Please note that the copy function is not enabled for this field.
If you wish to
modify
existing outcomes, please copy and paste the current outcome text into the Update field.
LOGIN
CREATE ACCOUNT
LOGIN
CREATE ACCOUNT
MY TRIALS
REGISTER TRIAL
FAQs
HINTS AND TIPS
DEFINITIONS
Trial Review
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this
information for consumers
Download to PDF
Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/ct2/show/NCT02255656
Registration number
NCT02255656
Ethics application status
Date submitted
30/09/2014
Date registered
2/10/2014
Date last updated
28/03/2022
Titles & IDs
Public title
Phase IIIB-IV Long-Term Follow-up Study for Patients Who Participated in CAMMS03409
Query!
Scientific title
A Long-term Follow-up Study for Multiple Sclerosis Patients Who Have Completed the Alemtuzumab Extension Study (CAMMS03409)
Query!
Secondary ID [1]
0
0
2013-003884-71
Query!
Secondary ID [2]
0
0
LPS13649
Query!
Universal Trial Number (UTN)
Query!
Trial acronym
TOPAZ
Query!
Linked study record
Query!
Health condition
Health condition(s) or problem(s) studied:
Relapsing Remitting Multiple Sclerosis
0
0
Query!
Condition category
Condition code
Intervention/exposure
Study type
Interventional
Query!
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
Query!
Intervention code [1]
0
0
Treatment: Drugs
Query!
Comparator / control treatment
Query!
Control group
Query!
Outcomes
Primary outcome [1]
0
0
Number of Participants With Treatment-Emergent Adverse Events (TEAEs), and Treatment-Emergent Serious Adverse Events (TESAEs)
Query!
Assessment method [1]
0
0
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.
Query!
Timepoint [1]
0
0
From Baseline until the end of the study (up to a maximum duration of 5.6 years)
Query!
Primary outcome [2]
0
0
Number of Participants With Infusion-Associated Reactions (IAR)
Query!
Assessment method [2]
0
0
Infusion-associated reactions (IAR) was defined as any adverse event occurring during and within 24 hours of alemtuzumab infusion.
Query!
Timepoint [2]
0
0
Within 24 hours of any alemtuzumab infusion
Query!
Primary outcome [3]
0
0
Number of Participants With Adverse Events of Special Interest (AESI)
Query!
Assessment method [3]
0
0
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.
Query!
Timepoint [3]
0
0
From Baseline until the end of the study (up to a maximum duration of 5.6 years)
Query!
Primary outcome [4]
0
0
Number of Participants With Potentially Clinically Significant Laboratory Abnormalities
Query!
Assessment method [4]
0
0
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).
Query!
Timepoint [4]
0
0
From Baseline until the end of the study (up to a maximum duration of 5.6 years)
Query!
Secondary outcome [1]
0
0
Annualized Relapse Rate
Query!
Assessment method [1]
0
0
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.
Query!
Timepoint [1]
0
0
Up to a maximum duration of 5.6 years
Query!
Secondary outcome [2]
0
0
Proportion of Participants Who Were Relapse Free
Query!
Assessment method [2]
0
0
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.
Query!
Timepoint [2]
0
0
Up to a maximum duration of 5.6 years
Query!
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
Query!
Assessment method [3]
0
0
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.
Query!
Timepoint [3]
0
0
Baseline (Month 0 of LPS13649), Month 6, 12, 18, 24, 30, 36, 42, 48, 54 and 60
Query!
Secondary outcome [4]
0
0
Brain Magnetic Resonance Imaging (MRI) Assessment: Number of Gadolinium Enhancing (Gd-enhancing) Lesions Per MRI Scan
Query!
Assessment method [4]
0
0
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.
Query!
Timepoint [4]
0
0
Up to a maximum duration of 5.6 years
Query!
Secondary outcome [5]
0
0
Brain Magnetic Resonance Imaging (MRI) Assessment: Number of New or Enlarged T2 Lesions Per MRI Scan
Query!
Assessment method [5]
0
0
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.
Query!
Timepoint [5]
0
0
Up to a maximum duration of 5.6 years
Query!
Secondary outcome [6]
0
0
Brain Magnetic Resonance Imaging (MRI) Assessment: Number of New T1 (and New Hypointense T1) Lesions Per MRI Scan
Query!
Assessment method [6]
0
0
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.
Query!
Timepoint [6]
0
0
Up to a maximum duration of 5.6 years
Query!
