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| ID | Type | Description | Link |
|---|---|---|---|
| 2013-003884-71 | |||
| U1111-1148-2987 | Other Identifier | UTN |
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Primary Objective:
To evaluate long-term safety of alemtuzumab.
Secondary Objectives:
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Alemtuzumab | Experimental | 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). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| alemtuzumab GZ402673 | Drug | Pharmaceutical form:concentrate for solution for infusion Route of administration: intravenous |
|
| 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:
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| 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. |
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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.
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| Name | Affiliation | Role |
|---|---|---|
| Clinical Sciences & Operations | Sanofi | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Investigational Site Number 1086 | Cullman | Alabama | 00000 | United States | ||
| Investigational Site Number 1031 |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 39935588 | Derived | Ziemssen T, Bass AD, Van Wijmeersch B, Eichau S, Richter S, Hoffmann F, Armstrong NM, Chirieac M, Cunha-Santos J, Singer BA. Long-term efficacy and safety of alemtuzumab in participants with highly active MS: TOPAZ clinical trial and interim analysis of TREAT-MS real-world study. Ther Adv Neurol Disord. 2025 Feb 10;18:17562864241306575. doi: 10.1177/17562864241306575. eCollection 2025. | |
| 37745914 |
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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
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Subgroup analysis ([Delayed Alemtuzumab Treatment[DAT] & Immediate Alemtuzumab Treatment[IAT]subgroup) was performed only for outcome measures and safety analysis. Participants who rolled over from CAMMS223(NCT00050778) to CAMMS03409 (NCT00930553),then subsequently enrolled and took 24 mg alemtuzumab in CAMMS324 (NCT00548405) study, were not considered as part of DAT or IAT subgroup & included in overall group only. Participant flow and Baseline analysis was performed on overall population only.](streamdown:incomplete-link)
The study was conducted at 142 study centers in 21 countries. A total of 1062 participants were screened between 7 January 2015 and 28 June 2016 and were enrolled in this current study (LPS13649 [TOPAZ]).
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| ID | Title | Description |
|---|---|---|
| FG000 | 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). |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Jan 28, 2020 | Jun 30, 2021 |
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| From Baseline until the end of the study (up to a maximum duration of 5.6 years) |
| 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) |
| Phoenix |
| Arizona |
| 85013 |
| United States |
| Investigational Site Number 1171 | Phoenix | Arizona | 85018 | United States |
| Investigational Site Number 1090 | Tucson | Arizona | 85704 | United States |
| Investigational Site Number 1040 | Berkeley | California | 94705 | United States |
| Investigational Site Number 1152 | Fullerton | California | 92835 | United States |
| Investigational Site Number 1093 | Pasadena | California | 91105 | United States |
| Investigational Site Number 1027 | Fort Collins | Colorado | 80528 | United States |
| Investigational Site Number 1078 | Jacksonville | Florida | 32209 | United States |
| Investigational Site Number 1059 | Maitland | Florida | 32751 | United States |
| Investigational Site Number 1173 | Sarasota | Florida | 34239 | United States |
| Investigational Site Number 1034 | Sunrise | Florida | 33351 | United States |
| Investigational Site Number 1005 | Tampa | Florida | 33609 | United States |
| Investigational Site Number 1049 | Tampa | Florida | 33612 | United States |
| Investigational Site Number 1008 | Northbrook | Illinois | 60062 | United States |
| Investigational Site Number 1001 | Fort Wayne | Indiana | 46845 | United States |
| Investigational Site Number 1024 | Indianapolis | Indiana | 46202 | United States |
| Investigational Site Number 1017 | Des Moines | Iowa | 50314 | United States |
| Investigational Site Number 1022 | Kansas City | Kansas | 66160 | United States |
| Investigational Site Number 1083 | Lenexa | Kansas | 66214 | United States |
| Investigational Site Number 1039 | Lexington | Kentucky | 40513 | United States |
| Investigational Site Number 1021 | Louisville | Kentucky | 40202 | United States |
| Investigational Site Number 1061 | Wellesley | Massachusetts | 02481 | United States |
| Investigational Site Number 1028 | Worcester | Massachusetts | 01655 | United States |
| Investigational Site Number 1025 | Ann Arbor | Michigan | 48105-2945 | United States |
| Investigational Site Number 1020 | Detroit | Michigan | 48201 | United States |
| Investigational Site Number 1054 | Traverse City | Michigan | 49684 | United States |
| Investigational Site Number 1084 | Kansas City | Missouri | 64111 | United States |
| Investigational Site Number 1092 | St Louis | Missouri | 63131 | United States |
| Investigational Site Number 1073 | Teaneck | New Jersey | 07666 | United States |
| Investigational Site Number 1014 | Albuquerque | New Mexico | 87131 | United States |
| Investigational Site Number 1081 | Mineola | New York | 11501 | United States |
| Investigational Site Number 1026 | New York | New York | 10029 | United States |
| Investigational Site Number 1160 | Patchogue | New York | 11772 | United States |
| Investigational Site Number 1015 | Rochester | New York | 14642 | United States |
| Investigational Site Number 1053 | Syracuse | New York | 13202 | United States |
| Investigational Site Number 1095 | Chapel Hill | North Carolina | 27599 | United States |
| Investigational Site Number 1082 | Winston-Salem | North Carolina | 27103 | United States |
| Investigational Site Number 1035 | Cleveland | Ohio | 44195 | United States |
| Investigational Site Number 1058 | Uniontown | Ohio | 44685 | United States |
| Investigational Site Number 1067 | Oklahoma City | Oklahoma | 73104 | United States |
| Investigational Site Number 1097 | Allentown | Pennsylvania | 18103 | United States |
| Investigational Site Number 1057 | Providence | Rhode Island | 02905 | United States |
| Investigational Site Number 1163 | Cordova | Tennessee | 38018 | United States |
| Investigational Site Number 1055 | Franklin | Tennessee | 37064 | United States |
| Investigational Site Number 1009 | Knoxville | Tennessee | 37922 | United States |
