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

A Long-term Follow-up Study for Multiple Sclerosis Patients Who Have Completed the Alemtuzumab Extension Study (CAMMS03409)

Primary Objective:

To evaluate long-term safety of alemtuzumab.

Secondary Objectives:

• To evaluate long term efficacy of alemtuzumab.
• To evaluate the safety profile of participants who received other Disease Modifying Treatment (DMT) following alemtuzumab treatment.
• To evaluate participant-reported Quality of Life (QoL) outcomes and health resource utilization of participant who received alemtuzumab.
• To evaluate as needed re-treatment with alemtuzumab and other DMTs.

Study Overview

• Status: Completed
• Conditions: Relapsing Remitting Multiple Sclerosis
• Intervention / Treatment: Drug: alemtuzumab GZ402673

Detailed Description

The total duration per participants was up to 5.6 years.

As per Study Investigator discretion, participants can be treated with additional courses of alemtuzumab or any commercialized DMTs.

All participants who completed CAMMS03409 were allowed into the study, which might include specific vulnerable populations. If the investigator decided to treat a participant with a course of alemtuzumab, appropriate cautionary measures were applied as indicated in the approved labelling, or, in ex-European Union countries where Lemtrada was not approved, according to the investigator's brochure.

• Study Type: Interventional
• Enrollment (Actual): 1062
• Phase: Phase 4

Contacts and Locations

Study Locations

• Argentina
  • Caba, Argentina, C1061ABD
    • Investigational Site Number 03208
• Australia
  • Auchenflower, Australia, 4066
    • Investigational Site Number 2013
  • Heidelberg, Australia, 3084
    • Investigational Site Number 2001
  • Hobart, Australia, 7000
    • Investigational Site Number 2011
  • Kogarah, Australia, 2217
    • Investigational Site Number 2012
  • Melbourne, Australia, 3065
    • Investigational Site Number 2003
  • Parkville, Australia, 3050
    • Investigational Site Number 2002
  • Southport, Australia, 4215
    • Investigational Site Number 2005
  • Sydney, Australia
    • Investigational Site Number 2009
  • Westmead, Australia, 2145
    • Investigational Site Number 2006
• Belgium
  • Bruxelles, Belgium, 1200
    • Investigational Site Number 5005
  • Esneux, Belgium, 4130
    • Investigational Site Number 5004
  • Leuven, Belgium, 3000
    • Investigational Site Number 5001
• Brazil
  • Porto Alegre, Brazil, 90110000
    • Investigational Site Number 3006
  • Recife, Brazil, 52010-040
    • Investigational Site Number 3002
  • São Paulo, Brazil, 01221-000
    • Investigational Site Number 3001
  • São Paulo, Brazil, 05403-000
    • Investigational Site Number 3003
• Canada
  • Calgary, Canada, T2N 2T9
    • Investigational Site Number 1102
  • Gatineau, Canada, J8Y1W2
    • Investigational Site Number 1105
  • Greenfield Park, Canada, J4V2J2
    • Investigational Site Number 1104
  • Kingston, Canada, K7L2V7
    • Investigational Site Number 1109
  • London, Canada, N6A5A5
    • Investigational Site Number 1110
  • Ottawa, Canada, K1H8L6
    • Investigational Site Number 1101
  • Vancouver, Canada, V6T1Z3
    • Investigational Site Number 1106
• Czechia
  • Brno, Czechia, 65691
    • Investigational Site Number 4803
  • Hradec Kralove, Czechia, 50005
    • Investigational Site Number 4804
  • Praha 2, Czechia, 12808
    • Investigational Site Number 4801
  • Teplice, Czechia, 41501
    • Investigational Site Number 4802
• Denmark
  • Aarhus N, Denmark, 8200
    • Investigational Site Number 5302
  • København Ø., Denmark, 2100
    • Investigational Site Number 5301
• Germany
  • Berlin, Germany, 13347
    • Investigational Site Number 4602
  • Dresden, Germany, 01307
    • Investigational Site Number 4607
  • Frankfurt am Main, Germany, 60590
    • Investigational Site Number 4634
  • Hamburg, Germany, 22307
    • Investigational Site Number 4622
  • Hannover, Germany, 30625
    • Investigational Site Number 4605
  • Hennigsdorf, Germany, 16761
