Modulation of Plasmacytoid Dendritic Cell Function in Multiple Sclerosis

Rutgers The State University of New Jersey

Status: Completed

Conditions: Multiple Sclerosis

Treatments: Drug: Interferon-beta 1b (Betaseron)

Study type: Observational

Funder types: Other; Industry

Identifiers

NCT00468182

0220060228

Details and patient eligibility

About

The purpose of this study is to determine whether interferon-beta impairs the ability of plasmacytoid dendritic cells to promote pathogenic immune responses in patients with multiple sclerosis.

Enrollment: 24 patients

Sex: All

Ages: 18 to 60 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Males and females, 18 to 60 year old, inclusive.
• Diagnosis of a relapsing form of multiple sclerosis as determined by revised McDonald Criteria or at least one clinical demyelinating episode with abnormal brain MRI study based on CHAMPS criteria
• Expanded disability status scale (EDSS) score less than 6 at entry.
• Understand and sign written informed consent prior to any testing under this protocol, including screening tests and evaluations that are not considered part of the subject's routine care.

Exclusion criteria

• Treatment with corticosteroids within one month prior to the study. Treatment with immunomodulatory drugs within last 3 months prior to the study.
• No history of treatment with Interferon-beta(IFN-beta) based drugs to exclude the possibility of IFN-beta neutralizing antibodies
• Any patient who is pregnant, intend to become pregnant, or breastfeeding at any time of the study.
• History of any significant cardiac, gastrointestinal, hepatic, pulmonary, or renal disease; immune deficiency; or other medical conditions that would preclude IFN-beta therapy.
• Primary Progressive Multiple Sclerosis patients or patients with Secondary Progressive Multiple Sclerosis with lack of recent clinical relapses for more than 2 years

Trial design

24 participants in 2 patient groups

1

Description:

MS patients or patients with CIS (Clinically isolated syndrome) who decided to be treated with IFN-beta for 3 months (with the option to continue Rx)

Treatment:

Drug: Interferon-beta 1b (Betaseron)

2

Description:

MS patients or patients with CIS(Clinically isolated syndrome)who decided to postpone the treatment with IFN-beta