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Trial record 1 of 1 for:    LPS13649
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Phase IIIB-IV Long-Term Follow-up Study for Patients Who Participated in CAMMS03409 (TOPAZ)

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ClinicalTrials.gov Identifier: NCT02255656
Recruitment Status : Completed
First Posted : October 2, 2014
Results First Posted : July 23, 2021
Last Update Posted : March 28, 2022
Sponsor:
Information provided by (Responsible Party):
Sanofi ( Genzyme, a Sanofi Company )

Study Type Interventional
Study Design Allocation: N/A;   Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Relapsing Remitting Multiple Sclerosis
Intervention Drug: alemtuzumab GZ402673
Enrollment 1062
Recruitment Details The study was conducted at 142 study centers in 21 countries. A total of 1062 participants were screened between 7 January 2015 and 28 June 2016 and were enrolled in this current study (LPS13649 [TOPAZ]).
Pre-assignment Details Subgroup analysis ([Delayed Alemtuzumab Treatment[DAT] & Immediate Alemtuzumab Treatment[IAT]subgroup) was performed only for outcome measures and safety analysis. Participants who rolled over from CAMMS223(NCT00050778) to CAMMS03409 (NCT00930553),then subsequently enrolled and took 24 mg alemtuzumab in CAMMS324 (NCT00548405) study, were not considered as part of DAT or IAT subgroup & included in overall group only. Participant flow and Baseline analysis was performed on overall population only.
Arm/Group Title Alemtuzumab
Hide Arm/Group Description All Participants who completed the study CAMMS03409 (extension study of CAMMS223 [NCT00050778], CAMMS323 [NCT00530348], or CAMMS324 [NCT00548405]) and received alemtuzumab within 48 months prior to enrollment were included in this LPS13649 study. Participants received alemtuzumab, intravenous infusion of 12 milligram per day (mg/day) for 3 consecutive days, at the study investigators' discretion; and at least 12 months after the prior treatment course in the current study (LPS13649).
Period Title: Overall Study
Started 1062
Completed 592
Not Completed 470
Reason Not Completed
Adverse Event             11
Poor compliance to protocol             3
Lost to Follow-up             30
Due to Coronavirus Disease (Covid-19)             300
Other             126
Arm/Group Title Alemtuzumab
Hide Arm/Group Description All Participants who completed the study CAMMS03409 (extension study of CAMMS223 [NCT00050778], CAMMS323 [NCT00530348], or CAMMS324 [NCT00548405]) and received alemtuzumab within 48 months prior to enrollment were included in this LPS13649 study. Participants received alemtuzumab, intravenous infusion of 12 mg/day for 3 consecutive days, at the study investigators' discretion; and at least 12 months after the prior treatment course in the current study (LPS13649).
Overall Number of Baseline Participants 1062
Hide Baseline Analysis Population Description
Analysis was performed on all enrolled participants.
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 1062 participants
41.2  (8.6)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 1062 participants
Female
686
  64.6%
Male
376
  35.4%
Race/Ethnicity, Customized  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 1062 participants
White
988
  93.0%
Black or African American
34
   3.2%
Asian
5
   0.5%
American Indian or Alaska native
6
   0.6%
Other
29
   2.7%
1.Primary Outcome
Title Number of Participants With Treatment-Emergent Adverse Events (TEAEs), and Treatment-Emergent Serious Adverse Events (TESAEs)
Hide Description An Adverse Event (AE) was any untoward medical occurrence in a participant administered a pharmaceutical product and which did not necessarily had to have causal relationship with treatment. TEAEs were defined as AEs that developed/worsened during the 'treatment period (time from Baseline until the end of the study LPS13649 [i.e. up to a maximum of 5.6 years]). Serious adverse events (SAEs) was any untoward medical occurrence that at any dose: resulted in death, was life-threatening, required inpatient hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity, was a congenital anomaly/birth defect, was a medically important event.
Time Frame From Baseline until the end of the study (up to a maximum duration of 5.6 years)
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis was performed on safety analysis set that included all participants who signed the informed consent form (ICF). As pre-specified, data collection and analysis for this outcome measure was done on the overall population along with 2 subgroups (DAT and IAT).
Arm/Group Title Delayed Alemtuzumab Treatment (DAT) Initial Alemtuzumab Treatment (IAT) Alemtuzumab
Hide Arm/Group Description:
Participants from the subcutaneous interferon beta-1a (SC IFNB1a) treatment arms of studies CAMMS323 and CAMMS324, who received their initial 2 treatment courses of alemtuzumab during the CAMMS03409 extension study were included in the DAT subgroup of the current study (LPS13649). Participants received alemtuzumab intravenous infusion of 12 mg/day for 3 consecutive days, at the study investigators' discretion; and at least 12 months after the prior treatment course in the current study (LPS13649).
Participants from the 12 mg/day alemtuzumab treatment arms of the studies CAMMS323 and CAMMS324 (who were subsequently enrolled in CAMMS03409 extension study and then entered in this study LPS13649) were included in the IAT subgroup of the current study (LPS13649). Participants received alemtuzumab intravenous infusion of 12 mg/day for 3 consecutive days, at the study investigators' discretion; and at least 12 months after the prior treatment course in the current study (LPS13649).
All Participants who completed the study CAMMS03409 (extension study of CAMMS223 [NCT00050778], CAMMS323 [NCT00530348], or CAMMS324 [NCT00548405]) and received alemtuzumab within 48 months prior to enrollment were included in this LPS13649 study. Participants received alemtuzumab, intravenous infusion of 12 mg/day for 3 consecutive days, at the study investigators' discretion; and at least 12 months after the prior treatment course in the current study (LPS13649).
Overall Number of Participants Analyzed 241 598 1062
Measure Type: Count of Participants
Unit of Measure: Participants
Any TEAE
204
  84.6%
500
  83.6%
879
  82.8%
Any TESAE
55
  22.8%
133
  22.2%
237
  22.3%
Any TEAE leading to death
0
   0.0%
10
   1.7%
11
   1.0%
Any TEAE leading to permanent treatment discontinuation
0
   0.0%
2
   0.3%
2
   0.2%
2.Primary Outcome
Title Number of Participants With Infusion-Associated Reactions (IAR)
Hide Description Infusion-associated reactions (IAR) was defined as any adverse event occurring during and within 24 hours of alemtuzumab infusion.
Time Frame Within 24 hours of any alemtuzumab infusion
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis was performed on re-treated population that included all participants who had signed the ICF and who had received study drug in the current study LPS13649. Here, 'Overall number of participants analyzed' = participants evaluable for this outcome measure. As pre-specified, data collection and analysis for this outcome measure was done on the overall population along with 2 subgroups (DAT and IAT).
Arm/Group Title Delayed Alemtuzumab Treatment (DAT) Initial Alemtuzumab Treatment (IAT) Alemtuzumab
Hide Arm/Group Description:
Participants from the SC IFNB1a treatment arms of studies CAMMS323 and CAMMS324, who received their initial 2 treatment courses of alemtuzumab during the CAMMS03409 extension study were included in the DAT subgroup of the current study (LPS13649). Participants received alemtuzumab intravenous infusion of 12 mg/day for 3 consecutive days, at the study investigators' discretion; and at least 12 months after the prior treatment course in the current study (LPS13649).
Participants from the 12 mg/day alemtuzumab treatment arms of the studies CAMMS323 and CAMMS324 (who were subsequently enrolled in CAMMS03409 extension study and then entered in this study LPS13649) were included in the IAT subgroup of the current study (LPS13649). Participants received alemtuzumab intravenous infusion of 12 mg/day for 3 consecutive days, at the study investigators' discretion; and at least 12 months after the prior treatment course in the current study (LPS13649).
All Participants who completed the study CAMMS03409 (extension study of CAMMS223 [NCT00050778], CAMMS323 [NCT00530348], or CAMMS324 [NCT00548405]) and received alemtuzumab within 48 months prior to enrollment were included in this LPS13649 study. Participants received alemtuzumab, intravenous infusion of 12 mg/day for 3 consecutive days, at the study investigators' discretion; and at least 12 months after the prior treatment course in the current study (LPS13649).
Overall Number of Participants Analyzed 83 164 294
Measure Type: Count of Participants
Unit of Measure: Participants
48
  57.8%
89
  54.3%
164
  55.8%
3.Primary Outcome
Title Number of Participants With Adverse Events of Special Interest (AESI)
Hide Description Adverse events of special interest included the following: hypersensitivity or anaphylaxis; pregnancy of a woman entered in the study; symptomatic overdose (serious or non-serious) with investigational medicinal Product (IMP); increase in alanine transaminase (ALT); autoimmune mediated conditions; hemophagocytic lymphohistiocytosis; progressive multifocal leukoencephalopathy; temporally associated AEs; serious infections; malignancy; and pneumonitis.
Time Frame From Baseline until the end of the study (up to a maximum duration of 5.6 years)
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis was performed on safety population. As pre-specified, data collection and analysis for this outcome measure was done on the overall population along with 2 subgroups (DAT and IAT).
Arm/Group Title Delayed Alemtuzumab Treatment (DAT) Initial Alemtuzumab Treatment (IAT) Alemtuzumab
Hide Arm/Group Description:
Participants from the SC IFNB1a treatment arms of studies CAMMS323 and CAMMS324, who received their initial 2 treatment courses of alemtuzumab during the CAMMS03409 extension study were included in the DAT subgroup of the current study (LPS13649). Participants received alemtuzumab intravenous infusion of 12 mg/day for 3 consecutive days, at the study investigators' discretion; and at least 12 months after the prior treatment course in the current study (LPS13649).
Participants from the 12 mg/day alemtuzumab treatment arms of the studies CAMMS323 and CAMMS324 (who were subsequently enrolled in CAMMS03409 extension study and then entered in this study LPS13649) were included in the IAT subgroup of the current study (LPS13649). Participants received alemtuzumab intravenous infusion of 12 mg/day for 3 consecutive days, at the study investigators' discretion; and at least 12 months after the prior treatment course in the current study (LPS13649).
All Participants who completed the study CAMMS03409 (extension study of CAMMS223 [NCT00050778], CAMMS323 [NCT00530348], and CAMMS324 [NCT00548405]) and received alemtuzumab within 48 months prior to enrollment were included in this LPS13649 study. Participants received alemtuzumab, intravenous infusion of 12 mg/day for 3 consecutive days, at the study investigators' discretion; and at least 12 months after the prior treatment course in the current study (LPS13649).
Overall Number of Participants Analyzed 241 598 1062
Measure Type: Count of Participants
Unit of Measure: Participants
Hypersensitivity or anaphylaxis
12
   5.0%
25
   4.2%
44
   4.1%
Pregnancy of a woman entered in the study
17
   7.1%
42
   7.0%
70
   6.6%
Symptomatic overdose (serious or non-serious) with IMP
0
   0.0%
0
   0.0%
0
   0.0%
Increase in ALT
0
   0.0%
0
   0.0%
1
   0.1%
Autoimmune mediated conditions
27
  11.2%
66
  11.0%
100
   9.4%
Hemophagocytic lymphohistiocytosis
0
   0.0%
0
   0.0%
0
   0.0%
Progressive multifocal leukoencephalopathy
0
   0.0%
0
   0.0%
0
   0.0%
Temporally associated AEs
2
   0.8%
4
   0.7%
9
   0.8%
Serious infections
10
   4.1%
35
   5.9%
60
   5.6%
Malignancy
6
   2.5%
15
   2.5%
27
   2.5%
Pneumonitis
0
   0.0%
0
   0.0%
0
   0.0%
4.Primary Outcome
Title Number of Participants With Potentially Clinically Significant Laboratory Abnormalities
Hide Description

Criteria for potentially clinically significant laboratory abnormalities included:

  • Hemoglobin (Hb): less than or equal to (<=)115 grams per liter (g/L)(Male [M]), <= 95 g/L (Female[ F]); greater than or equal to (>=)185 g/L (M), >= 165 g/L (F); Decrease From Baseline (DFB) >= 20 g/L.
  • Hematocrit: <= 0.37 volume/volume (v/v) (M); <= 0.32 v/v (F); >= 0.55 v/v (M); >= 0.5 v/v (F).
  • Red Blood Cells (RBCs): >=6 *10^12/L.
  • Platelets: <100 *10^9/L; >=700 *10^9/L. As pre-specified, data collection and analysis for this outcome measure was done on the overall population along with 2 subgroups (DAT and IAT).
Time Frame From Baseline until the end of the study (up to a maximum duration of 5.6 years)
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis was performed on all participants who had signed the ICF; and received study drug in the TOPAZ study; or in studies CAMMS223,CAMMS323,CAMMS324 or CAMMS03409, and did not complete 48 months of follow-up at the screening visit in the TOPAZ study. Here, 'Overall number of participants analyzed' = participants evaluable for this outcome measure and 'Number analyzed' = participants with available data for each specified category.
Arm/Group Title Delayed Alemtuzumab Treatment (DAT) Initial Alemtuzumab Treatment (IAT) Alemtuzumab (Overall)
Hide Arm/Group Description:
Participants from the SC IFNB1a treatment arms of studies CAMMS323 and CAMMS324, who received their initial 2 treatment courses of alemtuzumab during the CAMMS03409 extension study were included in the DAT subgroup of the current study (LPS13649). Participants received alemtuzumab intravenous infusion of 12 mg/day for 3 consecutive days, at the study investigators' discretion; and at least 12 months after the prior treatment course in the current study (LPS13649).
Participants from the 12 mg/day alemtuzumab treatment arms of the studies CAMMS323 and CAMMS324 (who were subsequently enrolled in CAMMS03409 extension study and then entered in this study LPS13649) were included in the IAT subgroup of the current study (LPS13649). Participants received alemtuzumab intravenous infusion of 12 mg/day for 3 consecutive days, at the study investigators' discretion; and at least 12 months after the prior treatment course in the current study (LPS13649).
All Participants who completed the study CAMMS03409 (extension study of CAMMS223 [NCT00050778], CAMMS323 [NCT00530348], or CAMMS324 [NCT00548405]) and received alemtuzumab within 48 months prior to enrollment were included in this LPS13649 study. Participants received alemtuzumab, intravenous infusion of 12 mg/day for 3 consecutive days, at the study investigators' discretion; and at least 12 months after the prior treatment course in the current study (LPS13649).
Overall Number of Participants Analyzed 214 316 619
Measure Type: Count of Participants
Unit of Measure: Participants
Hb:<=115 g/L, <=95 g/L Number Analyzed 214 participants 316 participants 619 participants
11
   5.1%
28
   8.9%
43
   6.9%
Hb: >=185 g/L, >=165 g/L Number Analyzed 214 participants 316 participants 619 participants
2
   0.9%
6
   1.9%
12
   1.9%
Hb: DFB >=20 g/L Number Analyzed 206 participants 293 participants 580 participants
32
  15.5%
50
  17.1%
98
  16.9%
Hematocrit: <= 0.37 v/v; <=0.32 v/v Number Analyzed 213 participants 315 participants 617 participants
20
   9.4%
42
  13.3%
70
  11.3%
Hematocrit: >=0.55 v/v; >=0.5 v/v Number Analyzed 213 participants 315 participants 617 participants
6
   2.8%
14
   4.4%
26
   4.2%
RBCs: >=6 *10^12/L Number Analyzed 214 participants 315 participants 618 participants
8
   3.7%
7
   2.2%
21
   3.4%
Platelets: <100 *10^9/L Number Analyzed 212 participants 314 participants 615 participants
5
   2.4%
16
   5.1%
25
   4.1%
Platelets: >=700 *10^9/L Number Analyzed 212 participants 314 participants 615 participants
1
   0.5%
0
   0.0%
1
   0.2%
5.Secondary Outcome
Title Annualized Relapse Rate
Hide Description Relapse was defined as new neurological symptoms or worsening of previous neurological symptoms with an objective change on neurological examination. Annualized relapse rate was obtained from the total number of confirmed relapses that occurred during the treatment follow up time of all participants divided by the total years of follow-up for all participants. The annualized relapse rate was estimated using a negative binomial model with robust variance estimation.