    • Investigational Site Number 4609
  • München, Germany, 81675
    • Investigational Site Number 4608
  • Rostock, Germany, 18147
    • Investigational Site Number 4610
  • Wermsdorf, Germany, 04779
    • Investigational Site Number 4613
• Israel
  • Ramat Gan, Israel, 52621
    • Investigational Site Number 5501
  • Tel Aviv, Israel
    • Investigational Site Number 5505
• Italy
  • Cagliari, Italy, 09126
    • Investigational Site Number 4112
  • Gallarate (VA), Italy, 21013
    • Investigational Site Number 4102
  • Orbassano (TO), Italy, 10043
    • Investigational Site Number 4106
  • Roma, Italy, 00189
    • Investigational Site Number 4110
• Mexico
  • Chihuahua, Mexico, 31203
    • Investigational Site Number 3105
  • Mexico, Mexico, 14260
    • Investigational Site Number 3102
• Netherlands
  • Sittard-Geleen, Netherlands, 6162BG
    • Investigational Site Number 4202
• Poland
  • Krakow, Poland, 31-505
    • Investigational Site Number 4902
  • Lodz, Poland, 90-324
    • Investigational Site Number 4901
  • Lublin, Poland, 20-090
    • Investigational Site Number 4903
  • Poznan, Poland, 60-355
    • Investigational Site Number 4904
  • Warszawa, Poland, 02-957
    • Investigational Site Number 4905
• Russian Federation
  • Kazan, Russian Federation, 420097
    • Investigational Site Number 6009
  • Moscow, Russian Federation, 1217015
    • Investigational Site Number 6001
  • Moscow, Russian Federation, 1217015
    • Investigational Site Number 6005
  • Moscow, Russian Federation
    • Investigational Site Number 6003
  • Nizhny Novgorod, Russian Federation
    • Investigational Site Number 6006
  • Pyatigorsk, Russian Federation
    • Investigational Site Number 6010
  • Saint-Petersburg, Russian Federation
    • Investigational Site Number 6002
  • Saint-Petersburg, Russian Federation
    • Investigational Site Number 6004
  • Saint-Petersburg, Russian Federation
    • Investigational Site Number 6008
  • Samara, Russian Federation
    • Investigational Site Number 6013
  • Ufa, Russian Federation
    • Investigational Site Number 6016
• Spain
  • Barcelona, Spain, 08035
    • Investigational Site Number 4301
  • Madrid, Spain, 28040
    • Investigational Site Number 4303
  • Málaga, Spain, 29010
    • Investigational Site Number 4305
  • Sevilla, Spain, 41071
    • Investigational Site Number 4304
• Sweden
  • Göteborg, Sweden, 41345
    • Investigational Site Number 4701
  • Umeå, Sweden, 90185
    • Investigational Site Number 4702
• Ukraine
  • Kharkov, Ukraine
    • Investigational Site Number 6102
  • Kiev, Ukraine
    • Investigational Site Number 6104
  • Lviv, Ukraine
    • Investigational Site Number 6103
• United Kingdom
  • Bristol, United Kingdom, BS105NB
    • Investigational Site Number 4004
  • Cambridge, United Kingdom, CB50QQ
    • Investigational Site Number 4001
  • Cardiff, United Kingdom, CF44XN
    • Investigational Site Number 4005
  • London, United Kingdom, E12AT
    • Investigational Site Number 4006
  • Salford, United Kingdom, M68HD
    • Investigational Site Number 4008
  • Sheffield, United Kingdom, S102JF
    • Investigational Site Number 4007
• United States
  • Alabama
    • Cullman, Alabama, United States, 00000
      • Investigational Site Number 1086
  • Arizona
    • Phoenix, Arizona, United States, 85013
      • Investigational Site Number 1031
    • Phoenix, Arizona, United States, 85018
      • Investigational Site Number 1171
    • Tucson, Arizona, United States, 85704
      • Investigational Site Number 1090
  • California
    • Berkeley, California, United States, 94705
      • Investigational Site Number 1040
    • Fullerton, California, United States, 92835
      • Investigational Site Number 1152
    • Pasadena, California, United States, 91105
      • Investigational Site Number 1093
  • Colorado
    • Fort Collins, Colorado, United States, 80528
      • Investigational Site Number 1027
  • Florida
    • Jacksonville, Florida, United States, 32209
      • Investigational Site Number 1078
    • Maitland, Florida, United States, 32751
