A Cross-Sectional Study of MSDx Complex 1 as a Marker for Active Disease in Multiple Sclerosis

August 31, 2020 updated by: MSDx, Inc.
This is a Cross-Sectional Study of MSDx Complex 1 as a Marker for Active Disease in Multiple Sclerosis.

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

Study Type

Observational

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Arizona
      • Tucson, Arizona, United States, 85741
        • Northwest NeuroSpecialists, PLLC

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

45 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients who currently diagnosed with relapsing remitting multiple sclerosis

Description

Inclusion Criteria:

  1. Age 45 years or older of either gender and of any racial/ethnic group.
  2. Subjects must be in generally good health.
  3. Subjects must be able and willing to comply with the requirements of the protocol.
  4. Must be diagnosed with RRMS
  5. Meets the criteria to enter Group 1 or Group 2

Exclusion Criteria:

  1. Subject is currently in middle of an active episode of an autoimmune condition (e.g. rheumatoid arthritis, system lupus erythematosis)
  2. Subject currently has a condition such as active influenza that would stimulate the immune system

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
Intervention / Treatment
Inactive Disease
Inactive disease; RRMS patients who have been treated with monthly infusions of Tysabri for 12 months and have had stable disease for the last 6 months or more and show stable or improving neurological deficits over 3 months on Tysabri.
Other: MSDx Complex-1 Biomarker Test
A biomarker test for the level of MSDx Complex-1
Active Disease
Active disease; RRMS patients in acute clinical relapse or with active MRI. Blood sample obtained within 30 days of event AND before steroid treatment (or) patients in early disease on or off first line agents with relapse in prior 3 months AND not treated with steroids for at least 2 months.
Other: MSDx Complex-1 Biomarker Test
A biomarker test for the level of MSDx Complex-1
Active Disease - Steroid Therapy
Patient with a diagnosis of relapsing remitting multiple sclerosis (RRMS) who is about to begin steroid therapy for a relapse in clinical symptoms (either diagnosed clinically or via gadolinium MRI).
Other: MSDx Complex-1 Biomarker Test
A biomarker test for the level of MSDx Complex-1

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Biomarker Differential
Time Frame: Baseline
A difference in the levels of Complex-1 between subjects with controlled, stable MS vs. subjects in acute MS relapse
Baseline

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Biomarker reduction with steroid therapy
Time Frame: 3 months
A decrease in the level of MSDx Complex-1 in response to steroid therapy for a relapse of MS.
3 months

Collaborators and Investigators

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

Sponsor

MSDx, Inc.

Investigators

  • Principal Investigator: Jeanette K Wendt, MD, Northwest NeuroSpecialists, PLLC

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 Major Dates

Study Start

January 1, 2012

Primary Completion (ANTICIPATED)

April 1, 2012

Study Completion (ANTICIPATED)

July 1, 2012

Study Registration Dates

First Submitted

February 21, 2012

First Submitted That Met QC Criteria

February 24, 2012

First Posted (ESTIMATE)

February 27, 2012

Study Record Updates

Last Update Posted (ACTUAL)

September 2, 2020

Last Update Submitted That Met QC Criteria

August 31, 2020

Last Verified

August 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MSDX0211

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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