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
Query!
Assessment method [7]
0
0
The total lesion volume (T1 lesions) was measured by MRI scan.
Query!
Timepoint [7]
0
0
Baseline (Month 0 of LPS13649), Month 12, Month 24, Month 36, Month 48 and Month 60
Query!
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
Query!
Assessment method [8]
0
0
The total lesion volume (T2 lesions) was measured by MRI scan.
Query!
Timepoint [8]
0
0
Baseline (Month 0 of LPS13649), Month 12, Month 24, Month 36, Month 48 and Month 60
Query!
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
Query!
Assessment method [9]
0
0
The brain parenchymal fraction was measured by MRI scan.
Query!
Timepoint [9]
0
0
Baseline (Month 0 of LPS13649), Month 12, Month 24, Month 36, Month 48 and Month 60
Query!
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
Query!
Assessment method [10]
0
0
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.
Query!
Timepoint [10]
0
0
Baseline (Month 0 of LPS13649), Month 12, Month 24, Month 36, Month 48 and Month 60
Query!
Secondary outcome [11]
0
0
Change From Baseline in Functional Assessment of Multiple Sclerosis (FAMS) Score at Month 12, 24, 36, 48, and 60
Query!
Assessment method [11]
0
0
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.
Query!
Timepoint [11]
0
0
Baseline (Month 0 of LPS13649), Month 12, Month 24, Month 36, Month 48 and Month 60
Query!
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
Query!
Assessment method [12]
0
0
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.
Query!
Timepoint [12]
0
0
Baseline (Month 0 of LPS13649), Month 12, Month 24, Month 36, Month 48 and Month 60
Query!
Secondary outcome [13]
0
0
Change From Baseline in EQ-5D Visual Analogue Scale (VAS) Scores at Month 12, 24, 36, 48, and 60
Query!
Assessment method [13]
0
0
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.
Query!
Timepoint [13]
0
0
Baseline (Month 0 of LPS13649), Month 12, Month 24, Month 36, Month 48 and Month 60
Query!
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
Query!
Assessment method [14]
0
0
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.
Query!
Timepoint [14]
0
0
Baseline (Month 0 of LPS13649), Month 12, Month 24, Month 36, Month 48 and Month 60
Query!
Secondary outcome [15]
0
0
Modified HRUQ: Number of Participants Who Reported Other Changes/Changes in Lifestyle Due to Multiple Sclerosis
Query!
Assessment method [15]
0
0
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.
Query!
Timepoint [15]
0
0
Baseline (Month 0 of LPS13649), Month 12, Month 24, Month 36, Month 48 and Month 60
Query!
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
Query!
Assessment method [16]
0
0
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.
Query!
Timepoint [16]
0
0
Baseline (Month 0 of LPS13649), Month 12, Month 24, Month 36, Month 48 and Month 60
Query!
Secondary outcome [17]
0
0
HRPQ: Total Scheduled Working Hours and Number of Hours Missed From Work Due to Multiple Sclerosis
Query!
Assessment method [17]
0
0
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.
Query!
Timepoint [17]
0
0
Baseline (Month 0 of LPS13649), Month 12, Month 24, Month 36, Month 48 and Month 60
Query!
Secondary outcome [18]
0
0
HRPQ: Percentage Impact on Work Output Due to Multiple Sclerosis
Query!
Assessment method [18]
0
0
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.
Query!
Timepoint [18]
0
0
Baseline (Month 0 of LPS13649), Month 12, Month 24, Month 36, Month 48 and Month 60
Query!
Secondary outcome [19]
0
0
HRPQ: Total Scheduled Household Chores Hours; Number of Hours Missed From Household Chores Due to Multiple Sclerosis
Query!
Assessment method [19]
0
0
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.
Query!
Timepoint [19]
0
0
Baseline (Month 0 of LPS13649), Month 12, Month 24, Month 36, Month 48 and Month 60
Query!
Secondary outcome [20]
0
0
HRPQ: Percentage Impact on Work Output for Household Chores Due to Multiple Sclerosis
Query!
Assessment method [20]
0
0
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.
Query!
Timepoint [20]
0
0
Baseline (Month 0 of LPS13649), Month 12, Month 24, Month 36, Month 48 and Month 60
Query!
Secondary outcome [21]
0
0
HRPQ: Duration of Disease (in Months) Since Development of Multiple Sclerosis
Query!
Assessment method [21]
0
0
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.