      • Investigational Site Number 1059
    • Sarasota, Florida, United States, 34239
      • Investigational Site Number 1173
    • Sunrise, Florida, United States, 33351
      • Investigational Site Number 1034
    • Tampa, Florida, United States, 33609
      • Investigational Site Number 1005
    • Tampa, Florida, United States, 33612
      • Investigational Site Number 1049
  • Illinois
    • Northbrook, Illinois, United States, 60062
      • Investigational Site Number 1008
  • Indiana
    • Fort Wayne, Indiana, United States, 46845
      • Investigational Site Number 1001
    • Indianapolis, Indiana, United States, 46202
      • Investigational Site Number 1024
  • Iowa
    • Des Moines, Iowa, United States, 50314
      • Investigational Site Number 1017
  • Kansas
    • Kansas City, Kansas, United States, 66160
      • Investigational Site Number 1022
    • Lenexa, Kansas, United States, 66214
      • Investigational Site Number 1083
  • Kentucky
    • Lexington, Kentucky, United States, 40513
      • Investigational Site Number 1039
    • Louisville, Kentucky, United States, 40202
      • Investigational Site Number 1021
  • Massachusetts
    • Wellesley, Massachusetts, United States, 02481
      • Investigational Site Number 1061
    • Worcester, Massachusetts, United States, 01655
      • Investigational Site Number 1028
  • Michigan
    • Ann Arbor, Michigan, United States, 48105-2945
      • Investigational Site Number 1025
    • Detroit, Michigan, United States, 48201
      • Investigational Site Number 1020
    • Traverse City, Michigan, United States, 49684
      • Investigational Site Number 1054
  • Missouri
    • Kansas City, Missouri, United States, 64111
      • Investigational Site Number 1084
    • Saint Louis, Missouri, United States, 63131
      • Investigational Site Number 1092
  • New Jersey
    • Teaneck, New Jersey, United States, 07666
      • Investigational Site Number 1073
  • New Mexico
    • Albuquerque, New Mexico, United States, 87131
      • Investigational Site Number 1014
  • New York
    • Mineola, New York, United States, 11501
      • Investigational Site Number 1081
    • New York, New York, United States, 10029
      • Investigational Site Number 1026
    • Patchogue, New York, United States, 11772
      • Investigational Site Number 1160
    • Rochester, New York, United States, 14642
      • Investigational Site Number 1015
    • Syracuse, New York, United States, 13202
      • Investigational Site Number 1053
  • North Carolina
    • Chapel Hill, North Carolina, United States, 27599
      • Investigational Site Number 1095
    • Winston-Salem, North Carolina, United States, 27103
      • Investigational Site Number 1082
  • Ohio
    • Cleveland, Ohio, United States, 44195
      • Investigational Site Number 1035
    • Uniontown, Ohio, United States, 44685
      • Investigational Site Number 1058
  • Oklahoma
    • Oklahoma City, Oklahoma, United States, 73104
      • Investigational Site Number 1067
  • Pennsylvania
    • Allentown, Pennsylvania, United States, 18103
      • Investigational Site Number 1097
  • Rhode Island
    • Providence, Rhode Island, United States, 02905
      • Investigational Site Number 1057
  • Tennessee
    • Cordova, Tennessee, United States, 38018
      • Investigational Site Number 1163
    • Franklin, Tennessee, United States, 37064
      • Investigational Site Number 1055
    • Knoxville, Tennessee, United States, 37922
      • Investigational Site Number 1009
    • Nashville, Tennessee, United States, 37215
      • Investigational Site Number 1042
  • Texas
    • Houston, Texas, United States, 77030
      • Investigational Site Number 1018
    • Round Rock, Texas, United States, 78681
      • Investigational Site Number 1002
    • San Antonio, Texas, United States
      • Investigational Site Number 1046
  • Virginia
    • Vienna, Virginia, United States, 22182
      • Investigational Site Number 1037
  • Washington
    • Seattle, Washington, United States, 98122
      • Investigational Site Number 1068