| Investigational Site Number 1042 | Nashville | Tennessee | 37215 | United States |
| Investigational Site Number 1018 | Houston | Texas | 77030 | United States |
| Investigational Site Number 1002 | Round Rock | Texas | 78681 | United States |
| Investigational Site Number 1046 | San Antonio | Texas | United States |
| Investigational Site Number 1037 | Vienna | Virginia | 22182 | United States |
| Investigational Site Number 1068 | Seattle | Washington | 98122 | United States |
| Investigational Site Number 03208 | CABA | C1061ABD | Argentina |
| Investigational Site Number 2013 | Auchenflower | 4066 | Australia |
| Investigational Site Number 2001 | Heidelberg | 3084 | Australia |
| Investigational Site Number 2011 | Hobart | 7000 | Australia |
| Investigational Site Number 2012 | Kogarah | 2217 | Australia |
| Investigational Site Number 2003 | Melbourne | 3065 | Australia |
| Investigational Site Number 2002 | Parkville | 3050 | Australia |
| Investigational Site Number 2005 | Southport | 4215 | Australia |
| Investigational Site Number 2009 | Sydney | Australia |
| Investigational Site Number 2006 | Westmead | 2145 | Australia |
| Investigational Site Number 5005 | Brussels | 1200 | Belgium |
| Investigational Site Number 5004 | Esneux | 4130 | Belgium |
| Investigational Site Number 5001 | Leuven | 3000 | Belgium |
| Investigational Site Number 3006 | Porto Alegre | 90110000 | Brazil |
| Investigational Site Number 3002 | Recife | 52010-040 | Brazil |
| Investigational Site Number 3001 | São Paulo | 01221-000 | Brazil |
| Investigational Site Number 3003 | São Paulo | 05403-000 | Brazil |
| Investigational Site Number 1102 | Calgary | T2N 2T9 | Canada |
| Investigational Site Number 1105 | Gatineau | J8Y1W2 | Canada |
| Investigational Site Number 1104 | Greenfield Park | J4V2J2 | Canada |
| Investigational Site Number 1109 | Kingston | K7L2V7 | Canada |
| Investigational Site Number 1110 | London | N6A5A5 | Canada |
| Investigational Site Number 1101 | Ottawa | K1H8L6 | Canada |
| Investigational Site Number 1106 | Vancouver | V6T1Z3 | Canada |
| Investigational Site Number 4803 | Brno | 65691 | Czechia |
| Investigational Site Number 4804 | Hradec Králové | 50005 | Czechia |
| Investigational Site Number 4801 | Prague | 12808 | Czechia |
| Investigational Site Number 4802 | Teplice | 41501 | Czechia |
| Investigational Site Number 5302 | Aarhus N | 8200 | Denmark |
| Investigational Site Number 5301 | København Ø | 2100 | Denmark |
| Investigational Site Number 4602 | Berlin | 13347 | Germany |
| Investigational Site Number 4607 | Dresden | 01307 | Germany |
| Investigational Site Number 4634 | Frankfurt am Main | 60590 | Germany |
| Investigational Site Number 4622 | Hamburg | 22307 | Germany |
| Investigational Site Number 4605 | Hanover | 30625 | Germany |
| Investigational Site Number 4609 | Hennigsdorf | 16761 | Germany |
| Investigational Site Number 4608 | München | 81675 | Germany |
| Investigational Site Number 4610 | Rostock | 18147 | Germany |
| Investigational Site Number 4613 | Wermsdorf | 04779 | Germany |
| Investigational Site Number 5501 | Ramat Gan | 52621 | Israel |
| Investigational Site Number 5505 | Tel Aviv | Israel |
| Investigational Site Number 4112 | Cagliari | 09126 | Italy |
| Investigational Site Number 4102 | Gallarate (VA) | 21013 | Italy |
| Investigational Site Number 4106 | Orbassano (TO) | 10043 | Italy |
| Investigational Site Number 4110 | Roma | 00189 | Italy |
| Investigational Site Number 3105 | Chihuahua City | 31203 | Mexico |
| Investigational Site Number 3102 | México | 14260 | Mexico |
| Investigational Site Number 4202 | Sittard-Geleen | 6162BG | Netherlands |
| Investigational Site Number 4902 | Krakow | 31-505 | Poland |
| Investigational Site Number 4901 | Lodz | 90-324 | Poland |
| Investigational Site Number 4903 | Lublin | 20-090 | Poland |
| Investigational Site Number 4904 | Poznan | 60-355 | Poland |
| Investigational Site Number 4905 | Warsaw | 02-957 | Poland |
| Investigational Site Number 6009 | Kazan' | 420097 | Russia |
| Investigational Site Number 6001 | Moscow | 1217015 | Russia |
| Investigational Site Number 6005 | Moscow | 1217015 | Russia |
| Investigational Site Number 6003 | Moscow | Russia |
| Investigational Site Number 6006 | Nizhny Novgorod | Russia |
| Investigational Site Number 6010 | Pyatigorsk | Russia |
| Investigational Site Number 6002 | Saint Petersburg | Russia |
| Investigational Site Number 6004 | Saint Petersburg | Russia |
| Investigational Site Number 6008 | Saint Petersburg | Russia |
| Investigational Site Number 6013 | Samara | Russia |
| Investigational Site Number 6016 | Ufa | Russia |
| Investigational Site Number 4301 | Barcelona | 08035 | Spain |
| Investigational Site Number 4303 | Madrid | 28040 | Spain |
| Investigational Site Number 4305 | Málaga | 29010 | Spain |
| Investigational Site Number 4304 | Seville | 41071 | Spain |
| Investigational Site Number 4701 | Gothenburg | 41345 | Sweden |
| Investigational Site Number 4702 | Umeå | 90185 | Sweden |
| Investigational Site Number 6102 | Kharkiv | Ukraine |
| Investigational Site Number 6104 | Kiev | Ukraine |
| Investigational Site Number 6103 | Lviv | Ukraine |
| Investigational Site Number 4004 | Bristol | BS105NB | United Kingdom |
| Investigational Site Number 4001 | Cambridge | CB50QQ | United Kingdom |
| Investigational Site Number 4005 | Cardiff | CF44XN | United Kingdom |
| Investigational Site Number 4006 | London | E12AT | United Kingdom |
| Investigational Site Number 4008 | Salford | M68HD | United Kingdom |
| Investigational Site Number 4007 | Sheffield | S102JF | United Kingdom |
| Derived |
| Coles AJ, Achiron A, Traboulsee A, Singer BA, Pozzilli C, Oreja-Guevara C, Giovannoni G, Comi G, Freedman MS, Ziemssen T, Shiota D, Rawlings AM, Wong AT, Chirieac M, Montalban X. Safety and efficacy with alemtuzumab over 13 years in relapsing-remitting multiple sclerosis: final results from the open-label TOPAZ study. Ther Adv Neurol Disord. 2023 Sep 21;16:17562864231194823. doi: 10.1177/17562864231194823. eCollection 2023. |
| 34882037 | Derived | 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. |
| 34378446 | Derived | 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. |
| 33476880 | Derived | 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. |
| 32710396 | Derived | 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. |
| 32583052 | Derived | 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. |
| 31762387 | Derived | 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. |
| 31654272 | Derived | 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. |
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Analysis was performed on all enrolled participants.