Time Frame Up to a maximum duration of 5.6 years
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis was performed on efficacy population which included all enrolled participants who had received study drug in studies CAMMS223, CAMMS323, CAMMS324 or CAMMS03409. As pre-specified, data collection and analysis for this outcome measure was done only on the 2 subgroups (DAT and IAT).
Arm/Group Title Delayed Alemtuzumab Treatment (DAT) Initial Alemtuzumab Treatment (IAT)
Hide Arm/Group Description:
Participants from the SC IFNB1a treatment arms of studies CAMMS323 and CAMMS324, who received their initial 2 treatment courses of alemtuzumab during the CAMMS03409 extension study were included in the DAT subgroup of the current study (LPS13649). Participants received alemtuzumab intravenous infusion of 12 mg/day for 3 consecutive days, at the study investigators' discretion; and at least 12 months after the prior treatment course in the current study (LPS13649).
Participants from the 12 mg/day alemtuzumab treatment arms of the studies CAMMS323 and CAMMS324 (who were subsequently enrolled in CAMMS03409 extension study and then entered in this study LPS13649) were included in the IAT subgroup of the current study (LPS13649). Participants received alemtuzumab intravenous infusion of 12 mg/day for 3 consecutive days, at the study investigators' discretion; and at least 12 months after the prior treatment course in the current study (LPS13649).
Overall Number of Participants Analyzed 241 598
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: relapses per participant per year
0.1994
(0.1710 to 0.2325)
0.1608
(0.1418 to 0.1823)
6.Secondary Outcome
Title Proportion of Participants Who Were Relapse Free
Hide Description Relapse was defined as new neurological symptoms or worsening of previous neurological symptoms with an objective change on neurological examination. The proportion of participants who were relapse free (without event) were estimated using the Kaplan-Meier method.
Time Frame Up to a maximum duration of 5.6 years
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis was performed on efficacy population. As pre-specified, data collection and analysis for this outcome measure was done only on the 2 subgroups (DAT and IAT).
Arm/Group Title Delayed Alemtuzumab Treatment (DAT) Initial Alemtuzumab Treatment (IAT)
Hide Arm/Group Description:
Participants from the SC IFNB1a treatment arms of studies CAMMS323 and CAMMS324, who received their initial 2 treatment courses of alemtuzumab during the CAMMS03409 extension study were included in the DAT subgroup of the current study (LPS13649). Participants received alemtuzumab intravenous infusion of 12 mg/day for 3 consecutive days, at the study investigators' discretion; and at least 12 months after the prior treatment course in the current study (LPS13649).
Participants from the 12 mg/day alemtuzumab treatment arms of the studies CAMMS323 and CAMMS324 (who were subsequently enrolled in CAMMS03409 extension study and then entered in this study LPS13649) were included in the IAT subgroup of the current study (LPS13649). Participants received alemtuzumab intravenous infusion of 12 mg/day for 3 consecutive days, at the study investigators' discretion; and at least 12 months after the prior treatment course in the current study (LPS13649).
Overall Number of Participants Analyzed 241 598
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: proportion of participants
29.59
(23.73 to 35.65)
36.86
(32.96 to 40.76)
7.Secondary Outcome
Title Change From Baseline in Expanded Disability Status Scale (EDSS) Score at Month 6, 12, 18, 24, 30, 36, 42, 48, 54 and 60
Hide Description EDSS is an ordinal scale in half-point increments that qualifies disability in participants with multiple sclerosis (MS). It consists of 8 ordinal rating scales assessing seven functional systems (pyramidal, cerebellar, brainstem, sensory, bowel and bladder, visual, cerebral, and other). EDSS total score ranges from 0 (normal neurological examination) to 10 (death due to MS), where higher scores indicated worst outcomes.
Time Frame Baseline (Month 0 of LPS13649), Month 6, 12, 18, 24, 30, 36, 42, 48, 54 and 60
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis was performed on efficacy population. Here, 'Number analyzed' = participants with available data for each specified category. As pre-specified, data collection and analysis for this outcome measure was done only on the 2 subgroups (DAT and IAT).
Arm/Group Title Delayed Alemtuzumab Treatment (DAT) Initial Alemtuzumab Treatment (IAT)
Hide Arm/Group Description:
Participants from the SC IFNB1a treatment arms of studies CAMMS323 and CAMMS324, who received their initial 2 treatment courses of alemtuzumab during the CAMMS03409 extension study were included in the DAT subgroup of the current study (LPS13649). Participants received alemtuzumab intravenous infusion of 12 mg/day for 3 consecutive days, at the study investigators' discretion; and at least 12 months after the prior treatment course in the current study (LPS13649).
Participants from the 12 mg/day alemtuzumab treatment arms of the studies CAMMS323 and CAMMS324 (who were subsequently enrolled in CAMMS03409 extension study and then entered in this study LPS13649) were included in the IAT subgroup of the current study (LPS13649). Participants received alemtuzumab intravenous infusion of 12 mg/day for 3 consecutive days, at the study investigators' discretion; and at least 12 months after the prior treatment course in the current study (LPS13649).
Overall Number of Participants Analyzed 241 598
Least Squares Mean (Standard Error)
Unit of Measure: score on a scale
Month 6 Number Analyzed 237 participants 583 participants
0.21  (0.092) 0.03  (0.065)
Month 12 Number Analyzed 234 participants 580 participants
0.27  (0.093) 0.08  (0.065)
Month 18 Number Analyzed 226 participants 562 participants
0.29  (0.096) 0.10  (0.067)
Month 24 Number Analyzed 227 participants 559 participants
0.28  (0.102) 0.15  (0.070)
Month 30 Number Analyzed 225 participants 547 participants
0.34  (0.102) 0.16  (0.071)
Month 36 Number Analyzed 219 participants 545 participants
0.38  (0.103) 0.18  (0.071)
Month 42 Number Analyzed 217 participants 515 participants
0.37  (0.103) 0.24  (0.071)
Month 48 Number Analyzed 204 participants 468 participants
0.46  (0.104) 0.27  (0.072)
Month 54 Number Analyzed 168 participants 346 participants
0.51  (0.106) 0.30  (0.074)
Month 60 Number Analyzed 55 participants 125 participants
0.43  (0.129) 0.32  (0.088)
8.Secondary Outcome
Title Brain Magnetic Resonance Imaging (MRI) Assessment: Number of Gadolinium Enhancing (Gd-enhancing) Lesions Per MRI Scan
Hide Description Number of Gd-enhancing lesions per scan was defined as the total number of Gd-enhancing lesions that occurred during the treatment period divided by the total number of scans performed during the treatment period. The adjusted cumulative count of lesions was estimated by a repeated negative binomial regression with generalized estimating equation (GEE) adjusted for analysis groups and geographic region as covariates.
Time Frame Up to a maximum duration of 5.6 years
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis was performed on efficacy population. As pre-specified, data collection and analysis for this outcome measure was done only on the 2 subgroups (DAT and IAT).
Arm/Group Title Delayed Alemtuzumab Treatment (DAT) Initial Alemtuzumab Treatment (IAT)
Hide Arm/Group Description:
Participants from the SC IFNB1a treatment arms of studies CAMMS323 and CAMMS324, who received their initial 2 treatment courses of alemtuzumab during the CAMMS03409 extension study were included in the DAT subgroup of the current study (LPS13649). Participants received alemtuzumab intravenous infusion of 12 mg/day for 3 consecutive days, at the study investigators' discretion; and at least 12 months after the prior treatment course in the current study (LPS13649).
Participants from the 12 mg/day alemtuzumab treatment arms of the studies CAMMS323 and CAMMS324 (who were subsequently enrolled in CAMMS03409 extension study and then entered in this study LPS13649) were included in the IAT subgroup of the current study (LPS13649). Participants received alemtuzumab intravenous infusion of 12 mg/day for 3 consecutive days, at the study investigators' discretion; and at least 12 months after the prior treatment course in the current study (LPS13649).
Overall Number of Participants Analyzed 241 598
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: lesions per scan
1.307
(0.880 to 1.941)
1.558
(1.153 to 2.105)
9.Secondary Outcome
Title Brain Magnetic Resonance Imaging (MRI) Assessment: Number of New or Enlarged T2 Lesions Per MRI Scan
Hide Description Number of new or enlarged T2 lesions per scan was defined as the total number of new or enlarged T2 lesion that occurred during treatment period divided by the total number of scans performed during treatment period. The adjusted cumulative count of lesions was estimated by a repeated negative binomial regression with GEE adjusted for analysis groups and geographic region as covariates.
Time Frame Up to a maximum duration of 5.6 years
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis was performed on efficacy population. As pre-specified, data collection and analysis for this outcome measure was done only on the 2 subgroups (DAT and IAT).
Arm/Group Title Delayed Alemtuzumab Treatment (DAT) Initial Alemtuzumab Treatment (IAT)
Hide Arm/Group Description:
Participants from the SC IFNB1a treatment arms of studies CAMMS323 and CAMMS324, who received their initial 2 treatment courses of alemtuzumab during the CAMMS03409 extension study were included in the DAT subgroup of the current study (LPS13649). Participants received alemtuzumab intravenous infusion of 12 mg/day for 3 consecutive days, at the study investigators' discretion; and at least 12 months after the prior treatment course in the current study (LPS13649).
Participants from the 12 mg/day alemtuzumab treatment arms of the studies CAMMS323 and CAMMS324 (who were subsequently enrolled in CAMMS03409 extension study and then entered in this study LPS13649) were included in the IAT subgroup of the current study (LPS13649). Participants received alemtuzumab intravenous infusion of 12 mg/day for 3 consecutive days, at the study investigators' discretion; and at least 12 months after the prior treatment course in the current study (LPS13649).
Overall Number of Participants Analyzed 241 598
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: lesions per scan
8.033
(6.001 to 10.753)
9.564
(7.656 to 11.946)
10.Secondary Outcome
Title Brain Magnetic Resonance Imaging (MRI) Assessment: Number of New T1 (and New Hypointense T1) Lesions Per MRI Scan
Hide Description Number of new T1 lesions per scan was defined as the total number of new T1 lesion (and New Hypointense T1) that occurred during treatment period divided by the total number of scans performed during treatment period.The adjusted cumulative count of lesions was estimated by a repeated negative binomial regression with GEE adjusted for analysis groups and geographic region as covariates.
Time Frame Up to a maximum duration of 5.6 years
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis was performed on efficacy population. As pre-specified, data collection and analysis for this outcome measure was done only on the 2 subgroups (DAT and IAT).
Arm/Group Title Delayed Alemtuzumab Treatment (DAT) Initial Alemtuzumab Treatment (IAT)
Hide Arm/Group Description:
Participants from the SC IFNB1a treatment arms of studies CAMMS323 and CAMMS324, who received their initial 2 treatment courses of alemtuzumab during the CAMMS03409 extension study were included in the DAT subgroup of the current study (LPS13649). Participants received alemtuzumab intravenous infusion of 12 mg/day for 3 consecutive days, at the study investigators' discretion; and at least 12 months after the prior treatment course in the current study (LPS13649).
Participants from the 12 mg/day alemtuzumab treatment arms of the studies CAMMS323 and CAMMS324 (who were subsequently enrolled in CAMMS03409 extension study and then entered in this study LPS13649) were included in the IAT subgroup of the current study (LPS13649). Participants received alemtuzumab intravenous infusion of 12 mg/day for 3 consecutive days, at the study investigators' discretion; and at least 12 months after the prior treatment course in the current study (LPS13649).
Overall Number of Participants Analyzed 241 598
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: lesions per scan
1.719
(1.141 to 2.589)
1.908
(1.386 to 2.628)
11.Secondary Outcome
Title Brain Magnetic Resonance Imaging (MRI) Assessment: Percent Change From Baseline in Volume of T1 Lesions at Months 12, 24, 36, 48, and 60
Hide Description The total lesion volume (T1 lesions) was measured by MRI scan.
Time Frame Baseline (Month 0 of LPS13649), Month 12, Month 24, Month 36, Month 48 and Month 60
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis was preformed on efficacy population. Here, 'Number analyzed' = participants with available data for each specified category. As pre-specified, data collection and analysis for this outcome measure was done only on the 2 subgroups (DAT and IAT).
Arm/Group Title Delayed Alemtuzumab Treatment (DAT) Initial Alemtuzumab Treatment (IAT)
Hide Arm/Group Description:
Participants from the SC IFNB1a treatment arms of studies CAMMS323 and CAMMS324, who received their initial 2 treatment courses of alemtuzumab during the CAMMS03409 extension study were included in the DAT subgroup of the current study (LPS13649). Participants received alemtuzumab intravenous infusion of 12 mg/day for 3 consecutive days, at the study investigators' discretion; and at least 12 months after the prior treatment course in the current study (LPS13649).
Participants from the 12 mg/day alemtuzumab treatment arms of the studies CAMMS323 and CAMMS324 (who were subsequently enrolled in CAMMS03409 extension study and then entered in this study LPS13649) were included in the IAT subgroup of the current study (LPS13649). Participants received alemtuzumab intravenous infusion of 12 mg/day for 3 consecutive days, at the study investigators' discretion; and at least 12 months after the prior treatment course in the current study (LPS13649).
Overall Number of Participants Analyzed 241 598
Mean (Standard Deviation)
Unit of Measure: percent change
Month 12 Number Analyzed 203 participants 501 participants
141.71  (449.79) 64.73  (241.92)
Month 24 Number Analyzed 202 participants 489 participants
130.73  (398.65) 67.48  (262.64)
Month 36 Number Analyzed 194 participants 478 participants
145.57  (404.35) 104.41  (524.62)
Month 48 Number Analyzed 185 participants 421 participants
163.30  (461.38) 76.90  (312.05)
Month 60 Number Analyzed 60 participants 116 participants
202.47  (499.46) 93.61  (260.51)
12.Secondary Outcome
Title Brain Magnetic Resonance Imaging (MRI) Assessment: Percent Change From Baseline in Volume of T2 Lesions at Months 12, 24, 36, 48, and 60
Hide Description The total lesion volume (T2 lesions) was measured by MRI scan.
Time Frame Baseline (Month 0 of LPS13649), Month 12, Month 24, Month 36, Month 48 and Month 60
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis was performed on efficacy population. Here, 'Number analyzed' = participants with available data for each specified category. As pre-specified, data collection and analysis for this outcome measure was done only on the 2 subgroups (DAT and IAT).
Arm/Group Title Delayed Alemtuzumab Treatment (DAT) Initial Alemtuzumab Treatment (IAT)
Hide Arm/Group Description:
Participants from the SC IFNB1a treatment arms of studies CAMMS323 and CAMMS324, who received their initial 2 treatment courses of alemtuzumab during the CAMMS03409 extension study were included in the DAT subgroup of the current study (LPS13649). Participants received alemtuzumab intravenous infusion of 12 mg/day for 3 consecutive days, at the study investigators' discretion; and at least 12 months after the prior treatment course in the current study (LPS13649).
