Phase 3
N=232
Rebif New Formulation (RNF) Quality of Life (QOL) Study
Relapsing Multiple Sclerosis
Bottom Line
View on ClinicalTrials.gov: NCT00472797 ↗Enrolled (actual)
232
Serious AEs
6.9%
Results posted
Sep 2009
Primary outcome: Primary: Percent Change in Global Side Effects (GSE) on Multiple Sclerosis Treatment Concerns Quesionnaire (MSTCQ) — 5.0 percent change — p=<0.001
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Rebif New Formulation Non Titrated (Drug); Rebif New Formulation Titrated (Drug)
- Age
- Adult · 18+ yrs
- Sex
- All
- Sponsor
- EMD Serono
- Primary completion
- Feb 2009
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percent Change in Global Side Effects (GSE) on Multiple Sclerosis Treatment Concerns Quesionnaire (MSTCQ) |
5.0 | <0.001 sig |
| SECONDARY Total Score for Global Side Effects on Multiple Sclerosis Treatment Concerns Questionnaire (MSTCQ) |
13.4; 13.4; 13.4; 14.0; 13.8; 13.9 | 0.466 |
| SECONDARY Change in Score From Baseline to Week 12 for All Domains Other Than Global Side Effects on Multiple Sclerosis Treatment Concerns Questionnaire (MSTCQ) |
-3.2; -2.9; -3.1; -3.3; -2.3; -2.8 | <0.001 sig |
| SECONDARY Total Score on Short-Form McGill Pain Questionnaire (SF-MPQ): Change in Baseline to Wk 12 |
0.7; 1.1; 0.9 | 0.302 |
| SECONDARY Tolerability in Pain Using Visual Analog Scale (VAS) |
51; 48; 101; 53; 48; 101 | — |
| SECONDARY Tolerability - Redness at Injection Site |
-2.3; -3.1; -2.7 | 0.899 |
Summary
To evaluate the impact on Quality of Life (QOL), tolerability, treatment satisfaction, and injection site redness Rebif treated subjects with relapsing forms of MS who transition to a new formulation of Rebif (RNF).
Eligibility Criteria
Inclusion Criteria
- Subject with a relapsing form of MS; diagnosis of MS is in accordance with the McDonald criteria
- Subject currently taking Rebif 44mcg tiw, and has been on this treatment for at least 6 months (24 weeks) prior to study enrollment
- Subject currently using Rebiject II and 29 gauge needle
- Subject is between 18 and 60 years old inclusive
- Subject is able to read and understand English
- Subject is willing to follow study procedures
- Subject has given written informed consent and signed HIPAA
- Female subjects must not be either pregnant or breast-feeding and must lack childbearing potential, as defined by either: i) Being post-menopausal or surgically sterile, or ii) Using a hormonal contraceptive, intra-uterine device, diaphragm with spermicide, or condom with spermicide, for the duration of the study. (Confirmation required within 30 days prior to start of the study)
Exclusion Criteria
- Use of any other injectable medications on a regular basis during the week prior to the screening period or during the screening or treatment periods. Receiving a single injection for treatment or prophylaxis of a condition unrelated to the subject's multiple sclerosis or the subject's Rebif® therapy (e.g., receiving a influenza or pneumococcus vaccination) is acceptable
- Subject receiving MS therapy in addition (i.e., combination therapy) to Rebif® within 3 months prior to study enrollment or at any time during study protocol.
- Subjects who have previously been on Rebif New Formulation (RNF).
- Subject with progressive forms of Multiple Sclerosis (MS).
- Subject with history of any chronic pain syndrome.
- Subject has any other disease apart from MS that could better explain the subjects signs and symptoms.
- Subject has complete transverse myelitis or bilateral optic neuritis.
- Subjects that use any investigational drug or experimental procedure within 12 weeks of visit 1.
- Subject received oral or systemic corticosteroids or ACTH within 30 days of visit 1 (prior to enrollment).
- 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.
- Subject has inadequate bone marrow reserve, defined as a white blood cell count less than 0.5 x lower limit of normal.
- Subject suffers from other current autoimmune disease.
- 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
- Subject is pregnant or attempting to conceive
- Visual or physical impairment that precludes completion of diaries and questionnaires.
Data sourced from ClinicalTrials.gov (NCT00472797). 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.