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

• Register: ClinicalTrials.gov
• Last refreshed on: 4 April 2022
• Main ID: NCT02255656
• Date of registration: 30/09/2014
• Prospective Registration: Yes
• Primary sponsor: Genzyme, a Sanofi Company
• Public title: Phase IIIB-IV Long-Term Follow-up Study for Patients Who Participated in CAMMS03409 TOPAZ
• Scientific title: A Long-term Follow-up Study for Multiple Sclerosis Patients Who Have Completed the Alemtuzumab Extension Study (CAMMS03409)
• Date of first enrolment: January 7, 2015
• Target sample size: 1062
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT02255656
• Study type: Interventional
• Study design: Allocation: N/A. Intervention model: Single Group Assignment. Primary purpose: Treatment. Masking: None (Open Label).
• Phase: Phase 4

Countries of recruitment

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

Contacts

• Name: Clinical Sciences & Operations
• Affiliation: Sanofi

Key inclusion & exclusion criteria

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.



Age minimum: 18 Years
Age maximum: N/A
Gender: All

Health Condition(s) or Problem(s) studied

Relapsing Remitting Multiple Sclerosis

Intervention(s)

Drug: alemtuzumab GZ402673

Primary Outcome(s)

Number of Participants With Adverse Events of Special Interest (AESI) [Time Frame: 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 [Time Frame: 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) [Time Frame: Within 24 hours of any alemtuzumab infusion]

Number of Participants With Treatment-Emergent Adverse Events (TEAEs), and Treatment-Emergent Serious Adverse Events (TESAEs) [Time Frame: From Baseline until the end of the study (up to a maximum duration of 5.6 years)]

Secondary Outcome(s)

Change From Baseline in Expanded Disability Status Scale (EDSS) Score at Month 6, 12, 18, 24, 30, 36, 42, 48, 54 and 60 [Time Frame: Baseline (Month 0 of LPS13649), Month 6, 12, 18, 24, 30, 36, 42, 48, 54 and 60]

HRPQ: Total Scheduled Household Chores Hours; Number of Hours Missed From Household Chores Due to Multiple Sclerosis [Time Frame: 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 [Time Frame: 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 [Time Frame: Baseline (Month 0 of LPS13649), Month 12, Month 24, Month 36, Month 48 and Month 60]

Brain Magnetic Resonance Imaging (MRI) Assessment: Number of New T1 (and New Hypointense T1) Lesions Per MRI Scan [Time Frame: 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 [Time Frame: Baseline (Month 0 of LPS13649), Month 12, Month 24, Month 36, Month 48 and Month 60]

Brain Magnetic Resonance Imaging (MRI) Assessment: Number of Gadolinium Enhancing (Gd-enhancing) Lesions Per MRI Scan [Time Frame: Up to a maximum duration of 5.6 years]

HRPQ: Total Scheduled Working Hours and Number of Hours Missed From Work Due to Multiple Sclerosis [Time Frame: 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 [Time Frame: 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 [Time Frame: 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 [Time Frame: 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 [Time Frame: Baseline (Month 0 of LPS13649), Month 12, Month 24, Month 36, Month 48 and Month 60]

Brain Magnetic Resonance Imaging (MRI) Assessment: Number of New or Enlarged T2 Lesions Per MRI Scan [Time Frame: Up to a maximum duration of 5.6 years]

Annualized Relapse Rate [Time Frame: Up to a maximum duration of 5.6 years]

Brain Magnetic Resonance Imaging (MRI) Assessment: Percent Change From Baseline in Volume of T2 Lesions at Months 12, 24, 36, 48, and 60 [Time Frame: 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 [Time Frame: 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 [Time Frame: 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 [Time Frame: Baseline up to end of the study (up to a maximum duration of 5.6 years)]

Change From Baseline in European Quality of Life -5 Dimension (EQ-5D) Score: Utility Scores at Month 12, 24, 36, 48, and 60 [Time Frame: 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 [Time Frame: Baseline (Month 0 of LPS13649), Month 12, Month 24, Month 36, Month 48 and Month 60]

HRPQ: Number of Participants Who Reported Impact on Work Due to Multiple Sclerosis [Time Frame: Baseline up to end of the study (up to a maximum duration of 5.6 years)]

Proportion of Participants Who Were Relapse Free [Time Frame: Up to a maximum duration of 5.6 years]

Secondary ID(s)

LPS13649

U1111-1148-2987

2013-003884-71

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Results

• Results available: Yes
• Date Posted: 23/07/2021
• URL: https://clinicaltrials.gov/ct2/show/results/NCT02255656