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| ID | Title | Description |
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| BG000 | 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 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). |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | |||||||||||||||||
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| Age, Continuous | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race/Ethnicity, Customized | Count of Participants | Participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||||||||
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| Primary | 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. | Analysis was performed on safety analysis set that included all participants who signed the informed consent form (ICF). As pre-specified, data collection and analysis for this outcome measure was done on the overall population along with 2 subgroups (DAT and IAT). | Posted | Count of Participants | Participants | From Baseline until the end of the study (up to a maximum duration of 5.6 years) |
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| Primary | 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. | Analysis was performed on re-treated population that included all participants who had signed the ICF and who had received study drug in the current study LPS13649. Here, 'Overall number of participants analyzed' = participants evaluable for this outcome measure. As pre-specified, data collection and analysis for this outcome measure was done on the overall population along with 2 subgroups (DAT and IAT). | Posted | Count of Participants | Participants | Within 24 hours of any alemtuzumab infusion |
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| Primary | 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. | Analysis was performed on safety population. As pre-specified, data collection and analysis for this outcome measure was done on the overall population along with 2 subgroups (DAT and IAT). | Posted | Count of Participants | Participants | From Baseline until the end of the study (up to a maximum duration of 5.6 years) |
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| Primary | Number of Participants With Potentially Clinically Significant Laboratory Abnormalities | Criteria for potentially clinically significant laboratory abnormalities included:
| Analysis was performed on all participants who had signed the ICF; and received study drug in the TOPAZ study; or in studies CAMMS223,CAMMS323,CAMMS324 or CAMMS03409, and did not complete 48 months of follow-up at the screening visit in the TOPAZ study. Here, 'Overall number of participants analyzed' = participants evaluable for this outcome measure and 'Number analyzed' = participants with available data for each specified category. | Posted | Count of Participants | Participants | From Baseline until the end of the study (up to a maximum duration of 5.6 years) |
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| Secondary | 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. | Analysis was performed on efficacy population which included all enrolled participants who had received study drug in studies CAMMS223, CAMMS323, CAMMS324 or CAMMS03409. As pre-specified, data collection and analysis for this outcome measure was done only on the 2 subgroups (DAT and IAT). | Posted | Number | 95% Confidence Interval | relapses per participant per year | Up to a maximum duration of 5.6 years |
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| Secondary | 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. | Analysis was performed on efficacy population. As pre-specified, data collection and analysis for this outcome measure was done only on the 2 subgroups (DAT and IAT). | Posted | Number | 95% Confidence Interval | proportion of participants | Up to a maximum duration of 5.6 years |
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| Secondary | 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. | Analysis was performed on efficacy population. Here, 'Number analyzed' = participants with available data for each specified category. As pre-specified, data collection and analysis for this outcome measure was done only on the 2 subgroups (DAT and IAT). | Posted | Least Squares Mean | Standard Error | score on a scale | Baseline (Month 0 of LPS13649), Month 6, 12, 18, 24, 30, 36, 42, 48, 54 and 60 |
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| Secondary | 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. | Analysis was performed on efficacy population. As pre-specified, data collection and analysis for this outcome measure was done only on the 2 subgroups (DAT and IAT). | Posted | Number | 95% Confidence Interval | lesions per scan | Up to a maximum duration of 5.6 years |
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| Secondary | 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. | Analysis was performed on efficacy population. As pre-specified, data collection and analysis for this outcome measure was done only on the 2 subgroups (DAT and IAT). | Posted | Number | 95% Confidence Interval | lesions per scan | Up to a maximum duration of 5.6 years |
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| Secondary | 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. | Analysis was performed on efficacy population. As pre-specified, data collection and analysis for this outcome measure was done only on the 2 subgroups (DAT and IAT). | Posted | Number | 95% Confidence Interval | lesions per scan | Up to a maximum duration of 5.6 years |
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| Secondary | 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. | Analysis was preformed on efficacy population. Here, 'Number analyzed' = participants with available data for each specified category. As pre-specified, data collection and analysis for this outcome measure was done only on the 2 subgroups (DAT and IAT). | Posted | Mean | Standard Deviation | percent change | Baseline (Month 0 of LPS13649), Month 12, Month 24, Month 36, Month 48 and Month 60 |
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| Secondary | 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. | Analysis was performed on efficacy population. Here, 'Number analyzed' = participants with available data for each specified category. As pre-specified, data collection and analysis for this outcome measure was done only on the 2 subgroups (DAT and IAT). | Posted | Mean | Standard Deviation | percent change | Baseline (Month 0 of LPS13649), Month 12, Month 24, Month 36, Month 48 and Month 60 |
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| Secondary | 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. | Analysis was performed on efficacy population. Here, 'Number analyzed' = participants with available data for each specified category. As pre-specified, data collection and analysis for this outcome measure was done only on the 2 subgroups (DAT and IAT). | Posted | Mean | Standard Deviation | percent change | Baseline (Month 0 of LPS13649), Month 12, Month 24, Month 36, Month 48 and Month 60 |
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| Secondary | 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. | Analysis was performed on efficacy population. Here, 'Number analyzed' = participants with available data for each specified category. As pre-specified, data collection and analysis for this outcome measure was done only on the 2 subgroups (DAT and IAT). | Posted | Mean | Standard Deviation | score on a scale | Baseline (Month 0 of LPS13649), Month 12, Month 24, Month 36, Month 48 and Month 60 |
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| Secondary | 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. | Analysis was performed on efficacy population. Here, 'Number analyzed' = participants with available data for each specified category. As pre-specified, data collection and analysis for this outcome measure was done only on the 2 subgroups (DAT and IAT). | Posted | Mean | Standard Deviation | score on a scale | Baseline (Month 0 of LPS13649), Month 12, Month 24, Month 36, Month 48 and Month 60 |
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| Secondary | 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. | Analysis was performed on efficacy population. Here, 'Number analyzed' = participants with available data for each specified category. As pre-specified, data collection and analysis for this outcome measure was done only on the 2 subgroups (DAT and IAT). | Posted | Mean | Standard Deviation | score on a scale | Baseline (Month 0 of LPS13649), Month 12, Month 24, Month 36, Month 48 and Month 60 |
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| Secondary | 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. | Analysis was performed on efficacy population. Here, 'Number analyzed' = participants with available data for each specified category. As pre-specified, data collection and analysis for this outcome measure was done only on the 2 subgroups (DAT and IAT). | Posted | Mean | Standard Deviation | score on a scale | Baseline (Month 0 of LPS13649), Month 12, Month 24, Month 36, Month 48 and Month 60 |
