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

Relapsing Remitting Multiple Sclerosis Clinical Trial

— TOPAZ  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02255656
• Other study ID #: LPS13649
• Secondary ID: 2013-003884-71U1
• Status: Completed
• Phase: Phase 4
• Start date: January 7, 2015
• Est. completion date: July 15, 2020

Study information

• Verified date: March 2022
• Source: Sanofi
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Primary Objective:

To evaluate long-term safety of alemtuzumab.

Secondary Objectives:

• To evaluate long term efficacy of alemtuzumab.

• To evaluate the safety profile of participants who received other Disease Modifying Treatment (DMT) following alemtuzumab treatment.

• To evaluate participant-reported Quality of Life (QoL) outcomes and health resource utilization of participant who received alemtuzumab.

• To evaluate as needed re-treatment with alemtuzumab and other DMTs.

Description:

The total duration per participants was up to 5.6 years.

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

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1062
• Est. completion date: July 15, 2020
• Est. primary completion date: July 15, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Multiple Sclerosis
• Multiple Sclerosis, Relapsing-Remitting
• Relapsing Remitting Multiple Sclerosis
• Sclerosis

Intervention

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

Locations

Country	Name	City	State
Argentina	Investigational Site Number 03208	Caba
Australia	Investigational Site Number 2013	Auchenflower
Australia	Investigational Site Number 2001	Heidelberg
Australia	Investigational Site Number 2011	Hobart
Australia	Investigational Site Number 2012	Kogarah
Australia	Investigational Site Number 2003	Melbourne
Australia	Investigational Site Number 2002	Parkville
Australia	Investigational Site Number 2005	Southport
Australia	Investigational Site Number 2009	Sydney
Australia	Investigational Site Number 2006	Westmead
Belgium	Investigational Site Number 5005	Bruxelles
Belgium	Investigational Site Number 5004	Esneux
Belgium	Investigational Site Number 5001	Leuven
Brazil	Investigational Site Number 3006	Porto Alegre
Brazil	Investigational Site Number 3002	Recife
Brazil	Investigational Site Number 3001	São Paulo
Brazil	Investigational Site Number 3003	São Paulo
Canada	Investigational Site Number 1102	Calgary
Canada	Investigational Site Number 1105	Gatineau
Canada	Investigational Site Number 1104	Greenfield Park
Canada	Investigational Site Number 1109	Kingston
Canada	Investigational Site Number 1110	London
Canada	Investigational Site Number 1101	Ottawa
Canada	Investigational Site Number 1106	Vancouver
Czechia	Investigational Site Number 4803	Brno
Czechia	Investigational Site Number 4804	Hradec Kralove
Czechia	Investigational Site Number 4801	Praha 2
Czechia	Investigational Site Number 4802	Teplice
Denmark	Investigational Site Number 5302	Aarhus N
Denmark	Investigational Site Number 5301	København Ø.
Germany	Investigational Site Number 4602	Berlin
Germany	Investigational Site Number 4607	Dresden
Germany	Investigational Site Number 4634	Frankfurt am Main
Germany	Investigational Site Number 4622	Hamburg
Germany	Investigational Site Number 4605	Hannover
Germany	Investigational Site Number 4609	Hennigsdorf
Germany	Investigational Site Number 4608	München
Germany	Investigational Site Number 4610	Rostock
Germany	Investigational Site Number 4613	Wermsdorf
Israel	Investigational Site Number 5501	Ramat Gan
Israel	Investigational Site Number 5505	Tel Aviv
Italy	Investigational Site Number 4112	Cagliari
Italy	Investigational Site Number 4102	Gallarate (VA)
Italy	Investigational Site Number 4106	Orbassano (TO)
Italy	Investigational Site Number 4110	Roma
Mexico	Investigational Site Number 3105	Chihuahua
Mexico	Investigational Site Number 3102	Mexico
Netherlands	Investigational Site Number 4202	Sittard-Geleen
Poland	Investigational Site Number 4902	Krakow
Poland	Investigational Site Number 4901	Lodz
Poland	Investigational Site Number 4903	Lublin
Poland	Investigational Site Number 4904	Poznan
Poland	Investigational Site Number 4905	Warszawa
Russian Federation	Investigational Site Number 6009	Kazan
Russian Federation	Investigational Site Number 6001	Moscow
Russian Federation	Investigational Site Number 6003	Moscow
Russian Federation	Investigational Site Number 6005	Moscow
Russian Federation	Investigational Site Number 6006	Nizhny Novgorod
Russian Federation	Investigational Site Number 6010	Pyatigorsk