Participants from the 12 mg/day alemtuzumab treatment arms of the studies CAMMS323 and CAMMS324 (who were subsequently enrolled in CAMMS03409 extension study and then entered in this study LPS13649) were included in the IAT subgroup of the current study (LPS13649). Participants received alemtuzumab intravenous infusion of 12 mg/day for 3 consecutive days, at the study investigators' discretion; and at least 12 months after the prior treatment course in the current study (LPS13649).
Overall Number of Participants Analyzed 241 598
Mean (Standard Deviation)
Unit of Measure: percent change
Month 12 Number Analyzed 226 participants 558 participants
21.44  (132.04) 9.09  (62.52)
Month 24 Number Analyzed 224 participants 542 participants
17.53  (76.73) 13.89  (62.45)
Month 36 Number Analyzed 216 participants 529 participants
24.24  (94.85) 22.02  (111.95)
Month 48 Number Analyzed 204 participants 462 participants
21.98  (80.06) 19.46  (70.72)
Month 60 Number Analyzed 67 participants 128 participants
32.03  (136.68) 17.95  (75.47)
13.Secondary Outcome
Title Brain Magnetic Resonance Imaging (MRI) Assessment: Percent Change From Baseline in Brain Parenchymal Fraction (BPF) at Month 12, 24, 36, 48, and 60
Hide Description The brain parenchymal fraction was measured by MRI scan.
Time Frame Baseline (Month 0 of LPS13649), Month 12, Month 24, Month 36, Month 48 and Month 60
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis was performed on efficacy population. Here, 'Number analyzed' = participants with available data for each specified category. As pre-specified, data collection and analysis for this outcome measure was done only on the 2 subgroups (DAT and IAT).
Arm/Group Title Delayed Alemtuzumab Treatment (DAT) Initial Alemtuzumab Treatment (IAT)
Hide Arm/Group Description:
Participants from the SC IFNB1a treatment arms of studies CAMMS323 and CAMMS324, who received their initial 2 treatment courses of alemtuzumab during the CAMMS03409 extension study were included in the DAT subgroup of the current study (LPS13649). Participants received alemtuzumab intravenous infusion of 12 mg/day for 3 consecutive days, at the study investigators' discretion; and at least 12 months after the prior treatment course in the current study (LPS13649).
Participants from the 12 mg/day alemtuzumab treatment arms of the studies CAMMS323 and CAMMS324 (who were subsequently enrolled in CAMMS03409 extension study and then entered in this study LPS13649) were included in the IAT subgroup of the current study (LPS13649). Participants received alemtuzumab intravenous infusion of 12 mg/day for 3 consecutive days, at the study investigators' discretion; and at least 12 months after the prior treatment course in the current study (LPS13649).
Overall Number of Participants Analyzed 241 598
Mean (Standard Deviation)
Unit of Measure: percent change
Month 12 Number Analyzed 221 participants 549 participants
-1.65  (1.59) -1.49  (1.55)
Month 24 Number Analyzed 220 participants 534 participants
-1.77  (1.56) -1.68  (1.64)
Month 36 Number Analyzed 215 participants 524 participants
-1.92  (1.56) -1.84  (1.71)
Month 48 Number Analyzed 203 participants 459 participants
-2.02  (1.58) -2.07  (1.78)
Month 60 Number Analyzed 66 participants 129 participants
-2.11  (1.67) -2.37  (1.65)
14.Secondary Outcome
Title Change From Baseline in Self-reported Quality of Life (QoL) as Assessed by the Medical Outcome Study (MOS) 36-Item Short-Form Health Survey (SF-36): Physical Component Summary (PCS) and Mental Component Summary (MCS) Scores at Month 12, 24, 36, 48, and 60
Hide Description The MOS SF-36 is an extensively validated and widely used measure of QoL that assesses participants' perceptions of health status and its impact on their lives. It consisted of 36 items organized into 8 scales (physical functioning, role physical, bodily pain, general health, vitality, social functioning, role emotional and mental health). Two summary measures of physical and mental health, the PCS and MCS, respectively, were derived from scale aggregates, and were reported in this outcome measure. The score range for each of these 2 summary scores was from 0 (worst) to 100 (best), higher scores indicated better QoL.
Time Frame Baseline (Month 0 of LPS13649), Month 12, Month 24, Month 36, Month 48 and Month 60
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis was performed on efficacy population. Here, 'Number analyzed' = participants with available data for each specified category. As pre-specified, data collection and analysis for this outcome measure was done only on the 2 subgroups (DAT and IAT).
Arm/Group Title Delayed Alemtuzumab Treatment (DAT) Initial Alemtuzumab Treatment (IAT)
Hide Arm/Group Description:
Participants from the SC IFNB1a treatment arms of studies CAMMS323 and CAMMS324, who received their initial 2 treatment courses of alemtuzumab during the CAMMS03409 extension study were included in the DAT subgroup of the current study (LPS13649). Participants received alemtuzumab intravenous infusion of 12 mg/day for 3 consecutive days, at the study investigators' discretion; and at least 12 months after the prior treatment course in the current study (LPS13649).
Participants from the 12 mg/day alemtuzumab treatment arms of the studies CAMMS323 and CAMMS324 (who were subsequently enrolled in CAMMS03409 extension study and then entered in this study LPS13649) were included in the IAT subgroup of the current study (LPS13649). Participants received alemtuzumab intravenous infusion of 12 mg/day for 3 consecutive days, at the study investigators' discretion; and at least 12 months after the prior treatment course in the current study (LPS13649).
Overall Number of Participants Analyzed 241 598
Mean (Standard Deviation)
Unit of Measure: score on a scale
PCS: Month 12 Number Analyzed 228 participants 559 participants
0.54  (9.38) 0.88  (8.72)
PCS: Month 24 Number Analyzed 216 participants 545 participants
0.20  (9.25) 0.59  (9.10)
PCS: Month 36 Number Analyzed 212 participants 534 participants
0.08  (9.88) 1.12  (9.18)
PCS: Month 48 Number Analyzed 199 participants 466 participants
-0.52  (10.15) 0.68  (9.57)
PCS: Month 60 Number Analyzed 80 participants 176 participants
-0.23  (8.85) 1.28  (8.88)
MCS: Month 12 Number Analyzed 228 participants 559 participants
2.21  (12.29) 0.89  (11.24)
MCS: Month 24 Number Analyzed 216 participants 545 participants
1.21  (12.23) 1.11  (11.93)
MCS: Month 36 Number Analyzed 212 participants 534 participants
1.55  (12.23) 0.94  (11.88)
MCS: Month 48 Number Analyzed 199 participants 466 participants
1.14  (12.93) 0.35  (12.38)
MCS: Month 60 Number Analyzed 80 participants 176 participants
0.94  (14.01) 0.45  (11.39)
15.Secondary Outcome
Title Change From Baseline in Functional Assessment of Multiple Sclerosis (FAMS) Score at Month 12, 24, 36, 48, and 60
Hide Description The FAMS is a self-reported multidimensional index comprising a total of 58 items on 7 subscales: mobility (7 items); symptoms (7 items); emotional well-being (7 items); general contentment (7 items); thinking and fatigue (9 items); family/social well-being (7 items); and additional concerns (14 items, these are not scored). Each item (except those for "additional concerns") was rated on a 5-point scale of 0 (lower quality of life) to 4 (higher quality of life). Total FAMS score was the sum of 44 scored items, which ranged from 0 (poor) to 176 (best), with higher numbers reflecting a higher quality of life.
Time Frame Baseline (Month 0 of LPS13649), Month 12, Month 24, Month 36, Month 48 and Month 60
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis was performed on efficacy population. Here, 'Number analyzed' = participants with available data for each specified category. As pre-specified, data collection and analysis for this outcome measure was done only on the 2 subgroups (DAT and IAT).
Arm/Group Title Delayed Alemtuzumab Treatment (DAT) Initial Alemtuzumab Treatment (IAT)
Hide Arm/Group Description:
Participants from the SC IFNB1a treatment arms of studies CAMMS323 and CAMMS324, who received their initial 2 treatment courses of alemtuzumab during the CAMMS03409 extension study were included in the DAT subgroup of the current study (LPS13649). Participants received alemtuzumab intravenous infusion of 12 mg/day for 3 consecutive days, at the study investigators' discretion; and at least 12 months after the prior treatment course in the current study (LPS13649).
Participants from the 12 mg/day alemtuzumab treatment arms of the studies CAMMS323 and CAMMS324 (who were subsequently enrolled in CAMMS03409 extension study and then entered in this study LPS13649) were included in the IAT subgroup of the current study (LPS13649). Participants received alemtuzumab intravenous infusion of 12 mg/day for 3 consecutive days, at the study investigators' discretion; and at least 12 months after the prior treatment course in the current study (LPS13649).
Overall Number of Participants Analyzed 241 598
Mean (Standard Deviation)
Unit of Measure: score on a scale
Month 12 Number Analyzed 230 participants 573 participants
1.05  (29.68) 2.83  (27.07)
Month 24 Number Analyzed 222 participants 551 participants
-0.45  (30.30) 2.73  (28.62)
Month 36 Number Analyzed 214 participants 532 participants
0.82  (30.52) 2.70  (28.94)
Month 48 Number Analyzed 202 participants 472 participants
-3.73  (31.46) 1.16  (29.38)
Month 60 Number Analyzed 81 participants 181 participants
-0.36  (31.25) 2.74  (26.61)
16.Secondary Outcome
Title Change From Baseline in European Quality of Life -5 Dimension (EQ-5D) Score: Utility Scores at Month 12, 24, 36, 48, and 60
Hide Description The EQ-5D is a generic, standardized instrument that provides a simple, descriptive profile and a single index value for health status used in the clinical and economic evaluation of health care as well as in population health surveys. The EQ-5D comprises 5 dimensions of health: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Each dimension measured on 3 levels: some, moderate, and extreme problems. The 5 dimensional 3-level systems was converted into single index utility score ranges from 0 to 100, where 100=best health state; and 0=worst health state; higher scores indicated better outcome.
Time Frame Baseline (Month 0 of LPS13649), Month 12, Month 24, Month 36, Month 48 and Month 60
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis was performed on efficacy population. Here, 'Number analyzed' = participants with available data for each specified category. As pre-specified, data collection and analysis for this outcome measure was done only on the 2 subgroups (DAT and IAT).
Arm/Group Title Delayed Alemtuzumab Treatment (DAT) Initial Alemtuzumab Treatment (IAT)
Hide Arm/Group Description:
Participants from the SC IFNB1a treatment arms of studies CAMMS323 and CAMMS324, who received their initial 2 treatment courses of alemtuzumab during the CAMMS03409 extension study were included in the DAT subgroup of the current study (LPS13649). Participants received alemtuzumab intravenous infusion of 12 mg/day for 3 consecutive days, at the study investigators' discretion; and at least 12 months after the prior treatment course in the current study (LPS13649).
Participants from the 12 mg/day alemtuzumab treatment arms of the studies CAMMS323 and CAMMS324 (who were subsequently enrolled in CAMMS03409 extension study and then entered in this study LPS13649) were included in the IAT subgroup of the current study (LPS13649). Participants received alemtuzumab intravenous infusion of 12 mg/day for 3 consecutive days, at the study investigators' discretion; and at least 12 months after the prior treatment course in the current study (LPS13649).
Overall Number of Participants Analyzed 241 598
Mean (Standard Deviation)
Unit of Measure: score on a scale
Month 12 Number Analyzed 231 participants 571 participants
-0.01  (0.26) -0.01  (0.26)
Month 24 Number Analyzed 225 participants 550 participants
-0.02  (0.28) -0.01  (0.26)
Month 36 Number Analyzed 218 participants 530 participants
-0.04  (0.27) -0.00  (0.26)
Month 48 Number Analyzed 207 participants 469 participants
-0.03  (0.27) -0.03  (0.27)
Month 60 Number Analyzed 83 participants 184 participants
-0.03  (0.29) -0.03  (0.25)
17.Secondary Outcome
Title Change From Baseline in EQ-5D Visual Analogue Scale (VAS) Scores at Month 12, 24, 36, 48, and 60
Hide Description EQ-5D VAS was used to record a participant's rating for his/her current health-related quality of life state and captured on a vertical VAS (0 to 100), where 0=worst imaginable health state to 100=best imaginable health state, and higher score indicated better outcome.
Time Frame Baseline (Month 0 of LPS13649), Month 12, Month 24, Month 36, Month 48 and Month 60
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis was performed on efficacy population. Here, 'Number analyzed' = participants with available data for each specified category. As pre-specified, data collection and analysis for this outcome measure was done only on the 2 subgroups (DAT and IAT).
Arm/Group Title Delayed Alemtuzumab Treatment (DAT) Initial Alemtuzumab Treatment (IAT)
Hide Arm/Group Description:
Participants from the SC IFNB1a treatment arms of studies CAMMS323 and CAMMS324, who received their initial 2 treatment courses of alemtuzumab during the CAMMS03409 extension study were included in the DAT subgroup of the current study (LPS13649). Participants received alemtuzumab intravenous infusion of 12 mg/day for 3 consecutive days, at the study investigators' discretion; and at least 12 months after the prior treatment course in the current study (LPS13649).
Participants from the 12 mg/day alemtuzumab treatment arms of the studies CAMMS323 and CAMMS324 (who were subsequently enrolled in CAMMS03409 extension study and then entered in this study LPS13649) were included in the IAT subgroup of the current study (LPS13649). Participants received alemtuzumab intravenous infusion of 12 mg/day for 3 consecutive days, at the study investigators' discretion; and at least 12 months after the prior treatment course in the current study (LPS13649).
Overall Number of Participants Analyzed 241 598
Mean (Standard Deviation)
Unit of Measure: score on a scale
Month 12 Number Analyzed 232 participants 560 participants
-2.09  (25.11) -1.05  (24.57)
Month 24 Number Analyzed 225 participants 545 participants
-1.57  (26.69) -0.39  (21.44)
Month 36 Number Analyzed 217 participants 527 participants
0.10  (22.61) 1.42  (20.64)
Month 48 Number Analyzed 199 participants 466 participants
-1.08  (23.66) -0.85  (23.94)
Month 60 Number Analyzed 82 participants 177 participants
-3.26  (27.04) -0.77  (26.26)
18.Secondary Outcome
Title Modified Healthcare Resource Utilization Questionnaire (HRUQ): Number of Participants Who Reported Change in Employment Situation, Availing of Sick Leaves, Admissions and Stays in Hospital, Rehabilitation Centers or Nursing Homes Due to Multiple Sclerosis
Hide Description Participants use of healthcare resources, non-medical resources, and informal care as well as their work capacity was assessed at scheduled study visits using a modified questionnaire (HRUQ) designed to evaluate the economic impact of MS. Questionnaire addresses the following content areas: employment situation and changes in employment situation due to MS;sick leaves,admissions and stays in hospital, rehabilitation centers, or nursing homes; typical MS-related investments (eg, stair and bed lift, ramps,rails) and devices (eg,walking aids,wheelchairs); assistance by community or social services (e.g. home nurse, transportation), or help from family or friends. Each question requires a binary answer (yes/no). Number of participants who reported "Yes" as an answer to "employment situation change; had sick leaves; had hospital admission; had spent time in rehabilitation center and had spent time in a nursing home or a similar institution" questions were reported in this outcome measure.