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| Secondary | 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. | Analysis was performed on efficacy population. Here, 'Overall number of participants analyzed' = participants evaluable for this outcome measure and 'Number analyzed' = participants with available data for each specified category. As pre-specified, data collection and analysis for this outcome measure was done on the overall population along with 2 subgroups (DAT and IAT). | Posted | Count of Participants | Participants | Baseline (Month 0 of LPS13649), Month 12, Month 24, Month 36, Month 48 and Month 60 |
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| Secondary | 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. | Analysis was performed on efficacy population. Here, 'Overall number of participants analyzed' = participants evaluable for this outcome measure and 'Number analyzed' = participants with available data for each specified category. As pre-specified, data collection and analysis for this outcome measure was done on the overall population along with 2 subgroups (DAT and IAT). | Posted | Count of Participants | Participants | Baseline (Month 0 of LPS13649), Month 12, Month 24, Month 36, Month 48 and Month 60 |
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| Secondary | 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. | Analysis was performed on efficacy population. Here, 'Overall number of participants analyzed' = participants evaluable for this outcome measure and 'Number analyzed' = participants with available data for each specified category. As pre-specified, data collection and analysis for this outcome measure was done on the overall population along with 2 subgroups (DAT and IAT). | Posted | Count of Participants | Participants | Baseline (Month 0 of LPS13649), Month 12, Month 24, Month 36, Month 48 and Month 60 |
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| Secondary | 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. | Analysis was performed on efficacy population. Here, 'Overall number of participants analyzed' = participants evaluable for this outcome measure and 'Number analyzed' = participants with available data for each specified category. As pre-specified, data collection and analysis for this outcome measure was done on the overall population along with 2 subgroups (DAT and IAT). | Posted | Mean | Standard Deviation | hours | Baseline (Month 0 of LPS13649), Month 12, Month 24, Month 36, Month 48 and Month 60 |
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| Secondary | 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. | Analysis was performed on efficacy population. Here, 'Overall number of participants analyzed' = participants evaluable for this outcome measure and 'Number analyzed' = participants with available data for each specified category. As pre-specified, data collection and analysis for this outcome measure was done on the overall population along with 2 subgroups (DAT and IAT). | Posted | Mean | Standard Deviation | percentage impact on work output | Baseline (Month 0 of LPS13649), Month 12, Month 24, Month 36, Month 48 and Month 60 |
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| Secondary | 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. | Analysis was performed on efficacy population.Here, 'Overall number of participants analyzed' = participants evaluable for this outcome measure and 'Number analyzed' = participants with available data for each specified category. As pre-specified, data collection and analysis for this outcome measure was done on the overall population along with 2 subgroups (DAT and IAT). | Posted | Mean | Standard Deviation | hours | Baseline (Month 0 of LPS13649), Month 12, Month 24, Month 36, Month 48 and Month 60 |
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| Secondary | 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. | Analysis was performed on efficacy population. Here, 'Overall number of participants analyzed' = participants evaluable for this outcome measure and 'Number analyzed' = participants with available data for each specified category. As pre-specified, data collection and analysis for this outcome measure was done on the overall population along with 2 subgroups (DAT and IAT). | Posted | Mean | Standard Deviation | percentage impact on work output | Baseline (Month 0 of LPS13649), Month 12, Month 24, Month 36, Month 48 and Month 60 |
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| Secondary | 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. | Analysis was performed on efficacy population. Here, 'Overall number of participants analyzed' = participants evaluable for this outcome measure. As pre-specified, data collection and analysis for this outcome measure was done on the overall population along with 2 subgroups (DAT and IAT). | Posted | Mean | Standard Deviation | months | Baseline up to end of the study (up to a maximum duration of 5.6 years) |
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| Secondary | 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. | Analysis was performed on efficacy population. Here, 'Overall number of participants analyzed' = participants evaluable for this outcome measure and 'Number analyzed' = participants with available data for each specified category. As pre-specified, data collection and analysis for this outcome measure was done on the overall population along with 2 subgroups (DAT and IAT). | Posted | Count of Participants | Participants | Baseline up to end of the study (up to a maximum duration of 5.6 years) |
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All Adverse Events were collected from the Baseline until the end of the study (up to a maximum duration of 5.6 years).
Reported adverse events and death were TEAEs that is AEs that developed/worsened during the 'treatment period' (time from Baseline until the end of the study). Analysis was performed on safety population. As pre-specified, safety analysis was done on the overall population along with 2 subgroups (DAT and IAT).
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Delayed Alemtuzumab Treatment (DAT) | Participants from the SC IFNB1a treatment arms of studies CAMMS323 and CAMMS324, who received their initial 2 treatment courses of alemtuzumab during the CAMMS03409 extension study were included in the DAT subgroup of the current study (LPS13649). Participants received alemtuzumab intravenous infusion of 12 mg/day for 3 consecutive days, at the study investigators' discretion; and at least 12 months after the prior treatment course in the current study (LPS13649). | 0 | 241 | 55 | 241 | 150 | 241 |
| EG001 | Initial Alemtuzumab Treatment (IAT) | Participants from the 12 mg/day alemtuzumab treatment arms of the studies CAMMS323 and CAMMS324 (who were subsequently enrolled in CAMMS03409 extension study and then entered in this study LPS13649) were included in the IAT subgroup of the current study (LPS13649). Participants received alemtuzumab intravenous infusion of 12 mg/day for 3 consecutive days, at the study investigators' discretion; and at least 12 months after the prior treatment course in the current study (LPS13649). | 10 | 598 | 133 | 598 | 338 | 598 |
| EG002 | 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 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). | 11 | 1,062 | 237 | 1,062 | 601 | 1,062 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Febrile Neutropenia | Blood and lymphatic system disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Immune Thrombocytopenia | Blood and lymphatic system disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Lymphopenia | Blood and lymphatic system disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Thrombocytopenia | Blood and lymphatic system disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Acute Left Ventricular Failure | Cardiac disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Acute Myocardial Infarction | Cardiac disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Atrioventricular Block | Cardiac disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Bundle Branch Block Left | Cardiac disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Coronary Artery Disease | Cardiac disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Left Ventricular Dysfunction | Cardiac disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Mitral Valve Incompetence | Cardiac disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Myocardial Infarction | Cardiac disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Pericardial Effusion | Cardiac disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Sinus Tachycardia | Cardiac disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Ventricular