201 underwent a washout period (placebo SC every 4 weeks for a total of 5 doses) and then received DAC HYP 150 mg SC every 4 weeks for a total of 8 doses.
Participants who previously received DAC HYP 150 mg SC injection in study 205MS201 received DAC HYP 150 mg SC every 4 weeks for a total of 13 doses.
Participants who previously received DAC HYP 300 mg SC in study 205MS201 underwent a washout period (placebo SC every 4 weeks for a total of 5 doses) and then received DAC HYP 300 mg SC every 4 weeks for a total of 8 doses.
Participants who previously received DAC HYP 300 mg SC in study 205MS201 received DAC HYP 300 mg SC every 4 weeks for a total of 13 doses.
Overall Number of Participants Analyzed 81 74 62 65 63 63
Mean (Standard Deviation)
Unit of Measure: percentage change in volume
-3.99  (35.543) -7.15  (39.932) -5.51  (49.970) -13.89  (18.089) -6.72  (22.721) -16.59  (17.436)
13.Secondary Outcome
Title Rate of Percentage Change From Baseline in Mean Total Brain Volume
Hide Description 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.
Time Frame Baseline, Week 52
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Per-protocol population (with a baseline and post-baseline assessment): randomized participants who received study treatment, excluding 18 participants from a single site (protocol violation) plus 75 for whom the time between the last dose of study treatment in 205MS201 (NCT00390221) and the first dose in 205MS202 (NCT00870740) was ≥ 56 days.
Arm/Group Title Placebo + DAC HYP 150 mg Placebo + DAC HYP 300 mg DAC HYP 150 mg + Washout DAC HYP 150 mg for 2 Years DAC HYP 300 mg + Washout DAC HYP 300 mg for 2 Years
Hide Arm/Group Description:
Participants who previously received placebo in study 205MS201 (NCT00390221) received DAC HYP 150 mg subcutaneous (SC) injection every 4 weeks for a total of 13 doses.
Participants who previously received placebo in study received DAC HYP 300 mg SC injection every 4 weeks for a total of 13 doses.
Participants who previously received DAC HYP 150 mg SC injection in study 205MS201 underwent a washout period (placebo SC every 4 weeks for a total of 5 doses) and then received DAC HYP 150 mg SC every 4 weeks for a total of 8 doses.
Participants who previously received DAC HYP 150 mg SC injection in study 205MS201 received DAC HYP 150 mg SC every 4 weeks for a total of 13 doses.
Participants who previously received DAC HYP 300 mg SC in study 205MS201 underwent a washout period (placebo SC every 4 weeks for a total of 5 doses) and then received DAC HYP 300 mg SC every 4 weeks for a total of 8 doses.
Participants who previously received DAC HYP 300 mg SC in study 205MS201 received DAC HYP 300 mg SC every 4 weeks for a total of 13 doses.
Overall Number of Participants Analyzed 79 76 61 64 63 62
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: rate of percentage change
-0.772
(-0.978 to -0.565)
-0.930
(-1.141 to -0.719)
-0.622
(-0.857 to -0.387)
-0.528
(-0.758 to -0.297)
-0.505
(-0.736 to -0.274)
-0.452
(-0.685 to -0.219)
Time Frame Study Entry Week 0 (Baseline; Week 52 Visit from study 205MS201 [NCT00390221]) through Week 72 ± 5 days or early termination.
