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

• 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.

• Registration Number: EUCTR2005-005751-18-GB
• Lead Sponsor: CL Biomedicine R&D Unit

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2006-02-17
• Last Update Posted: 3 April 2012

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

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
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

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.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: To assess whether switching MS subjects with NAbs induced by IFNß-1a (Rebif® 22µg or 44µg) to 500mcg IFNß-1b (Betaferon®) re-induces tolerance to IFNß, i.e. causes a higher than expected rate of reversion from NAb-positive to NAb-negative. ;Secondary Objective: There are no secondary objectives to the trial.;Primary end point(s): The primary endpoint is time until confirmed NAb-negative status will be assessed, i.e. two consecutive NAb-negative samples taken 3 months apart. This will be compared between the two randomised groups (those taking interferon-beta-1b (Betaferon®) 500mcg subcutaneously every other day)and those remaining on subcutaneous interferon-beta-1a three times a week therapy (Rebif-22 or Rebif-44). The interferon-beta-1b 500 micrograms subcutaneously every other day (Betaferon) treatment group will also be compared with a historical control group treated with interferon-beta-1a 22 or 44 micrograms subcutaneously three times a week.