Time Frame Baseline (Month 0 of LPS13649), Month 12, Month 24, Month 36, Month 48 and Month 60
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis was performed on efficacy population. Here, 'Overall number of participants analyzed' = participants evaluable for this outcome measure and 'Number analyzed' = participants with available data for each specified category. As pre-specified, data collection and analysis for this outcome measure was done on the overall population along with 2 subgroups (DAT and IAT).
Arm/Group Title Delayed Alemtuzumab Treatment (DAT) Initial Alemtuzumab Treatment (IAT) Alemtuzumab
Hide Arm/Group Description:
Participants from the SC IFNB1a treatment arms of studies CAMMS323 and CAMMS324, who received their initial 2 treatment courses of alemtuzumab during the CAMMS03409 extension study were included in the DAT subgroup of the current study (LPS13649). Participants received alemtuzumab intravenous infusion of 12 mg/day for 3 consecutive days, at the study investigators' discretion; and at least 12 months after the prior treatment course in the current study (LPS13649).
Participants from the 12 mg/day alemtuzumab treatment arms of the studies CAMMS323 and CAMMS324 (who were subsequently enrolled in CAMMS03409 extension study and then entered in this study LPS13649) were included in the IAT subgroup of the current study (LPS13649). Participants received alemtuzumab intravenous infusion of 12 mg/day for 3 consecutive days, at the study investigators' discretion; and at least 12 months after the prior treatment course in the current study (LPS13649).
All Participants who completed the study CAMMS03409 (extension study of CAMMS223 [NCT00050778], CAMMS323 [NCT00530348], or CAMMS324 [NCT00548405]) and received alemtuzumab within 48 months prior to enrollment were included in this LPS13649 study. Participants received alemtuzumab, intravenous infusion of 12 mg/day for 3 consecutive days, at the study investigators' discretion; and at least 12 months after the prior treatment course in the current study (LPS13649).
Overall Number of Participants Analyzed 231 573 1020
Measure Type: Count of Participants
Unit of Measure: Participants
Employment situation change: Month 0 Number Analyzed 84 participants 224 participants 381 participants
3
   3.6%
7
   3.1%
12
   3.1%
Employment situation change: Month 12 Number Analyzed 230 participants 573 participants 1014 participants
11
   4.8%
25
   4.4%
44
   4.3%
Employment situation change: Month 24 Number Analyzed 220 participants 537 participants 960 participants
14
   6.4%
19
   3.5%
40
   4.2%
Employment situation change: Month 36 Number Analyzed 217 participants 518 participants 929 participants
12
   5.5%
26
   5.0%
44
   4.7%
Employment situation change: Month 48 Number Analyzed 200 participants 467 participants 850 participants
4
   2.0%
24
   5.1%
38
   4.5%
Employment situation change: Month 60 Number Analyzed 81 participants 182 participants 367 participants
3
   3.7%
8
   4.4%
14
   3.8%
Had sick leaves: Month 0 Number Analyzed 57 participants 157 participants 265 participants
6
  10.5%
14
   8.9%
21
   7.9%
Had sick leaves: Month 12 Number Analyzed 127 participants 373 participants 642 participants
19
  15.0%
45
  12.1%
77
  12.0%
Had sick leaves: Month 24 Number Analyzed 148 participants 360 participants 645 participants
23
  15.5%
42
  11.7%
80
  12.4%
Had sick leaves: Month 36 Number Analyzed 145 participants 324 participants 584 participants
21
  14.5%
44
  13.6%
78
  13.4%
Had sick leaves: Month 48 Number Analyzed 134 participants 307 participants 565 participants
18
  13.4%
31
  10.1%
60
  10.6%
Had sick leaves: Month 60 Number Analyzed 56 participants 127 participants 266 participants
9
  16.1%
10
   7.9%
25
   9.4%
Had hospital admission: Month 0 Number Analyzed 73 participants 203 participants 337 participants
4
   5.5%
23
  11.3%
32
   9.5%
Had hospital admission: Month 12 Number Analyzed 231 participants 570 participants 1018 participants
28
  12.1%
59
  10.4%
109
  10.7%
Had hospital admission: Month 24 Number Analyzed 223 participants 544 participants 974 participants
26
  11.7%
53
   9.7%
95
   9.8%
Had hospital admission: Month 36 Number Analyzed 218 participants 522 participants 938 participants
27
  12.4%
58
  11.1%
106
  11.3%
Had hospital admission: Month 48 Number Analyzed 202 participants 471 participants 859 participants
20
   9.9%
51
  10.8%
89
  10.4%
Had hospital admission: Month 60 Number Analyzed 81 participants 184 participants 374 participants
12
  14.8%
11
   6.0%
28
   7.5%
Had spent time in rehabilitation center: Month 0 Number Analyzed 74 participants 200 participants 334 participants
0
   0.0%
6
   3.0%
8
   2.4%
Had spent time in rehabilitation center: Month 12 Number Analyzed 230 participants 573 participants 1020 participants
12
   5.2%
21
   3.7%
45
   4.4%
Had spent time in rehabilitation center: Month 24 Number Analyzed 223 participants 540 participants 968 participants
17
   7.6%
18
   3.3%
45
   4.6%
Had spent time in rehabilitation center: Month 36 Number Analyzed 217 participants 532 participants 946 participants
12
   5.5%
19
   3.6%
36
   3.8%
Had spent time in rehabilitation center: Month 48 Number Analyzed 203 participants 474 participants 864 participants
12
   5.9%
24
   5.1%
45
   5.2%
Had spent time in rehabilitation center: Month 60 Number Analyzed 81 participants 184 participants 374 participants
5
   6.2%
6
   3.3%
18
   4.8%
Had spent time in a nursing home: Month 0 Number Analyzed 73 participants 198 participants 332 participants
0
   0.0%
0
   0.0%
0
   0.0%
Had spent time in a nursing home: Month 12 Number Analyzed 229 participants 572 participants 1019 participants
0
   0.0%
5
   0.9%
8
   0.8%
Had spent time in a nursing home: Month 24 Number Analyzed 222 participants 545 participants 972 participants
3
   1.4%
4
   0.7%
7
   0.7%
Had spent time in a nursing home: Month 36 Number Analyzed 218 participants 523 participants 938 participants
3
   1.4%
3
   0.6%
8
   0.9%
Had spent time in a nursing home: Month 48 Number Analyzed 202 participants 472 participants 860 participants
4
   2.0%
4
   0.8%
11
   1.3%
Had spent time in a nursing home: Month 60 Number Analyzed 81 participants 184 participants 369 participants
0
   0.0%
4
   2.2%
6
   1.6%
19.Secondary Outcome
Title Modified HRUQ: Number of Participants Who Reported Other Changes/Changes in Lifestyle Due to Multiple Sclerosis
Hide Description Participants use of healthcare resources, non-medical resources, and informal care as well as their work capacity was assessed at scheduled study visits using a modified questionnaire (HRUQ) designed to evaluate the economic impact of MS.Questionnaire addresses following content areas: employment situation and changes in employment situation due to MS; admissions and stays in hospital, rehabilitation centers, or nursing homes; typical MS-related investments(e.g.stair and bed lift,ramps,rails) and devices(e.g.walking aids,wheelchairs);assistance by community or social services(e.g.home nurse, transportation), or help from family or friends. Each question requires a binary answer (yes/no). Number of participants who reported other changes/changes in lifestyle due to MS, i.e."Yes" as an answer to "had made changes to your house, apartment, car or did you require any special equipment or aids; assistance required; other assistance required" questions were reported in this outcome measure.
Time Frame Baseline (Month 0 of LPS13649), Month 12, Month 24, Month 36, Month 48 and Month 60
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis was performed on efficacy population. Here, 'Overall number of participants analyzed' = participants evaluable for this outcome measure and 'Number analyzed' = participants with available data for each specified category. As pre-specified, data collection and analysis for this outcome measure was done on the overall population along with 2 subgroups (DAT and IAT).
Arm/Group Title Delayed Alemtuzumab Treatment (DAT) Initial Alemtuzumab Treatment (IAT) Alemtuzumab
Hide Arm/Group Description:
Participants from the SC IFNB1a treatment arms of studies CAMMS323 and CAMMS324, who received their initial 2 treatment courses of alemtuzumab during the CAMMS03409 extension study were included in the DAT subgroup of the current study (LPS13649). Participants received alemtuzumab intravenous infusion of 12 mg/day for 3 consecutive days, at the study investigators' discretion; and at least 12 months after the prior treatment course in the current study (LPS13649).
Participants from the 12 mg/day alemtuzumab treatment arms of the studies CAMMS323 and CAMMS324 (who were subsequently enrolled in CAMMS03409 extension study and then entered in this study LPS13649) were included in the IAT subgroup of the current study (LPS13649). Participants received alemtuzumab intravenous infusion of 12 mg/day for 3 consecutive days, at the study investigators' discretion; and at least 12 months after the prior treatment course in the current study (LPS13649).
All Participants who completed the study CAMMS03409 (extension study of CAMMS223 [NCT00050778], CAMMS323 [NCT00530348], or CAMMS324 [NCT00548405]) and received alemtuzumab within 48 months prior to enrollment were included in this LPS13649 study. Participants received alemtuzumab, intravenous infusion of 12 mg/day for 3 consecutive days, at the study investigators' discretion; and at least 12 months after the prior treatment course in the current study (LPS13649).
Overall Number of Participants Analyzed 231 573 1020
Measure Type: Count of Participants
Unit of Measure: Participants
Had made changes to your house, apartment, car: Month 0 Number Analyzed 75 participants 202 participants 339 participants
0
   0.0%
3
   1.5%
7
   2.1%
Had made changes to your house, apartment, car: Month 12 Number Analyzed 231 participants 571 participants 1020 participants
11
   4.8%
21
   3.7%
42
   4.1%
Had made changes to your house, apartment, car: Month 24 Number Analyzed 222 participants 544 participants 972 participants
10
   4.5%
25
   4.6%
47
   4.8%
Had made changes to your house, apartment, car: Month 36 Number Analyzed 219 participants 527 participants 944 participants
16
   7.3%
15
   2.8%
45
   4.8%
Had made changes to your house, apartment, car: Month 48 Number Analyzed 203 participants 472 participants 859 participants
10
   4.9%
25
   5.3%
42
   4.9%
Had made changes to your house, apartment, car: Month 60 Number Analyzed 80 participants 185 participants 372 participants
5
   6.3%
3
   1.6%
12
   3.2%
Had required assistance: Month 0 Number Analyzed 72 participants 201 participants 335 participants
4
   5.6%
10
   5.0%
24
   7.2%
Had required assistance: Month 12 Number Analyzed 227 participants 573 participants 1015 participants
24
  10.6%
45
   7.9%
88
   8.7%
Had required assistance: Month 24 Number Analyzed 221 participants 535 participants 962 participants
26
  11.8%
44
   8.2%
86
   8.9%
Had required assistance: Month 36 Number Analyzed 217 participants 522 participants 937 participants
22
  10.1%
35
   6.7%
79
   8.4%
Had required assistance: Month 48 Number Analyzed 203 participants 466 participants 852 participants
12
   5.9%
45
   9.7%
75
   8.8%
Had required assistance: Month 60 Number Analyzed 82 participants 180 participants 369 participants
8
   9.8%
10
   5.6%
26
   7.0%
Had required other assistance: Month 0 Number Analyzed 71 participants 202 participants 335 participants
15
  21.1%
48
  23.8%
77
  23.0%
Had required other assistance: Month 12 Number Analyzed 226 participants 572 participants 1011 participants
57
  25.2%
144
  25.2%
252
  24.9%
Had required other assistance: Month 24 Number Analyzed 222 participants 530 participants 958 participants
57
  25.7%
135
  25.5%
241
  25.2%
Had required other assistance: Month 36 Number Analyzed 217 participants 523 participants 936 participants
48
  22.1%
119
  22.8%
215
  23.0%
Had required other assistance: Month 48 Number Analyzed 201 participants 463 participants 848 participants
49
  24.4%
119
  25.7%
211
  24.9%
Had required other assistance: Month 60 Number Analyzed 82 participants 180 participants 367 participants
22
  26.8%
27
  15.0%
66
  18.0%
20.Secondary Outcome
Title Health Related Productivity Questionnaire (HRPQ): Number of Participants Reporting Current Employment Status (Part Time/Full Time/Not Employed) Due to Multiple Sclerosis
Hide Description Participants use of healthcare resources, non-medical resources, and informal care as well as their work capacity was assessed at scheduled study visits using a modified questionnaire (HRPQ) designed to evaluate the economic impact of MS. The questionnaire addresses the following content area: participant reported data regarding employment status, work productivity, impact on household chores due to MS. Current employment status of participants (i.e. Part Time/Full Time/Not Employed) was reported in this outcome measure.
Time Frame Baseline (Month 0 of LPS13649), Month 12, Month 24, Month 36, Month 48 and Month 60
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis was performed on efficacy population. Here, 'Overall number of participants analyzed' = participants evaluable for this outcome measure and 'Number analyzed' = participants with available data for each specified category. As pre-specified, data collection and analysis for this outcome measure was done on the overall population along with 2 subgroups (DAT and IAT).
Arm/Group Title Delayed Alemtuzumab Treatment (DAT) Initial Alemtuzumab Treatment (IAT) Alemtuzumab
Hide Arm/Group Description:
Participants from the SC IFNB1a treatment arms of studies CAMMS323 and CAMMS324, who received their initial 2 treatment courses of alemtuzumab during the CAMMS03409 extension study were included in the DAT subgroup of the current study (LPS13649). Participants received alemtuzumab intravenous infusion of 12 mg/day for 3 consecutive days, at the study investigators' discretion; and at least 12 months after the prior treatment course in the current study (LPS13649).
Participants from the 12 mg/day alemtuzumab treatment arms of the studies CAMMS323 and CAMMS324 (who were subsequently enrolled in CAMMS03409 extension study and then entered in this study LPS13649) were included in the IAT subgroup of the current study (LPS13649). Participants received alemtuzumab intravenous infusion of 12 mg/day for 3 consecutive days, at the study investigators' discretion; and at least 12 months after the prior treatment course in the current study (LPS13649).
All Participants who completed the study CAMMS03409 (extension study of CAMMS223 [NCT00050778], CAMMS323 [NCT00530348], or CAMMS324 [NCT00548405]) and received alemtuzumab within 48 months prior to enrollment were included in this LPS13649 study. Participants received alemtuzumab, intravenous infusion of 12 mg/day for 3 consecutive days, at the study investigators' discretion; and at least 12 months after the prior treatment course in the current study (LPS13649).
