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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

This study has been completed.
Sponsor:
Information provided by:
Wayne State University
ClinicalTrials.gov Identifier:
NCT01020370
First received: November 24, 2009
Last updated: NA
Last verified: November 2009
History: No changes posted
  Purpose

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
Multiple Sclerosis

Study Type: Observational
Study Design: 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 NLM:

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

Further study details as provided by Wayne State University:

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

Groups/Cohorts
Alemtuzumab Group
Interferon Beta-1a SC Group

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01020370

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

No publications provided

ClinicalTrials.gov Identifier: NCT01020370     History of Changes
Other Study ID Numbers: CAMMS030081ST
Study First Received: November 24, 2009
Last Updated: November 24, 2009
Health Authority: United States: Institutional Review Board

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:
Multiple Sclerosis
Sclerosis
Multiple Sclerosis, Relapsing-Remitting
Demyelinating Autoimmune Diseases, CNS
Autoimmune Diseases of the Nervous System
Nervous System Diseases
Demyelinating Diseases
Autoimmune Diseases
Immune System Diseases
 Pathologic Processes
Alemtuzumab
Campath 1G
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on May 19, 2013