Arrhythmia | Cardiac disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Atrial Septal Defect | Congenital, familial and genetic disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Congenital Cystic Kidney Disease | Congenital, familial and genetic disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Congenital Nail Disorder | Congenital, familial and genetic disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Foetal Chromosome Abnormality | Congenital, familial and genetic disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Trisomy 21 | Congenital, familial and genetic disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Haematotympanum | Ear and labyrinth disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Vertigo | Ear and labyrinth disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Autoimmune Hypothyroidism | Endocrine disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Autoimmune Thyroid Disorder | Endocrine disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Autoimmune Thyroiditis | Endocrine disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Basedow's Disease | Endocrine disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Hyperthyroidism | Endocrine disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Hypothyroidism | Endocrine disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Thyroid Dermatopathy | Endocrine disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Cataract | Eye disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Endocrine Ophthalmopathy | Eye disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Exophthalmos | Eye disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Eyelid Ptosis | Eye disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Glaucoma | Eye disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Optic Ischaemic Neuropathy | Eye disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Periorbital Oedema | Eye disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Abdominal Pain Upper | Gastrointestinal disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Colitis Ulcerative | Gastrointestinal disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Gastric Ulcer Perforation | Gastrointestinal disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Gastritis | Gastrointestinal disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Haematemesis | Gastrointestinal disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Haemorrhoids | Gastrointestinal disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Inguinal Hernia | Gastrointestinal disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Intestinal Ischaemia | Gastrointestinal disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Intestinal Obstruction | Gastrointestinal disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Intussusception | Gastrointestinal disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Obstructive Pancreatitis | Gastrointestinal disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Pancreatitis Acute | Gastrointestinal disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Pancreatitis Chronic | Gastrointestinal disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Small Intestinal Obstruction | Gastrointestinal disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Catheter Site Pain | General disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Complication Associated With Device | General disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Death | General disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Drug Intolerance | General disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Hyperthermia | General disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Non-Cardiac Chest Pain | General disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Sudden Death | General disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Cholecystitis | Hepatobiliary disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Cholelithiasis | Hepatobiliary disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Drug Hypersensitivity | Immune system disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Immune Reconstitution Inflammatory Syndrome | Immune system disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Sarcoidosis | Immune system disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Abdominal Abscess | Infections and infestations | MedDRA 23.0 | Systematic Assessment |
| |
| Abscess Rupture | Infections and infestations | MedDRA 23.0 | Systematic Assessment |
| |
| Anal Abscess | Infections and infestations | MedDRA 23.0 | Systematic Assessment |
| |
| Appendicitis | Infections and infestations | MedDRA 23.0 | Systematic Assessment |
| |
| Bacteraemia | Infections and infestations | MedDRA 23.0 | Systematic Assessment |
| |
| Bacterial Sepsis | Infections and infestations | MedDRA 23.0 | Systematic Assessment |
| |
| Cellulitis | Infections and infestations | MedDRA 23.0 | Systematic Assessment |
| |
| Cellulitis Staphylococcal | Infections and infestations | MedDRA 23.0 | Systematic Assessment |
| |
| Clostridium Difficile Colitis | Infections and infestations | MedDRA 23.0 | Systematic Assessment |
| |
| Clostridium Difficile Infection | Infections and infestations | MedDRA 23.0 | Systematic Assessment |
| |
| Diverticulitis | Infections and infestations | MedDRA 23.0 | Systematic Assessment |
| |
| Endocarditis | Infections and infestations | MedDRA 23.0 | Systematic Assessment |
| |
| Erysipelas | Infections and infestations | MedDRA 23.0 | Systematic Assessment |
| |
| Escherichia Urinary Tract Infection | Infections and infestations | MedDRA 23.0 | Systematic Assessment |
| |
| Gangrene | Infections and infestations | MedDRA 23.0 | Systematic Assessment |
| |
| Gastroenteritis | Infections and infestations | MedDRA 23.0 | Systematic Assessment |
| |
| Gastrointestinal Bacterial Infection | Infections and infestations | MedDRA 23.0 | Systematic Assessment |
| |
| Herpes Zoster | Infections and infestations | MedDRA 23.0 | Systematic Assessment |
| |
| Herpes Zoster Infection Neurological | Infections and infestations | MedDRA 23.0 | Systematic Assessment |
| |
| Infected Bite | Infections and infestations | MedDRA 23.0 | Systematic Assessment |
| |
| Infected Lymphocele | Infections and infestations | MedDRA 23.0 | Systematic Assessment |
| |
| Influenza | Infections and infestations | MedDRA 23.0 | Systematic Assessment |
| |
| Klebsiella Infection | Infections and infestations | MedDRA 23.0 | Systematic Assessment |
| |
| Localised Infection | Infections and infestations | MedDRA 23.0 | Systematic Assessment |
| |
| Neonatal Pneumonia | Infections and infestations | MedDRA 23.0 | Systematic Assessment |
| |
| Osteomyelitis Acute | Infections and infestations | MedDRA 23.0 | Systematic Assessment |
| |
| Periodontitis | Infections and infestations | MedDRA 23.0 | Systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA 23.0 | Systematic Assessment |
| |
| Pneumonia Bacterial | Infections and infestations | MedDRA 23.0 | Systematic Assessment |
| |
| Pneumonia Streptococcal | Infections and infestations | MedDRA 23.0 | Systematic Assessment |
| |
| Postoperative Wound Infection | Infections and infestations | MedDRA 23.0 | Systematic Assessment |
| |
| Pyelonephritis | Infections and infestations | MedDRA 23.0 | Systematic Assessment |
| |
| Scrotal Abscess | Infections and infestations | MedDRA 23.0 | Systematic Assessment |
| |
| Sepsis | Infections and infestations | MedDRA 23.0 | Systematic Assessment |
| |
| Septic Shock | Infections and infestations | MedDRA 23.0 | Systematic Assessment |
| |
| Urinary Tract Infection | Infections and infestations | MedDRA 23.0 | Systematic Assessment |
| |
| Urinary Tract Infection Bacterial | Infections and infestations | MedDRA 23.0 | Systematic Assessment |
| |
| Urosepsis | Infections and infestations | MedDRA 23.0 | Systematic Assessment |
| |
| Uterine Infection | Infections and infestations | MedDRA 23.0 | Systematic Assessment |
| |
| Accidental Overdose | Injury, poisoning and procedural complications | MedDRA 23.0 | Systematic Assessment |
| |
| Ankle Fracture | Injury, poisoning and procedural complications | MedDRA 23.0 | Systematic Assessment |
| |
| Brain Contusion | Injury, poisoning and procedural complications | MedDRA 23.0 | Systematic Assessment |
| |
| Burns Third Degree | Injury, poisoning and procedural complications | MedDRA 23.0 | Systematic Assessment |
| |
| Craniocerebral Injury | Injury, poisoning and procedural complications | MedDRA 23.0 | Systematic Assessment |
| |
| Face Injury | Injury, poisoning and procedural complications | MedDRA 23.0 | Systematic Assessment |
| |
| Fall | Injury, poisoning and procedural complications | MedDRA 23.0 | Systematic Assessment |
| |
| Femur Fracture | Injury, poisoning and procedural complications | MedDRA 23.0 | Systematic Assessment |
| |
| Foot Fracture | Injury, poisoning and procedural complications | MedDRA 23.0 | Systematic Assessment |