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Placebo + DAC HYP 150 mg Placebo + DAC HYP 300 mg DAC HYP 150 mg + Washout DAC HYP 150 mg for 2 Years DAC HYP 300 mg + Washout DAC HYP 300 mg for 2 Years
Hide Arm/Group Description Participants who previously received placebo in study 205MS201 (NCT00390221) received DAC HYP 150 mg subcutaneous (SC) injection every 4 weeks for a total of 13 doses. Participants who previously received placebo in study 205MS201 (NCT00390221) received DAC HYP 300 mg SC injection every 4 weeks for a total of 13 doses. Participants who previously received DAC HYP 150 mg SC injection in study 205MS201 (NCT00390221) underwent a washout period (placebo SC every 4 weeks for a total of 5 doses) and then received DAC HYP 150 mg SC every 4 weeks for a total of 8 doses. Participants who previously received DAC HYP 150 mg SC injection in study 205MS201 (NCT00390221) received DAC HYP 150 mg SC every 4 weeks for a total of 13 doses. Participants who previously received DAC HYP 300 mg SC in study 205MS201 (NCT00390221) underwent a washout period (placebo SC every 4 weeks for a total of 5 doses) and then received DAC HYP 300 mg SC every 4 weeks for a total of 8 doses. Participants who previously received DAC HYP 300 mg SC in study 205MS201 (NCT00390221) received DAC HYP 300 mg SC every 4 weeks for a total of 13 doses.
All-Cause Mortality
Placebo + DAC HYP 150 mg Placebo + DAC HYP 300 mg DAC HYP 150 mg + Washout DAC HYP 150 mg for 2 Years DAC HYP 300 mg + Washout DAC HYP 300 mg for 2 Years
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/--   --/--   --/--   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Placebo + DAC HYP 150 mg Placebo + DAC HYP 300 mg DAC HYP 150 mg + Washout DAC HYP 150 mg for 2 Years DAC HYP 300 mg + Washout DAC HYP 300 mg for 2 Years
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   15/86 (17.44%)   11/84 (13.10%)   18/86 (20.93%)   15/86 (17.44%)   14/88 (15.91%)   11/87 (12.64%) 
Blood and lymphatic system disorders             
Anaemia  1  0/86 (0.00%)  0/84 (0.00%)  0/86 (0.00%)  1/86 (1.16%)  0/88 (0.00%)  0/87 (0.00%) 
Leukopenia  1  0/86 (0.00%)  0/84 (0.00%)  0/86 (0.00%)  0/86 (0.00%)  0/88 (0.00%)  1/87 (1.15%) 
Endocrine disorders             
Basedow's disease  1  0/86 (0.00%)  0/84 (0.00%)  0/86 (0.00%)  0/86 (0.00%)  0/88 (0.00%)  1/87 (1.15%) 
Hyperthyroidism  1  0/86 (0.00%)  0/84 (0.00%)  0/86 (0.00%)  0/86 (0.00%)  0/88 (0.00%)  1/87 (1.15%) 
Gastrointestinal disorders             
Colitis ulcerative  1  0/86 (0.00%)  0/84 (0.00%)  0/86 (0.00%)  0/86 (0.00%)  0/88 (0.00%)  1/87 (1.15%) 
General disorders             
Influenza like illness  1  0/86 (0.00%)  0/84 (0.00%)  1/86 (1.16%)  0/86 (0.00%)  0/88 (0.00%)  0/87 (0.00%) 
Hepatobiliary disorders             