Overall Number of Participants Analyzed 234 575 1025
Measure Type: Count of Participants
Unit of Measure: Participants
Full time: Month 0 Number Analyzed 234 participants 575 participants 1025 participants
127
  54.3%
297
  51.7%
528
  51.5%
Part time: Month 0 Number Analyzed 234 participants 575 participants 1025 participants
20
   8.5%
54
   9.4%
98
   9.6%
Not employed: Month 0 Number Analyzed 234 participants 575 participants 1025 participants
87
  37.2%
224
  39.0%
399
  38.9%
Full time: Month 12 Number Analyzed 229 participants 569 participants 1013 participants
121
  52.8%
291
  51.1%
511
  50.4%
Part time: Month 12 Number Analyzed 229 participants 569 participants 1013 participants
20
   8.7%
53
   9.3%
104
  10.3%
Not employed: Month 12 Number Analyzed 229 participants 569 participants 1013 participants
88
  38.4%
225
  39.5%
398
  39.3%
Full time: Month 24 Number Analyzed 223 participants 549 participants 980 participants
118
  52.9%
273
  49.7%
488
  49.8%
Part time: Month 24 Number Analyzed 223 participants 549 participants 980 participants
21
   9.4%
66
  12.0%
117
  11.9%
Not employed: Month 24 Number Analyzed 223 participants 549 participants 980 participants
84
  37.7%
210
  38.3%
375
  38.3%
Full time: Month 36 Number Analyzed 216 participants 530 participants 943 participants
109
  50.5%
273
  51.5%
478
  50.7%
Part time: Month 36 Number Analyzed 216 participants 530 participants 943 participants
23
  10.6%
57
  10.8%
108
  11.5%
Not employed: Month 36 Number Analyzed 216 participants 530 participants 943 participants
84
  38.9%
200
  37.7%
357
  37.9%
Full time: Month 48 Number Analyzed 204 participants 469 participants 860 participants
108
  52.9%
225
  48.0%
424
  49.3%
Part time: Month 48 Number Analyzed 204 participants 469 participants 860 participants
21
  10.3%
57
  12.2%
103
  12.0%
Not employed: Month 48 Number Analyzed 204 participants 469 participants 860 participants
75
  36.8%
187
  39.9%
333
  38.7%
Full time: Month 60 Number Analyzed 82 participants 183 participants 374 participants
37
  45.1%
97
  53.0%
189
  50.5%
Part time: Month 60 Number Analyzed 82 participants 183 participants 374 participants
10
  12.2%
18
   9.8%
43
  11.5%
Not employed: Month 60 Number Analyzed 82 participants 183 participants 374 participants
35
  42.7%
68
  37.2%
142
  38.0%
21.Secondary Outcome
Title HRPQ: Total Scheduled Working Hours and Number of Hours Missed From Work Due to Multiple Sclerosis
Hide Description Participants use of healthcare resources, non-medical resources, and informal care as well as their work capacity was assessed at scheduled study visits using a modified questionnaire (HRPQ) designed to evaluate the economic impact of MS. The questionnaire addresses the following content area: participant reported data regarding employment status, work productivity, impact on household chores due to MS. Data for "total scheduled working hours of participants; number of hours missed from work by participants due to MS" were reported in this outcome measure.
Time Frame Baseline (Month 0 of LPS13649), Month 12, Month 24, Month 36, Month 48 and Month 60
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis was performed on efficacy population. Here, 'Overall number of participants analyzed' = participants evaluable for this outcome measure and 'Number analyzed' = participants with available data for each specified category. As pre-specified, data collection and analysis for this outcome measure was done on the overall population along with 2 subgroups (DAT and IAT).
Arm/Group Title Delayed Alemtuzumab Treatment (DAT) Initial Alemtuzumab Treatment (IAT) Alemtuzumab
Hide Arm/Group Description:
Participants from the SC IFNB1a treatment arms of studies CAMMS323 and CAMMS324, who received their initial 2 treatment courses of alemtuzumab during the CAMMS03409 extension study were included in the DAT subgroup of the current study (LPS13649). Participants received alemtuzumab intravenous infusion of 12 mg/day for 3 consecutive days, at the study investigators' discretion; and at least 12 months after the prior treatment course in the current study (LPS13649).
Participants from the 12 mg/day alemtuzumab treatment arms of the studies CAMMS323 and CAMMS324 (who were subsequently enrolled in CAMMS03409 extension study and then entered in this study LPS13649) were included in the IAT subgroup of the current study (LPS13649). Participants received alemtuzumab intravenous infusion of 12 mg/day for 3 consecutive days, at the study investigators' discretion; and at least 12 months after the prior treatment course in the current study (LPS13649).
All Participants who completed the study CAMMS03409 (extension study of CAMMS223 [NCT00050778], CAMMS323 [NCT00530348], or CAMMS324 [NCT00548405]) and received alemtuzumab within 48 months prior to enrollment were included in this LPS13649 study. Participants received alemtuzumab, intravenous infusion of 12 mg/day for 3 consecutive days, at the study investigators' discretion; and at least 12 months after the prior treatment course in the current study (LPS13649).
Overall Number of Participants Analyzed 153 380 675
Mean (Standard Deviation)
Unit of Measure: hours
Total scheduled working hours: Month 0 Number Analyzed 153 participants 374 participants 660 participants
34.0  (14.6) 32.2  (16.1) 32.9  (16.1)
Total scheduled working hours: Month 12 Number Analyzed 152 participants 380 participants 675 participants
33.6  (15.4) 32.3  (16.6) 32.5  (16.6)
Total scheduled working hours: Month 24 Number Analyzed 149 participants 367 participants 647 participants
33.2  (15.5) 30.8  (16.1) 31.6  (16.1)
Total scheduled working hours: Month 36 Number Analyzed 137 participants 343 participants 615 participants
33.6  (16.4) 33.1  (15.1) 33.3  (15.3)
Total scheduled working hours: Month 48 Number Analyzed 137 participants 302 participants 559 participants
34.4  (19.7) 31.3  (16.3) 32.9  (17.0)
Total scheduled working hours: Month 60 Number Analyzed 52 participants 124 participants 249 participants
27.3  (18.9) 31.1  (15.8) 31.1  (16.6)
Number of hours missed from work: Month 0 Number Analyzed 8 participants 21 participants 39 participants
9.8  (12.1) 15.2  (15.0) 11.7  (12.8)
Number of hours missed from work: Month 12 Number Analyzed 14 participants 23 participants 47 participants
6.7  (3.6) 10.1  (12.2) 9.0  (10.2)
Number of hours missed from work: Month 24 Number Analyzed 9 participants 22 participants 41 participants
6.7  (6.1) 10.6  (11.3) 10.4  (10.9)
Number of hours missed from work: Month 36 Number Analyzed 6 participants 21 participants 35 participants
9.3  (5.9) 24.7  (65.4) 18.7  (50.8)
Number of hours missed from work: Month 48 Number Analyzed 11 participants 21 participants 42 participants
21.5  (23.1) 37.7  (107.6) 28.0  (77.1)
Number of hours missed from work: Month 60 Number Analyzed 2 participants 5 participants 12 participants
14.5  (13.4) 13.4  (13.4) 13.9  (13.0)
22.Secondary Outcome
Title HRPQ: Percentage Impact on Work Output Due to Multiple Sclerosis
Hide Description Participants use of healthcare resources, non-medical resources, and informal care as well as their work capacity was assessed at scheduled study visits using a modified questionnaire (HRPQ) designed to evaluate the economic impact of MS. The questionnaire addresses the following content area: participant reported data regarding employment status, work productivity, impact on household chores due to MS. Percentage impact on work output due to MS were reported in this outcome measure.
Time Frame Baseline (Month 0 of LPS13649), Month 12, Month 24, Month 36, Month 48 and Month 60
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis was performed on efficacy population. Here, 'Overall number of participants analyzed' = participants evaluable for this outcome measure and 'Number analyzed' = participants with available data for each specified category. As pre-specified, data collection and analysis for this outcome measure was done on the overall population along with 2 subgroups (DAT and IAT).
Arm/Group Title Delayed Alemtuzumab Treatment (DAT) Initial Alemtuzumab Treatment (IAT) Alemtuzumab (Overall)
Hide Arm/Group Description:
Participants from the SC IFNB1a treatment arms of studies CAMMS323 and CAMMS324, who received their initial 2 treatment courses of alemtuzumab during the CAMMS03409 extension study were included in the DAT subgroup of the current study (LPS13649). Participants received alemtuzumab intravenous infusion of 12 mg/day for 3 consecutive days, at the study investigators' discretion; and at least 12 months after the prior treatment course in the current study (LPS13649).
Participants from the 12 mg/day alemtuzumab treatment arms of the studies CAMMS323 and CAMMS324 (who were subsequently enrolled in CAMMS03409 extension study and then entered in this study LPS13649) were included in the IAT subgroup of the current study (LPS13649). Participants received alemtuzumab intravenous infusion of 12 mg/day for 3 consecutive days, at the study investigators' discretion; and at least 12 months after the prior treatment course in the current study (LPS13649).
All Participants who completed the study CAMMS03409 (extension study of CAMMS223 [NCT00050778], CAMMS323 [NCT00530348], or CAMMS324 [NCT00548405]) and received alemtuzumab within 48 months prior to enrollment were included in this LPS13649 study. Participants received alemtuzumab, intravenous infusion of 12 mg/day for 3 consecutive days, at the study investigators' discretion; and at least 12 months after the prior treatment course in the current study (LPS13649).
Overall Number of Participants Analyzed 145 351 622
Mean (Standard Deviation)
Unit of Measure: percentage impact on work output
Month 0 Number Analyzed 145 participants 349 participants 622 participants
6.2  (14.4) 10.2  (22.3) 8.5  (19.5)
Month 12 Number Analyzed 138 participants 351 participants 622 participants
8.7  (18.0) 9.5  (21.5) 9.0  (20.2)
Month 24 Number Analyzed 137 participants 335 participants 596 participants
9.9  (20.4) 9.4  (21.2) 9.8  (21.3)
Month 36 Number Analyzed 128 participants 316 participants 571 participants
9.2  (20.0) 9.9  (21.3) 9.4  (19.9)
Month 48 Number Analyzed 129 participants 279 participants 525 participants
12.2  (25.4) 9.3  (21.7) 9.7  (22.0)
Month 60 Number Analyzed 43 participants 115 participants 231 participants
11.7  (22.3) 8.1  (18.9) 9.2  (19.9)
23.Secondary Outcome
Title HRPQ: Total Scheduled Household Chores Hours; Number of Hours Missed From Household Chores Due to Multiple Sclerosis
Hide Description Participants use of healthcare resources, non-medical resources, and informal care as well as their work capacity was assessed at scheduled study visits using a modified questionnaire (HRPQ) designed to evaluate the economic impact of MS. The questionnaire addresses the following content area: participant reported data regarding employment status, work productivity, impact on household chores due to MS. Data for "total scheduled household chores hours; number of hours missed from planned household chores by participants due to MS" were reported in this outcome measure.
Time Frame Baseline (Month 0 of LPS13649), Month 12, Month 24, Month 36, Month 48 and Month 60
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis was performed on efficacy population.Here, 'Overall number of participants analyzed' = participants evaluable for this outcome measure and 'Number analyzed' = participants with available data for each specified category. As pre-specified, data collection and analysis for this outcome measure was done on the overall population along with 2 subgroups (DAT and IAT).
Arm/Group Title Delayed Alemtuzumab Treatment (DAT) Initial Alemtuzumab Treatment (IAT) Alemtuzumab
Hide Arm/Group Description:
Participants from the SC IFNB1a treatment arms of studies CAMMS323 and CAMMS324, who received their initial 2 treatment courses of alemtuzumab during the CAMMS03409 extension study were included in the DAT subgroup of the current study (LPS13649). Participants received alemtuzumab intravenous infusion of 12 mg/day for 3 consecutive days, at the study investigators' discretion; and at least 12 months after the prior treatment course in the current study (LPS13649).
Participants from the 12 mg/day alemtuzumab treatment arms of the studies CAMMS323 and CAMMS324 (who were subsequently enrolled in CAMMS03409 extension study and then entered in this study LPS13649) were included in the IAT subgroup of the current study (LPS13649). Participants received alemtuzumab intravenous infusion of 12 mg/day for 3 consecutive days, at the study investigators' discretion; and at least 12 months after the prior treatment course in the current study (LPS13649).
All Participants who completed the study CAMMS03409 (extension study of CAMMS223 [NCT00050778], CAMMS323 [NCT00530348], or CAMMS324 [NCT00548405]) and received alemtuzumab within 48 months prior to enrollment were included in this LPS13649 study. Participants received alemtuzumab, intravenous infusion of 12 mg/day for 3 consecutive days, at the study investigators' discretion; and at least 12 months after the prior treatment course in the current study (LPS13649).
Overall Number of Participants Analyzed 228 562 1004
Mean (Standard Deviation)
Unit of Measure: hours
Total scheduled household chores hours: Month 0 Number Analyzed 228 participants 558 participants 993 participants
9.8  (8.3) 11.0  (11.0) 10.8  (10.6)
Total scheduled household chores hours: Month 12 Number Analyzed 226 participants 562 participants 1004 participants
10.3  (10.1) 11.1  (11.7) 10.9  (11.5)
Total scheduled household chores hours: Month 24 Number Analyzed 219 participants 538 participants 954 participants
10.2  (11.6) 10.9  (11.4) 10.6  (11.4)
Total scheduled household chores hours: Month 36 Number Analyzed 203 participants 505 participants 899 participants
9.7  (10.2) 11.7  (13.1) 11.0  (12.1)
Total scheduled household chores hours: Month 48 Number Analyzed 193 participants 452 participants 825 participants
9.9  (8.9) 10.5  (10.6) 10.3  (10.3)
Total scheduled household chores hours: Month 60 Number Analyzed 77 participants 178 participants 363 participants
10.4  (8.7) 11.2  (11.1) 11.5  (12.6)
Number of hours missed from household chores: Month 0 Number Analyzed 39 participants 104 participants 188 participants
4.7  (3.3) 6.5  (6.9) 6.0  (5.9)
Number of hours missed from household chores: Month 12 Number Analyzed 47 participants 90 participants 173 participants
4.9  (3.5) 6.8  (7.7) 6.2  (6.6)
Number of hours missed from household chores: Month 24 Number Analyzed 35 participants 104 participants 181 participants
7.8  (9.0) 7.1  (10.6) 6.6  (9.3)
Number of hours missed from household chores: Month 36 Number Analyzed 33 participants 91 participants 161 participants
6.1  (7.4) 7.7  (14.2) 7.0  (11.7)
Number of hours missed from household chores: Month 48 Number Analyzed 37 participants 74 participants 143 participants
4.8  (4.3) 6.2  (10.6) 5.7  (8.4)
Number of hours missed from household chores: Month 60 Number Analyzed 15 participants 24 participants 51 participants
5.3  (5.2) 5.8  (5.1) 5.9  (5.1)
24.Secondary Outcome
Title HRPQ: Percentage Impact on Work Output for Household Chores Due to Multiple Sclerosis
Hide Description Participants use of healthcare resources, non-medical resources, and informal care as well as their work capacity was assessed at scheduled study visits using a modified questionnaire (HRPQ) designed to evaluate the economic impact of MS. The questionnaire addresses the following content area: participant reported data regarding employment status, work productivity, impact on household chores due to MS. Percentage impact on work output for household chores due to MS were reported in this outcome measure.
Time Frame Baseline (Month 0 of LPS13649), Month 12, Month 24, Month 36, Month 48 and Month 60
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis was performed on efficacy population. Here, 'Overall number of participants analyzed' = participants evaluable for this outcome measure and 'Number analyzed' = participants with available data for each specified category. As pre-specified, data collection and analysis for this outcome measure was done on the overall population along with 2 subgroups (DAT and IAT).