Query!
Timepoint [21]
0
0
Baseline up to end of the study (up to a maximum duration of 5.6 years)
Query!
Secondary outcome [22]
0
0
HRPQ: Number of Participants Who Reported Impact on Work Due to Multiple Sclerosis
Query!
Assessment method [22]
0
0
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.
Query!
Timepoint [22]
0
0
Baseline up to end of the study (up to a maximum duration of 5.6 years)
Query!
Eligibility
Key inclusion criteria
Inclusion criteria:
Participant had completed at least 48 months of the Extension Study CAMMS03409. Signed
written informed consent form.
Query!
Minimum age
18
Years
Query!
Query!
Maximum age
No limit
Query!
Query!
Sex
Both males and females
Query!
Can healthy volunteers participate?
No
Query!
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.
Query!
Study design
Purpose of the study
Treatment
Query!
Allocation to intervention
N/A
Query!
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Query!
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Query!
Masking / blinding
Open (masking not used)
Query!
Who is / are masked / blinded?
Query!
Query!
Query!
Query!
Intervention assignment
Single group
Query!
Other design features
Query!
Phase
Phase 4
Query!
Type of endpoint/s
Query!
Statistical methods / analysis
Query!
Recruitment
Recruitment status
Completed
Query!
Data analysis
Query!
Reason for early stopping/withdrawal
Query!
Other reasons
Query!
Date of first participant enrolment
Anticipated
Query!
Actual
7/01/2015
Query!
Date of last participant enrolment
Anticipated
Query!
Actual
Query!
Date of last data collection
Anticipated
Query!
Actual
15/07/2020
Query!
Sample size
Target
Query!
Accrual to date
Query!
Final
1062
Query!
Recruitment in Australia
Recruitment state(s)
Query!
Recruitment hospital [1]
0
0
Investigational Site Number 2013 - Auchenflower
Query!
Recruitment hospital [2]
0
0
Investigational Site Number 2001 - Heidelberg
Query!
Recruitment hospital [3]
0
0
Investigational Site Number 2011 - Hobart
Query!
Recruitment hospital [4]
0
0
Investigational Site Number 2012 - Kogarah
Query!
Recruitment hospital [5]
0
0
Investigational Site Number 2003 - Melbourne
Query!
Recruitment hospital [6]
0
0
Investigational Site Number 2002 - Parkville
Query!
Recruitment hospital [7]
0
0
Investigational Site Number 2005 - Southport
Query!
Recruitment hospital [8]
0
0
Investigational Site Number 2009 - Sydney
Query!
Recruitment hospital [9]
0
0
Investigational Site Number 2006 - Westmead
Query!
Recruitment postcode(s) [1]
0
0
4066 - Auchenflower
Query!
Recruitment postcode(s) [2]
0
0
3084 - Heidelberg
Query!
Recruitment postcode(s) [3]
0
0
7000 - Hobart
Query!
Recruitment postcode(s) [4]
0
0
2217 - Kogarah
Query!
Recruitment postcode(s) [5]
0
0
3065 - Melbourne
Query!
Recruitment postcode(s) [6]
0
0
3050 - Parkville
Query!
Recruitment postcode(s) [7]
0
0
4215 - Southport
Query!
Recruitment postcode(s) [8]
0
0
- Sydney
Query!
Recruitment postcode(s) [9]
0
0
2145 - Westmead
Query!
Recruitment outside Australia
Country [1]
0
0
United States of America
Query!
State/province [1]
0
0
Alabama
Query!
Country [2]
0
0
United States of America
Query!
State/province [2]
0
0
Arizona
Query!
Country [3]
0
0
United States of America
Query!
State/province [3]
0
0
California
Query!
Country [4]
0
0
United States of America
Query!
State/province [4]
0
0
Colorado
Query!
Country [5]
0
0
United States of America
Query!
State/province [5]
0
0
Florida
Query!
Country [6]
0
0
United States of America
Query!
State/province [6]
0
0
Illinois
Query!
Country [7]
0
0
United States of America
Query!
State/province [7]
0
0
Indiana
Query!
Country [8]
0
0
United States of America
Query!
State/province [8]
0
0
Iowa
Query!
Country [9]
0
0
United States of America
Query!
State/province [9]
0
0
Kansas
Query!
Country [10]
0
0
United States of America
Query!
State/province [10]
0
0
Kentucky
Query!
Country [11]
0
0
United States of America
Query!