| |
| Head Injury | Injury, poisoning and procedural complications | MedDRA 23.0 | Systematic Assessment |
| |
| Humerus Fracture | Injury, poisoning and procedural complications | MedDRA 23.0 | Systematic Assessment |
| |
| Induced Abortion Failed | Injury, poisoning and procedural complications | MedDRA 23.0 | Systematic Assessment |
| |
| Intentional Overdose | Injury, poisoning and procedural complications | MedDRA 23.0 | Systematic Assessment |
| |
| Meniscus Injury | Injury, poisoning and procedural complications | MedDRA 23.0 | Systematic Assessment |
| |
| Post Procedural Hypotension | Injury, poisoning and procedural complications | MedDRA 23.0 | Systematic Assessment |
| |
| Radius Fracture | Injury, poisoning and procedural complications | MedDRA 23.0 | Systematic Assessment |
| |
| Skull Fractured Base | Injury, poisoning and procedural complications | MedDRA 23.0 | Systematic Assessment |
| |
| Subdural Haematoma | Injury, poisoning and procedural complications | MedDRA 23.0 | Systematic Assessment |
| |
| Tendon Rupture | Injury, poisoning and procedural complications | MedDRA 23.0 | Systematic Assessment |
| |
| Tibia Fracture | Injury, poisoning and procedural complications | MedDRA 23.0 | Systematic Assessment |
| |
| Traumatic Fracture | Injury, poisoning and procedural complications | MedDRA 23.0 | Systematic Assessment |
| |
| Ulna Fracture | Injury, poisoning and procedural complications | MedDRA 23.0 | Systematic Assessment |
| |
| Upper Limb Fracture | Injury, poisoning and procedural complications | MedDRA 23.0 | Systematic Assessment |
| |
| Wrist Fracture | Injury, poisoning and procedural complications | MedDRA 23.0 | Systematic Assessment |
| |
| Antiphospholipid Antibodies Positive | Investigations | MedDRA 23.0 | Systematic Assessment |
| |
| Human Papilloma Virus Test Positive | Investigations | MedDRA 23.0 | Systematic Assessment |
| |
| Lymphocyte Count Decreased | Investigations | MedDRA 23.0 | Systematic Assessment |
| |
| Dehydration | Metabolism and nutrition disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Diabetes Mellitus | Metabolism and nutrition disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Diabetic Ketosis | Metabolism and nutrition disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Electrolyte Imbalance | Metabolism and nutrition disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Hyperglycaemia | Metabolism and nutrition disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Type 1 Diabetes Mellitus | Metabolism and nutrition disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Type 2 Diabetes Mellitus | Metabolism and nutrition disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Back Pain | Musculoskeletal and connective tissue disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Joint Contracture | Musculoskeletal and connective tissue disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Muscular Weakness | Musculoskeletal and connective tissue disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Musculoskeletal Pain | Musculoskeletal and connective tissue disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Osteonecrosis | Musculoskeletal and connective tissue disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Systemic Lupus Erythematosus | Musculoskeletal and connective tissue disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Basal Cell Carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 23.0 | Systematic Assessment |
| |
| Breast Cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 23.0 | Systematic Assessment |
| |
| Brenner Tumour | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 23.0 | Systematic Assessment |
| |
| Cervix Carcinoma Stage 0 | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 23.0 | Systematic Assessment |
| |
| Cutaneous T-Cell Lymphoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 23.0 | Systematic Assessment |
| |
| Gallbladder Cancer Stage Iii | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 23.0 | Systematic Assessment |
| |
| Intraductal Proliferative Breast Lesion | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 23.0 | Systematic Assessment |
| |
| Invasive Ductal Breast Carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 23.0 | Systematic Assessment |
| |
| Invasive Lobular Breast Carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 23.0 | Systematic Assessment |
| |
| Laryngeal Squamous Cell Carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 23.0 | Systematic Assessment |
| |
| Lung Squamous Cell Carcinoma Stage Iii | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 23.0 | Systematic Assessment |
| |
| Malignant Melanoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 23.0 | Systematic Assessment |
| |
| Malignant Melanoma In Situ | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 23.0 | Systematic Assessment |
| |
| Malignant Neoplasm Of Unknown Primary Site | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 23.0 | Systematic Assessment |
| |
| Neuroma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 23.0 | Systematic Assessment |
| |
| Non-Hodgkin's Lymphoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 23.0 | Systematic Assessment |
| |
| Ovarian Adenoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 23.0 | Systematic Assessment |
| |
| Ovarian Cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 23.0 | Systematic Assessment |
| |
| Ovarian Germ Cell Teratoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 23.0 | Systematic Assessment |
| |
| Prostate Cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 23.0 | Systematic Assessment |
| |
| Rectal Cancer Metastatic | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 23.0 | Systematic Assessment |
| |
| Squamous Cell Carcinoma Of Skin | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 23.0 | Systematic Assessment |
| |
| Uterine Cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 23.0 | Systematic Assessment |
| |
| Uterine Leiomyoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 23.0 | Systematic Assessment |
| |
| Ataxia | Nervous system disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Dizziness | Nervous system disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Dysarthria | Nervous system disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Encephalopathy | Nervous system disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Epilepsy | Nervous system disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Generalised Tonic-Clonic Seizure | Nervous system disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Limbic Encephalitis | Nervous system disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Loss Of Consciousness | Nervous system disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Lumbosacral Radiculopathy | Nervous system disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Multiple Sclerosis | Nervous system disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Multiple Sclerosis Relapse | Nervous system disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Optic Neuritis | Nervous system disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Partial Seizures | Nervous system disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Post Herpetic Neuralgia | Nervous system disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Postural Tremor | Nervous system disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Resting Tremor | Nervous system disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Sciatica | Nervous system disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Seizure | Nervous system disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Syncope | Nervous system disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Toxic Encephalopathy | Nervous system disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Trigeminal Neuralgia | Nervous system disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Uhthoff's Phenomenon | Nervous system disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Abortion Missed | Pregnancy, puerperium and perinatal conditions | MedDRA 23.0 | Systematic Assessment |
| |
| Abortion Spontaneous | Pregnancy, puerperium and perinatal conditions | MedDRA 23.0 | Systematic Assessment |
| |
| Anembryonic Gestation | Pregnancy, puerperium and perinatal conditions | MedDRA 23.0 | Systematic Assessment |
| |
| Ectopic Pregnancy | Pregnancy, puerperium and perinatal conditions | MedDRA 23.0 | Systematic Assessment |
| |
| Foetal Distress Syndrome | Pregnancy, puerperium and perinatal conditions | MedDRA 23.0 | Systematic Assessment |
| |
| Hellp Syndrome | Pregnancy, puerperium and perinatal conditions | MedDRA 23.0 | Systematic Assessment |
| |
| Missed Labour | Pregnancy, puerperium and perinatal conditions | MedDRA 23.0 | Systematic Assessment |
| |
| Pre-Eclampsia | Pregnancy, puerperium and perinatal conditions | MedDRA 23.0 | Systematic Assessment |
| |