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion criteria:

Participant had completed at least 48 months of the Extension Study CAMMS03409. Signed written informed consent form.

Exclusion criteria:

Participant participating in another investigational interventional study.

The above information was not intended to contain all considerations relevant to a participant's potential participation in a clinical trial.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: Alemtuzumab; 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).

Drug: alemtuzumab GZ402673; Pharmaceutical form:concentrate for solution for infusion Route of administration: intravenous

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Participants With Treatment-Emergent Adverse Events (TEAEs), and Treatment-Emergent Serious Adverse Events (TESAEs)	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.	From Baseline until the end of the study (up to a maximum duration of 5.6 years)
Number of Participants With Infusion-Associated Reactions (IAR)	Infusion-associated reactions (IAR) was defined as any adverse event occurring during and within 24 hours of alemtuzumab infusion.	Within 24 hours of any alemtuzumab infusion
Number of Participants With Adverse Events of Special Interest (AESI)	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.	From Baseline until the end of the study (up to a maximum duration of 5.6 years)
Number of Participants With Potentially Clinically Significant Laboratory Abnormalities	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).	From Baseline until the end of the study (up to a maximum duration of 5.6 years)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Annualized Relapse Rate	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.	Up to a maximum duration of 5.6 years
Proportion of Participants Who Were Relapse Free	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.	Up to a maximum duration of 5.6 years
Change From Baseline in Expanded Disability Status Scale (EDSS) Score at Month 6, 12, 18, 24, 30, 36, 42, 48, 54 and 60	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.	Baseline (Month 0 of LPS13649), Month 6, 12, 18, 24, 30, 36, 42, 48, 54 and 60
Brain Magnetic Resonance Imaging (MRI) Assessment: Number of Gadolinium Enhancing (Gd-enhancing) Lesions Per MRI Scan	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.	Up to a maximum duration of 5.6 years
Brain Magnetic Resonance Imaging (MRI) Assessment: Number of New or Enlarged T2 Lesions Per MRI Scan	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.	Up to a maximum duration of 5.6 years
Brain Magnetic Resonance Imaging (MRI) Assessment: Number of New T1 (and New Hypointense T1) Lesions Per MRI Scan	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.	Up to a maximum duration of 5.6 years
Brain Magnetic Resonance Imaging (MRI) Assessment: Percent Change From Baseline in Volume of T1 Lesions at Months 12, 24, 36, 48, and 60	The total lesion volume (T1 lesions) was measured by MRI scan.	Baseline (Month 0 of LPS13649), Month 12, Month 24, Month 36, Month 48 and Month 60
Brain Magnetic Resonance Imaging (MRI) Assessment: Percent Change From Baseline in Volume of T2 Lesions at Months 12, 24, 36, 48, and 60	The total lesion volume (T2 lesions) was measured by MRI scan.	Baseline (Month 0 of LPS13649), Month 12, Month 24, Month 36, Month 48 and Month 60
Brain Magnetic Resonance Imaging (MRI) Assessment: Percent Change From Baseline in Brain Parenchymal Fraction (BPF) at Month 12, 24, 36, 48, and 60	The brain parenchymal fraction was measured by MRI scan.	Baseline (Month 0 of LPS13649), Month 12, Month 24, Month 36, Month 48 and Month 60
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	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.	Baseline (Month 0 of LPS13649), Month 12, Month 24, Month 36, Month 48 and Month 60
Change From Baseline in Functional Assessment of Multiple Sclerosis (FAMS) Score at Month 12, 24, 36, 48, and 60	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.	Baseline (Month 0 of LPS13649), Month 12, Month 24, Month 36, Month 48 and Month 60
Change From Baseline in European Quality of Life -5 Dimension (EQ-5D) Score: Utility Scores at Month 12, 24, 36, 48, and 60	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.	Baseline (Month 0 of LPS13649), Month 12, Month 24, Month 36, Month 48 and Month 60
Change From Baseline in EQ-5D Visual Analogue Scale (VAS) Scores at Month 12, 24, 36, 48, and 60	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.	Baseline (Month 0 of LPS13649), Month 12, Month 24, Month 36, Month 48 and Month 60
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	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.	Baseline (Month 0 of LPS13649), Month 12, Month 24, Month 36, Month 48 and Month 60
Modified HRUQ: Number of Participants Who Reported Other Changes/Changes in Lifestyle Due to Multiple Sclerosis	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.	Baseline (Month 0 of LPS13649), Month 12, Month 24, Month 36, Month 48 and Month 60
Health Related Productivity Questionnaire (HRPQ): Number of Participants Reporting Current Employment Status (Part Time/Full Time/Not Employed) Due to Multiple Sclerosis	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.	Baseline (Month 0 of LPS13649), Month 12, Month 24, Month 36, Month 48 and Month 60
HRPQ: Total Scheduled Working Hours and Number of Hours Missed From Work Due to Multiple Sclerosis	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.	Baseline (Month 0 of LPS13649), Month 12, Month 24, Month 36, Month 48 and Month 60
HRPQ: Percentage Impact on Work Output Due to Multiple Sclerosis	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.	Baseline (Month 0 of LPS13649), Month 12, Month 24, Month 36, Month 48 and Month 60
HRPQ: Total Scheduled Household Chores Hours; Number of Hours Missed From Household Chores Due to Multiple Sclerosis	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.	Baseline (Month 0 of LPS13649), Month 12, Month 24, Month 36, Month 48 and Month 60
HRPQ: Percentage Impact on Work Output for Household Chores Due to Multiple Sclerosis	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.	Baseline (Month 0 of LPS13649), Month 12, Month 24, Month 36, Month 48 and Month 60
HRPQ: Duration of Disease (in Months) Since Development of Multiple Sclerosis	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.	Baseline up to end of the study (up to a maximum duration of 5.6 years)
HRPQ: Number of Participants Who Reported Impact on Work Due to Multiple Sclerosis	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.	Baseline up to end of the study (up to a maximum duration of 5.6 years)

