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

MSDx, Inc.

Status: Withdrawn

Conditions: Multiple Sclerosis

Treatments: Other: MSDx Complex-1 Biomarker Test

Study type: Observational

Funder types: Industry

Identifiers

NCT01539395

MSDX0211

Details and patient eligibility

About

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

Sex: All

Ages: 45+ years old

Volunteers: No Healthy Volunteers

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

Trial design

0 participants in 3 patient groups

Inactive Disease

Description:

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.

Treatment:

Other: MSDx Complex-1 Biomarker Test

Active Disease

Description:

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.

Treatment:

Other: MSDx Complex-1 Biomarker Test

Active Disease - Steroid Therapy

Description:

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).

Treatment:

Other: MSDx Complex-1 Biomarker Test