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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/NCT02255656




Registration number
NCT02255656
Ethics application status
Date submitted
30/09/2014
Date registered
2/10/2014
Date last updated
23/07/2021

Titles & IDs
Public title
Phase IIIB-IV Long-Term Follow-up Study for Patients Who Participated in CAMMS03409
Scientific title
A Long-term Follow-up Study for Multiple Sclerosis Patients Who Have Completed the Alemtuzumab Extension Study (CAMMS03409)
Secondary ID [1] 0 0
2013-003884-71
Secondary ID [2] 0 0
LPS13649
Universal Trial Number (UTN)
Trial acronym
TOPAZ
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Relapsing Remitting Multiple Sclerosis 0 0
Condition category
Condition code

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - alemtuzumab GZ402673

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).


Treatment: Drugs: alemtuzumab GZ402673
Pharmaceutical form:concentrate for solution for infusion Route of administration: intravenous

Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
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.
Timepoint [1] 0 0
From Baseline until the end of the study (up to a maximum duration of 5.6 years)
Primary outcome [2] 0 0
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.
Timepoint [2] 0 0
Within 24 hours of any alemtuzumab infusion
Primary outcome [3] 0 0
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.
Timepoint [3] 0 0
From Baseline until the end of the study (up to a maximum duration of 5.6 years)
Primary outcome [4] 0 0
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).
Timepoint [4] 0 0
From Baseline until the end of the study (up to a maximum duration of 5.6 years)
Secondary outcome [1] 0 0
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.
Timepoint [1] 0 0
Up to a maximum duration of 5.6 years
Secondary outcome [2] 0 0
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.
Timepoint [2] 0 0
Up to a maximum duration of 5.6 years
Secondary outcome [3] 0 0
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.
Timepoint [3] 0 0
Baseline (Month 0 of LPS13649), Month 6, 12, 18, 24, 30, 36, 42, 48, 54 and 60
Secondary outcome [4] 0 0
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.
Timepoint [4] 0 0
Up to a maximum duration of 5.6 years
Secondary outcome [5] 0 0
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.
Timepoint [5] 0 0
Up to a maximum duration of 5.6 years
Secondary outcome [6] 0 0
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.
Timepoint [6] 0 0
Up to a maximum duration of 5.6 years
Secondary outcome [7] 0 0
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.
Timepoint [7] 0 0
Baseline (Month 0 of LPS13649), Month 12, Month 24, Month 36, Month 48 and Month 60
Secondary outcome [8] 0 0
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.
Timepoint [8] 0 0
Baseline (Month 0 of LPS13649), Month 12, Month 24, Month 36, Month 48 and Month 60
Secondary outcome [9] 0 0
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.
Timepoint [9] 0 0
Baseline (Month 0 of LPS13649), Month 12, Month 24, Month 36, Month 48 and Month 60
Secondary outcome [10] 0 0
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.
Timepoint [10] 0 0
Baseline (Month 0 of LPS13649), Month 12, Month 24, Month 36, Month 48 and Month 60
Secondary outcome [11] 0 0
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.
Timepoint [11] 0 0
Baseline (Month 0 of LPS13649), Month 12, Month 24, Month 36, Month 48 and Month 60
Secondary outcome [12] 0 0
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.
Timepoint [12] 0 0
Baseline (Month 0 of LPS13649), Month 12, Month 24, Month 36, Month 48 and Month 60
Secondary outcome [13] 0 0
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.
Timepoint [13] 0 0
Baseline (Month 0 of LPS13649), Month 12, Month 24, Month 36, Month 48 and Month 60
Secondary outcome [14] 0 0
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.
Timepoint [14] 0 0
Baseline (Month 0 of LPS13649), Month 12, Month 24, Month 36, Month 48 and Month 60
Secondary outcome [15] 0 0
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.
Timepoint [15] 0 0
Baseline (Month 0 of LPS13649), Month 12, Month 24, Month 36, Month 48 and Month 60
Secondary outcome [16] 0 0
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.
Timepoint [16] 0 0
Baseline (Month 0 of LPS13649), Month 12, Month 24, Month 36, Month 48 and Month 60
Secondary outcome [17] 0 0
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.
Timepoint [17] 0 0
Baseline (Month 0 of LPS13649), Month 12, Month 24, Month 36, Month 48 and Month 60
Secondary outcome [18] 0 0
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.
Timepoint [18] 0 0
Baseline (Month 0 of LPS13649), Month 12, Month 24, Month 36, Month 48 and Month 60
Secondary outcome [19] 0 0
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.
Timepoint [19] 0 0
Baseline (Month 0 of LPS13649), Month 12, Month 24, Month 36, Month 48 and Month 60
Secondary outcome [20] 0 0
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.
Timepoint [20] 0 0
Baseline (Month 0 of LPS13649), Month 12, Month 24, Month 36, Month 48 and Month 60
Secondary outcome [21] 0 0
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.
Timepoint [21] 0 0
Baseline up to end of the study (up to a maximum duration of 5.6 years)
Secondary outcome [22] 0 0
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.
Timepoint [22] 0 0
Baseline up to end of the study (up to a maximum duration of 5.6 years)