Autoimmune hepatitis  1  0/86 (0.00%)  0/84 (0.00%)  0/86 (0.00%)  0/86 (0.00%)  1/88 (1.14%)  0/87 (0.00%) 
Chronic hepatitis  1  0/86 (0.00%)  0/84 (0.00%)  0/86 (0.00%)  0/86 (0.00%)  0/88 (0.00%)  1/87 (1.15%) 
Hepatic steatosis  1  0/86 (0.00%)  0/84 (0.00%)  1/86 (1.16%)  0/86 (0.00%)  0/88 (0.00%)  0/87 (0.00%) 
Jaundice  1  0/86 (0.00%)  0/84 (0.00%)  0/86 (0.00%)  0/86 (0.00%)  1/88 (1.14%)  0/87 (0.00%) 
Immune system disorders             
Allergy to arthropod sting  1  0/86 (0.00%)  0/84 (0.00%)  0/86 (0.00%)  1/86 (1.16%)  0/88 (0.00%)  0/87 (0.00%) 
Drug hypersensitivity  1  0/86 (0.00%)  0/84 (0.00%)  0/86 (0.00%)  1/86 (1.16%)  0/88 (0.00%)  0/87 (0.00%) 
Infections and infestations             
Appendicitis  1  0/86 (0.00%)  0/84 (0.00%)  1/86 (1.16%)  0/86 (0.00%)  0/88 (0.00%)  0/87 (0.00%) 
Bronchitis  1  1/86 (1.16%)  1/84 (1.19%)  0/86 (0.00%)  0/86 (0.00%)  1/88 (1.14%)  0/87 (0.00%) 
Cellulitis  1  1/86 (1.16%)  0/84 (0.00%)  0/86 (0.00%)  0/86 (0.00%)  0/88 (0.00%)  0/87 (0.00%) 
Infectious mononucleosis  1  0/86 (0.00%)  0/84 (0.00%)  0/86 (0.00%)  1/86 (1.16%)  0/88 (0.00%)  0/87 (0.00%) 
Klebsiella infection  1  0/86 (0.00%)  0/84 (0.00%)  0/86 (0.00%)  0/86 (0.00%)  0/88 (0.00%)  1/87 (1.15%) 
Lung infection  1  1/86 (1.16%)  0/84 (0.00%)  0/86 (0.00%)  0/86 (0.00%)  0/88 (0.00%)  0/87 (0.00%) 
Meningitis aseptic  1  0/86 (0.00%)  0/84 (0.00%)  1/86 (1.16%)  0/86 (0.00%)  0/88 (0.00%)  0/87 (0.00%) 
Mycobacterium abscessus infection  1  1/86 (1.16%)  0/84 (0.00%)  0/86 (0.00%)  0/86 (0.00%)  0/88 (0.00%)  0/87 (0.00%) 
Pneumonia  1  1/86 (1.16%)  0/84 (0.00%)  0/86 (0.00%)  0/86 (0.00%)  0/88 (0.00%)  0/87 (0.00%) 
Pyelonephritis chronic  1  0/86 (0.00%)  0/84 (0.00%)  0/86 (0.00%)  1/86 (1.16%)  0/88 (0.00%)  0/87 (0.00%) 
Sinusitis  1  0/86 (0.00%)  0/84 (0.00%)  0/86 (0.00%)  0/86 (0.00%)  0/88 (0.00%)  1/87 (1.15%) 
Tracheobronchitis  1  0/86 (0.00%)  0/84 (0.00%)  1/86 (1.16%)  0/86 (0.00%)  0/88 (0.00%)  0/87 (0.00%) 
Upper respiratory tract infection bacterial  1  0/86 (0.00%)  0/84 (0.00%)  0/86 (0.00%)  0/86 (0.00%)  1/88 (1.14%)  0/87 (0.00%) 
Injury, poisoning and procedural complications             
Joint dislocation  1  0/86 (0.00%)  0/84 (0.00%)  0/86 (0.00%)  1/86 (1.16%)  0/88 (0.00%)  0/87 (0.00%) 
Musculoskeletal and connective tissue disorders             
Back pain  1  0/86 (0.00%)  0/84 (0.00%)  0/86 (0.00%)  1/86 (1.16%)  0/88 (0.00%)  0/87 (0.00%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)             
Breast cancer  1  0/86 (0.00%)  1/84 (1.19%)  0/86 (0.00%)  0/86 (0.00%)  0/88 (0.00%)  0/87 (0.00%) 
Nervous system disorders             
Demyelination  1  0/86 (0.00%)  1/84 (1.19%)  0/86 (0.00%)  0/86 (0.00%)  0/88 (0.00%)  0/87 (0.00%) 
Haemorrhagic stroke  1  0/86 (0.00%)  0/84 (0.00%)  0/86 (0.00%)  0/86 (0.00%)  0/88 (0.00%)  1/87 (1.15%) 
