Overview

This trial is active, not recruiting.

Condition relapsing remitting multiple sclerosis
Treatment alemtuzumab gz402673
Phase phase 4
Sponsor Genzyme, a Sanofi Company
Start date January 2015
End date March 2020
Trial size 812 participants
Trial identifier NCT02255656, 2013-003884-71, LPS13649, U1111-1148-2987

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 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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Endpoint classification safety study
Intervention model single group assignment
Masking open label
Primary purpose treatment
Arm
(Experimental)
Intravenous infusion for 3 consecutive days, at the study investigators' discretion; and at least 12 months after the prior treatment course
alemtuzumab gz402673
Pharmaceutical form:concentrate for solution for infusion Route of administration: intravenous

Primary Outcomes

Measure
Incidence, duration, grade/intensity, relationship to study drug, and outcome of the following: Serious Adverse Events; Adverse Events
time frame: up to a maximum of 5.5 years
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
time frame: up to a maximum of 5.5 years
Changes in laboratory parameters
time frame: up to a maximum of 5.5 years

Secondary Outcomes

Measure
Annualized relapse rate (AR)
time frame: up to a maximum of 5.5 years
Proportion of participants relapse free
time frame: up to a maximum of 5.5 years
Change over time in Expanded Disability Status Scale (EDSS) scores
time frame: up to a maximum of 5.5 years
Change over time in brain imaging findings
time frame: up to a maximum of 5.5 years
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
time frame: up to a maximum of 5.5 years
Change over time in the Functional Assessment of Multiple Sclerosis (FAMS)
time frame: up to a maximum of 5.5 years
Change over time in the EuroQoL in 5 Dimensions (EQ-5D)
time frame: up to a maximum of 5.5 years
Pharmaco-economic evaluation (Modify Health Resources Utilization Questionnaire [HRUQ] / Health Related Productivity Questionnaire [HRPQ])
time frame: up to a maximum of 5.5 years

Eligibility Criteria

Male or female participants at least 18 years old.

Inclusion criteria: Patient has completed at least 48 months of the Extension Study CAMMS03409. Signed written informed consent form. Exclusion criteria: Patient participating in another investigational interventional study. The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.

Additional Information

Official title A Long-term Follow-up Study for Multiple Sclerosis Patients Who Have Completed the Alemtuzumab Extension Study (CAMMS03409)
Description The total duration per patient is up to 5.5 years. As per Study Investigator discretion, patients can be treated with additional courses of alemtuzumab or any commercialized disease modifying treatment. All patients who complete CAMM03409 will be allowed into the study, which may include specific vulnerable populations. If the investigator decides to treat a patient with a course of alemtuzumab, appropriate cautionary measures will be applied as indicated in the approved labelling, or, in ex-EU countries where Lemtrada is not approved, according to the investigator's brochure.
Trial information was received from ClinicalTrials.gov and was last updated in August 2016.
Information provided to ClinicalTrials.gov by Sanofi.