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

November 24, 2009 updated by: Wayne State University

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

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.

Study Overview

Status

Completed

Conditions

Study Type

Observational

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
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

Outcome Measure
Compare the effect of alemtuzumab to interferon beta-1a SC on non-conventional MRI outcomes

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Wayne State University

Investigators

  • Principal Investigator: Omar Khan, MD, Wayne State University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

First Submitted

November 24, 2009

First Submitted That Met QC Criteria

November 24, 2009

First Posted (Estimate)

November 25, 2009

Study Record Updates

Last Update Posted (Estimate)

November 25, 2009

Last Update Submitted That Met QC Criteria

November 24, 2009

Last Verified

November 1, 2009

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CAMMS030081ST

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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