Russian Federation	Investigational Site Number 6002	Saint-Petersburg
Russian Federation	Investigational Site Number 6004	Saint-Petersburg
Russian Federation	Investigational Site Number 6008	Saint-Petersburg
Russian Federation	Investigational Site Number 6013	Samara
Russian Federation	Investigational Site Number 6016	Ufa
Spain	Investigational Site Number 4301	Barcelona
Spain	Investigational Site Number 4303	Madrid
Spain	Investigational Site Number 4305	Málaga
Spain	Investigational Site Number 4304	Sevilla
Sweden	Investigational Site Number 4701	Göteborg
Sweden	Investigational Site Number 4702	Umeå
Ukraine	Investigational Site Number 6102	Kharkov
Ukraine	Investigational Site Number 6104	Kiev
Ukraine	Investigational Site Number 6103	Lviv
United Kingdom	Investigational Site Number 4004	Bristol
United Kingdom	Investigational Site Number 4001	Cambridge
United Kingdom	Investigational Site Number 4005	Cardiff
United Kingdom	Investigational Site Number 4006	London
United Kingdom	Investigational Site Number 4008	Salford
United Kingdom	Investigational Site Number 4007	Sheffield
United States	Investigational Site Number 1014	Albuquerque	New Mexico
United States	Investigational Site Number 1097	Allentown	Pennsylvania
United States	Investigational Site Number 1025	Ann Arbor	Michigan
United States	Investigational Site Number 1040	Berkeley	California
United States	Investigational Site Number 1095	Chapel Hill	North Carolina
United States	Investigational Site Number 1035	Cleveland	Ohio
United States	Investigational Site Number 1163	Cordova	Tennessee
United States	Investigational Site Number 1086	Cullman	Alabama
United States	Investigational Site Number 1017	Des Moines	Iowa
United States	Investigational Site Number 1020	Detroit	Michigan
United States	Investigational Site Number 1027	Fort Collins	Colorado
United States	Investigational Site Number 1001	Fort Wayne	Indiana
United States	Investigational Site Number 1055	Franklin	Tennessee
United States	Investigational Site Number 1152	Fullerton	California
United States	Investigational Site Number 1018	Houston	Texas
United States	Investigational Site Number 1024	Indianapolis	Indiana
United States	Investigational Site Number 1078	Jacksonville	Florida
United States	Investigational Site Number 1022	Kansas City	Kansas
United States	Investigational Site Number 1084	Kansas City	Missouri
United States	Investigational Site Number 1009	Knoxville	Tennessee
United States	Investigational Site Number 1083	Lenexa	Kansas
United States	Investigational Site Number 1039	Lexington	Kentucky
United States	Investigational Site Number 1021	Louisville	Kentucky
United States	Investigational Site Number 1059	Maitland	Florida
United States	Investigational Site Number 1081	Mineola	New York
United States	Investigational Site Number 1042	Nashville	Tennessee
United States	Investigational Site Number 1026	New York	New York
United States	Investigational Site Number 1008	Northbrook	Illinois
United States	Investigational Site Number 1067	Oklahoma City	Oklahoma
United States	Investigational Site Number 1093	Pasadena	California
United States	Investigational Site Number 1160	Patchogue	New York
United States	Investigational Site Number 1031	Phoenix	Arizona
United States	Investigational Site Number 1171	Phoenix	Arizona
United States	Investigational Site Number 1057	Providence	Rhode Island
United States	Investigational Site Number 1015	Rochester	New York
United States	Investigational Site Number 1002	Round Rock	Texas
United States	Investigational Site Number 1092	Saint Louis	Missouri
United States	Investigational Site Number 1046	San Antonio	Texas
United States	Investigational Site Number 1173	Sarasota	Florida
United States	Investigational Site Number 1068	Seattle	Washington
United States	Investigational Site Number 1034	Sunrise	Florida
United States	Investigational Site Number 1053	Syracuse	New York
United States	Investigational Site Number 1005	Tampa	Florida
United States	Investigational Site Number 1049	Tampa	Florida
United States	Investigational Site Number 1073	Teaneck	New Jersey
United States	Investigational Site Number 1054	Traverse City	Michigan
United States	Investigational Site Number 1090	Tucson	Arizona
United States	Investigational Site Number 1058	Uniontown	Ohio
United States	Investigational Site Number 1037	Vienna	Virginia
United States	Investigational Site Number 1061	Wellesley	Massachusetts
United States	Investigational Site Number 1082	Winston-Salem	North Carolina
United States	Investigational Site Number 1028	Worcester	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
Genzyme, a Sanofi Company

