Phase IIIB-IV Long-Term Follow-up Study for Patients Who Participated in CAMMS03409
| Status: | Active, not recruiting |
|---|---|
| Conditions: | Neurology, Neurology |
| Therapuetic Areas: | Neurology |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 4/6/2019 |
| Start Date: | January 7, 2015 |
| End Date: | June 2020 |
A Long-term Follow-up Study for Multiple Sclerosis Patients Who Have Completed the Alemtuzumab Extension Study (CAMMS03409)
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.
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.
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.
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.
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.
We found this trial at
51
sites
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