Arm/Group Title Delayed Alemtuzumab Treatment (DAT) Initial Alemtuzumab Treatment (IAT) Alemtuzumab
Hide Arm/Group Description:
Participants from the SC IFNB1a treatment arms of studies CAMMS323 and CAMMS324, who received their initial 2 treatment courses of alemtuzumab during the CAMMS03409 extension study were included in the DAT subgroup of the current study (LPS13649). Participants received alemtuzumab intravenous infusion of 12 mg/day for 3 consecutive days, at the study investigators' discretion; and at least 12 months after the prior treatment course in the current study (LPS13649).
Participants from the 12 mg/day alemtuzumab treatment arms of the studies CAMMS323 and CAMMS324 (who were subsequently enrolled in CAMMS03409 extension study and then entered in this study LPS13649) were included in the IAT subgroup of the current study (LPS13649). Participants received alemtuzumab intravenous infusion of 12 mg/day for 3 consecutive days, at the study investigators' discretion; and at least 12 months after the prior treatment course in the current study (LPS13649).
All Participants who completed the study CAMMS03409 (extension study of CAMMS223 [NCT00050778], CAMMS323 [NCT00530348], or CAMMS324 [NCT00548405]) and received alemtuzumab within 48 months prior to enrollment were included in this LPS13649 study. Participants received alemtuzumab, intravenous infusion of 12 mg/day for 3 consecutive days, at the study investigators' discretion; and at least 12 months after the prior treatment course in the current study (LPS13649).
Overall Number of Participants Analyzed 212 531 947
Mean (Standard Deviation)
Unit of Measure: percentage impact on work output
Month 0 Number Analyzed 212 participants 531 participants 947 participants
16.0  (23.8) 16.4  (26.0) 16.8  (25.8)
Month 12 Number Analyzed 208 participants 524 participants 931 participants
18.3  (27.3) 16.6  (26.6) 17.7  (27.5)
Month 24 Number Analyzed 197 participants 501 participants 886 participants
20.3  (28.5) 18.5  (27.4) 19.4  (28.1)
Month 36 Number Analyzed 183 participants 453 participants 813 participants
17.5  (25.9) 16.5  (26.2) 17.6  (26.6)
Month 48 Number Analyzed 180 participants 415 participants 769 participants
19.8  (28.8) 17.0  (26.8) 18.6  (27.7)
Month 60 Number Analyzed 75 participants 170 participants 344 participants
18.8  (28.3) 13.1  (22.9) 14.8  (25.0)
25.Secondary Outcome
Title HRPQ: Duration of Disease (in Months) Since Development of Multiple Sclerosis
Hide Description Participants use of healthcare resources, non-medical resources, and informal care as well as their work capacity was assessed at scheduled study visits using a modified questionnaire (HRPQ) designed to evaluate the economic impact of MS. The questionnaire addresses the following content area: participant reported data regarding employment status, work productivity, impact on household chores due to MS. Mean and standard deviation data for duration of MS disease (in months) since the start of MS development in participants was reported in this outcome measure.
Time Frame Baseline up to end of the study (up to a maximum duration of 5.6 years)
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis was performed on efficacy population. Here, 'Overall number of participants analyzed' = participants evaluable for this outcome measure. As pre-specified, data collection and analysis for this outcome measure was done on the overall population along with 2 subgroups (DAT and IAT).
Arm/Group Title Delayed Alemtuzumab Treatment (DAT) Initial Alemtuzumab Treatment (IAT) Alemtuzumab
Hide Arm/Group Description:
Participants from the SC IFNB1a treatment arms of studies CAMMS323 and CAMMS324, who received their initial 2 treatment courses of alemtuzumab during the CAMMS03409 extension study were included in the DAT subgroup of the current study (LPS13649). Participants received alemtuzumab intravenous infusion of 12 mg/day for 3 consecutive days, at the study investigators' discretion; and at least 12 months after the prior treatment course in the current study (LPS13649).
Participants from the 12 mg/day alemtuzumab treatment arms of the studies CAMMS323 and CAMMS324 (who were subsequently enrolled in CAMMS03409 extension study and then entered in this study LPS13649) were included in the IAT subgroup of the current study (LPS13649). Participants received alemtuzumab intravenous infusion of 12 mg/day for 3 consecutive days, at the study investigators' discretion; and at least 12 months after the prior treatment course in the current study (LPS13649).
All Participants who completed the study CAMMS03409 (extension study of CAMMS223 [NCT00050778], CAMMS323 [NCT00530348], or CAMMS324 [NCT00548405]) and received alemtuzumab within 48 months prior to enrollment were included in this LPS13649 study. Participants received alemtuzumab, intravenous infusion of 12 mg/day for 3 consecutive days, at the study investigators' discretion; and at least 12 months after the prior treatment course in the current study (LPS13649).
Overall Number of Participants Analyzed 228 559 997
Mean (Standard Deviation)
Unit of Measure: months
10.3  (4.0) 10.2  (5.0) 10.5  (4.5)
26.Secondary Outcome
Title HRPQ: Number of Participants Who Reported Impact on Work Due to Multiple Sclerosis
Hide Description Participants use of healthcare resources, non-medical resources, and informal care as well as their work capacity was assessed at scheduled study visits using a modified questionnaire (HRPQ) designed to evaluate the economic impact of MS. The questionnaire addresses the following content area: participant reported data regarding employment status, work productivity, impact on household chores due to MS. Number of participants who reported "Yes" as an answer to questions related to impact on work: "forced me to work part-time when I wanted to work full-time; kept me from having a job when I wanted to work full-time; kept me from having a job when I wanted to work part-time; none of the above" questions were reported in this outcome measure.
Time Frame Baseline up to end of the study (up to a maximum duration of 5.6 years)
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis was performed on efficacy population. Here, 'Overall number of participants analyzed' = participants evaluable for this outcome measure and 'Number analyzed' = participants with available data for each specified category. As pre-specified, data collection and analysis for this outcome measure was done on the overall population along with 2 subgroups (DAT and IAT).
Arm/Group Title Delayed Alemtuzumab Treatment (DAT) Initial Alemtuzumab Treatment (IAT) Alemtuzumab
Hide Arm/Group Description:
Participants from the SC IFNB1a treatment arms of studies CAMMS323 and CAMMS324, who received their initial 2 treatment courses of alemtuzumab during the CAMMS03409 extension study were included in the DAT subgroup of the current study (LPS13649). Participants received alemtuzumab intravenous infusion of 12 mg/day for 3 consecutive days, at the study investigators' discretion; and at least 12 months after the prior treatment course in the current study (LPS13649).
Participants from the 12 mg/day alemtuzumab treatment arms of the studies CAMMS323 and CAMMS324 (who were subsequently enrolled in CAMMS03409 extension study and then entered in this study LPS13649) were included in the IAT subgroup of the current study (LPS13649). Participants received alemtuzumab intravenous infusion of 12 mg/day for 3 consecutive days, at the study investigators' discretion; and at least 12 months after the prior treatment course in the current study (LPS13649).
All Participants who completed the study CAMMS03409 (extension study of CAMMS223 [NCT00050778], CAMMS323 [NCT00530348], or CAMMS324 [NCT00548405]) and received alemtuzumab within 48 months prior to enrollment were included in this LPS13649 study. Participants received alemtuzumab, intravenous infusion of 12 mg/day for 3 consecutive days, at the study investigators' discretion; and at least 12 months after the prior treatment course in the current study (LPS13649).
Overall Number of Participants Analyzed 164 399 709
Measure Type: Count of Participants
Unit of Measure: Participants
My MS or treatments forced me to work part-time when I wanted to work full-time Number Analyzed 22 participants 81 participants 125 participants
22
 100.0%
81
 100.0%
125
 100.0%
My MS or treatments kept me from having a job when I wanted to work full-time Number Analyzed 32 participants 88 participants 168 participants
32
 100.0%
88
 100.0%
168
 100.0%
My MS or treatments kept me from having a job when I wanted to work part-time Number Analyzed 20 participants 42 participants 81 participants
20
 100.0%
42
 100.0%
81
 100.0%
None of the above Number Analyzed 164 participants 399 participants 709 participants
164
 100.0%
399
 100.0%
709
 100.0%
Time Frame All Adverse Events were collected from the Baseline until the end of the study (up to a maximum duration of 5.6 years).
Adverse Event Reporting Description Reported adverse events and death were TEAEs that is AEs that developed/worsened during the 'treatment period' (time from Baseline until the end of the study). Analysis was performed on safety population. As pre-specified, safety analysis was done on the overall population along with 2 subgroups (DAT and IAT).
 
Arm/Group Title Delayed Alemtuzumab Treatment (DAT) Initial Alemtuzumab Treatment (IAT) Alemtuzumab
Hide Arm/Group Description Participants from the SC IFNB1a treatment arms of studies CAMMS323 and CAMMS324, who received their initial 2 treatment courses of alemtuzumab during the CAMMS03409 extension study were included in the DAT subgroup of the current study (LPS13649). Participants received alemtuzumab intravenous infusion of 12 mg/day for 3 consecutive days, at the study investigators' discretion; and at least 12 months after the prior treatment course in the current study (LPS13649). Participants from the 12 mg/day alemtuzumab treatment arms of the studies CAMMS323 and CAMMS324 (who were subsequently enrolled in CAMMS03409 extension study and then entered in this study LPS13649) were included in the IAT subgroup of the current study (LPS13649). Participants received alemtuzumab intravenous infusion of 12 mg/day for 3 consecutive days, at the study investigators' discretion; and at least 12 months after the prior treatment course in the current study (LPS13649). All Participants who completed the study CAMMS03409 (extension study of CAMMS223 [NCT00050778], CAMMS323 [NCT00530348], or CAMMS324 [NCT00548405]) and received alemtuzumab within 48 months prior to enrollment were included in this LPS13649 study. Participants received alemtuzumab, intravenous infusion of 12 mg/day for 3 consecutive days, at the study investigators' discretion; and at least 12 months after the prior treatment course in the current study (LPS13649).
All-Cause Mortality
Delayed Alemtuzumab Treatment (DAT) Initial Alemtuzumab Treatment (IAT) Alemtuzumab
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/241 (0.00%)      10/598 (1.67%)      11/1062 (1.04%)    
Hide Serious Adverse Events
Delayed Alemtuzumab Treatment (DAT) Initial Alemtuzumab Treatment (IAT) Alemtuzumab
