Transition to Rebif New Formulation
A Randomized, Multicenter, Two-arm, Open-label, Phase IIIb Study to Evaluate the Satisfaction in Relapsing Multiple Sclerosis Subjects Transitioning to Rebif® New Formulation From Rebif® (Interferon Beta-1a) With Ibuprofen When Necessary (PRN) or as Prophylaxis
What it found
Results are posted in the registry, but without a statistical test of the main measure. See the numbers below.
What was tested
Treatment tested
- Rebif New Formulation + prophylactic Ibuprofen
- Rebif New Formulation + ibuprofen PRN
Results by group
Multiple Sclerosis Treatment Concern Questionnaire (MSTCQ) Flu-like Symptom Score
4 weeks
| Group | Value | Interval | Number analysed |
|---|---|---|---|
| Transition With Prophylactic Ibuprofen | 8.5 MSTCQ score (units on a scale) | 7.4–9.6 | 56 |
| Transition With PRN Ibuprofen | 9.1 MSTCQ score (units on a scale) | 8.1–10.2 | 54 |
Transition With Prophylactic Ibuprofen
Transition With PRN Ibuprofen
Values as posted on ClinicalTrials.gov. Outcomes measured differently across trials are not directly comparable.
Safety
| Group | Participants at risk | Serious adverse events | Deaths |
|---|---|---|---|
| Transition With Prophylactic Ibuprofen | 59 | 1 (1.7%) | |
| Transition With PRN Ibuprofen | 57 | 0 (0.0%) |
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
Multiple Sclerosis Treatment Concern Questionnaire (MSTCQ) Flu-like Symptom Score
4 weeks
Safety
Other measures (4)
Multiple Sclerosis Treatment Concern Questionnaire (MSTCQ) Total Score
4 weeks
SafetyMultiple Sclerosis Treatment Concern Questionnaire (MSTCQ) Injection Satisfaction Score
4 weeks
Quality of life (reported by participants)Multiple Sclerosis Treatment Concern Questionnaire (MSTCQ) Injection Site Reaction Score
4 weeks
SafetyMultiple Sclerosis Treatment Concern Questionnaire (MSTCQ) Global Side Effects Score
4 weeks
Safety
Who could take part
Relapsing MS · 18 to 60
Show the full criteria
Inclusion criteria
* Subject with relapsing forms of Multiple Sclerosis (MS) * Expanded disability status scale (EDSS) score \< 5.5 at study entry * Subjects who have been administering Rebif 44 mcg three times a week for at least 6 months prior to study enrolment * Subject currently using Rebiject II and who will use their own Rebiject II for the Rebif New Formulation injections * Subject is between 18 and 60 years old inclusive * Female subjects must be neither pregnant nor breast-feeding and must lack childbearing potential, as defined by either: post-menopausal or surgically sterile, or use a highly effective method of contraception. * Subject is willing to follow study procedures * Subject is willing and must not present any contra-indication to taking ibuprofen during 4 weeks of the study * Subject has given written informed consent
Exclusion criteria
* Secondary Progressive Multiple Sclerosis without superimposed attacks * Use of any other injectible medications during the week prior to the screening period, during the screening or treatment periods * Subject receiving MS therapy in addition (i.e. combination therapy) to Rebif within 3 months prior to study enrolment or at any time during study protocol * History of any chronic pain syndrome * Subjects that use any investigational drug or experimental procedure within 12 weeks of visit * Subject received corticosteroids or adrenocorticotrophic hormone (ACTH) within 30 days of visit 1 * Subject with flu-like symptoms (FLS) associated with any cause (i.e. no current flu and no FLS related to Interferon in the week prior to baseline) * Subject has abnormal liver function, defined by a total bilirubin > 1.5 times the upper limit of normal, aspartate aminotransferase (AST) or alanine aminotransferase (ALT) > 2.5 times the upper limit of the normal values. * Subject has inadequate bone marrow reserve, defined as a total white blood cell count \< 3.0 x 109/L, platelet count \< 75 x 109/L, haemoglobin \< 100 g/L. * Subject suffers from an active autoimmune disease other than MS * Subject suffers from major medical or psychiatric illness * Subject has seizures history or is currently experiencing seizures not adequately controlled by anti-epileptics * Subject is pregnant or attempting to conceive * Visual or physical impairment that precludes completion of diaries and questionnaires by himself/herself * Contraindication to ibuprofen:known hypersensitivity to the active ingredient ibuprofen * Known hypersensitivity to non-steroidal anti-inflammatory drugs which can lead to asthmatic attacks, gastric and/or intestinal ulcers, gastro-intestinal bleeding, cerebro-vascular bleeding or other active bleeding, severe hepatic dysfunction, severe kidney dysfunction, severe cardiac insufficiency, or systemic lupus erythematosus
As registered. Criteria can change, so ask the trial team or your neurologist.
About this trial
In the sponsor's words
To assess patient satisfaction with respect to the incidence of flu-like symptoms (FLS) in patients with multiple sclerosis transitioned from current Rebif (subcutaneously injected interferon beta-1a, 44 mcg three-times-weekly) to the new formulation of Rebif (RNF) while receiving ibuprofen either prophylactically or only when necessary (PRN) after the occurence of flu-like symptoms.
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History
Started
Jul 2007
Main results due
Apr 2008
Finished
Apr 2008
Results posted
Jul 2010