Countries where clinical trial is conducted

United States,  Argentina,  Australia,  Belgium,  Brazil,  Canada,  Czechia,  Denmark,  Germany,  Israel,  Italy,  Mexico,  Netherlands,  Poland,  Russian Federation,  Spain,  Sweden,  Ukraine,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
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.	From Baseline until the end of the study (up to a maximum duration of 5.6 years)
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.	Within 24 hours of any alemtuzumab infusion
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.	From Baseline until the end of the study (up to a maximum duration of 5.6 years)
Primary	Number of Participants With Potentially Clinically Significant Laboratory Abnormalities	Criteria for potentially clinically significant laboratory abnormalities included: Hemoglobin (Hb): less than or equal to (<=)115 grams per liter (g/L)(Male [M]), <= 95 g/L (Female[ F]); greater than or equal to (>=)185 g/L (M), >= 165 g/L (F); Decrease From Baseline (DFB) >= 20 g/L.; Hematocrit: <= 0.37 volume/volume (v/v) (M); <= 0.32 v/v (F); >= 0.55 v/v (M); >= 0.5 v/v (F).; Red Blood Cells (RBCs): >=6 *10^12/L.; Platelets: <100 *10^9/L; >=700 *10^9/L. As pre-specified, data collection and analysis for this outcome measure was done on the overall population along with 2 subgroups (DAT and IAT).	From Baseline until the end of the study (up to a maximum duration of 5.6 years)
Secondary	Annualized Relapse Rate	Relapse was defined as new neurological symptoms or worsening of previous neurological symptoms with an objective change on neurological examination. Annualized relapse rate was obtained from the total number of confirmed relapses that occurred during the treatment follow up time of all participants divided by the total years of follow-up for all participants. The annualized relapse rate was estimated using a negative binomial model with robust variance estimation.	Up to a maximum duration of 5.6 years
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.	Up to a maximum duration of 5.6 years
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.	Baseline (Month 0 of LPS13649), Month 6, 12, 18, 24, 30, 36, 42, 48, 54 and 60
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.	Up to a maximum duration of 5.6 years
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.	Up to a maximum duration of 5.6 years
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.	Up to a maximum duration of 5.6 years
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.	Baseline (Month 0 of LPS13649), Month 12, Month 24, Month 36, Month 48 and Month 60
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.	Baseline (Month 0 of LPS13649), Month 12, Month 24, Month 36, Month 48 and Month 60
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.	Baseline (Month 0 of LPS13649), Month 12, Month 24, Month 36, Month 48 and Month 60
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.	Baseline (Month 0 of LPS13649), Month 12, Month 24, Month 36, Month 48 and Month 60
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.	Baseline (Month 0 of LPS13649), Month 12, Month 24, Month 36, Month 48 and Month 60
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.	Baseline (Month 0 of LPS13649), Month 12, Month 24, Month 36, Month 48 and Month 60
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.	Baseline (Month 0 of LPS13649), Month 12, Month 24, Month 36, Month 48 and Month 60
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.	Baseline (Month 0 of LPS13649), Month 12, Month 24, Month 36, Month 48 and Month 60
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.	Baseline (Month 0 of LPS13649), Month 12, Month 24, Month 36, Month 48 and Month 60
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.	Baseline (Month 0 of LPS13649), Month 12, Month 24, Month 36, Month 48 and Month 60
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.	Baseline (Month 0 of LPS13649), Month 12, Month 24, Month 36, Month 48 and Month 60
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.	Baseline (Month 0 of LPS13649), Month 12, Month 24, Month 36, Month 48 and Month 60
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.	Baseline (Month 0 of LPS13649), Month 12, Month 24, Month 36, Month 48 and Month 60
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.	Baseline (Month 0 of LPS13649), Month 12, Month 24, Month 36, Month 48 and Month 60
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.	Baseline up to end of the study (up to a maximum duration of 5.6 years)
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.	Baseline up to end of the study (up to a maximum duration of 5.6 years)