Phase IIIB-IV long term follow-up study for patients who participated in CAMMS03409

Phase 1

Conditions: Relapsing-remitting multiple sclerosis
MedDRA version: 21.1Level: PTClassification code 10063399Term: Relapsing-remitting multiple sclerosisSystem Organ Class: 10029205 - Nervous system disorders
Therapeutic area: Diseases [C] - Nervous System Diseases [C10]

Registration Number: EUCTR2013-003884-71-NL

Lead Sponsor: Genzyme Corporation

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 1248

Inclusion Criteria

- Patient has completed at least 48 months of the Extension Study CAMMS03409
- Signed written informed consent form
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 1248
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

- Patient participating in another investigational interventional study

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: To evaluate long term safety of alemtuzumab;Secondary Objective: - To evaluate long term efficacy of alemtuzumab<br>- To evaluate the safety profile of patients who received other Disease Modifying Treatment's (DMT) following alemtuzumab treatment<br>- To evaluate patient-reported Quality of Life (QoL) outcomes and health resource utilization of patients who received alemtuzumab<br>- To evaluate as needed re-treatment with alemtuzumab and other DMTs;Primary end point(s): - Incidence, duration, grade/intensity, relationship to study drug, and outcome of the following: Serious Adverse Events; Adverse Events including infusion-associated reactions (IAR)<br>- Incidence, nature, seriousness, grade/intensity, relationship to study drug, and outcome of the following adverse events of special interest: Autoimmune mediated conditions, Malignancy, Serious Infections, Cervical dysplasia<br>- Changes in laboratory parameters;Timepoint(s) of evaluation of this end point: Up to a maximum of 5.5 years

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): - Annualized relapse rate (ARR)<br>- Proportion of participants relapse free <br>- Change over time in Expanded Disability Status Scale (EDSS) scores<br>- Change over time in brain imaging findings<br>- Change over time in self-reported quality of life (QoL) as assessed by the Medical Outcome Study (MOS) 36-Item Short-Form Health Survey (SF-36) Version 2<br>- Change over time in the Functional Assessment of Multiple Sclerosis (FAMS)<br>- Change over time in the EuroQoL in 5 Dimensions (EQ-5D)<br>- Pharmaco-economic evaluation (Modify Health Resources Utilization Questionnaire [HRUQ] / Health Related Productivity Questionnaire [HRPQ]);Timepoint(s) of evaluation of this end point: Up to a maximum of 5.5 years

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