Rebif New Formulation (RNF) Quality of Life (QOL) Study
A Randomized, Multicenter, Two-arm, 12 Week Phase IIIb Study to Evaluate Quality of Life (QOL) Measures in Subjects With Relapsing Forms of Multiple Sclerosis (MS) Who Are Transitioning From Rebif® (Interferon Beta-1a) to Rebif New Formulation (RNF)
What it found
The main measure showed a statistically significant benefit.
| Measure | Estimate | 95% CI | p |
|---|---|---|---|
| Percent Change in Global Side Effects (GSE) on Multiple Sclerosis Treatment Concerns Quesionnaire (MSTCQ) | mean 2.73 | 2.73–2.73 | <0.001 |
Statistical analysis as posted on ClinicalTrials.gov.
What was tested
Treatment tested
- Rebif New Formulation Non Titrated
- Rebif New Formulation Titrated
Results by group
Percent Change in Global Side Effects (GSE) on Multiple Sclerosis Treatment Concerns Quesionnaire (MSTCQ)
% change from Baseline to Week 12
| Group | Value | Interval | Number analysed |
|---|---|---|---|
| All New Formulation of Rebif Subjects | 5.0 percent change | 17.7 (Standard Deviation) | 230 |
p = <0.001; mean 2.73 (95% CI 2.73–2.73)
Values as posted on ClinicalTrials.gov. Outcomes measured differently across trials are not directly comparable.
Safety
| Group | Participants at risk | Serious adverse events | Deaths |
|---|---|---|---|
| Non-Titrated | 118 | 10 (8.5%) | |
| Titrated | 113 | 6 (5.3%) | |
| All New Formulation of Rebif Subjects | 231 | 16 (6.9%) |
As posted on ClinicalTrials.gov. Serious adverse events include any serious health event during the trial, whether or not the treatment caused it.
What it measured
Main measures
Percent Change in Global Side Effects (GSE) on Multiple Sclerosis Treatment Concerns Quesionnaire (MSTCQ)
% change from Baseline to Week 12
Quality of life (reported by participants)Safety
Other measures (5)
Total Score for Global Side Effects on Multiple Sclerosis Treatment Concerns Questionnaire (MSTCQ)
Baseline and Week 12
Quality of life (reported by participants)SafetyChange in Score From Baseline to Week 12 for All Domains Other Than Global Side Effects on Multiple Sclerosis Treatment Concerns Questionnaire (MSTCQ)
Baseline to Week 12
Quality of life (reported by participants)SafetyTotal Score on Short-Form McGill Pain Questionnaire (SF-MPQ): Change in Baseline to Wk 12
Baseline to Week 12
PainSafetyTolerability in Pain Using Visual Analog Scale (VAS)
Baseline to Week 12
PainSafetyTolerability - Redness at Injection Site
Baseline to Week 12 (LOCF)
Safety
Who could take part
Relapsing MS · 18 to 60
Show the full criteria
Inclusion criteria
1. Subject with a relapsing form of MS; diagnosis of MS is in accordance with the McDonald criteria 2. Subject currently taking Rebif 44mcg tiw, and has been on this treatment for at least 6 months (24 weeks) prior to study enrollment 3. Subject currently using Rebiject II and 29 gauge needle 4. Subject is between 18 and 60 years old inclusive 5. Subject is able to read and understand English 6. Subject is willing to follow study procedures 7. Subject has given written informed consent and signed HIPAA 8. 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
1. 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 2. 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. 3. Subjects who have previously been on Rebif New Formulation (RNF). 4. Subject with progressive forms of Multiple Sclerosis (MS). 5. Subject with history of any chronic pain syndrome. 6. Subject has any other disease apart from MS that could better explain the subjects signs and symptoms. 7. Subject has complete transverse myelitis or bilateral optic neuritis. 8. Subjects that use any investigational drug or experimental procedure within 12 weeks of visit 1. 9. Subject received oral or systemic corticosteroids or ACTH within 30 days of visit 1 (prior to enrollment). 10. 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. 11. Subject has inadequate bone marrow reserve, defined as a white blood cell count less than 0.5 x lower limit of normal. 12. Subject suffers from other current autoimmune disease. 13. 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 14. Subject is pregnant or attempting to conceive 15. Visual or physical impairment that precludes completion of diaries and questionnaires.
As registered. Criteria can change, so ask the trial team or your neurologist.
About this trial
In the sponsor's words
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).
Loading reviews and guidelines…
History
Started
Apr 2007
Main results due
Feb 2009
Finished
Nov 2009
Results posted
Sept 2009