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   55/241 (22.82%)      133/598 (22.24%)      237/1062 (22.32%)    
Blood and lymphatic system disorders       
Febrile Neutropenia  1  0/241 (0.00%)  0 0/598 (0.00%)  0 1/1062 (0.09%)  1
Immune Thrombocytopenia  1  0/241 (0.00%)  0 2/598 (0.33%)  4 2/1062 (0.19%)  4
Lymphopenia  1  0/241 (0.00%)  0 1/598 (0.17%)  1 1/1062 (0.09%)  1
Thrombocytopenia  1  1/241 (0.41%)  1 2/598 (0.33%)  2 3/1062 (0.28%)  3
Cardiac disorders       
Acute Left Ventricular Failure  1  0/241 (0.00%)  0 1/598 (0.17%)  1 1/1062 (0.09%)  1
Acute Myocardial Infarction  1  1/241 (0.41%)  1 2/598 (0.33%)  2 4/1062 (0.38%)  4
Atrioventricular Block  1  0/241 (0.00%)  0 1/598 (0.17%)  1 1/1062 (0.09%)  1
Bundle Branch Block Left  1  0/241 (0.00%)  0 1/598 (0.17%)  1 1/1062 (0.09%)  1
Coronary Artery Disease  1  1/241 (0.41%)  1 0/598 (0.00%)  0 2/1062 (0.19%)  2
Left Ventricular Dysfunction  1  1/241 (0.41%)  1 0/598 (0.00%)  0 1/1062 (0.09%)  1
Mitral Valve Incompetence  1  0/241 (0.00%)  0 1/598 (0.17%)  1 1/1062 (0.09%)  1
Myocardial Infarction  1  1/241 (0.41%)  1 1/598 (0.17%)  1 2/1062 (0.19%)  2
Pericardial Effusion  1  0/241 (0.00%)  0 1/598 (0.17%)  1 1/1062 (0.09%)  1
Sinus Tachycardia  1  1/241 (0.41%)  1 0/598 (0.00%)  0 2/1062 (0.19%)  2
Ventricular Arrhythmia  1  0/241 (0.00%)  0 1/598 (0.17%)  1 1/1062 (0.09%)  1
Congenital, familial and genetic disorders       
Atrial Septal Defect  1  1/241 (0.41%)  1 0/598 (0.00%)  0 1/1062 (0.09%)  1
Congenital Cystic Kidney Disease  1  1/241 (0.41%)  1 0/598 (0.00%)  0 1/1062 (0.09%)  1
Congenital Nail Disorder  1  0/241 (0.00%)  0 0/598 (0.00%)  0 1/1062 (0.09%)  1
Foetal Chromosome Abnormality  1  0/241 (0.00%)  0 1/598 (0.17%)  1 1/1062 (0.09%)  1
Trisomy 21  1  0/241 (0.00%)  0 1/598 (0.17%)  1 1/1062 (0.09%)  1
Ear and labyrinth disorders       
Haematotympanum  1  0/241 (0.00%)  0 1/598 (0.17%)  1 1/1062 (0.09%)  1
Vertigo  1  0/241 (0.00%)  0 1/598 (0.17%)  1 1/1062 (0.09%)  1
Endocrine disorders       
Autoimmune Hypothyroidism  1  1/241 (0.41%)  1 0/598 (0.00%)  0 1/1062 (0.09%)  1
Autoimmune Thyroid Disorder  1  1/241 (0.41%)  1 0/598 (0.00%)  0 1/1062 (0.09%)  1
Autoimmune Thyroiditis  1  1/241 (0.41%)  1 0/598 (0.00%)  0 1/1062 (0.09%)  1
Basedow's Disease  1  2/241 (0.83%)  2 4/598 (0.67%)  4 7/1062 (0.66%)  7
Hyperthyroidism  1  0/241 (0.00%)  0 0/598 (0.00%)  0 1/1062 (0.09%)  3
Hypothyroidism  1  0/241 (0.00%)  0 1/598 (0.17%)  1 1/1062 (0.09%)  1
Thyroid Dermatopathy  1  0/241 (0.00%)  0 1/598 (0.17%)  1 1/1062 (0.09%)  1
Eye disorders       
Cataract  1  0/241 (0.00%)  0 1/598 (0.17%)  2 1/1062 (0.09%)  2
Endocrine Ophthalmopathy  1  0/241 (0.00%)  0 1/598 (0.17%)  1 1/1062 (0.09%)  1
Exophthalmos  1  1/241 (0.41%)  2 0/598 (0.00%)  0 1/1062 (0.09%)  2
Eyelid Ptosis  1  1/241 (0.41%)  1 0/598 (0.00%)  0 1/1062 (0.09%)  1
Glaucoma  1  0/241 (0.00%)  0 1/598 (0.17%)  1 1/1062 (0.09%)  1
Optic Ischaemic Neuropathy  1  0/241 (0.00%)  0 0/598 (0.00%)  0 1/1062 (0.09%)  1
Periorbital Oedema  1  0/241 (0.00%)  0 1/598 (0.17%)  1 1/1062 (0.09%)  1
Gastrointestinal disorders       
Abdominal Pain Upper  1  0/241 (0.00%)  0 1/598 (0.17%)  1 1/1062 (0.09%)  1
Colitis Ulcerative  1  0/241 (0.00%)  0 0/598 (0.00%)  0 1/1062 (0.09%)  1
Diarrhoea  1  1/241 (0.41%)  2 0/598 (0.00%)  0 1/1062 (0.09%)  2
Gastric Ulcer Perforation  1  0/241 (0.00%)  0 1/598 (0.17%)  1 1/1062 (0.09%)  1
Gastritis  1  0/241 (0.00%)  0 2/598 (0.33%)  2 3/1062 (0.28%)  3
Haematemesis  1  1/241 (0.41%)  1 0/598 (0.00%)  0 1/1062 (0.09%)  1
Haemorrhoids  1  0/241 (0.00%)  0 1/598 (0.17%)  1 1/1062 (0.09%)  1
Inguinal Hernia  1  0/241 (0.00%)  0 2/598 (0.33%)  2 2/1062 (0.19%)  2
Intestinal Ischaemia  1  0/241 (0.00%)  0 1/598 (0.17%)  1 1/1062 (0.09%)  1
Intestinal Obstruction  1  0/241 (0.00%)  0 0/598 (0.00%)  0 1/1062 (0.09%)  1
Intussusception  1  0/241 (0.00%)  0 1/598 (0.17%)  1 1/1062 (0.09%)  1
Obstructive Pancreatitis  1  0/241 (0.00%)  0 0/598 (0.00%)  0 1/1062 (0.09%)  1
Pancreatitis Acute  1  2/241 (0.83%)  2 0/598 (0.00%)  0 2/1062 (0.19%)  2
Pancreatitis Chronic  1  0/241 (0.00%)  0 0/598 (0.00%)  0 1/1062 (0.09%)  2
Small Intestinal Obstruction  1  0/241 (0.00%)  0 1/598 (0.17%)  3 1/1062 (0.09%)  3
General disorders       
Catheter Site Pain  1  0/241 (0.00%)  0 1/598 (0.17%)  1 1/1062 (0.09%)  1
Complication Associated With Device  1  0/241 (0.00%)  0 1/598 (0.17%)  1 1/1062 (0.09%)  1
Death  1  0/241 (0.00%)  0 2/598 (0.33%)  2 2/1062 (0.19%)  2
Drug Intolerance  1  1/241 (0.41%)  1 0/598 (0.00%)  0 1/1062 (0.09%)  1
Hyperthermia  1  0/241 (0.00%)  0 1/598 (0.17%)  1 1/1062 (0.09%)  1
Non-Cardiac Chest Pain  1  1/241 (0.41%)  1 1/598 (0.17%)  1 2/1062 (0.19%)  2
Pyrexia  1  0/241 (0.00%)  0 1/598 (0.17%)  1 1/1062 (0.09%)  1
Sudden Death  1  0/241 (0.00%)  0 1/598 (0.17%)  1 1/1062 (0.09%)  1
Hepatobiliary disorders       
Cholecystitis  1  2/241 (0.83%)  2 0/598 (0.00%)  0 3/1062 (0.28%)  3
Cholelithiasis  1  1/241 (0.41%)  1 2/598 (0.33%)  2 4/1062 (0.38%)  4
Immune system disorders       
Drug Hypersensitivity  1  0/241 (0.00%)  0 1/598 (0.17%)  1 1/1062 (0.09%)  1
Immune Reconstitution Inflammatory Syndrome  1  1/241 (0.41%)  2 0/598 (0.00%)  0 1/1062 (0.09%)  2
Sarcoidosis  1  1/241 (0.41%)  1 0/598 (0.00%)  0 1/1062 (0.09%)  1
Infections and infestations       
Abdominal Abscess  1  0/241 (0.00%)  0 1/598 (0.17%)  1 1/1062 (0.09%)  1
Abscess Rupture  1  0/241 (0.00%)  0 1/598 (0.17%)  1 1/1062 (0.09%)  1
Anal Abscess  1  0/241 (0.00%)  0 0/598 (0.00%)  0 1/1062 (0.09%)  1
Appendicitis  1  0/241 (0.00%)  0 2/598 (0.33%)  2 2/1062 (0.19%)  2
Bacteraemia  1  0/241 (0.00%)  0 1/598 (0.17%)  1 1/1062 (0.09%)  1
Bacterial Sepsis  1  1/241 (0.41%)  1 0/598 (0.00%)  0 1/1062 (0.09%)  1
Cellulitis  1  0/241 (0.00%)  0 3/598 (0.50%)  7 4/1062 (0.38%)  8
Cellulitis Staphylococcal  1  0/241 (0.00%)  0 0/598 (0.00%)  0 1/1062 (0.09%)  1
Clostridium Difficile Colitis  1  0/241 (0.00%)  0 2/598 (0.33%)  2 2/1062 (0.19%)  2
Clostridium Difficile Infection  1  1/241 (0.41%)  1 0/598 (0.00%)  0 1/1062 (0.09%)  1
Diverticulitis  1  1/241 (0.41%)  1 0/598 (0.00%)  0 1/1062 (0.09%)  1
Endocarditis  1  0/241 (0.00%)  0 0/598 (0.00%)  0 1/1062 (0.09%)  2
Erysipelas  1  0/241 (0.00%)  0 1/598 (0.17%)  1 1/1062 (0.09%)  1
Escherichia Urinary Tract Infection  1  0/241 (0.00%)  0 1/598 (0.17%)  1 1/1062 (0.09%)  1
Gangrene  1  0/241 (0.00%)  0 1/598 (0.17%)  1 1/1062 (0.09%)  1
Gastroenteritis  1  0/241 (0.00%)  0 1/598 (0.17%)  1 1/1062 (0.09%)  1
Gastrointestinal Bacterial Infection  1  0/241 (0.00%)  0 0/598 (0.00%)  0 1/1062 (0.09%)  1
Herpes Zoster  1  0/241 (0.00%)  0 3/598 (0.50%)  3 3/1062 (0.28%)  3
Herpes Zoster Infection Neurological  1  0/241 (0.00%)  0 1/598 (0.17%)  1 1/1062 (0.09%)  1
Infected Bite  1  0/241 (0.00%)  0 1/598 (0.17%)  1 1/1062 (0.09%)  1
Infected Lymphocele  1  0/241 (0.00%)  0 1/598 (0.17%)  2 1/1062 (0.09%)  2
Influenza  1  0/241 (0.00%)  0 0/598 (0.00%)  0 1/1062 (0.09%)  1
Klebsiella Infection  1  0/241 (0.00%)  0 1/598 (0.17%)  1 1/1062 (0.09%)  1
Localised Infection  1  0/241 (0.00%)  0 0/598 (0.00%)  0 1/1062 (0.09%)  1
Neonatal Pneumonia  1  1/241 (0.41%)  1 0/598 (0.00%)  0 1/1062 (0.09%)  1
Osteomyelitis Acute  1  0/241 (0.00%)  0 1/598 (0.17%)  1 1/1062 (0.09%)  1
Periodontitis  1  0/241 (0.00%)  0 1/598 (0.17%)  1 1/1062 (0.09%)  1
Pneumonia  1  1/241 (0.41%)  1 4/598 (0.67%)  4 9/1062 (0.85%)  10
Pneumonia Bacterial  1  0/241 (0.00%)  0 2/598 (0.33%)  2 2/1062 (0.19%)  2
Pneumonia Streptococcal  1  1/241 (0.41%)  1 0/598 (0.00%)  0 1/1062 (0.09%)  1
Postoperative Wound Infection  1  0/241 (0.00%)  0 2/598 (0.33%)  2 2/1062 (0.19%)  2
Pyelonephritis  1  1/241 (0.41%)  1 1/598 (0.17%)  1 3/1062 (0.28%)  3
Scrotal Abscess  1  1/241 (0.41%)  1 0/598 (0.00%)  0 1/1062 (0.09%)  1
Sepsis  1  1/241 (0.41%)  1 2/598 (0.33%)  3 5/1062 (0.47%)  7
Septic Shock  1  0/241 (0.00%)  0 3/598 (0.50%)  3 4/1062 (0.38%)  4
Urinary Tract Infection  1  2/241 (0.83%)  3 4/598 (0.67%)  4 9/1062 (0.85%)  10
Urinary Tract Infection Bacterial  1  0/241 (0.00%)  0 1/598 (0.17%)  1 1/1062 (0.09%)  1
Urosepsis  1  0/241 (0.00%)  0 1/598 (0.17%)  1 2/1062 (0.19%)  2
Uterine Infection  1  1/241 (0.41%)  1 0/598 (0.00%)  0 1/1062 (0.09%)  1
Injury, poisoning and procedural complications       
Accidental Overdose  1  0/241 (0.00%)  0 1/598 (0.17%)  1 1/1062 (0.09%)  1
Ankle Fracture  1  0/241 (0.00%)  0 2/598 (0.33%)  2 3/1062 (0.28%)  3
Brain Contusion  1  0/241 (0.00%)  0 1/598 (0.17%)  1 1/1062 (0.09%)  1
Burns Third Degree  1  0/241 (0.00%)  0 0/598 (0.00%)  0 1/1062 (0.09%)  1
Craniocerebral Injury  1  0/241 (0.00%)  0 1/598 (0.17%)  1 1/1062 (0.09%)  1
Face Injury  1  0/241 (0.00%)  0 1/598 (0.17%)  1 1/1062 (0.09%)  1
Fall  1  1/241 (0.41%)  2 1/598 (0.17%)  1 2/1062 (0.19%)  3
Femur Fracture  1  1/241 (0.41%)  1 0/598 (0.00%)  0 1/1062 (0.09%)  1
Foot Fracture  1  0/241 (0.00%)  0 0/598 (0.00%)  0 1/1062 (0.09%)  1
Head Injury  1  0/241 (0.00%)  0 1/598 (0.17%)  1 1/1062 (0.09%)  1
Humerus Fracture  1  1/241 (0.41%)  1 0/598 (0.00%)  0 1/1062 (0.09%)  1
Induced Abortion Failed  1  0/241 (0.00%)  0 0/598 (0.00%)  0 1/1062 (0.09%)  1
Intentional Overdose  1  0/241 (0.00%)  0 1/598 (0.17%)  3 1/1062 (0.09%)  3
Meniscus Injury  1  0/241 (0.00%)  0 0/598 (0.00%)  0 1/1062 (0.09%)  1
Post Procedural Hypotension  1  1/241 (0.41%)  1 0/598 (0.00%)  0 1/1062 (0.09%)  1
Radius Fracture  1  0/241 (0.00%)  0 0/598 (0.00%)  0 1/1062 (0.09%)  1
Skull Fractured Base  1  0/241 (0.00%)  0 1/598 (0.17%)  1 1/1062 (0.09%)  1
Subdural Haematoma  1  0/241 (0.00%)  0 1/598 (0.17%)  1 1/1062 (0.09%)  1
Tendon Rupture  1  0/241 (0.00%)  0 1/598 (0.17%)  1 1/1062 (0.09%)  1
Tibia Fracture  1  0/241 (0.00%)  0 0/598 (0.00%)  0 1/1062 (0.09%)  1
Traumatic Fracture  1  0/241 (0.00%)  0 2/598 (0.33%)  2 2/1062 (0.19%)  2
Ulna Fracture  1  1/241 (0.41%)  1 0/598 (0.00%)  0 1/1062 (0.09%)  1
Upper Limb Fracture  1  0/241 (0.00%)  0 0/598 (0.00%)  0 1/1062 (0.09%)  1
Wrist Fracture  1  0/241 (0.00%)  0 0/598 (0.00%)  0 1/1062 (0.09%)  1
Investigations       
Antiphospholipid Antibodies Positive  1  1/241 (0.41%)  1 0/598 (0.00%)  0 1/1062 (0.09%)  1
Human Papilloma Virus Test Positive  1  0/241 (0.00%)  0 0/598 (0.00%)  0 1/1062 (0.09%)  1
Lymphocyte Count Decreased  1  0/241 (0.00%)  0 2/598 (0.33%)  2 2/1062 (0.19%)  2
Metabolism and nutrition disorders       
Dehydration  1  1/241 (0.41%)  1 1/598 (0.17%)  1 2/1062 (0.19%)  2
Diabetes Mellitus  1  0/241 (0.00%)  0 0/598 (0.00%)  0 1/1062 (0.09%)  1
Diabetic Ketosis  1  0/241 (0.00%)  0 1/598 (0.17%)  1 1/1062 (0.09%)  1
Electrolyte Imbalance  1  1/241 (0.41%)  1 0/598 (0.00%)  0 1/1062 (0.09%)  1
Hyperglycaemia  1  1/241 (0.41%)  1 0/598 (0.00%)  0 1/1062 (0.09%)  1
Type 1 Diabetes Mellitus  1  0/241 (0.00%)  0 3/598 (0.50%)  4 3/1062 (0.28%)  4
Type 2 Diabetes Mellitus  1  1/241 (0.41%)  1 0/598 (0.00%)  0 1/1062 (0.09%)  1
Musculoskeletal and connective tissue disorders       
Arthralgia  1  0/241 (0.00%)  0 1/598 (0.17%)  2 1/1062 (0.09%)  2
Back Pain  1  0/241 (0.00%)  0 1/598 (0.17%)  1 1/1062 (0.09%)  1
Joint Contracture  1  0/241 (0.00%)  0 1/598 (0.17%)  1 1/1062 (0.09%)  1
Muscular Weakness  1  0/241 (0.00%)  0 1/598 (0.17%)  2 1/1062 (0.09%)  2
