Phase IIIB-IV Long-Term Follow-up Study for Patients Who Participated in CAMMS03409 (TOPAZ)
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|ClinicalTrials.gov Identifier: NCT02255656|
Recruitment Status : Active, not recruiting
First Posted : October 2, 2014
Last Update Posted : April 5, 2019
To evaluate long-term safety of alemtuzumab.
- 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|
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||812 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|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|
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
- 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 ]
- 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 ]
- Changes in laboratory parameters [ Time Frame: up to a maximum of 5.5 years ]
- 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 ]
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
|Study Director:||Clinical Sciences & Operations||Sanofi|