Eligibility
Key inclusion criteria
Inclusion criteria:

Participant had completed at least 48 months of the Extension Study CAMMS03409. Signed
written informed consent form.
Minimum age
18 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
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 design
Purpose of the study
Treatment
Allocation to intervention
N/A
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Phase 4
Type of endpoint(s)
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
Investigational Site Number 2013 - Auchenflower
Recruitment hospital [2] 0 0
Investigational Site Number 2001 - Heidelberg
Recruitment hospital [3] 0 0
Investigational Site Number 2011 - Hobart
Recruitment hospital [4] 0 0
Investigational Site Number 2012 - Kogarah
Recruitment hospital [5] 0 0
Investigational Site Number 2003 - Melbourne
Recruitment hospital [6] 0 0
Investigational Site Number 2002 - Parkville
Recruitment hospital [7] 0 0
Investigational Site Number 2005 - Southport
Recruitment hospital [8] 0 0
Investigational Site Number 2009 - Sydney
Recruitment hospital [9] 0 0
Investigational Site Number 2006 - Westmead
Recruitment postcode(s) [1] 0 0
4066 - Auchenflower
Recruitment postcode(s) [2] 0 0
3084 - Heidelberg
Recruitment postcode(s) [3] 0 0
7000 - Hobart
Recruitment postcode(s) [4] 0 0
2217 - Kogarah
Recruitment postcode(s) [5] 0 0
3065 - Melbourne
Recruitment postcode(s) [6] 0 0
3050 - Parkville
Recruitment postcode(s) [7] 0 0
4215 - Southport
Recruitment postcode(s) [8] 0 0
- Sydney
Recruitment postcode(s) [9] 0 0
2145 - Westmead
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Alabama
Country [2] 0 0
United States of America
State/province [2] 0 0
Arizona
Country [3] 0 0
United States of America
State/province [3] 0 0
California
Country [4] 0 0
United States of America
State/province [4] 0 0
Colorado
Country [5] 0 0
United States of America
State/province [5] 0 0
Florida
Country [6] 0 0
United States of America
State/province [6] 0 0
Illinois
Country [7] 0 0
United States of America
State/province [7] 0 0
Indiana
Country [8] 0 0
United States of America
State/province [8] 0 0
Iowa
Country [9] 0 0
United States of America
State/province [9] 0 0
Kansas
Country [10] 0 0
United States of America
State/province [10] 0 0
Kentucky
Country [11] 0 0
United States of America
State/province [11] 0 0
Massachusetts
Country [12] 0 0
United States of America
State/province [12] 0 0
Michigan
Country [13] 0 0
United States of America
State/province [13] 0 0
Missouri
Country [14] 0 0
United States of America
State/province [14] 0 0
New Jersey
Country [15] 0 0
United States of America
State/province [15] 0 0
New Mexico
Country [16] 0 0
United States of America
State/province [16] 0 0
New York
Country [17] 0 0
United States of America
State/province [17] 0 0
North Carolina
Country [18] 0 0
United States of America
State/province [18] 0 0
Ohio
Country [19] 0 0
United States of America
State/province [19] 0 0
Oklahoma
Country [20] 0 0
United States of America
State/province [20] 0 0
Pennsylvania
Country [21] 0 0
United States of America
State/province [21] 0 0
Rhode Island
Country [22] 0 0
United States of America
State/province [22] 0 0
Tennessee
Country [23] 0 0
United States of America
State/province [23] 0 0
Texas
Country [24] 0 0
United States of America
State/province [24] 0 0
Virginia
Country [25] 0 0
United States of America
State/province [25] 0 0
Washington
Country [26] 0 0
Argentina
State/province [26] 0 0
Caba
Country [27] 0 0
Belgium
State/province [27] 0 0
Bruxelles
Country [28] 0 0
Belgium
State/province [28] 0 0
Esneux
Country [29] 0 0
Belgium
State/province [29] 0 0
Leuven
Country [30] 0 0
Brazil
State/province [30] 0 0
Porto Alegre
Country [31] 0 0
Brazil
State/province [31] 0 0
Recife
Country [32] 0 0
Brazil
State/province [32] 0 0
São Paulo
Country [33] 0 0
Canada