Musculoskeletal Pain  1  0/241 (0.00%)  0 2/598 (0.33%)  2 2/1062 (0.19%)  2
Osteonecrosis  1  0/241 (0.00%)  0 0/598 (0.00%)  0 1/1062 (0.09%)  1
Systemic Lupus Erythematosus  1  0/241 (0.00%)  0 1/598 (0.17%)  1 1/1062 (0.09%)  1
Neoplasms benign, malignant and unspecified (incl cysts and polyps)       
Basal Cell Carcinoma  1  0/241 (0.00%)  0 1/598 (0.17%)  3 2/1062 (0.19%)  4
Breast Cancer  1  0/241 (0.00%)  0 0/598 (0.00%)  0 1/1062 (0.09%)  1
Brenner Tumour  1  0/241 (0.00%)  0 1/598 (0.17%)  1 1/1062 (0.09%)  1
Cervix Carcinoma Stage 0  1  1/241 (0.41%)  1 0/598 (0.00%)  0 1/1062 (0.09%)  1
Cutaneous T-Cell Lymphoma  1  1/241 (0.41%)  1 0/598 (0.00%)  0 1/1062 (0.09%)  1
Gallbladder Cancer Stage Iii  1  0/241 (0.00%)  0 1/598 (0.17%)  1 1/1062 (0.09%)  1
Intraductal Proliferative Breast Lesion  1  1/241 (0.41%)  1 0/598 (0.00%)  0 1/1062 (0.09%)  1
Invasive Ductal Breast Carcinoma  1  0/241 (0.00%)  0 1/598 (0.17%)  1 3/1062 (0.28%)  3
Invasive Lobular Breast Carcinoma  1  1/241 (0.41%)  1 0/598 (0.00%)  0 1/1062 (0.09%)  1
Laryngeal Squamous Cell Carcinoma  1  1/241 (0.41%)  1 0/598 (0.00%)  0 1/1062 (0.09%)  1
Lung Squamous Cell Carcinoma Stage Iii  1  0/241 (0.00%)  0 0/598 (0.00%)  0 1/1062 (0.09%)  1
Malignant Melanoma  1  0/241 (0.00%)  0 1/598 (0.17%)  1 1/1062 (0.09%)  1
Malignant Melanoma In Situ  1  0/241 (0.00%)  0 1/598 (0.17%)  1 1/1062 (0.09%)  1
Malignant Neoplasm Of Unknown Primary Site  1  0/241 (0.00%)  0 1/598 (0.17%)  1 1/1062 (0.09%)  1
Neuroma  1  0/241 (0.00%)  0 1/598 (0.17%)  1 1/1062 (0.09%)  1
Non-Hodgkin's Lymphoma  1  0/241 (0.00%)  0 1/598 (0.17%)  1 1/1062 (0.09%)  1
Ovarian Adenoma  1  1/241 (0.41%)  1 1/598 (0.17%)  1 2/1062 (0.19%)  2
Ovarian Cancer  1  1/241 (0.41%)  1 0/598 (0.00%)  0 1/1062 (0.09%)  1
Ovarian Germ Cell Teratoma  1  0/241 (0.00%)  0 0/598 (0.00%)  0 1/1062 (0.09%)  1
Prostate Cancer  1  0/241 (0.00%)  0 1/598 (0.17%)  1 1/1062 (0.09%)  1
Rectal Cancer Metastatic  1  0/241 (0.00%)  0 1/598 (0.17%)  1 1/1062 (0.09%)  1
Squamous Cell Carcinoma Of Skin  1  0/241 (0.00%)  0 1/598 (0.17%)  1 1/1062 (0.09%)  1
Uterine Cancer  1  1/241 (0.41%)  1 0/598 (0.00%)  0 1/1062 (0.09%)  1
Uterine Leiomyoma  1  1/241 (0.41%)  1 3/598 (0.50%)  3 5/1062 (0.47%)  5
Nervous system disorders       
Ataxia  1  0/241 (0.00%)  0 1/598 (0.17%)  1 1/1062 (0.09%)  1
Dizziness  1  0/241 (0.00%)  0 1/598 (0.17%)  1 1/1062 (0.09%)  1
Dysarthria  1  0/241 (0.00%)  0 1/598 (0.17%)  1 1/1062 (0.09%)  1
Encephalopathy  1  0/241 (0.00%)  0 2/598 (0.33%)  2 2/1062 (0.19%)  2
Epilepsy  1  0/241 (0.00%)  0 1/598 (0.17%)  1 1/1062 (0.09%)  1
Generalised Tonic-Clonic Seizure  1  0/241 (0.00%)  0 2/598 (0.33%)  2 2/1062 (0.19%)  2
Headache  1  2/241 (0.83%)  2 1/598 (0.17%)  1 3/1062 (0.28%)  3
Limbic Encephalitis  1  0/241 (0.00%)  0 1/598 (0.17%)  1 1/1062 (0.09%)  1
Loss Of Consciousness  1  0/241 (0.00%)  0 1/598 (0.17%)  1 1/1062 (0.09%)  1
Lumbosacral Radiculopathy  1  0/241 (0.00%)  0 1/598 (0.17%)  1 1/1062 (0.09%)  1
Multiple Sclerosis  1  0/241 (0.00%)  0 0/598 (0.00%)  0 1/1062 (0.09%)  1
Multiple Sclerosis Relapse  1  6/241 (2.49%)  6 18/598 (3.01%)  30 30/1062 (2.82%)  43
Optic Neuritis  1  0/241 (0.00%)  0 1/598 (0.17%)  1 1/1062 (0.09%)  1
Partial Seizures  1  0/241 (0.00%)  0 1/598 (0.17%)  1 1/1062 (0.09%)  1
Post Herpetic Neuralgia  1  0/241 (0.00%)  0 1/598 (0.17%)  1 1/1062 (0.09%)  1
Postural Tremor  1  0/241 (0.00%)  0 1/598 (0.17%)  1 1/1062 (0.09%)  1
Resting Tremor  1  0/241 (0.00%)  0 1/598 (0.17%)  1 1/1062 (0.09%)  1
Sciatica  1  0/241 (0.00%)  0 1/598 (0.17%)  1 1/1062 (0.09%)  1
Seizure  1  0/241 (0.00%)  0 1/598 (0.17%)  1 1/1062 (0.09%)  1
Syncope  1  0/241 (0.00%)  0 2/598 (0.33%)  2 2/1062 (0.19%)  2
Toxic Encephalopathy  1  0/241 (0.00%)  0 1/598 (0.17%)  2 1/1062 (0.09%)  2
Trigeminal Neuralgia  1  0/241 (0.00%)  0 1/598 (0.17%)  1 1/1062 (0.09%)  1
Uhthoff's Phenomenon  1  3/241 (1.24%)  3 5/598 (0.84%)  5 9/1062 (0.85%)  9
Pregnancy, puerperium and perinatal conditions       
Abortion Missed  1  0/241 (0.00%)  0 0/598 (0.00%)  0 2/1062 (0.19%)  2
Abortion Spontaneous  1  3/241 (1.24%)  5 6/598 (1.00%)  7 11/1062 (1.04%)  15
Anembryonic Gestation  1  1/241 (0.41%)  2 0/598 (0.00%)  0 1/1062 (0.09%)  2
Ectopic Pregnancy  1  1/241 (0.41%)  1 0/598 (0.00%)  0 1/1062 (0.09%)  1
Foetal Distress Syndrome  1  0/241 (0.00%)  0 0/598 (0.00%)  0 1/1062 (0.09%)  1
Hellp Syndrome  1  0/241 (0.00%)  0 1/598 (0.17%)  1 1/1062 (0.09%)  1
Missed Labour  1  0/241 (0.00%)  0 1/598 (0.17%)  1 1/1062 (0.09%)  1
Pre-Eclampsia  1  0/241 (0.00%)  0 2/598 (0.33%)  2 2/1062 (0.19%)  2
Pregnancy  1  2/241 (0.83%)  3 4/598 (0.67%)  4 7/1062 (0.66%)  8
Prolonged Labour  1  0/241 (0.00%)  0 0/598 (0.00%)  0 1/1062 (0.09%)  1
Psychiatric disorders       
Alcoholism  1  1/241 (0.41%)  1 0/598 (0.00%)  0 1/1062 (0.09%)  1
Behaviour Disorder  1  1/241 (0.41%)  1 0/598 (0.00%)  0 1/1062 (0.09%)  1
Completed Suicide  1  0/241 (0.00%)  0 1/598 (0.17%)  1 1/1062 (0.09%)  1
Confusional State  1  0/241 (0.00%)  0 1/598 (0.17%)  1 1/1062 (0.09%)  1
Depression  1  2/241 (0.83%)  2 2/598 (0.33%)  2 4/1062 (0.38%)  4
Depression Suicidal  1  1/241 (0.41%)  1 1/598 (0.17%)  1 2/1062 (0.19%)  2
Drug Abuse  1  1/241 (0.41%)  1 0/598 (0.00%)  0 1/1062 (0.09%)  1
Major Depression  1  0/241 (0.00%)  0 2/598 (0.33%)  2 2/1062 (0.19%)  2
Mental Disorder  1  1/241 (0.41%)  1 0/598 (0.00%)  0 1/1062 (0.09%)  1
Substance-Induced Psychotic Disorder  1  0/241 (0.00%)  0 1/598 (0.17%)  1 1/1062 (0.09%)  1
Suicidal Ideation  1  0/241 (0.00%)  0 1/598 (0.17%)  1 1/1062 (0.09%)  1
Suicide Attempt  1  2/241 (0.83%)  2 2/598 (0.33%)  3 4/1062 (0.38%)  5
Renal and urinary disorders       
Acute Kidney Injury  1  1/241 (0.41%)  1 0/598 (0.00%)  0 1/1062 (0.09%)  1
Cystitis Haemorrhagic  1  0/241 (0.00%)  0 1/598 (0.17%)  1 1/1062 (0.09%)  1
Lupus Nephritis  1  0/241 (0.00%)  0 1/598 (0.17%)  1 1/1062 (0.09%)  1
Nephrolithiasis  1  2/241 (0.83%)  3 2/598 (0.33%)  2 5/1062 (0.47%)  7
Renal Colic  1  0/241 (0.00%)  0 1/598 (0.17%)  1 1/1062 (0.09%)  1
Renal Injury  1  0/241 (0.00%)  0 1/598 (0.17%)  2 1/1062 (0.09%)  2
Reproductive system and breast disorders       
Cervical Dysplasia  1  1/241 (0.41%)  1 3/598 (0.50%)  3 5/1062 (0.47%)  5
Cystocele  1  0/241 (0.00%)  0 0/598 (0.00%)  0 1/1062 (0.09%)  1
Endometriosis  1  1/241 (0.41%)  1 0/598 (0.00%)  0 1/1062 (0.09%)  1
Female Genital Tract Fistula  1  0/241 (0.00%)  0 1/598 (0.17%)  1 1/1062 (0.09%)  1
Menorrhagia  1  1/241 (0.41%)  1 0/598 (0.00%)  0 2/1062 (0.19%)  2
Metrorrhagia  1  0/241 (0.00%)  0 1/598 (0.17%)  1 2/1062 (0.19%)  2
Uterine Polyp  1  0/241 (0.00%)  0 1/598 (0.17%)  1 1/1062 (0.09%)  1
Vaginal Haemorrhage  1  0/241 (0.00%)  0 1/598 (0.17%)  1 1/1062 (0.09%)  1
Respiratory, thoracic and mediastinal disorders       
Acute Respiratory Failure  1  1/241 (0.41%)  1 1/598 (0.17%)  1 3/1062 (0.28%)  3
Asthma  1  1/241 (0.41%)  1 1/598 (0.17%)  1 2/1062 (0.19%)  2
Atelectasis  1  0/241 (0.00%)  0 1/598 (0.17%)  1 1/1062 (0.09%)  1
Dyspnoea  1  0/241 (0.00%)  0 1/598 (0.17%)  1 1/1062 (0.09%)  1
Nasal Septum Deviation  1  0/241 (0.00%)  0 0/598 (0.00%)  0 1/1062 (0.09%)  1
Organising Pneumonia  1  0/241 (0.00%)  0 1/598 (0.17%)  1 1/1062 (0.09%)  1
Pneumomediastinum  1  1/241 (0.41%)  1 0/598 (0.00%)  0 1/1062 (0.09%)  1
Pulmonary Embolism  1  0/241 (0.00%)  0 3/598 (0.50%)  3 3/1062 (0.28%)  3
Pulmonary Fibrosis  1  0/241 (0.00%)  0 1/598 (0.17%)  1 1/1062 (0.09%)  1
Skin and subcutaneous tissue disorders       
Angioedema  1  0/241 (0.00%)  0 2/598 (0.33%)  3 2/1062 (0.19%)  3
Decubitus Ulcer  1  0/241 (0.00%)  0 1/598 (0.17%)  1 1/1062 (0.09%)  1
Erythema  1  1/241 (0.41%)  1 0/598 (0.00%)  0 1/1062 (0.09%)  1
Rash  1  0/241 (0.00%)  0 1/598 (0.17%)  1 1/1062 (0.09%)  1
Skin Ulcer  1  0/241 (0.00%)  0 0/598 (0.00%)  0 1/1062 (0.09%)  1
Vascular disorders       
Deep Vein Thrombosis  1  0/241 (0.00%)  0 1/598 (0.17%)  1 1/1062 (0.09%)  1
Flushing  1  0/241 (0.00%)  0 0/598 (0.00%)  0 1/1062 (0.09%)  1
Hypertension  1  0/241 (0.00%)  0 0/598 (0.00%)  0 1/1062 (0.09%)  1
Peripheral Artery Thrombosis  1  0/241 (0.00%)  0 2/598 (0.33%)  2 2/1062 (0.19%)  2
1
Term from vocabulary, MedDRA 23.0
Indicates events were collected by systematic assessment
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Delayed Alemtuzumab Treatment (DAT) Initial Alemtuzumab Treatment (IAT) Alemtuzumab
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   150/241 (62.24%)      338/598 (56.52%)      601/1062 (56.59%)    
Gastrointestinal disorders       
Nausea  1  13/241 (5.39%)  13 18/598 (3.01%)  18 37/1062 (3.48%)  37
General disorders       
Fatigue  1  15/241 (6.22%)  17 19/598 (3.18%)  19 43/1062 (4.05%)  45
Infections and infestations       
Bronchitis  1  14/241 (5.81%)  17 44/598 (7.36%)  54 67/1062 (6.31%)  81
Herpes Zoster  1  15/241 (6.22%)  16 29/598 (4.85%)  35 50/1062 (4.71%)  57
Influenza  1  13/241 (5.39%)  13 25/598 (4.18%)  28 48/1062 (4.52%)  55
Nasopharyngitis  1  34/241 (14.11%)  60 73/598 (12.21%)  112 129/1062 (12.15%)  204
Sinusitis  1  11/241 (4.56%)  11 34/598 (5.69%)  45 57/1062 (5.37%)  71
Upper Respiratory Tract Infection  1  27/241 (11.20%)  29 50/598 (8.36%)  73 96/1062 (9.04%)  123
Urinary Tract Infection  1  37/241 (15.35%)  56 78/598 (13.04%)  143 151/1062 (14.22%)  271
Injury, poisoning and procedural complications       
Fall  1  15/241 (6.22%)  20 27/598 (4.52%)  34 54/1062 (5.08%)  74
Musculoskeletal and connective tissue disorders       
Arthralgia  1  19/241 (7.88%)  27 39/598 (6.52%)  45 69/1062 (6.50%)  86
Back Pain  1  16/241 (6.64%)  16 30/598 (5.02%)  34 62/1062 (5.84%)  68
Nervous system disorders       
Headache  1  37/241 (15.35%)  52 67/598 (11.20%)  87 125/1062 (11.77%)  164
Pregnancy, puerperium and perinatal conditions       
Pregnancy  1  14/241 (5.81%)  23 39/598 (6.52%)  46 63/1062 (5.93%)  86
Psychiatric disorders       
Depression  1  13/241 (5.39%)  13 25/598 (4.18%)  26 43/1062 (4.05%)  45
Insomnia  1  16/241 (6.64%)  17 29/598 (4.85%)  32 57/1062 (5.37%)  62
Skin and subcutaneous tissue disorders       
Rash  1  13/241 (5.39%)  16 26/598 (4.35%)  34 51/1062 (4.80%)  64
1
Term from vocabulary, MedDRA 23.0
Indicates events were collected by systematic assessment
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.
The Sponsor supports publication of clinical trial results but may request that investigators temporarily delay or alter publications in order to protect proprietary information. The Sponsor may also require that the results of multicenter studies be published only in their entirety and not as individual site data.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Trial Transparency Team
Organization: Sanofi
Phone: 800-633-1610 ext 6#
EMail: Contact-US@sanofi.com
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Layout table for additonal information
Responsible Party: Sanofi ( Genzyme, a Sanofi Company )
ClinicalTrials.gov Identifier: NCT02255656    
Other Study ID Numbers: LPS13649
2013-003884-71
U1111-1148-2987 ( Other Identifier: UTN )
First Submitted: September 30, 2014
First Posted: October 2, 2014
Results First Submitted: June 30, 2021
Results First Posted: July 23, 2021
Last Update Posted: March 28, 2022