A multi-centre randomised study to evaluate the efficacy of Betaferon-interferon-beta-1b (IFNB-1B) 500 mcg therapy in the induction of tolerance to IFNB in MS patients with neutralising antibodies (NAbs) to IFNB-1a (Rebif) - Betaferon NaB Anergy Study

CL Biomedicine R&D Unit0 sites100 target enrollmentFebruary 17, 2006

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Multiple sclerosis (MS) is an inflammatory demyelinating disease of the central nervous system of unknown aetiology. It is the commonest cause of disability in young adults. The prevalence in the UK is approximately 125/100,000 of the population with an annual incidence of 6/100,000. Approximately 80,000 individuals are affected with MS in the UK.
Sponsor: CL Biomedicine R&D Unit
Enrollment: 100
Status: Active, not recruiting
Last Updated: 14 years ago

No summary available.

Registry

who.int

Start Date

February 17, 2006

End Date

TBD

Last Updated

14 years ago

Study Type

Interventional clinical trial of medicinal product

Sex

All

Sponsor

CL Biomedicine R&D Unit

•Confirmed diagnosis of MS according to the McDonald criteria (Appendix 1\).
•Current treatment with Rebif® (22 or 44\) s.c. TIW for at least 6 months or more
•Two consecutive positive NAb titres of ?20NU at least 4 weeks apart.
•Age over 18 years and less than 65 years.
•Expanded Disability Status Scale (EDSS) score not to exceed 6\.5\.
•Women of childbearing potential must agree to practice adequate contraception methods, defined as barrier methods with spermicide, surgical sterilisation of self or male partner, combined oral contraceptives or intrauterine device/system. All female subjects who are not post\-menopausal or surgically sterile must have a negative blood pregnancy test at screening.
•Must give written informed consent and authorise the release and use of protected health information, as required by local law.
•Able and willing to undergo blood sampling at regular intervals as defined by the protocol.
•Able to comply with study requirements.
•Are the trial subjects under 18? no

•Treatment with other immunosuppressive, immunomodulatory, or experimental treatments within the last 6 months of enrollment in the study, but excluding pulsed intravenous or oral steroids for treatment of MS relapse.
•Patients presenting a severe or unstable disorder: poorly controlled diabetes, arterial hypertension, severe cardiac insufficiency, unstable ischemic heart disease, clinically significant laboratory abnormality, or any medical condition which, in the opinion of the chief investigator, would pose additional risk in administering IFNß\-1b to the patient.
•Presence of chronic or recurrent infection.
•Exposure to any other investigational drug within 30 days of enrollment in the study.
•History of malignancy unless an exception is granted by the Chief Investigator.
•History of human immunodeficiency virus (HIV).
•History of drug or alcohol abuse within 6 months prior to enrollment into the study.