Collaborators and Investigators

• Sponsor: Genzyme, a Sanofi Company

Publications and helpful links

General Publications

• 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.
• 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.
• 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.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): January 7, 2015
• Primary Completion (Actual): July 15, 2020
• Study Completion (Actual): July 15, 2020

Study Registration Dates

• First Submitted: September 30, 2014
• First Submitted That Met QC Criteria: September 30, 2014
• First Posted (Estimate): October 2, 2014

Study Record Updates

• Last Update Posted (Actual): March 28, 2022
• Last Update Submitted That Met QC Criteria: March 21, 2022
• Last Verified: March 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Nervous System Diseases; Immune System Diseases; Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Demyelinating Diseases; Autoimmune Diseases; Multiple Sclerosis; Sclerosis; Multiple Sclerosis, Relapsing-Remitting; Antineoplastic Agents; Antineoplastic Agents, Immunological; Alemtuzumab
• Other Study ID Numbers: LPS13649; 2013-003884-71; U1111-1148-2987 (Other Identifier: UTN)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Qualified researchers may request access to patient level data and related study documents including the clinical study report, study protocol with any amendments, blank case report form, statistical analysis plan, and dataset specifications. Patient level data will be anonymized and study documents will be redacted to protect the privacy of trial participants. Further details on Sanofi's data sharing criteria, eligible studies, and process for requesting access can be found at: https://vivli.org

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No