State/province [11]
0
0
Massachusetts
Query!
Country [12]
0
0
United States of America
Query!
State/province [12]
0
0
Michigan
Query!
Country [13]
0
0
United States of America
Query!
State/province [13]
0
0
Missouri
Query!
Country [14]
0
0
United States of America
Query!
State/province [14]
0
0
New Jersey
Query!
Country [15]
0
0
United States of America
Query!
State/province [15]
0
0
New Mexico
Query!
Country [16]
0
0
United States of America
Query!
State/province [16]
0
0
New York
Query!
Country [17]
0
0
United States of America
Query!
State/province [17]
0
0
North Carolina
Query!
Country [18]
0
0
United States of America
Query!
State/province [18]
0
0
Ohio
Query!
Country [19]
0
0
United States of America
Query!
State/province [19]
0
0
Oklahoma
Query!
Country [20]
0
0
United States of America
Query!
State/province [20]
0
0
Pennsylvania
Query!
Country [21]
0
0
United States of America
Query!
State/province [21]
0
0
Rhode Island
Query!
Country [22]
0
0
United States of America
Query!
State/province [22]
0
0
Tennessee
Query!
Country [23]
0
0
United States of America
Query!
State/province [23]
0
0
Texas
Query!
Country [24]
0
0
United States of America
Query!
State/province [24]
0
0
Virginia
Query!
Country [25]
0
0
United States of America
Query!
State/province [25]
0
0
Washington
Query!
Country [26]
0
0
Argentina
Query!
State/province [26]
0
0
Caba
Query!
Country [27]
0
0
Belgium
Query!
State/province [27]
0
0
Bruxelles
Query!
Country [28]
0
0
Belgium
Query!
State/province [28]
0
0
Esneux
Query!
Country [29]
0
0
Belgium
Query!
State/province [29]
0
0
Leuven
Query!
Country [30]
0
0
Brazil
Query!
State/province [30]
0
0
Porto Alegre
Query!
Country [31]
0
0
Brazil
Query!
State/province [31]
0
0
Recife
Query!
Country [32]
0
0
Brazil
Query!
State/province [32]
0
0
São Paulo
Query!
Country [33]
0
0
Canada
Query!
State/province [33]
0
0
Calgary
Query!
Country [34]
0
0
Canada
Query!
State/province [34]
0
0
Gatineau
Query!
Country [35]
0
0
Canada
Query!
State/province [35]
0
0
Greenfield Park
Query!
Country [36]
0
0
Canada
Query!
State/province [36]
0
0
Kingston
Query!
Country [37]
0
0
Canada
Query!
State/province [37]
0
0
London
Query!
Country [38]
0
0
Canada
Query!
State/province [38]
0
0
Ottawa
Query!
Country [39]
0
0
Canada
Query!
State/province [39]
0
0
Vancouver
Query!
Country [40]
0
0
Czechia
Query!
State/province [40]
0
0
Brno
Query!
Country [41]
0
0
Czechia
Query!
State/province [41]
0
0
Hradec Kralove
Query!
Country [42]
0
0
Czechia
Query!
State/province [42]
0
0
Praha 2
Query!
Country [43]
0
0
Czechia
Query!
State/province [43]
0
0
Teplice
Query!
Country [44]
0
0
Denmark
Query!
State/province [44]
0
0
Aarhus N
Query!
Country [45]
0
0
Denmark
Query!
State/province [45]
0
0
København Ø.
Query!
Country [46]
0
0
Germany
Query!
State/province [46]
0
0
Berlin
Query!
Country [47]
0
0
Germany
Query!
State/province [47]
0
0
Dresden
Query!
Country [48]
0
0
Germany
Query!
State/province [48]
0
0
Frankfurt am Main
Query!
Country [49]
0
0
Germany
Query!
State/province [49]
0
0
Hamburg
Query!
Country [50]
0
0
Germany
Query!
State/province [50]
0
0
Hannover
Query!
Country [51]
0
0
Germany
Query!
State/province [51]
0
0
Hennigsdorf
Query!
Country [52]
0
0
Germany
Query!
State/province [52]
0
0
München
Query!
Country [53]
0
0
Germany
Query!
State/province [53]
0
0
Rostock
Query!
Country [54]
0
0
Germany
Query!
State/province [54]
0
0
Wermsdorf
Query!
Country [55]
0
0
Israel
Query!
State/province [55]
0
0
Ramat Gan
Query!
