Multiple Sclerosis MedDRA version: 9.1 Level: LLT Classification code 10028245 Term: Multiple sclerosis
Conditions
Interventions
Trade Name: Mitoxantrone
Product Name: Mitoxantrone
Product Code: PL 04515/0127
Pharmaceutical Form: Concentrate for solution for infusion
Trade Name: Rebif®
Pharmaceutical Form: Solution for injecti
Sponsors
Queen Mary, University of London
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 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
Exclusion criteria: 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Perform a “proof-of-concept” phase IIa clinical trial to induce tolerance to IFNß in subjects with NAbs to IFNß-1a. ;Secondary Objective: Assess the safety and study the immunological mechanisms underlying the high dose intravenous induction of tolerance to IFNß. ;Primary end point(s): Proof of concept study to assess the safety and immunological effects of high dose intravenous IFNß-1a human serum albumin-free formulation (Rebif® New Formulation or RNF) after a transient, peripheral leukocyte depletion with Mitoxantrone with the objective to tolerize patients with NAbs to IFNß. | — |
Countries
United Kingdom
Outcome results
None listed