| Pregnancy | Pregnancy, puerperium and perinatal conditions | MedDRA 23.0 | Systematic Assessment |
| |
| Prolonged Labour | Pregnancy, puerperium and perinatal conditions | MedDRA 23.0 | Systematic Assessment |
| |
| Alcoholism | Psychiatric disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Behaviour Disorder | Psychiatric disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Completed Suicide | Psychiatric disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Confusional State | Psychiatric disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Depression | Psychiatric disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Depression Suicidal | Psychiatric disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Drug Abuse | Psychiatric disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Major Depression | Psychiatric disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Mental Disorder | Psychiatric disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Substance-Induced Psychotic Disorder | Psychiatric disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Suicidal Ideation | Psychiatric disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Suicide Attempt | Psychiatric disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Acute Kidney Injury | Renal and urinary disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Cystitis Haemorrhagic | Renal and urinary disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Lupus Nephritis | Renal and urinary disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Nephrolithiasis | Renal and urinary disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Renal Colic | Renal and urinary disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Renal Injury | Renal and urinary disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Cervical Dysplasia | Reproductive system and breast disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Cystocele | Reproductive system and breast disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Endometriosis | Reproductive system and breast disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Female Genital Tract Fistula | Reproductive system and breast disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Menorrhagia | Reproductive system and breast disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Metrorrhagia | Reproductive system and breast disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Uterine Polyp | Reproductive system and breast disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Vaginal Haemorrhage | Reproductive system and breast disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Acute Respiratory Failure | Respiratory, thoracic and mediastinal disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Asthma | Respiratory, thoracic and mediastinal disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Atelectasis | Respiratory, thoracic and mediastinal disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Nasal Septum Deviation | Respiratory, thoracic and mediastinal disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Organising Pneumonia | Respiratory, thoracic and mediastinal disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Pneumomediastinum | Respiratory, thoracic and mediastinal disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Pulmonary Embolism | Respiratory, thoracic and mediastinal disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Pulmonary Fibrosis | Respiratory, thoracic and mediastinal disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Angioedema | Skin and subcutaneous tissue disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Decubitus Ulcer | Skin and subcutaneous tissue disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Erythema | Skin and subcutaneous tissue disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Rash | Skin and subcutaneous tissue disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Skin Ulcer | Skin and subcutaneous tissue disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Deep Vein Thrombosis | Vascular disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Flushing | Vascular disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Hypertension | Vascular disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Peripheral Artery Thrombosis | Vascular disorders | MedDRA 23.0 | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Nausea | Gastrointestinal disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Fatigue | General disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Bronchitis | Infections and infestations | MedDRA 23.0 | Systematic Assessment |
| |
| Herpes Zoster | Infections and infestations | MedDRA 23.0 | Systematic Assessment |
| |
| Influenza | Infections and infestations | MedDRA 23.0 | Systematic Assessment |
| |
| Nasopharyngitis | Infections and infestations | MedDRA 23.0 | Systematic Assessment |
| |
| Sinusitis | Infections and infestations | MedDRA 23.0 | Systematic Assessment |
| |
| Upper Respiratory Tract Infection | Infections and infestations | MedDRA 23.0 | Systematic Assessment |
| |
| Urinary Tract Infection | Infections and infestations | MedDRA 23.0 | Systematic Assessment |
| |
| Fall | Injury, poisoning and procedural complications | MedDRA 23.0 | Systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Back Pain | Musculoskeletal and connective tissue disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Pregnancy | Pregnancy, puerperium and perinatal conditions | MedDRA 23.0 | Systematic Assessment |
| |
| Depression | Psychiatric disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Insomnia | Psychiatric disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Rash | Skin and subcutaneous tissue disorders | MedDRA 23.0 | Systematic Assessment |
|
The Sponsor supports publication of clinical trial results but may request that investigators temporarily delay or alter publications in order to protect proprietary information. The Sponsor may also require that the results of multicenter studies be published only in their entirety and not as individual site data.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Trial Transparency Team | Sanofi | 800-633-1610 | 6# | Contact-US@sanofi.com |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Mar 9, 2020 | Jun 30, 2021 | SAP_001.pdf |
| ID | Term |
|---|---|
| D020529 | Multiple Sclerosis, Relapsing-Remitting |
| ID | Term |
|---|---|
| D009103 | Multiple Sclerosis |
| D020278 | Demyelinating Autoimmune Diseases, CNS |
| D020274 | Autoimmune Diseases of the Nervous System |
| D009422 | Nervous System Diseases |
| D003711 | Demyelinating Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
Not provided
Not provided
| Asian |
|
| American Indian or Alaska native |
|
| Other |
|
| Title | Measurements |
|---|---|
|
| Any TEAE leading to death |
|
| Any TEAE leading to permanent treatment discontinuation |
|
| OG002 | 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 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). |
|
|
| OG002 | Alemtuzumab | All Participants who completed the study CAMMS03409 (extension study of CAMMS223 [NCT00050778], CAMMS323 [NCT00530348], and CAMMS324 [NCT00548405]) and received alemtuzumab within 48 months prior to enrollment were included in this LPS13649 study. Participants received alemtuzumab, intravenous infusion of 12 mg/day for 3 consecutive days, at the study investigators' discretion; and at least 12 months after the prior treatment course in the current study (LPS13649). |
|
|
| OG001 | Initial Alemtuzumab Treatment (IAT) | Participants from the 12 mg/day alemtuzumab treatment arms of the studies CAMMS323 and CAMMS324 (who were subsequently enrolled in CAMMS03409 extension study and then entered in this study LPS13649) were included in the IAT subgroup of the current study (LPS13649). Participants received alemtuzumab intravenous infusion of 12 mg/day for 3 consecutive days, at the study investigators' discretion; and at least 12 months after the prior treatment course in the current study (LPS13649). |
| OG002 | Alemtuzumab (Overall) | All Participants who completed the study CAMMS03409 (extension study of CAMMS223 [NCT00050778], CAMMS323 [NCT00530348], or CAMMS324 [NCT00548405]) and received alemtuzumab within 48 months prior to enrollment were included in this LPS13649 study. Participants received alemtuzumab, intravenous infusion of 12 mg/day for 3 consecutive days, at the study investigators' discretion; and at least 12 months after the prior treatment course in the current study (LPS13649). |
|
|
Participants from the 12 mg/day alemtuzumab treatment arms of the studies CAMMS323 and CAMMS324 (who were subsequently enrolled in CAMMS03409 extension study and then entered in this study LPS13649) were included in the IAT subgroup of the current study (LPS13649). Participants received alemtuzumab intravenous infusion of 12 mg/day for 3 consecutive days, at the study investigators' discretion; and at least 12 months after the prior treatment course in the current study (LPS13649).