Country [56]
0
0
Israel
Query!
State/province [56]
0
0
Tel Aviv
Query!
Country [57]
0
0
Italy
Query!
State/province [57]
0
0
Cagliari
Query!
Country [58]
0
0
Italy
Query!
State/province [58]
0
0
Gallarate (VA)
Query!
Country [59]
0
0
Italy
Query!
State/province [59]
0
0
Orbassano (TO)
Query!
Country [60]
0
0
Italy
Query!
State/province [60]
0
0
Roma
Query!
Country [61]
0
0
Mexico
Query!
State/province [61]
0
0
Chihuahua
Query!
Country [62]
0
0
Mexico
Query!
State/province [62]
0
0
Mexico
Query!
Country [63]
0
0
Netherlands
Query!
State/province [63]
0
0
Sittard-Geleen
Query!
Country [64]
0
0
Poland
Query!
State/province [64]
0
0
Krakow
Query!
Country [65]
0
0
Poland
Query!
State/province [65]
0
0
Lodz
Query!
Country [66]
0
0
Poland
Query!
State/province [66]
0
0
Lublin
Query!
Country [67]
0
0
Poland
Query!
State/province [67]
0
0
Poznan
Query!
Country [68]
0
0
Poland
Query!
State/province [68]
0
0
Warszawa
Query!
Country [69]
0
0
Russian Federation
Query!
State/province [69]
0
0
Kazan
Query!
Country [70]
0
0
Russian Federation
Query!
State/province [70]
0
0
Moscow
Query!
Country [71]
0
0
Russian Federation
Query!
State/province [71]
0
0
Nizhny Novgorod
Query!
Country [72]
0
0
Russian Federation
Query!
State/province [72]
0
0
Pyatigorsk
Query!
Country [73]
0
0
Russian Federation
Query!
State/province [73]
0
0
Saint-Petersburg
Query!
Country [74]
0
0
Russian Federation
Query!
State/province [74]
0
0
Samara
Query!
Country [75]
0
0
Russian Federation
Query!
State/province [75]
0
0
Ufa
Query!
Country [76]
0
0
Spain
Query!
State/province [76]
0
0
Barcelona
Query!
Country [77]
0
0
Spain
Query!
State/province [77]
0
0
Madrid
Query!
Country [78]
0
0
Spain
Query!
State/province [78]
0
0
Málaga
Query!
Country [79]
0
0
Spain
Query!
State/province [79]
0
0
Sevilla
Query!
Country [80]
0
0
Sweden
Query!
State/province [80]
0
0
Göteborg
Query!
Country [81]
0
0
Sweden
Query!
State/province [81]
0
0
Umeå
Query!
Country [82]
0
0
Ukraine
Query!
State/province [82]
0
0
Kharkov
Query!
Country [83]
0
0
Ukraine
Query!
State/province [83]
0
0
Kiev
Query!
Country [84]
0
0
Ukraine
Query!
State/province [84]
0
0
Lviv
Query!
Country [85]
0
0
United Kingdom
Query!
State/province [85]
0
0
Bristol
Query!
Country [86]
0
0
United Kingdom
Query!
State/province [86]
0
0
Cambridge
Query!
Country [87]
0
0
United Kingdom
Query!
State/province [87]
0
0
Cardiff
Query!
Country [88]
0
0
United Kingdom
Query!
State/province [88]
0
0
London
Query!
Country [89]
0
0
United Kingdom
Query!
State/province [89]
0
0
Salford
Query!
Country [90]
0
0
United Kingdom
Query!
State/province [90]
0
0
Sheffield
Query!
Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Query!
Name
Genzyme, a Sanofi Company
Query!
Address
Query!
Country
Query!
Ethics approval
Ethics application status
Query!
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.
Query!
Trial website
https://clinicaltrials.gov/ct2/show/NCT02255656
Query!
Trial related presentations / publications
Query!
Public notes
Query!
Contacts
Principal investigator
Name
0
0
Clinical Sciences & Operations
Query!
Address
0
0
Sanofi
Query!
Country
0
0
Query!
Phone
0
0
Query!
Fax
0
0
Query!
Email
0
0
Query!
Contact person for public queries
Name
0
0
Query!
Address
0
0
Query!
Country
0
0
Query!
Phone
0
0
Query!
Fax
0
0
Query!
Email
0
0
Query!
Contact person for scientific queries
Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT02255656
Download to PDF