Phase IIIB-IV Long-Term Follow-up Study for Patients Who Participated in CAMMS03409 (TOPAZ)

• 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: Genzyme, a Sanofi Company
• 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

Participant Flow

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
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

Baseline Characteristics

Arm/Group Title		Alemtuzumab
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
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%

Outcome Measures

1. Primary Outcome

Title	Number of Participants With Treatment-Emergent Adverse Events (TEAEs), and Treatment-Emergent Serious Adverse Events (TESAEs)
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)

Outcome Measure Data

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
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)
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

Outcome Measure Data

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
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)
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)

Outcome Measure Data

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
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
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)

Outcome Measure Data

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)
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
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

Outcome Measure Data

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)
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
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

Outcome Measure Data

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)
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
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

Outcome Measure Data

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)
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
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

Outcome Measure Data

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)
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
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

Outcome Measure Data

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)
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
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

Outcome Measure Data

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)
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
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

Outcome Measure Data

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)
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
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

Outcome Measure Data

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)
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
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

Outcome Measure Data

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)
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
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

Outcome Measure Data

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)
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
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

Outcome Measure Data

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)
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
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

Outcome Measure Data

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)
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
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

Outcome Measure Data

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)
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
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

Outcome Measure Data

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
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
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

Outcome Measure Data

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
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
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

Outcome Measure Data

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
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
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

Outcome Measure Data

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
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
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

Outcome Measure Data

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)
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
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

Outcome Measure Data

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
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
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

Outcome Measure Data

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
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
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)

Outcome Measure Data

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
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
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)

Outcome Measure Data

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
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%

Adverse Events

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
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%)
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
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

Limitations and Caveats

[Not Specified]

More Information

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

• 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):

Coles AJ, Jones JL, Vermersch P, Traboulsee A, Bass AD, Boster A, Chan A, Comi G, Fernandez O, Giovannoni G, Kubala Havrdova E, LaGanke C, Montalban X, Oreja-Guevara C, Piehl F, Wiendl H, Ziemssen T. Autoimmunity and long-term safety and efficacy of alemtuzumab for multiple sclerosis: Benefit/risk following review of trial and post-marketing data. Mult Scler. 2022 Apr;28(5):842-846. doi: 10.1177/13524585211061335. Epub 2021 Dec 9.

Kuhle J, Daizadeh N, Benkert P, Maceski A, Barro C, Michalak Z, Sormani MP, Godin J, Shankara S, Samad TA, Jacobs A, Chung L, Rӧsch N, Kaiser C, Mitchell CP, Leppert D, Havari E, Kappos L. Sustained reduction of serum neurofilament light chain over 7 years by alemtuzumab in early relapsing-remitting MS. Mult Scler. 2022 Apr;28(4):573-582. doi: 10.1177/13524585211032348. Epub 2021 Aug 11.

Bass AD, Arroyo R, Boster AL, Boyko AN, Eichau S, Ionete C, Limmroth V, Navas C, Pelletier D, Pozzilli C, Ravenscroft J, Sousa L, Tintore M, Uitdehaag BMJ, Baker DP, Daizadeh N, Choudhry Z, Rog D; CARE-MS I, CARE-MS II, CAMMS03409, and TOPAZ investigators. Alemtuzumab outcomes by age: Post hoc analysis from the randomized CARE-MS studies over 8 years. Mult Scler Relat Disord. 2021 Apr;49:102717. doi: 10.1016/j.msard.2020.102717. Epub 2020 Dec 24.

Ziemssen T, Bass AD, Berkovich R, Comi G, Eichau S, Hobart J, Hunter SF, LaGanke C, Limmroth V, Pelletier D, Pozzilli C, Schippling S, Sousa L, Traboulsee A, Uitdehaag BMJ, Van Wijmeersch B, Choudhry Z, Daizadeh N, Singer BA; CARE-MS I, CARE-MS II, CAMMS03409, and TOPAZ investigators. Efficacy and Safety of Alemtuzumab Through 9 Years of Follow-up in Patients with Highly Active Disease: Post Hoc Analysis of CARE-MS I and II Patients in the TOPAZ Extension Study. CNS Drugs. 2020 Sep;34(9):973-988. doi: 10.1007/s40263-020-00749-x.

Steingo B, Al Malik Y, Bass AD, Berkovich R, Carraro M, Fernandez O, Ionete C, Massacesi L, Meuth SG, Mitsikostas DD, Pardo G, Simm RF, Traboulsee A, Choudhry Z, Daizadeh N, Compston DAS; CAMMS223, CAMMS03409, and TOPAZ Investigators. Long-term efficacy and safety of alemtuzumab in patients with RRMS: 12-year follow-up of CAMMS223. J Neurol. 2020 Nov;267(11):3343-3353. doi: 10.1007/s00415-020-09983-1. Epub 2020 Jun 24.

Comi G, Alroughani R, Boster AL, Bass AD, Berkovich R, Fernandez O, Kim HJ, Limmroth V, Lycke J, Macdonell RA, Sharrack B, Singer BA, Vermersch P, Wiendl H, Ziemssen T, Jacobs A, Daizadeh N, Rodriguez CE, Traboulsee A; CARE-MS I, CARE-MS II, CAMMS03409, and TOPAZ Investigators. Efficacy of alemtuzumab in relapsing-remitting MS patients who received additional courses after the initial two courses: Pooled analysis of the CARE-MS, extension, and TOPAZ studies. Mult Scler. 2020 Dec;26(14):1866-1876. doi: 10.1177/1352458519888610. Epub 2019 Nov 25.

Okai AF, Amezcua L, Berkovich RR, Chinea AR, Edwards KR, Steingo B, Walker A, Jacobs AK, Daizadeh N, Williams MJ; CARE-MS I, CARE-MS II, CAMMS03409, and TOPAZ Investigators. Efficacy and Safety of Alemtuzumab in Patients of African Descent with Relapsing-Remitting Multiple Sclerosis: 8-Year Follow-up of CARE-MS I and II (TOPAZ Study). Neurol Ther. 2019 Dec;8(2):367-381. doi: 10.1007/s40120-019-00159-2. Epub 2019 Oct 25.

• 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