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

A long-term follow-up study for Multiple Sclerosis patients who have completed the alemtuzumab Extension Study (CAMMS03409) - TOPAZ

Status

Active, not recruiting

Phases

Phase 3Phase 4

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2013-003884-71-BE

Enrollment

799

Registered

2014-08-04

Start date

2015-02-05

Completion date

Unknown

Last updated

2022-03-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Relapsing-remitting multiple sclerosis MedDRA version: 17.0 Level: PT Classification code 10063399 Term: Relapsing-remitting multiple sclerosis System Organ Class: 10029205 - Nervous system disorders

Interventions

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 c

Eligibility

Sex/Gender

All

Inclusion 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

Exclusion criteria: - Patient participating in another investigational interventional study

Design outcomes

Secondary

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

Measure

Time frame

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

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Primary

Measure	Time frame
Main Objective: To evaluate long-term safety of alemtuzumab;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.	—

Measure

Time frame

Main Objective: To evaluate long-term safety of alemtuzumab;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.

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Countries

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

Public ContactBrigitte De Witte

Sanofi Belgium

Contact-us@sanofi.com+32 2 710 56 18

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026