State/province [33] 0 0
Calgary
Country [34] 0 0
Canada
State/province [34] 0 0
Gatineau
Country [35] 0 0
Canada
State/province [35] 0 0
Greenfield Park
Country [36] 0 0
Canada
State/province [36] 0 0
Kingston
Country [37] 0 0
Canada
State/province [37] 0 0
London
Country [38] 0 0
Canada
State/province [38] 0 0
Ottawa
Country [39] 0 0
Canada
State/province [39] 0 0
Vancouver
Country [40] 0 0
Czechia
State/province [40] 0 0
Brno
Country [41] 0 0
Czechia
State/province [41] 0 0
Hradec Kralove
Country [42] 0 0
Czechia
State/province [42] 0 0
Praha 2
Country [43] 0 0
Czechia
State/province [43] 0 0
Teplice
Country [44] 0 0
Denmark
State/province [44] 0 0
Aarhus N
Country [45] 0 0
Denmark
State/province [45] 0 0
København Ø.
Country [46] 0 0
Germany
State/province [46] 0 0
Berlin
Country [47] 0 0
Germany
State/province [47] 0 0
Dresden
Country [48] 0 0
Germany
State/province [48] 0 0
Frankfurt am Main
Country [49] 0 0
Germany
State/province [49] 0 0
Hamburg
Country [50] 0 0
Germany
State/province [50] 0 0
Hannover
Country [51] 0 0
Germany
State/province [51] 0 0
Hennigsdorf
Country [52] 0 0
Germany
State/province [52] 0 0
München
Country [53] 0 0
Germany
State/province [53] 0 0
Rostock
Country [54] 0 0
Germany
State/province [54] 0 0
Wermsdorf
Country [55] 0 0
Israel
State/province [55] 0 0
Ramat Gan
Country [56] 0 0
Israel
State/province [56] 0 0
Tel Aviv
Country [57] 0 0
Italy
State/province [57] 0 0
Cagliari
Country [58] 0 0
Italy
State/province [58] 0 0
Gallarate (VA)
Country [59] 0 0
Italy
State/province [59] 0 0
Orbassano (TO)
Country [60] 0 0
Italy
State/province [60] 0 0
Roma
Country [61] 0 0
Mexico
State/province [61] 0 0
Chihuahua
Country [62] 0 0
Mexico
State/province [62] 0 0
Mexico
Country [63] 0 0
Netherlands
State/province [63] 0 0
Sittard-Geleen
Country [64] 0 0
Poland
State/province [64] 0 0
Krakow
Country [65] 0 0
Poland
State/province [65] 0 0
Lodz
Country [66] 0 0
Poland
State/province [66] 0 0
Lublin
Country [67] 0 0
Poland
State/province [67] 0 0
Poznan
Country [68] 0 0
Poland
State/province [68] 0 0
Warszawa
Country [69] 0 0
Russian Federation
State/province [69] 0 0
Kazan
Country [70] 0 0
Russian Federation
State/province [70] 0 0
Moscow
Country [71] 0 0
Russian Federation
State/province [71] 0 0
Nizhny Novgorod
Country [72] 0 0
Russian Federation
State/province [72] 0 0
Pyatigorsk
Country [73] 0 0
Russian Federation
State/province [73] 0 0
Saint-Petersburg
Country [74] 0 0
Russian Federation
State/province [74] 0 0
Samara
Country [75] 0 0
Russian Federation
State/province [75] 0 0
Ufa
Country [76] 0 0
Spain
State/province [76] 0 0
Barcelona
Country [77] 0 0
Spain
State/province [77] 0 0
Madrid
Country [78] 0 0
Spain
State/province [78] 0 0
Málaga
Country [79] 0 0
Spain
State/province [79] 0 0
Sevilla
Country [80] 0 0
Sweden
State/province [80] 0 0
Göteborg
Country [81] 0 0
Sweden
State/province [81] 0 0
Umeå
Country [82] 0 0
Ukraine
State/province [82] 0 0
Kharkov
Country [83] 0 0
Ukraine
State/province [83] 0 0
Kiev
Country [84] 0 0
Ukraine
State/province [84] 0 0
Lviv
Country [85] 0 0
United Kingdom
State/province [85] 0 0
Bristol
Country [86] 0 0
United Kingdom
State/province [86] 0 0
Cambridge
Country [87] 0 0
United Kingdom
State/province [87] 0 0
Cardiff
Country [88] 0 0
United Kingdom
State/province [88] 0 0
London
Country [89] 0 0
United Kingdom
State/province [89] 0 0
Salford
Country [90] 0 0
United Kingdom
State/province [90] 0 0
Sheffield

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Genzyme, a Sanofi Company
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
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.
Trial website
https://clinicaltrials.gov/show/NCT02255656
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Clinical Sciences & Operations
Address 0 0
Sanofi
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Summary results
Other publications