Ischaemic neuropathy  1  0/86 (0.00%)  1/84 (1.19%)  0/86 (0.00%)  0/86 (0.00%)  0/88 (0.00%)  0/87 (0.00%) 
Multiple sclerosis  1  0/86 (0.00%)  0/84 (0.00%)  0/86 (0.00%)  1/86 (1.16%)  0/88 (0.00%)  0/87 (0.00%) 
Multiple sclerosis relapse  1  9/86 (10.47%)  7/84 (8.33%)  12/86 (13.95%)  9/86 (10.47%)  12/88 (13.64%)  5/87 (5.75%) 
Pregnancy, puerperium and perinatal conditions             
Abortion spontaneous  1  0/86 (0.00%)  0/84 (0.00%)  0/86 (0.00%)  1/86 (1.16%)  0/88 (0.00%)  0/87 (0.00%) 
Psychiatric disorders             
Mental disorder due to a general medical condition  1  0/86 (0.00%)  1/84 (1.19%)  0/86 (0.00%)  0/86 (0.00%)  0/88 (0.00%)  0/87 (0.00%) 
Renal and urinary disorders             
Glomerulonephritis  1  0/86 (0.00%)  0/84 (0.00%)  0/86 (0.00%)  0/86 (0.00%)  0/88 (0.00%)  1/87 (1.15%) 
Mesangioproliferative glomerulonephritis  1  0/86 (0.00%)  0/84 (0.00%)  0/86 (0.00%)  0/86 (0.00%)  0/88 (0.00%)  1/87 (1.15%) 
Nephrotic syndrome  1  0/86 (0.00%)  0/84 (0.00%)  0/86 (0.00%)  0/86 (0.00%)  0/88 (0.00%)  1/87 (1.15%) 
Reproductive system and breast disorders             
Adenomyosis  1  0/86 (0.00%)  0/84 (0.00%)  0/86 (0.00%)  0/86 (0.00%)  0/88 (0.00%)  1/87 (1.15%) 
Breast inflammation  1  1/86 (1.16%)  0/84 (0.00%)  0/86 (0.00%)  0/86 (0.00%)  0/88 (0.00%)  0/87 (0.00%) 
Endometriosis  1  1/86 (1.16%)  0/84 (0.00%)  0/86 (0.00%)  0/86 (0.00%)  0/88 (0.00%)  0/87 (0.00%) 
Uterine haemorrhage  1  0/86 (0.00%)  0/84 (0.00%)  1/86 (1.16%)  0/86 (0.00%)  0/88 (0.00%)  0/87 (0.00%) 
Respiratory, thoracic and mediastinal disorders             
Pulmonary embolism  1  0/86 (0.00%)  0/84 (0.00%)  0/86 (0.00%)  0/86 (0.00%)  1/88 (1.14%)  0/87 (0.00%) 
Pulmonary granuloma  1  1/86 (1.16%)  0/84 (0.00%)  0/86 (0.00%)  0/86 (0.00%)  0/88 (0.00%)  0/87 (0.00%) 
Skin and subcutaneous tissue disorders             
Dermatitis exfoliative  1  0/86 (0.00%)  0/84 (0.00%)  0/86 (0.00%)  0/86 (0.00%)  0/88 (0.00%)  1/87 (1.15%) 
Drug eruption  1  1/86 (1.16%)  0/84 (0.00%)  0/86 (0.00%)  0/86 (0.00%)  0/88 (0.00%)  1/87 (1.15%) 
Eczema  1  1/86 (1.16%)  0/84 (0.00%)  0/86 (0.00%)  0/86 (0.00%)  0/88 (0.00%)  1/87 (1.15%) 
Pityriasis rubra pilaris  1  0/86 (0.00%)  0/84 (0.00%)  1/86 (1.16%)  0/86 (0.00%)  0/88 (0.00%)  0/87 (0.00%) 
Urticaria  1  0/86 (0.00%)  0/84 (0.00%)  0/86 (0.00%)  0/86 (0.00%)  0/88 (0.00%)  1/87 (1.15%) 
Vascular disorders             
Deep vein thrombosis  1  0/86 (0.00%)  0/84 (0.00%)  0/86 (0.00%)  0/86 (0.00%)  1/88 (1.14%)  0/87 (0.00%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 16.1
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Placebo + DAC HYP 150 mg Placebo + DAC HYP 300 mg DAC HYP 150 mg + Washout DAC HYP 150 mg for 2 Years DAC HYP 300 mg + Washout DAC HYP 300 mg for 2 Years
