A multicentre, single arm, open-label, phase IIIb study to evaluate the safety and antigenicity of Rebif® (IFN-beta-1a) in subjects with relapsing forms of multiple sclerosis. - Rebif® New Formulation in RMS

• Conditions: Relapsing form of MS; diagnosis of MS is in accordance with the McDonald criteria; MedDRA version: 7.0Level: PTClassification code 10028245

• Registration Number: EUCTR2004-003799-13-SE
• Lead Sponsor: Serono International SA

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2004-12-23
• Last Update Posted: 1 May 2012

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 230

Inclusion Criteria

1. Subject has a relapsing form of MS; diagnosis of MS is in accordance with the McDonald criteria (31).
2. Subject is eligible for interferon therapy.
3. Subject is between 18 and 60 years old.
4. Subject has an EDSS <6.0.
5. Subject is willing to follow study procedures.
6. Subject has given written informed consent.
7. Female subjects must be neither pregnant nor breast-feeding, and must lack childbearing potential, as defined by either:
· Being post-menopausal or surgically sterile, or
· Using a hormonal contraceptive, intra-uterine device, diaphragm with spermicide or condom with spermicide for the duration of the study.
Confirmation that the subject is not pregnant must be established by a negative serum or urinary hCG test within 7 days prior to start of study treatment. A pregnancy test is not required if the subject is post-menopausal or surgically sterile.
Are the trial subjects under 18?
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)
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

1. Subject has a Clinically Isolated Syndrome (CIS), Primary Progressive MS, or Secondary Progressive MS without superimposed relapses.
2. Subject had any prior interferon beta therapy (either beta-1b or beta-1a)
3. Subject has an ongoing MS relapse.
4. Subject received any other approved disease modifying therapy for MS (e.g. glatiramer acetate) or any cytokine or anti-cytokine therapy within the 3 months prior to SD1.
5. Subject had prior use of cladribine or has previously received total lymphoid irradiation.
6. Subject received oral or systemic corticosteroids or ACTH within 30 days of SD1.
7. Subject received intravenous immunoglobulins or underwent plasmapheresis within the 6 months prior to SD1.
8. Subject received immunomodulatory or immunosuppressive therapy (including but not limited to cyclophosphamide, cyclosporin, methotrexate, azathioprine, linomide, mitoxantrone, teriflunomide, natalizumab, laquinimod, Campath) within the 12 months prior to SD1.
9. Subject requires chronic or monthly pulse corticosteroids during the study.
10. Subject received any investigational drug or experimental procedure within 12 weeks of SD1.
11. Subject has inadequate liver function, defined by a total bilirubin, aspartate aminotransferase (AST) or alanine aminotransferase (ALT) or alkaline phosphatase > 2.5 times the upper limit of the normal values
12. Subject has inadequate bone marrow reserve, defined as a white blood cell count less than 0.5 x lower limit of normal.
13. Subject suffers from current autoimmune disease.
14. Subject suffers from major medical or psychiatric illness that in the opinion of the investigator creates undue risk to the subject or could affect compliance with the study protocol.
15. Subject has a known allergy to IFN or the excipient(s).

Study & Design

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

Primary Outcome Measures

Name	Time	Method
Main Objective: The primary objective of the study is to compare the antigenicity of the new FBS-free/HSA-free Rebif® formulation (RNF) to historical data;Secondary Objective: - To examine the time course of NAb development in subjects with relapsing forms of MS newly exposed to RNF.<br>- To determine if pre-existing factors affect NAb development through collection of baseline subject demographic data and disease characteristics.<br>- To determine the overall safety of RNF compared to the known safety profile of the current formulation of Rebif.<br>- To describe changes in PD markers.<br>- To assess the clinical status of subjects throughout the study by assessing EDSS and collecting documentation on relapses.;Primary end point(s): The primary endpoint is the proportion of subjects that are NAb positive at the Week 96 visit.