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

NCT01539395 | Withdrawn

• 1 other identifier: MSDX0211
• Study Type: observational
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Multiple Sclerosis

Keywords

Relapsing Remitting; MS

Outcome Measures

Primary Outcomes (1)

• Biomarker Differential

  A difference in the levels of Complex-1 between subjects with controlled, stable MS vs. subjects in acute MS relapse

  Baseline

Secondary Outcomes (1)

• Biomarker reduction with steroid therapy

  3 months

Study Arms (3)

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

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

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

Interventions

MSDx Complex-1 Biomarker Test OTHER

A biomarker test for the level of MSDx Complex-1

Active Disease; Active Disease - Steroid Therapy; Inactive Disease

Eligibility Criteria

• Age: 45 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients who currently diagnosed with relapsing remitting multiple sclerosis

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• MSDx, Inc.: lead

Study Sites (1)

Northwest NeuroSpecialists, PLLC

Tucson, Arizona, 85741, United States

Location

Biospecimen

Retention: SAMPLES WITH DNA

Blood remaining after testing for MSDx Complex-1 will be retained for evaluation for other MS biomarkers

MeSH Terms

Conditions

Multiple Sclerosis

Condition Hierarchy (Ancestors)

Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Nervous System Diseases; Demyelinating Diseases; Autoimmune Diseases; Immune System Diseases

Study Officials

• Jeanette K Wendt, MD

  Northwest NeuroSpecialists, PLLC

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 21, 2012
• First Posted: February 27, 2012
• Study Start: January 1, 2012
• Primary Completion: April 1, 2012
• Study Completion: July 1, 2012
• Last Updated: September 2, 2020

Record last verified: 2020-08

Locations

US (1)