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

Relapsing Remitting Multiple Sclerosis Clinical Trial

Official title: A Long-term Follow-up Study for Multiple Sclerosis Patients Who Have Completed the Alemtuzumab Extension Study (CAMMS03409)

Status Completed

Clinical Trial 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.

Clinical Trial Description

The total duration per participants was up to 5.6 years.

As per Study Investigator discretion, participants can be treated with additional courses of alemtuzumab or any commercialized DMTs.

All participants who completed CAMMS03409 were allowed into the study, which might include specific vulnerable populations. If the investigator decided to treat a participant with a course of alemtuzumab, appropriate cautionary measures were applied as indicated in the approved labelling, or, in ex-European Union countries where Lemtrada was not approved, according to the investigator's brochure. ;

Related Conditions & MeSH terms

• Multiple Sclerosis
• Multiple Sclerosis, Relapsing-Remitting
• Relapsing Remitting Multiple Sclerosis
• Sclerosis

• NCT number: NCT02255656
• Study type: Interventional
• Source: Sanofi
• Status: Completed
• Phase: Phase 4
• Start date: January 7, 2015
• Completion date: July 15, 2020