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Exploratory Study to Investigate the Reparative and Regenerative Potential of Alemtuzumab in Relapsing-Remitting Multiple Sclerosis Patients Participating in the CARE MS I and MS II Studies

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: NCT01020370
Recruitment Status : Completed
First Posted : November 25, 2009
Last Update Posted : November 25, 2009
Sponsor:
Information provided by:

Study Description
Brief Summary:
The primary goal of this study will be to explore the reparative and regenerative potential of alemtuzumab in RRMS patients who are participating in the CARE MS I and CARE MS II studies using conventional and non-conventional MRI sequences.

Condition or disease
Multiple Sclerosis

Study Design

Study Type : Observational
Observational Model: Cohort
Time Perspective: Prospective
Official Title: An Exploratory Study to Investigate the Reparative and Regenerative Potential of Alemtuzumab in Relapsing-Remitting Multiple Sclerosis: A Multi-Parametric Non-Conventional MRI Sub-Study in Patient Participating in the CARE MS I and CARE MS II Studies

Resource links provided by the National Library of Medicine

Drug Information available for: Alemtuzumab
U.S. FDA Resources

Groups and Cohorts

Group/Cohort
Alemtuzumab Group
Interferon Beta-1a SC Group


Outcome Measures

Primary Outcome Measures :
  1. Explore the reparative and regenerative potential of alemtuzumab in RRMS patients who are participating in the CARE MS I and CARE MS II studies

Secondary Outcome Measures :
  1. Compare the effect of alemtuzumab to interferon beta-1a SC on non-conventional MRI outcomes

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients with RRMS who are participating in the CARE MS I and CARE MS II studies and are receiving either alemtuzumab or interferon beta-1a SC
Criteria

Inclusion Criteria:

  • Participating in either the CARE MS I or CARE MS II studies

Exclusion Criteria:

  • Not a participant in the CARE MS I or CARE MS II studies
Contacts and Locations

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): NCT01020370


Sponsors and Collaborators
Wayne State University
Investigators
Principal Investigator: Omar Khan, MD Wayne State University
More Information

ClinicalTrials.gov Identifier: NCT01020370     History of Changes
Other Study ID Numbers: CAMMS030081ST
First Posted: November 25, 2009    Key Record Dates
Last Update Posted: November 25, 2009
Last Verified: November 2009

Keywords provided by Wayne State University:
Patients with RRMS who are participating in the CARE MS I and CARE MS II

Additional relevant 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