|
|
|
|
Participants from the 12 mg/day alemtuzumab treatment arms of the studies CAMMS323 and CAMMS324 (who were subsequently enrolled in CAMMS03409 extension study and then entered in this study LPS13649) were included in the IAT subgroup of the current study (LPS13649). Participants received alemtuzumab intravenous infusion of 12 mg/day for 3 consecutive days, at the study investigators' discretion; and at least 12 months after the prior treatment course in the current study (LPS13649). |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
| OG001 | Initial Alemtuzumab Treatment (IAT) | Participants from the 12 mg/day alemtuzumab treatment arms of the studies CAMMS323 and CAMMS324 (who were subsequently enrolled in CAMMS03409 extension study and then entered in this study LPS13649) were included in the IAT subgroup of the current study (LPS13649). Participants received alemtuzumab intravenous infusion of 12 mg/day for 3 consecutive days, at the study investigators' discretion; and at least 12 months after the prior treatment course in the current study (LPS13649). |
|
|
| OG001 | Initial Alemtuzumab Treatment (IAT) | Participants from the 12 mg/day alemtuzumab treatment arms of the studies CAMMS323 and CAMMS324 (who were subsequently enrolled in CAMMS03409 extension study and then entered in this study LPS13649) were included in the IAT subgroup of the current study (LPS13649). Participants received alemtuzumab intravenous infusion of 12 mg/day for 3 consecutive days, at the study investigators' discretion; and at least 12 months after the prior treatment course in the current study (LPS13649). |
|
|
| OG001 | Initial Alemtuzumab Treatment (IAT) | Participants from the 12 mg/day alemtuzumab treatment arms of the studies CAMMS323 and CAMMS324 (who were subsequently enrolled in CAMMS03409 extension study and then entered in this study LPS13649) were included in the IAT subgroup of the current study (LPS13649). Participants received alemtuzumab intravenous infusion of 12 mg/day for 3 consecutive days, at the study investigators' discretion; and at least 12 months after the prior treatment course in the current study (LPS13649). |
|
|
|
|
Participants from the SC IFNB1a treatment arms of studies CAMMS323 and CAMMS324, who received their initial 2 treatment courses of alemtuzumab during the CAMMS03409 extension study were included in the DAT subgroup of the current study (LPS13649). Participants received alemtuzumab intravenous infusion of 12 mg/day for 3 consecutive days, at the study investigators' discretion; and at least 12 months after the prior treatment course in the current study (LPS13649). |
| OG001 | Initial Alemtuzumab Treatment (IAT) | Participants from the 12 mg/day alemtuzumab treatment arms of the studies CAMMS323 and CAMMS324 (who were subsequently enrolled in CAMMS03409 extension study and then entered in this study LPS13649) were included in the IAT subgroup of the current study (LPS13649). Participants received alemtuzumab intravenous infusion of 12 mg/day for 3 consecutive days, at the study investigators' discretion; and at least 12 months after the prior treatment course in the current study (LPS13649). |
| OG002 | 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 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). |
|
|
| OG001 | Initial Alemtuzumab Treatment (IAT) | Participants from the 12 mg/day alemtuzumab treatment arms of the studies CAMMS323 and CAMMS324 (who were subsequently enrolled in CAMMS03409 extension study and then entered in this study LPS13649) were included in the IAT subgroup of the current study (LPS13649). Participants received alemtuzumab intravenous infusion of 12 mg/day for 3 consecutive days, at the study investigators' discretion; and at least 12 months after the prior treatment course in the current study (LPS13649). |
| OG002 | 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 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). |
|
|
| OG001 | Initial Alemtuzumab Treatment (IAT) | Participants from the 12 mg/day alemtuzumab treatment arms of the studies CAMMS323 and CAMMS324 (who were subsequently enrolled in CAMMS03409 extension study and then entered in this study LPS13649) were included in the IAT subgroup of the current study (LPS13649). Participants received alemtuzumab intravenous infusion of 12 mg/day for 3 consecutive days, at the study investigators' discretion; and at least 12 months after the prior treatment course in the current study (LPS13649). |
| OG002 | 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 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). |
|
|
| OG001 | Initial Alemtuzumab Treatment (IAT) | Participants from the 12 mg/day alemtuzumab treatment arms of the studies CAMMS323 and CAMMS324 (who were subsequently enrolled in CAMMS03409 extension study and then entered in this study LPS13649) were included in the IAT subgroup of the current study (LPS13649). Participants received alemtuzumab intravenous infusion of 12 mg/day for 3 consecutive days, at the study investigators' discretion; and at least 12 months after the prior treatment course in the current study (LPS13649). |
| OG002 | 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 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). |
|
|
| OG001 |
| Initial Alemtuzumab Treatment (IAT) |
Participants from the 12 mg/day alemtuzumab treatment arms of the studies CAMMS323 and CAMMS324 (who were subsequently enrolled in CAMMS03409 extension study and then entered in this study LPS13649) were included in the IAT subgroup of the current study (LPS13649). Participants received alemtuzumab intravenous infusion of 12 mg/day for 3 consecutive days, at the study investigators' discretion; and at least 12 months after the prior treatment course in the current study (LPS13649). |
| OG002 | Alemtuzumab (Overall) | All Participants who completed the study CAMMS03409 (extension study of CAMMS223 [NCT00050778], CAMMS323 [NCT00530348], or CAMMS324 [NCT00548405]) and received alemtuzumab within 48 months prior to enrollment were included in this LPS13649 study. Participants received alemtuzumab, intravenous infusion of 12 mg/day for 3 consecutive days, at the study investigators' discretion; and at least 12 months after the prior treatment course in the current study (LPS13649). |
|
|
| OG001 | Initial Alemtuzumab Treatment (IAT) | Participants from the 12 mg/day alemtuzumab treatment arms of the studies CAMMS323 and CAMMS324 (who were subsequently enrolled in CAMMS03409 extension study and then entered in this study LPS13649) were included in the IAT subgroup of the current study (LPS13649). Participants received alemtuzumab intravenous infusion of 12 mg/day for 3 consecutive days, at the study investigators' discretion; and at least 12 months after the prior treatment course in the current study (LPS13649). |
| OG002 | 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 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). |
|
|
| OG001 | Initial Alemtuzumab Treatment (IAT) | Participants from the 12 mg/day alemtuzumab treatment arms of the studies CAMMS323 and CAMMS324 (who were subsequently enrolled in CAMMS03409 extension study and then entered in this study LPS13649) were included in the IAT subgroup of the current study (LPS13649). Participants received alemtuzumab intravenous infusion of 12 mg/day for 3 consecutive days, at the study investigators' discretion; and at least 12 months after the prior treatment course in the current study (LPS13649). |
| OG002 | 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 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). |
|
|
| Initial Alemtuzumab Treatment (IAT) |
Participants from the 12 mg/day alemtuzumab treatment arms of the studies CAMMS323 and CAMMS324 (who were subsequently enrolled in CAMMS03409 extension study and then entered in this study LPS13649) were included in the IAT subgroup of the current study (LPS13649). Participants received alemtuzumab intravenous infusion of 12 mg/day for 3 consecutive days, at the study investigators' discretion; and at least 12 months after the prior treatment course in the current study (LPS13649). |
| OG002 | 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 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). |
|
|
| OG001 | Initial Alemtuzumab Treatment (IAT) | Participants from the 12 mg/day alemtuzumab treatment arms of the studies CAMMS323 and CAMMS324 (who were subsequently enrolled in CAMMS03409 extension study and then entered in this study LPS13649) were included in the IAT subgroup of the current study (LPS13649). Participants received alemtuzumab intravenous infusion of 12 mg/day for 3 consecutive days, at the study investigators' discretion; and at least 12 months after the prior treatment course in the current study (LPS13649). |
| OG002 | 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 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). |
|
|