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

• Register: EUCTR
• Last refreshed on: 26 February 2018
• Main ID: EUCTR2013-003884-71-IT
• Date of registration: 28/10/2014
• Prospective Registration: Yes
• Primary sponsor: Genzyme Corporation
• Public title: Phase IIIB-IV long term follow-up study for patients who participated in CAMMS03409
• Scientific title: A long-term follow-up study for Multiple Sclerosis patients who have completed the alemtuzumab Extension Study (CAMMS03409) - TOPAZ
• Date of first enrolment: 22/12/2014
• Target sample size: 799
• Recruitment status: Authorised-recruitment may be ongoing or finished
• URL: https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2013-003884-71
• Study type: Interventional clinical trial of medicinal product
• Study design: Controlled: no; Randomised: Open: Single blind: Double blind: Parallel group: Cross over: Other: If controlled, specify comparator, Other Medicinial Product: Placebo: Other:
• Phase: Human pharmacology (Phase I): no Therapeutic exploratory (Phase II): no Therapeutic confirmatory - (Phase III): yes Therapeutic use (Phase IV): yes

Countries of recruitment

Argentina, Australia, Belgium, Brazil, Canada, Croatia, Czech Republic, Denmark, France, Germany, Israel, Italy, Mexico, Netherlands, Poland, Russian Federation, Serbia, Spain, Sweden, Ukraine, United Kingdom

Contacts

• Name: CONTACT POINT
• Affiliation: SANOFI S.P.A.

• Name: CONTACT POINT
• Affiliation: SANOFI S.P.A.

Key inclusion & exclusion criteria

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 799
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


Age minimum:
Age maximum:
Gender:
Female: yes
Male: yes

Health Condition(s) or Problem(s) studied

Therapeutic area: Diseases [C] - Nervous System Diseases [C10]

Relapsing-remitting multiple sclerosis
MedDRA version: 17.1 Level: PT Classification code 10063399 Term: Relapsing-remitting multiple sclerosis System Organ Class: 10029205 - Nervous system disorders

Intervention(s)

Trade Name: Lemtrada
Product Name: Lemtrada
Product Code: GZ402673
Pharmaceutical Form: Concentrate for solution for infusion
INN or Proposed INN: alemtuzumab
CAS Number: 216503-57-0
Current Sponsor code: GZ402673
Concentration unit: mg/ml milligram(s)/millilitre
Concentration type: equal
Concentration number: 10-

Primary Outcome(s)

Secondary Objective: - To evaluate long term efficacy of alemtuzumab
- To evaluate the safety profile of patients who received other Disease Modifying Treatment's (DMT) following alemtuzumab treatment
- To evaluate patient-reported Quality of Life (QoL) outcomes and health resource utilization of patients who received alemtuzumab
- 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
- Incidence, nature, seriousness, grade/intensity, relationship to study drug, and outcome of the following adverse events of special interest: Specific autoimmune mediated conditions, Infusion-associated reactions, Malignancy, Infections
- Changes in laboratory parameters

Timepoint(s) of evaluation of this end point: Final analysis at study completion (Up to a maximum of 5.5 years). Yearly interim analysis.

Main Objective: To evaluate long-term safety of alemtuzumab

Secondary Outcome(s)

Timepoint(s) of evaluation of this end point: Final analysis at study completion (Up to a maximum of 5.5 years). Yearly interim analysis.

Secondary end point(s): - Annualized relapse rate (ARR)
- Proportion of participants relapse free
- Change over time in Expanded Disability Status Scale (EDSS) scores
- Change over time in brain imaging findings
- 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
- Change over time in the Functional Assessment of Multiple Sclerosis (FAMS)
- Change over time in the EuroQoL in 5 Dimensions (EQ-5D)
- Pharmaco-economic evaluation (Modified Health Resources Utilization Questionnaire (HRUQ) / Health Related Productivity Questionnaire (HRPQ))

Secondary ID(s)

LPS13649

2013-003884-71-BE

Source(s) of Monetary Support

Genzyme Corporation