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   43/86 (50.00%)   37/84 (44.05%)   47/86 (54.65%)   38/86 (44.19%)   45/88 (51.14%)   43/87 (49.43%) 
Gastrointestinal disorders             
Diarrhoea  1  4/86 (4.65%)  4/84 (4.76%)  1/86 (1.16%)  5/86 (5.81%)  2/88 (2.27%)  1/87 (1.15%) 
General disorders             
Fatigue  1  5/86 (5.81%)  1/84 (1.19%)  2/86 (2.33%)  3/86 (3.49%)  4/88 (4.55%)  3/87 (3.45%) 
Pyrexia  1  2/86 (2.33%)  1/84 (1.19%)  2/86 (2.33%)  1/86 (1.16%)  6/88 (6.82%)  5/87 (5.75%) 
Infections and infestations             
Nasopharyngitis  1  12/86 (13.95%)  8/84 (9.52%)  11/86 (12.79%)  10/86 (11.63%)  10/88 (11.36%)  15/87 (17.24%) 
Oral herpes  1  5/86 (5.81%)  1/84 (1.19%)  6/86 (6.98%)  1/86 (1.16%)  6/88 (6.82%)  2/87 (2.30%) 
Pharyngitis  1  5/86 (5.81%)  3/84 (3.57%)  4/86 (4.65%)  5/86 (5.81%)  2/88 (2.27%)  5/87 (5.75%) 
Respiratory tract infection viral  1  3/86 (3.49%)  3/84 (3.57%)  5/86 (5.81%)  1/86 (1.16%)  4/88 (4.55%)  2/87 (2.30%) 
Upper respiratory tract infection  1  6/86 (6.98%)  4/84 (4.76%)  7/86 (8.14%)  9/86 (10.47%)  6/88 (6.82%)  7/87 (8.05%) 
Investigations             
Alanine aminotransferase increased  1  2/86 (2.33%)  2/84 (2.38%)  3/86 (3.49%)  4/86 (4.65%)  3/88 (3.41%)  5/87 (5.75%) 
Musculoskeletal and connective tissue disorders             
Back pain  1  1/86 (1.16%)  7/84 (8.33%)  2/86 (2.33%)  2/86 (2.33%)  2/88 (2.27%)  3/87 (3.45%) 
Nervous system disorders             
Headache  1  5/86 (5.81%)  4/84 (4.76%)  5/86 (5.81%)  4/86 (4.65%)  8/88 (9.09%)  6/87 (6.90%) 
Multiple sclerosis relapse  1  16/86 (18.60%)  13/84 (15.48%)  25/86 (29.07%)  13/86 (15.12%)  17/88 (19.32%)  13/87 (14.94%) 
Skin and subcutaneous tissue disorders             
Rash  1  3/86 (3.49%)  5/84 (5.95%)  5/86 (5.81%)  4/86 (4.65%)  3/88 (3.41%)  5/87 (5.75%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 16.1
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Our agreement is subject to confidentiality but generally the PI can publish, for noncommercial purposes only, results and methods of the trial, but no other Sponsor Confidential Information. PI must give Sponsor no less than 60 days to review any manuscript for a proposed publication and must delay publication for up to an additional 90 days thereafter if Sponsor needs to file any patent application to protect any of Sponsor's intellectual property contained in the proposed publication.
Results Point of Contact
Name/Title: Biogen Study Medical Director
Organization: Biogen
Responsible Party: Biogen
ClinicalTrials.gov Identifier: NCT00870740     History of Changes
Other Study ID Numbers: 205-MS-202
EUDRA CT No.: 2008-005559-46
First Submitted: March 26, 2009
First Posted: March 27, 2009
Results First Submitted: May 31, 2016
Results First Posted: August 30, 2016
Last Update Posted: August 30, 2016