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

NCT02255656 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 1062

Last updated 2022-03-28

Study results available
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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 participants who received other Disease Modifying Treatment (DMT) following alemtuzumab treatment.
* To evaluate participant-reported Quality of Life (QoL) outcomes and health resource utilization of participant who received alemtuzumab.
* To evaluate as needed re-treatment with alemtuzumab and other DMTs.

Conditions

  • Relapsing Remitting Multiple Sclerosis

Interventions

DRUG

alemtuzumab GZ402673

Pharmaceutical form:concentrate for solution for infusion Route of administration: intravenous

Sponsors & Collaborators

  • Genzyme, a Sanofi Company

    lead INDUSTRY

Principal Investigators

  • Clinical Sciences & Operations · Sanofi

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-01-07
Primary Completion
2020-07-15
Completion
2020-07-15
FDA Drug
Yes

Countries

  • United States
  • Argentina
  • Australia
  • Belgium
  • Brazil
  • Canada
  • Czechia
  • Denmark
  • Germany
  • Israel
  • Italy
  • Mexico
  • Netherlands
  • Poland
  • Russia
  • Spain
  • Sweden
  • Ukraine
  • United Kingdom

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02255656 on ClinicalTrials.gov