Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT02255656
Recruitment Status : Active, not recruiting
First Posted : October 2, 2014
Last Update Posted : April 5, 2019
Sponsor:
Information provided by (Responsible Party):
Sanofi ( Genzyme, a Sanofi Company )

Brief 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.
  • To develop biomarkers predictive of autoimmune conditions including thyroid disorders and immune thrombocytopenia. This will include collection of samples from patients who have not yet developed any auto immune conditions; these samples would be used as controls.
  • To explore efficacy and safety markers through data analysis.
  • To explore genetic variation related to MS disease manifestation through data analysis.

Condition or disease Intervention/treatment Phase
Relapsing Remitting Multiple Sclerosis Drug: alemtuzumab GZ402673 Phase 4

Detailed 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.


Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 812 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Long-term Follow-up Study for Multiple Sclerosis Patients Who Have Completed the Alemtuzumab Extension Study (CAMMS03409)
Actual Study Start Date : January 7, 2015
Estimated Primary Completion Date : June 2020
Estimated Study Completion Date : June 2020

Resource links provided by the National Library of Medicine

Drug Information available for: Alemtuzumab

Arm Intervention/treatment
Experimental: GZ402673 alemtuzumab
Intravenous infusion for 3 consecutive days, at the study investigators' discretion; and at least 12 months after the prior treatment course
Drug: alemtuzumab GZ402673
Pharmaceutical form:concentrate for solution for infusion Route of administration: intravenous




Primary Outcome Measures :
  1. Incidence, duration, grade/intensity, relationship to study drug, and outcome of the following: Serious Adverse Events; Adverse Events including infusion-associated reactions (IAR) [ Time Frame: up to a maximum of 5.5 years ]
  2. Incidence, nature, seriousness, grade/intensity, relationship to study drug, and outcome of the following adverse events of special interest: Autoimmune mediated conditions, Malignancy, Serious Infections, Cervical dysplasia [ Time Frame: up to a maximum of 5.5 years ]
  3. Changes in laboratory parameters [ Time Frame: up to a maximum of 5.5 years ]

Secondary Outcome Measures :
  1. Annualized relapse rate (AR) [ Time Frame: up to a maximum of 5.5 years ]
  2. Proportion of participants relapse free [ Time Frame: up to a maximum of 5.5 years ]
  3. Change over time in Expanded Disability Status Scale (EDSS) scores [ Time Frame: up to a maximum of 5.5 years ]
  4. Change over time in brain imaging findings [ Time Frame: up to a maximum of 5.5 years ]
  5. 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 ]
  6. Change over time in the Functional Assessment of Multiple Sclerosis (FAMS) [ Time Frame: up to a maximum of 5.5 years ]
  7. Change over time in the EuroQoL in 5 Dimensions (EQ-5D) [ Time Frame: up to a maximum of 5.5 years ]
  8. Pharmaco-economic evaluation (Modify Health Resources Utilization Questionnaire [HRUQ] / Health Related Productivity Questionnaire [HRPQ]) [ Time Frame: up to a maximum of 5.5 years ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02255656


  Show 131 Study Locations
Sponsors and Collaborators
Genzyme, a Sanofi Company
Investigators
Layout table for investigator information
Study Director: Clinical Sciences & Operations Sanofi

Layout table for additonal information
Responsible Party: Genzyme, a Sanofi Company
ClinicalTrials.gov Identifier: NCT02255656     History of Changes
Other Study ID Numbers: LPS13649
2013-003884-71
U1111-1148-2987 ( Other Identifier: UTN )
First Posted: October 2, 2014    Key Record Dates
Last Update Posted: April 5, 2019
Last Verified: April 2019

Additional relevant MeSH terms:
Layout table for MeSH terms
Sclerosis
Multiple Sclerosis
Multiple Sclerosis, Relapsing-Remitting
Pathologic Processes
Demyelinating Autoimmune Diseases, CNS
Autoimmune Diseases of the Nervous System
Nervous System Diseases
Demyelinating Diseases
Autoimmune Diseases
Immune System Diseases
Alemtuzumab
Antineoplastic Agents, Immunological
Antineoplastic Agents