Phase 3
Completed N=260
Rebif New Formulation (RNF) in Relapsing Forms of Multiple Sclerosis
Source: ClinicalTrials.gov NCT00110396 ↗Enrolled (actual)
260
Serious AEs
5.8%
Results posted
Jul 2010
Primary outcomePrimary: Number of Participants Who Were Neutralising Antibody (NAb) Positive at the Week 96 Visit. — 45 participants
Summary
The primary objective of the study is to compare the immunogenicity of the new fetal bovine serum (FBS)-free/human serum albumin (HSA)-free Rebif® formulation (RNF) to historical data.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants Who Were Neutralising Antibody (NAb) Positive at the Week 96 Visit. |
45 | — |
| SECONDARY Number of Participants Who Were Neutralising Antibody (NAb) Positive at Anytime During the Study |
49 | — |
| SECONDARY Number of Participants With Binding Antibodies (BAb) at Week 96 |
74 | — |
Eligibility Criteria
Inclusion Criteria
- Participant has a relapsing form of Multiple Sclerosis (MS); diagnosis of MS is in accordance with the McDonald criteria
- Participant is eligible for interferon therapy
- Participant is between 18 and 60 years old
- Participant has an Expanded Disability Status Scale (EDSS) 2.5 times the upper limit of the normal values.
- Participant has inadequate bone marrow reserve, defined as a white blood cell count less than 0.5 x lower limit of normal.
- Participant suffers from current autoimmune disease.
- Participant 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.
- Participant has a known allergy to IFN or the excipients.
Data sourced from ClinicalTrials.gov (NCT00110396). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.