An exploratory phase IIa study to evaluate the safety and immunological effects of intravenous interferonß-1a (IFNß-1a, Rebif®) therapy in the induction of tolerance to IFNß in MS patients with neutralising antibodies (NAbs) to subcutaneous IFNß-1a (Rebif® or Avonex®) - Tolerance induction with intravenous IFNß-1a

• Conditions: Multiple Sclerosis; MedDRA version: 9.1Level: LLTClassification code 10028245Term: Multiple sclerosis

• Registration Number: EUCTR2008-000256-26-GB
• Lead Sponsor: Queen Mary, University of London

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2010-12-08
• Last Update Posted: 30 June 2014

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 15

Inclusion Criteria

1.Confirmed diagnosis of MS according to the McDonald criteria
2.Current treatment with Rebif® (22 or 44) s.c. TIW or Avonex® i.m. once per week for at least 12 months
3.At least one relapse in the last 12 months
4.Two consecutive positive NAb titers of =20NU at least 4 weeks apart
5.Age over 18 years and less than 65 years
6.EDSS not to exceed 6.5
7.Women of childbearing potential must agree to practice adequate contraception
8.Must give written informed consent and authorize the release and use of protected health information
9.Able and willing to undergo blood sampling at regular intervals as defined by the protocol
10.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

1.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
2.History of WHO grade 3 or 4 liver toxicity with IFNß-1a
3.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-1 to the patient
4.Presence of chronic or recurrent infection or human immunodeficiency virus
5.Exposure to any other investigational drug within 30 days of enrollment in the study
6.History of malignancy unless an exception is granted by the Chief Investigator
7.History of drug or alcohol abuse within 6 months prior to enrollment into the study
8.Pregnancy or breast feeding

Study & Design

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