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

Genzyme

Status and phase: Completed; Phase 4

Conditions: Relapsing Remitting Multiple Sclerosis

Treatments: Drug: alemtuzumab GZ402673

Study type: Interventional

Funder types: Industry

Identifiers

NCT02255656

LPS13649

2013-003884-71

U1111-1148-2987 (Other Identifier)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 1,062 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

---

1,062 participants in 1 patient group

Alemtuzumab

Experimental group

Description:

All Participants who completed the study CAMMS03409 (extension study of CAMMS223 \[NCT00050778\], CAMMS323 \[NCT00530348\], or CAMMS324 \[NCT00548405\]) and received alemtuzumab within 48 months prior to enrollment were included in this LPS13649 study. Participants received alemtuzumab, intravenous infusion of 12 milligram per day (mg/day) for 3 consecutive days, at the study investigators' discretion; and at least 12 months after the prior treatment course in the current study (LPS13649).

Treatment:

Drug: alemtuzumab GZ402673